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Document 52013XC1025(08)

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

OJ C 311, 25.10.2013, p. 8–221 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

25.10.2013   

EN

Official Journal of the European Union

C 311/8


Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC  (1) or Article 38 of Directive 2001/82/EC  (2) )

2013/C 311/02

—   Issuing, maintenance or modification of a national marketing authorization

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

5.9.2013

Okrido

See Annex I

See Annex I

6.9.2013

24.9.2013

Deltanil

See Annex II

See Annex II

26.9.2013

13.9.2013

Iron

See Annex III

See Annex III

16.9.2013

18.9.2013

Aprotinin

See Annex IV

See Annex IV

19.9.2013

25.9.2013

Cydectin

See Annex V

See Annex V

26.9.2013

12.9.2013

Targocid

See Annex VI

See Annex VI

13.9.2013

5.9.2013

Flupirtine

See Annex VII

See Annex VII

6.9.2013

6.9.2013

Doramectin

See Annex VIII

See Annex VIII

9.9.2013

25.9.2013

Diclofenac

See Annex IX

See Annex IX

26.9.2013

27.9.2013

Ergot derivatives (dihydroergocristine)

See Annex X

See Annex X

30.9.2013

27.9.2013

Ergot derivatives (dihydroergocryptine)

See Annex XI

See Annex XI

30.9.2013

27.9.2013

Ergot derivatives (nicergoline)

See Annex XII

See Annex XII

30.9.2013

27.9.2013

Ergot derivatives (dihydroergotamine)

See Annex XIII

See Annex XIII

30.9.2013


—   Suspension of a national marketing authorization

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

27.9.2013

Ergot derivatives (dihydroergocristine)

See Annex X

See Annex X

30.9.2013

27.9.2013

Ergot derivatives (dihydroergocryptine)

See Annex XI

See Annex XI

30.9.2013

27.9.2013

Ergot derivatives (nicergoline)

See Annex XII

See Annex XII

30.9.2013

27.9.2013

Ergot derivatives (dihydroergotamine)

See Annex XIII

See Annex XIII

30.9.2013


—   Lift of suspension of a national marketing authorization

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

18.9.2013

Aprotinin

See Annex IV

See Annex IV

19.9.2013


(1)  OJ L 311, 28.11.01, p. 67.

(2)  OJ L 311, 28.11.01, p. 1.


ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT/ MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

Member State

EU/EEA

Marketing authorisation holder

Applicant

Invented name / Name

Strength

Pharmaceutical form

Route of administration

Content (concentration)

Germany

 

Pharmapol Arzneimittelvertrieb-GmbH,

Kaddenbusch 11, 25578 Daegeling,

Germany

Okrido

6 mg/ml

Oral Solution

Oral use

 

Netherlands

 

Pharmapol Arzneimittelvertrieb-GmbH,

Kaddenbusch 11, 25578 Daegeling,

Germany

Okrido

6 mg/ml

Oral Solution

Oral use

 

United Kingdom

Pharmapol Arzneimittelvertrieb-GmbH,

Kaddenbusch 11, 25578 Daegeling,

Germany

 

Okrido

6 mg/ml

Oral Solution

Oral use

 


ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

Member State EU/EEA

Applicant

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Pour- on Lösung zum Übergießen für Rinder und Schafe

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Belgium

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Solution pour-on pour bovins et ovins

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Belgium

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 100 mg Solution spot-on pour bovins

Deltamethrin

10 mg/ml

Spot-on solution

Cattle

Topical use

Bulgaria

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Делтанил 10 мг/мл пур он разтвор, предназначен за говеда и овце.

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Cyprus

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Διάλυμα για επίχυση για βοοειδή και πρόβατα

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Czech Republic

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml pour-on roztok pro aplikaci na kůži skotu a ovcí

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Denmark

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Pour- on opløsning til kvæg og får

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Estonia

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil, 10 mg/ml, kriipsususpensioon veistele ja lammastele

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

France

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Solution pour-on pour bovins et ovins

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

France

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 100 mg Solution spot-on pour bovins

Deltamethrin

10 mg/ml

Spot-on solution

Cattle

Topical use

Germany

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Pour- on Lösung zum Übergießen für Rinder und Schafe

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Germany

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 100 mg Spot- on Lösung zum Auftropfen für Rinder

Deltamethrin

10 mg/ml

Spot-on solution

Cattle

Topical use

Greece

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Διάλυμα για επίχυση για βοοειδή και πρόβατα

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Hungary

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Pour- on szarvasmarha és juh részére

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Iceland

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml áhella, lausn fyrir nautgripi og sauöfé

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Ireland

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Pour- on Solution for cattle and sheep

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Italy

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml soluzione Pour-on per bovini ed ovini

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Latvia

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil, 10 mg/ml, šķīdums uzliešanai uz muguras liellopiem un aitām

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Lithuania

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil, 10 mg/ml, užpilamasis tirpalas galvijams ir avims

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Luxembourg

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Solution pour-on pour bovins et ovins

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

The Netherlands

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Pour- on Oplossing voor runderen en schapen

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

The Netherlands

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 100 mg Spot- on Oplossing voor runderen

Deltamethrin

10 mg/ml

Spot-on solution

Cattle

Topical use

Poland

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10mg/ml, roztwór do polewania dla bydła i owiec

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Portugal

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml solução Spot- on para bovinos e ovinos

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Romania

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml soluție pour-on pentru bovine și ovine

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Slovakia

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

DELTANIL 10 mg/ml Pour-on roztok pre hovädzí dobytok a ovce

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Slovenia

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml raztopina za kožni poliv za govedo in ovce

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

Spain

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml solución pour-on para bovino y ovino

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

United Kingdom

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 10 mg/ml Pour- on Solution for cattle and sheep

Deltamethrin

10 mg/ml

Pour-on solution

Cattle and sheep

Topical use

United Kingdom

Virbac

1'ere Avenue, 2065m - LID

06516 Carros CEDEX FRANCE

Deltanil 100 mg Spot- on Solution for cattle

Deltamethrin

10 mg/ml

Spot-on solution

Cattle

Topical use


ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State

(in EEA)

Marketing authorisation holder

INN

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

CosmoFer 50 mg/ml Injektionslösung und Infusionslösung

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Austria

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject 50 mg Eisen/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

50 mg/ml

Solution for injection/infusion

Intravenous use

Austria

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

FerMed 100 mg/5 ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Austria

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Austria

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer 100 mg/ml Injektions- oder Infusionslösung

100 mg/ml

Solution for injection/infusion

Intravenous use

Austria

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer 20 mg/ml - Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Belgium

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

Belgium

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monover

100 mg/ml

Solution for injection/infusion

Intravenous use

Belgium

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Belgium

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric Carboxymaltose

Injectafer

50 mg/ml

Solution for injection/infusion

Intravenous use

Bulgaria

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Bulgaria

Pharmalog AG,

33 Cherni vrah blvd.,

1421 Sofia

Bulgaria

Iron sucrose complex

Idafer

20 mg/ml

Solution for injection

Intravenous use

Bulgaria

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection

Intravenous use

Bulgaria

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

Cyprus

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML

50 mg/ml

Solution for injection/infusion

Intravenous use

Cyprus

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MONOFER SOLUTION FOR INJECTION OR INFUSION 100 MG/ML

100 mg/ml

Solution for injection/infusion

Intravenous use

Cyprus

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

COSMOFER SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML

50 mg/ml

Solution for injection/infusion

Intravenous use

Cyprus

The Star Medicines Importers & co ltd,

9A Loukis Akritas Street,

P.O.box 50151,

3601 Lemesos,

Cyprus

Iron sucrose complex

VENOFER INJECTION 100 MG IRON/5 ML

100 mg/5 ml

Solution for injection

Intravenous use

Cyprus

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FERROLOGIC SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20 MG/ML

20 mg/ml

Solution for injection/infusion

Intravenous use

Czech Republic

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER

20 mg/ml

Solution for injection

Intravenous use

Czech Republic

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FERROLOGIC 20 MG/ML

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Czech Republic

PHARMABIDE LTD

20, Lakonias str, 15234 Halandri

Athens -

Greece

Iron sucrose complex

IRON SUCROSE PHARMABIDE 20 MG/ML

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Czech Republic

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

FERION 20 MG/ML

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Czech Republic

Sanofi-Aventis, s.r.o.

Evropská 846/176a

160 00 Praha 6

Czech Republic

sodium ferric gluconate complex

FERRLECIT

12,5 mg/ml

Solution for injection

Intravenous use

Czech Republic

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT

50 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Denmark

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Denmark

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Jerndextran "Pharmacosmos"

50 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MonoFer

100 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Estonia

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Estonia

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Estonia

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Estonia

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Estonia

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

Estonia

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

Iron (III)-hydroxide dextran complex

Ferrum Lek

50 mg/ml

Solution for injection

Intramuscular use

Finland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Finland

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Finland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Finland

Alternova A/S

Lodshusvej 11

4230 Skaelskoer

Denmark

Iron sucrose complex

Venotrix

20 mg/ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Finland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

Finland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

France

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric Carboxymaltose

FERINJECT 50 mg/ml, solution injectable/pour perfusion

50 mg/ml

Solution for injection/infusion

Intravenous use

France

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER 20 mg/ml, solution injectable

20 mg/ml

Solution for injection

Intravenous use

France

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

FERRISAT 50 mg/ml, solution injectable ou pour perfusion

50 mg/ml

Solution for injection/infusion

Intravenous use

France

Pharmaki Generics Ltd

5 Bourlet Close

W1W 7BL London

United Kingdom

Iron sucrose complex

FER ACTAVIS 100 mg/5 ml, solution injectable

100 mg/5 ml

Solution for injection

Intravenous use

France

IBD3 Pharma Consulting

Immeuble l'Orient

10, place Charles Béraudier

69003 Lyon

France

Iron sucrose complex

FER IBD3 PHARMA CONSULTING 100 mg/5 ml, solution à diluer pour perfusion

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

France

Mylan SAS

117, allée des Parcs

69800 Saint-Priest

France

Iron sucrose complex

FER MYLAN 100 mg/5 ml, solution à diluer pour perfusion

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

Iron sucrose complex

FER SANDOZ 100 mg/5 ml, solution à diluer pour perfusion

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

FRANCE

Iron sucrose complex

FER TEVA PHARMA 100 mg/5 ml, solution injectable (IV)

100 mg/5 ml

Solution for injection

Intravenous use

Germany

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml Injektionslösung/ Konzentrat zur Herstellung einer Infusionslösung

1 709 mg/5 ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Germany

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

FerMed

1 563 - 1 887 mg/5 ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Germany

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

Nefro-Fer

1 563 - 1 887 mg/5 ml

Solution for injection

Intravenous use

Germany

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer 100 mg/ml Lösung zur Injektion/Infusion

377-465 mg/ml

Solution for injection/infusion

Intravenous use

Germany

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50,

D-65926 Frankfurt am Main

Germany

sodium ferric gluconate complex

Ferrlecit 40 mg

1 288,9 mg/3.2 ml

Solution for injection

Intravenous use

Germany

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50,

D-65926 Frankfurt am Main

Germany

sodium ferric gluconate complex

Ferrlecit 62,5 mg

2 013,9 mg/5 ml

Solution for injection

Intravenous use

Germany

Pharmacosmos A/S

Roervangsvei 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

CosmoFer 50 mg/ml Injektionslösong und Infusionslösung

312,5 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Germany

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose complex

FERINJECT 50 mg Eisen/ml Injektions- und Infusionslösung

180 mg/ml

Solution for injection/infusion

Intravenous use

Germany

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer 20 mg FR / ml Injektionslösung

2 700 mg/5ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Greece

Medicus SA

Valaoritou 10

Metamorfosi

Attikis 14452

Greece

Iron sucrose complex

REOXYL

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Vianex S.A.

Tatoiou Street

Nea Erythrea 14671

Greece

Iron sucrose complex

INTRAFER

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Alapis ABEE

Aftokratoros Nikolaou 2

Athens 17671

Greece

Iron sucrose complex

FAREMIO

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Intermed ABEE

Kalyftaki 27

Athens 14564

Greece

Iron sucrose complex

DEXTRIFER-S

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Demo ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

Iron (III) hydroxide dextran

COSMOFER

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Greece

Rafarm AEBE

Korinthou 12,

N. Psychiko, 15451

Greece

Iron sucrose complex

FERROVIN

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Nephrotech S.A.

Parnithos 44

Metamorfosi Attikis 14452

Greece

Iron sucrose complex

SUCRO-FER

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Uni-Pharma Kleon Tseitis

Pharmaceutical Laboratories

14KM National Highway

Athens-Lamia

Kifissia 14564

Greece

Iron sucrose complex

HEMAFER-S

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

Greece

Verisfield (UK) Ltd, U.K.

41 Chalton street

London, NW1 1JD

United Kingdom

Iron sucrose complex

NEPHROFEROL

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Iron sucrose complex

FERRINEMIA

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Specifar AEBE

28th October Street 1

Agia Barbara 12351

Greece

Iron sucrose complex

ALVOFER

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

Greece

Alet Pharmaceuticals

M. Alexander 121,

Agia Varvara, 12351

Greece

Iron sucrose complex

SUCROVEN

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

Greece

Target Pharma Ltd

Menandrou 54

Athens 10431

Greece

Iron sucrose complex

IRONCROSE

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Iron(III)-hydroxide dextran complex

IRONATE

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Greece

Demo ABEE

21st km National Highway

Athens-Lamia, 14565

Greece

Iron(III) isomaltoside complex

MONOFER

100 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Greece

Viofar EPE

Ethnikis Antistaseos & Trifyllias,

Aharnai, 13671

Greece

Iron sucrose complex

VENIRON

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

Greece

Medicus SA

Valaoritou 10

Metamorfosi

Attikis 14452

Greece

Iron(III)-hydroxide dextran complex

IRON (III)-HYDROXIDE DEXTRAN COMPLEX/BIOMEDIC LABORATORIES

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Hungary

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Hungary

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection/infusion

Intravenous use

Hungary

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection/infusion

Intravenous use

Hungary

Sanofi-Aventis Zrt

Tó utca 1-5,

1045 Budapest

Hungary

Sodium ferric gluconate complex

Ferrlecit

12,5 mg/ml

Solution for injection

Intravenous use

Iceland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Iceland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for infusion

Intravenous use

Iceland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Intravenous use

Ireland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

CosmoFer 50 mg/ml solution for infusion and injection

50 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monover 100 mg/ml solution for injection/infusion (ampoules)

100 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monover 100 mg/ml solution for injection/infusion (vials)

100 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, ampoule

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Ireland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT 50 mg iron/ml solution for injection/infusion

50 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex)

Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, vial

20 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FerroLogic 20 mg/ml solution for injection/concentrate for solution for infusion

20 mg/ml

Solution for injection

Intravenous use

Italy

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT

50 mg/ml

Solution for injection/infusion

Intravenous use

Italy

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FERRO SACCARATO FME

20 mg/ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Italy

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER

20 mg/ml

Solution for injection

Intravenous use

Italy

Sanofi-Aventis SPA

Viale Luigi Bodio, 37/B

20158 Milano

Italy

sodium ferric gluconate complex

FERLIXIT

62,5 mg/5 ml

Oral solution or solution for infusion

Oral use

Intravenous use

Latvia

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Latvia

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Intravenous use

Latvia

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FerroLogic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Latvia

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

CosmoFer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Latvia

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

Lithuania

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Lithuania

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Intravenous use

Lithuania

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Lithuania

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

Lithuania

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Ferric (III) hydroxide dextran complex

CosmoFer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Luxembourg

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Injectafer-50 mg/l

50 mg/ml

Solution for injection

Intravenous use

Luxembourg

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer-50 mg/ml

50 mg/ml

Solution for injection

Intravenous use

Luxembourg

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

Fermed-100 mg/5 ml

100 mg/5 ml

Solution for perfusion

Intravenous use

Luxembourg

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic-20 mg/ml

20 mg/ml

Solution for perfusion

Intravenous use

Malta

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT 50 mg iron/ml solution for injection/infusion

50 mg/ml

Solution for injection/infusion

Intravenous use

Malta

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex.

Ferrologic 20 mg/ml solution for injection/concentrate for solution for infusion

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Norway

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Parenteral use

Norway

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Parenteral use

Norway

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Parenteral use

Norway

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Parenteral use

Norway

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Parenteral use

Norway

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Uniferon

200 mg/ml

Solution for injection

Parenteral use

Norway

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Parenteral use

Poland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

CosmoFer

50 mg/ml

Solution for injection/infusion

Intravenous use

Poland

VIFOR France SA

123 Rue Jules Guesde

92200 Neuilly-sur-Seine

France

ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection

Intravenous use

Poland

VIFOR France SA

123 Rue Jules Guesde

92200 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection/infusion

Intravenous use

Poland

Fresenius Medical Care Nephrologica Deutschland GmbH

61346 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Poland

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

Iron(III) isomaltoside complex

Ferrum-Lek

50 mg/ml

Solution for injection

Intramuscular use

Poland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monover

100 mg/ml

Solution for injection/infusion

Intravenous use

Portugal

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Referen

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Vifor France, SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Combino Pharm Portugal, Unipessoal, Lda.

Lagoas Park

Edifício 8

Piso 0 2740-268 Porto Salvo

Portugal

Iron sucrose complex

Óxido Férrico Sacarosado Combino

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Farmoz - Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2,

Abrunheira

2710-089 Sintra

Portugal

Iron sucrose complex

Óxido Férrico Sacarosado Farmoz

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Iron sucrose complex

Óxido Férrico Sacarosado Generis

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Laboratórios Normon, S.A.

Rua Armando Villar,

Lote 42 1o Dto. Quinta das Patinhas, Cobre

2750 - 777 Cascais

Portugal

Iron sucrose complex

Óxido Férrico Sacarosado Normon

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Vifor France, SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Portugal

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Portugal

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Monofar

100 mg/ml

Solution for injection/infusion

Intravenous use

Romania

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER®

20 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Romania

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MONOFER 100 mg/ml

100 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Romania

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

FERINJECT 50 mg fer/ml

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Slovak Republic

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Slovak Republic

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion 20 mg/ml

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Slovak Republic

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Slovak Republic

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Intravenous use

Slovenia

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml raztopina za injiciranje/ koncentrat za raztopino za infundiranje

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Slovenia

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

carboxymaltose

Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje

50 mg/ml

Solution for injection/infusion

Intravenous use

Slovenia

Lek farmacevtska družba d.d.,

Verovškova 57,

1000 Ljubljana

Slovenia

Iron sucrose complex

Venofer 20 mg/ml raztopina za injiciranje/ koncentrat za raztopino za infundiranje

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

COSMOFER 50 mg/ml SOLUCION PARA PERFUSION E INYECCION

50 mg/ml

Solution for injection

Solution for infusion

Intravenous use

intramuscular use

Spain

GUERBET B.P.

57400 ROISSY CdG

CEDEX F-95943

France

Iron sucrose complex

ENDOREM 11,2 mg FE/ml CONCENTRADO PARA SUSPENSION PARA PERFUSION

11,2 mg/ml

Concentrate for suspension for infusion

Intravenous use

Spain

G.E.S. Genericos Espanoles Laboratorio

S.A.Cólquide, 6 - Portal 2, 1

Oficina F.Las Rozas

28230 MADRID

Spain

Iron sucrose complex

FERIV 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61346 Bad Homburg

Germany

Iron sucrose complex

HIERRO SACAROSA FME 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

Laboratorios Normon S.A.

Ronda de Valdecarrizo 6

28760 Tres Cantos

Madrid

Spain

Iron sucrose complex

HIERRO SACAROSA NORMON 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

FERMED 100 mg/ 5 ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

FERINJECT 50 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION

50 mg/ml

Solution for injection

Solution for infusion

Intravenous use

Spain

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MONOFERRO 100 mg/ml SOLUCIÓN INYECTABLE O PARA PERFUSIÓN

100 mg/ml

Solution for injection

Solution for infusion

Intravenous use

Sweden

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer®

20 mg/ml

Concentrate for solution for injection

Intravenous use

Sweden

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer®

50 mg/ml

Solution for injection

Intravenous use

Sweden

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection

Intravenous use

Sweden

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61346 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Concentrate for solution for injection

Intravenous use

Sweden

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion

20 mg/ml

Concentrate for solution for injection

Intravenous use

Sweden

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MonoFer®

100 mg/ml

Solution for injection

Intravenous use

The Netherlands

Pharmamatch B.V.

Egelenburg 2

Amsterdam GK - 1081

The Netherlands

Iron sucrose complex

IJzerhydroxide sacharose complex bevattende 20 mg/ml IJzer PHARMAMATCH, oplossing/concentraat voor oplossing voor injectie

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

The Netherlands

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FerroLogic 20 mg/ml, oplossing voor injectie of concentraat voor oplossing voor infusie

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

The Netherlands

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MonoFer 100 mg/ml oplossing voor injectie/infusie

100 mg/ml

Solution for injection/infusion

Intravenous use

The Netherlands

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer 20 mg/ml ijzer (III), oplossing voor injectie of concentraat voor oplossing voor intraveneuze infusie

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

The Netherlands

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

FERINJECT 50 mg ijzer/ ml, oplossing voor injectie/infusie

50 mg/ml

Solution for injection/infusion

Intravenous use

The Netherlands

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

CosmoFer 50 mg/ml oplossing voor infusie en injectie

50 mg/ml

Solution for injection/infusion

Intravenous use

The Netherlands

Pharmachemie B.V.

Haarlem - 2031 GA

The Netherlands

Iron sucrose complex

IJzerhydroxide sacharose complex 20 mg/ml PCH, oplossing voor injectie/concentraat voor oplossing voor infusie

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

United Kingdom

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection/infusion

Intravenous use

United Kingdom

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

United Kingdom

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Diafer

50 mg/ml

Solution for injection

Intravenous use

United Kingdom

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III)-hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

United Kingdom

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

United Kingdom

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use


ANNEX IV

LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Aprotinin containing medicinal products with Marketing Authorisation in the European Union

Member State

(EU/EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

AT - Austria

Bayer Austria GmbH

Herbststraße 6-10

A-1160 Wien

Austria

Trasylol 10 000 KIE/ml - Infusionsflasche

10 000 KIU/ml

solution for infusion

intravenous use

BE-Belgium

Belgium Bayer S.A.

14, J.E. Mommaertslaan

B- 1831 Diegem

Belgium

Trasylol

10 000 KIU/ml

solution for infusion

intravenous use

CZ - Czech Republic

Chemical Works of Gedeon Richter Plc.,

HU-1103 Budapest,

Gyömrői út 19-21.,

Hungary

Gordox

10 ku/ml

solution for injection

intravenous use

CZ - Czech Republic

Bayer Schering Pharma AG

Mullerstrasse 178

13353 Berlin

Germany

Trasylol 500 000 KIE

10 ku/ml

solution for infusion

intravenous use

DE - Germany

Bayer Pharma Aktiengesellschaft

registered business address:

Müllerstr. 178

D-13353 Berlin

postal address:

D-13342 Berlin

Trasynin 0,5

70,0 mg /50 ml

solution for infusion

intravenous use

DE - Germany

Bayer Pharma Aktiengesellschaft

registered business address:

Müllerstr. 178

D-13353 Berlin

postal address:

D-13342 Berlin

Trasynin 1,0

140,0 mg /100 ml

solution for infusion

intravenous use

DE - Germany

Bayer Pharma Aktiengesellschaft

registered business address:

Müllerstr. 78

D-13353 Berlin

postal address:

D-13342 Berlin

Trasynin 2,0

280,0 mg /200 ml

solution for infusion

intravenous use

DE - Germany

Bayer Vital GmbH

D-51373 Leverkusen

Trasylol 0,5

70,0 mg /50 ml

solution for infusion

intravenous use

DE - Germany

Bayer Vital GmbH

D-51373 Leverkusen

Trasylol 1,0

140,0 mg /100 ml

solution for infusion

intravenous use

DE - Germany

Bayer Vital GmbH

D-51373 Leverkusen

Trasylol 2,0

280,0 mg /200 ml

solution for infusion

intravenous use

DK - Denmark

Bayer Schering Pharma AG,

Müllerstrasse 170-178,

DE-13342 Berlin,

Germany

Trasylol

10 000 KIE/ml

solution for injection

intravenous use

EL - Greece

Bayer Hellas AG

18 - 20, Sorou Str.

151 25, Marousi - Athens

TRASYLOL

500 000 KIU/50ML

solution for infusion

intravenous use

ES - Spain

QUIMICA FARMACEUTICA BAYER, S.L

Av. Baix Llobregat, 3-5

08970 Sant Joan Despi

Barcelona - España

TRASYLOL SOLUCIÓN PARA PERFUSIÓN INTRAVENOSA

10 000 K 10 000 KIU/ml IU/ml

solution for perfusion

intravenous use

FI - Finland

Bayer HealthCare AG,

51368 Leverkusen,

Germany

TRASYLOL

10 000 KIU/ml

solution for injection/infusion

intravenous use

FR - France

BAYER SANTE - 220,

avenue de la recherche - 59120 LOOS

Trasylol

1 000 000 KUI/100 mL

solution for injection

intravenous use

FR - France

BAYER SANTE - 220,

avenue de la recherche - 59120 LOOS

Trasylol

2 000 000 KUI/200 mL

solution for injection

intravenous use

FR - France

BAYER SANTE - 220,

avenue de la recherche - 59120 LOOS

Trasylol

500 000 UIK/50 mL

solution for injection

intravenous use

HU - Hungary

Richter Gedeon Nyrt.

Gyömrői út 19-21.

1103 Budapest,

Hungary

Gordox

100 000 KIU/10 ml

solution for injection

intravenous use

HU - Hungary

Richter Gedeon Nyrt.

Gyömrői út 19-21.

1103 Budapest,

Hungary

Gordox

500 000 KIU/50 ml

solution for infusion

intravenous use

HU - Hungary

Bayer Healthcare AG

Kaiser-Wilhelm-Allee, Bldg. E39

51368 Leverkusen,

Germany

Trasylol

500 000 KIU/50 ml

solution for infusion

intravenous use

LU - Luxembourg

Bayer S.A.

14, J.E. Mommaertslaan

B- 1831 Diegem

TRASYLOL

50 000 U/50ml

solution for injection

intravenous use

LV - Latvia

Gedeon Richter Ltd.

Gyomroi ut 19-21

Budapest HU-1103

Hungary

Gordox 10 000 KSV/ml šķīdums infūzijām

10 000 KIU/ml

solution for infusion

intravenous use

MT - Malta

Bayer Plc

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

United Kingdom

trading as Bayer Plc, Pharmaceutical division

TRASYLOL

10 000 KIU/ML

solution for infusion

intravenous use

NL - Netherlands

Bayer B.V.

Energieweg 1

3641 RT Mijdrecht

The Netherlands

Trasylol 500 000, oplossing voor infusie 10 000 KIE/ml

10 000 KIU/ml

solution for infusion

intravenous use

PL - Poland

Bayer Pharma AG

Berlin, D-13342

Germany

Trasylol

555,6 Ph.Eur.u. (1 000 000 KIU)

solution for infusion

intravenous use

PL - Poland

Bayer Pharma AG

Berlin, D-13342

Germany

Trasylol

1 111,1 Ph.Eur.u. (2 000 000 KIU)

solution for infusion

intravenous use

PL - Poland

Bayer Pharma AG

Berlin, D-13342

Germany

Trasylol

277,8 j. Ph. Eur. (500 000 KIU)

solution for infusion

intravenous use

PT - Portugal

Bayer Portugal, S.A.

Rua Quinta do Pinheiro 5

2794-003 Carnaxide

Portugal

Trasylol

500 000 U.I.C/50 ml

solution for infusion

intravenous use

PT - Portugal

Bayer Portugal, S.A.

Rua Quinta do Pinheiro 5

2794-003 Carnaxide

Portugal

Trasylol 1 000 000 UIC

1 000 000 U.I.C/100 ml

solution for infusion

intravenous use

PT - Portugal

Bayer Portugal, S.A.

Rua Quinta do Pinheiro 5

2794-003 Carnaxide

Portugal

Trasylol 2 000 000 UIC

2 000 000 U.I.C/200 ml

solution for infusion

Intravenous use

SE - Sweden

Bayer Schering Pharma AG

Müllerstrasse 178

DE-133 42 Berlin

Germany

Trasylol

10 000 KIE/ml

solution for injection/infusion

intravenous use

SK - Slovakia

Richter Gedeon Nyrt.,

Budapest 10,

Pf. 27., H-1475

Hungary

GORDOX

100 000 IU/10 ml

solution for injection

intravenous use

SL - Slovenia

Bayer d.o.o.,

Bravničarjeva 13,

Ljubljana,

Slovenia

TRASYLOL

10 000 KIU/ml

solution for injection and infusion

intravenous use

UK - United Kingdom

Bayer plc

Bayer House

Strawberry Hill

Newbury,

Berkshire RG14 1JA

UK

Trasylol Solution

10,000 KIU/ML

solution for injection

intravenous use

UK - United Kingdom

Nordic Pharma Limited,

Abbey House,

1650 Arlington Business Park,

Theale, Reading,

Berkshire RG7 4SA,

UK

Aprotinin 10,000 KIU/ml Injection

10,000 KIU/ml

solution for injection

intravenous use


ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

Member State

EU/EEA

Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Route of administration

Animal species

Austria

Pfizer Corp. Austria G.m.b.H.

Floridsdorfer Hauptstraße 1

A - 1210 Wien

Austria

Cydectin TriclaMox 5 mg/ml + 200 mg/ml lösung zum aufgießen für Rinder

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Belgium

Pfizer Animal Health s.a.

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

Cydectin TriclaMox 5 mg/ml + 200 mg/ml

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Denmark

Pfizer Oy, Animal Health

Tietokuja 4

00330 Helsinki

Finland

Cydectin TriclaMox

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

France

Pfizer Holding France

23-25 avenue du Docteur Lannelongue

F – 75668 Paris Cedex 14

France

Cydectine TriclaMox 5 mg/ml + 200 mg/ml Solution pour pour-on bovins

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Germany

Pfizer GmbH

Linkstraße 10

10785 Berlin

Germany

Cydectin® TriclaMox 5 mg/ml + 200 mg/ml Lösung zum Aufgießen für Rinder

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Greece

Pfizer Hellas AE

Mesogion Avenue 243

154 51 N. Psychiko

Athens

Greece

Cydectin TriclaMox

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Ireland

Pfizer Healthcare Ireland

Ringaskiddy

Co Cork

Ireland

Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Italy

Pfizer Italia S.r.l.

Via Isonzo 71

04100 Latina

Italy

Cydectin TriclaMox 5 mg/ml + 200 mg/ml soluzione Pour-on per bovini

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Luxembourg

Pfizer Animal Health s.a.

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

Cydectin TriclaMox 5 mg/ml + 200 mg/ml

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Portugal

Laboratórios Pfizer, Lda

Lagoas Park – Edíficio 10

2740-271 Porto Salvo

Portugal

Cydectin TriclaMox 5 mg/ml + 200 mg/ml solução para unção contínua para bovinos

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Slovenia

Pfizer Luxembourg SARL

51, Avenue J.F.Kennedy

L-1855 Luxembourg

Luksemburg

Cydectin TriclaMox

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

Spain

Zoetis Spain, S.L.

Avda. de Europa 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Cydectin Triclamox 5 mg/ml + 200 mg/ml Solución Pour-on para Bovino

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg

United Kingdom

Pfizer Ltd

Ramsgate Road

Sandwich CT13 9NJ

United Kingdom

Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle

Moxidectin

5,0 mg

Pour-on solution

Topical – on the back of the animal

Cattle

Triclabendazole

200,0 mg


ANNEX VI

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA

Marketing Authorisation Holder company name, address

Invented name Name

Strength

Pharmaceutical Form

Route of administration

Content (concentration)

Austria

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10,

A-1220 Vienna,

Austria

Targocid 100 mg Trockenstechampullen mit Lösungsmittel

100 mg

powder and solvent for solution for injection/ infusion and oral solution

intramuscular use, intravenous use, oral use

100 mg/1.5 ml

Austria

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10,

A-1220 Vienna,

Austria

Targocid 200 mg Trockenstechampullen mit Lösungsmittel

200 mg

powder and solvent for solution for injection/ infusion and oral solution

intramuscular use, intravenous use, oral use

200 mg/3 ml

Austria

sanofi-aventis GmbH,

Leonard-Bernstein-Straße 10,

A-1220 Vienna,

Austria

Targocid 400 mg Trockenstechampullen mit Lösungsmittel

400 mg

powder and solvent for solution for injection/ infusion and oral solution

intramuscular use, intravenous use, oral use

400 mg/3 ml

Belgium

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Belgium

Targocid 200 mg, poeder en oplosmiddel voor oplossing voor injectie

200 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Belgium

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Belgium

Targocid 400 mg, poeder en oplosmiddel voor oplossing voor injectie

400 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Bulgaria

sanofi-aventis Bulgaria EOOD

1303 Sofia,

103 Alexander Stamboliiski Blvd. fl.8.,

Bulgaria

TARGOCID 400mg powder and solvent for solution for injection/infusion

400 mg

powder and solvent for solution for injection/infusion

intramuscular use/intravenous use, oral use

400 mg/3 ml

Czech Republic

sanofi-aventis, s.r.o.

Evropská 846/176a,

160 00 Praha 6,

Czech Republic

Targocid 200 mg

200 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Czech Republic

sanofi-aventis, s.r.o.

Evropská 846/176a,

160 00 Praha 6,

Czech Republic

Targocid 400 mg

400 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Denmark

sanofi-aventis Denmark A/S

Slotsmarken 13,

2970 Hoersholm,

Denmark

Targocid

100 mg

powder for solution for injection

intramuscular use/intravenous use

100 mg/1.5 ml

Denmark

sanofi-aventis Denmark A/S

Slotsmarken 13,

2970 Hoersholm,

Denmark

Targocid

200 mg

powder for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Denmark

sanofi-aventis Denmark A/S

Slotsmarken 13,

2970 Hoersholm,

Denmark

Targocid

400 mg

powder for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Finland

sanofi-aventis Oy

Huopalahdentie 24

PL 22

00351 Helsinki,

Finland

Targocid 200 mg injektio- ja infuusiokuiva-aine, liuosta varten

200 mg

powder for solution for injection/ infusion

intramuscular use/intravenous use

200 mg/3 ml

Finland

sanofi-aventis Oy

Huopalahdentie 24

PL 22

00351 Helsinki,

Finland

Targocid 400 mg injektio- ja infuusiokuiva-aine, liuosta varten

400 mg

powder for solution for injection/ infusion

intramuscular use/intravenous use

400 mg/3 ml

France

sanofi-aventis France

1-13 Bd Romain Rolland

75014 Paris,

France

TARGOCID 100 mg, lyophilisat et solution pour usage parentéral

100 mg

powder and solvent for injection

intramuscular use/intravenous use

100 mg/1.5 ml

France

sanofi-aventis France

1-13 Bd Romain Rolland

75014 Paris,

France

TARGOCID 200 mg, lyophilisat et solution pour usage parentéral

200 mg

powder and solvent for injection

intramuscular use/intravenous use

200 mg/3 ml

France

sanofi-aventis France

1-13 Bd Romain Rolland

75014 Paris,

France

TARGOCID 400 mg, lyophilisat et solution pour usage parentéral

400 mg

powder and solvent for injection

intramuscular use/intravenous use

400 mg/3 ml

Germany

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Deutschland

Targocid® 100 mg

100 mg

powder and solvent for solution for infusion/injection or oral solution

intramuscular use/intravenous use, oral use

100 mg/1.5 ml

Germany

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Deutschland

Targocid® 200 mg

200 mg

powder and solvent for solution for infusion/injection or oral solution

intramuscular use/intravenous use, oral use

200 mg/3 ml

Germany

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Deutschland

Targocid® 400 mg

400 mg

powder and solvent for solution for infusion/injection or oral solution

intramuscular use/intravenous use, oral use

400 mg/3 ml

Germany

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Deutschland

Teicoplanin Sanofi-Aventis 100 mg

100 mg

powder and solvent for solution for infusion/injection or oral solution

intramuscular use/intravenous use, oral use

100 mg/1.5 ml

Germany

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Deutschland

Teicoplanin Sanofi-Aventis 200 mg

200 mg

powder and solvent for solution for infusion/injection or oral solution

intramuscular use/intravenous use, oral use

200 mg/3 ml

Germany

sanofi-aventis Deutschland GmbH

Industriepark Höchst, Geb. K 703,

65926 Frankfurt am Main,

Deutschland

Teicoplanin Sanofi-Aventis 400 mg

400 mg

powder and solvent for solution for infusion/injection or oral solution

intramuscular use/intravenous use, oral use

400 mg/3 ml

Greece

Vianex S.A.

Tatoiou Street

14671 Nea Erythrea,

Greece

TARGOCID®

200 mg

Powder and solvent for injection or infusion

intramuscular use/intravenous use

200 mg/3 ml

Greece

Vianex S.A.

Tatoiou Street

14671 Nea Erythrea,

Greece

TARGOCID®

400mg

Powder and solvent for injection or infusion

intramuscular use/intravenous use

400 mg/3 ml

Hungary

sanofi-aventis Zrt.

1-5. Tó u.,

1045 Budapest,

Hungary

Targocid 200 mg por és oldószer oldatos injekcióhoz

200 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Hungary

sanofi-aventis Zrt.

1-5. Tó u.,

1045 Budapest,

Hungary

Targocid 400 mg por és oldószer oldatos injekcióhoz

400 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Ireland

sanofi-aventis Ireland Ltd., T/A Sanofi

18 Riverwalk

Citywest Business Campus, Dublin 24,

Ireland

Targocid 200mg Powder and Solvent for Solution for Injection

200 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Ireland

sanofi-aventis Ireland Ltd., T/A Sanofi

18 Riverwalk

Citywest Business Campus, Dublin 24,

Ireland

Targocid 400mg Powder and Solvent for Solution for Injection

400 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Italy

sanofi-aventis SPA

Viale L. Bodio, 37/B –

20158 Milano,

Italy

TARGOSID

200 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Italy

sanofi-aventis SPA

Viale L. Bodio, 37/B –

20158 Milano,

Italy

TARGOSID

400 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Italy

sanofi-aventis SPA

Viale L. Bodio, 37/B –

20158 Milano,

Italy

TEICOMID

200 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Italy

sanofi-aventis SPA

Viale L. Bodio, 37/B –

20158 Milano,

Italy

TEICOMID

400 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Luxembourg

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Belgium

TARGOCID

200 mg

powder for injectable preparations

intramuscular use/intravenous use

200 mg/3 ml

Luxembourg

sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem,

Belgium

TARGOCID

400 mg

powder for injectable preparations

intramuscular use/intravenous use

400 mg/3 ml

Malta

Sanofi-Aventis Malta Ltd.

Triq Kan. K. Pirotta,

Birkirkara BKR1114,

Malta

Targocid® 200 mg

200 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Netherlands

sanofi-aventis Netherlands BV.

Kampenringweg 45 D-E,

2803 PE Gouda,

The Netherlands

TARGOCID® 200

200 mg

powder for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Netherlands

sanofi-aventis Netherlands BV.

Kampenringweg 45 D-E,

2803 PE Gouda,

The Netherlands

TARGOCID® 400

400 mg

powder for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Norway

sanofi-aventis Norge AS,

Strandveien 15,

PO Box 133, 1325 Lysaker,

Norway

TARGOCID®

400 mg

powder for solution for injection/infusion

intramuscular use/intravenous use

400 mg/3 ml

Poland

Aventis Pharma Ltd.

One Onslow Street,

Guildford, Surrey

GU1 4YS,

United Kingdom

TARGOCID

200 mg

powder and solvent for solution for injection and infusion

intramuscular use/intravenous use

200 mg/3 ml

Poland

Aventis Pharma Ltd.

One Onslow Street,

Guildford, Surrey

GU1 4YS,

United Kingdom

TARGOCID

400 mg

powder and solvent for solution for injection and infusion

intramuscular use/intravenous use

400 mg/3 ml

Portugal

Sanofi - Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 – 3o Piso

2740-244 Porto Salvo

Portugal

Targosid

200 mg/3 ml

powder and solvent for solution for injection or for infusion

intramuscular use/intravenous use

200 mg/3 ml

Portugal

Sanofi - Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 – 3o Piso

2740-244 Porto Salvo

Portugal

Targosid

400 mg/3 ml

powder and solvent for solution for injection or for infusion

intramuscular use/intravenous use

400 mg/3 ml

Romania

Aventis Pharma Ltd.

Trading as sanofi-aventis or Sanofi

One Onslow Street,

Guildford Surrey,

GU1 4YS,

United Kingdom

TARGOCID® 200 mg

200 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

200 mg/3 ml

Romania

Aventis Pharma Ltd.

Trading as sanofi-aventis or Sanofi

One Onslow Street,

Guildford Surrey,

GU1 4YS,

United Kingdom

TARGOCID® 400 mg

400 mg

powder and solvent for solution for injection

intramuscular use/intravenous use

400 mg/3 ml

Slovak Republic

sanofi-aventis Pharma

Slovakia s.r.o Einsteinova 24,

85101 Bratislava,

Slovak Republic

Targocid 200

200 mg

powder and solvent for solution for injection or infusion

intramuscular use/intravenous use, oral use

200 mg/3 ml

Slovak Republic

sanofi-aventis Pharma

Slovakia s.r.o Einsteinova 24,

85101 Bratislava,

Slovak Republic

Targocid 400

400 mg

powder and solvent for solution for injection or infusion

intramuscular use/intravenous use, oral use

400 mg/3 ml

Slovenia

sanofi-aventis d.o.o.

Dunajska cesta 151

1000 Ljubljana

Slovenia

Targocid 200 mg prašek in vehikel za raztopino za injiciranje ali infundiranje

200 mg

powder and solvent for solution for injection or infusion

intramuscular use/intravenous use

200 mg/3 ml

Slovenia

sanofi-aventis d.o.o.

Dunajska cesta 151

1000 Ljubljana

Slovenia

Targocid 400 mg prašek in vehikel za raztopino za injiciranje ali infundiranje

400 mg

powder and solvent for solution for injection or infusion

intramuscular use/intravenous use

400 mg/3 ml

Spain

Marion Merrell S.A.

Martínez Villergas, 52

28027 Madrid

Spain

TARGOCID

200 mg

powder and solvent for solution for injection or infusion

intramuscular use/intravenous use

200 mg/3 ml

Spain

Marion Merrell S.A.

Martínez Villergas, 52

28027 Madrid

Spain

TARGOCID

400 mg

powder and solvent for solution for injection or infusion

intramuscular use/intravenous use

400 mg/3 ml

Sweden

sanofi-aventis AB

Box 14142

167 14 Bromma,

Sweden

Targocid

200 mg

Powder for injection-/infusion, solution

intramuscular use/intravenous use

200 mg/3 ml

Sweden

sanofi-aventis AB

Box 14142

167 14 Bromma,

Sweden

Targocid

400 mg

Powder for injection-/infusion, solution

intramuscular use/intravenous use

400 mg/3 ml

United Kingdom

Aventis Pharma Ltd. (or trading as Marion Merrell or Aventis Pharma)

One Onslow Street

Guildford

Surrey

GU1 4YS

United Kingdom

or trading as

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

United Kingdom

TARGOCID®

200 mg

powder for injection

intramuscular use/intravenous use

200 mg/3 ml

United Kingdom

Aventis Pharma Ltd. (or trading as Marion Merrell or Aventis Pharma)

One Onslow Street

Guildford

Surrey

GU1 4YS

United Kingdom

or trading as

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

United Kingdom

TARGOCID®

400 mg

powder for injection

intramuscular use/intravenous use

400 mg/3 ml


ANNEX VII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State

(in EEA)

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of administration

Bulgaria

Zentiva k.s.

130 U kabelovn

Prague 10237

Czech Republic

Flupizen

100 mg

capsule, hard

oral use

Estonia

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

KATADOLON

100 mg

capsule, hard

oral use

Germany

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Flupirtinmaleat AbZ 100 mg Kapseln

100 mg

capsule, hard

oral use

Germany

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Germany

Flupirtinmaleat AL 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Awegal inject

164,5 mg / 3 ml

solution for injection

intramuscular use

Germany

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon inject

164,5 mg / 3 ml

solution for injection

intramuscular use

Germany

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon Kinderzäpfchen

75 mg

suppository

rectal use

Germany

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon Zäpfchen

150 mg

suppository

rectal use

Germany

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Trancopal Dolo

100 mg

capsule

oral use

Germany

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Trancopal Dolo Suppositorien

150 mg

suppository

rectal use

Germany

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon S long

400 mg

prolonged release tablet

oral use

Germany

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon

100 mg

capsule, hard

oral use

Germany

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Trancolong

400 mg

prolonged release tablet

oral use

Germany

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Katadolon retard

400 mg

prolonged release tablet

oral use

Germany

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Flupirtinmaleat Winthrop 400 mg Retardtabletten

400 mg

prolonged release tablet

oral use

Germany

CT Arzneimittel GmmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Flupirtinmaleat-CT 100 mg Hartkapsel

100 mg

capsule, hard

oral use

Germany

CT Arzneimittel GmmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Flupin 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Dolokadin einmal täglich

400 mg

prolonged release tablet

oral use

Germany

Hormosan Pharma GmbH

Wilhelmshöher Str. 106

60389 Frankfurt

Germany

Flupigamma 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

Hormosan Pharma GmbH

Wilhelmshöher Str. 106

60389 Frankfurt

Germany

Flupirtinmaleat-Hormosan 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Flupigil 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Flupigil 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

Midas Pharma GmbH

Rheinstr. 49

55218 Ingelheim

Germany

Flupirtinmaleat Midas 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Flupirtinmaleat-ratiopharm 100 mg Hartkapsel

100 mg

capsule, hard

oral use

Germany

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Miflumal 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

Vitapharma Generics GmbH

Benzstr. 1

61352 Bad Homburg v. d. H.

Germany

Flupirtinmaleat Vitapharma 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

Vitapharma Generics GmbH

Benzstr. 1

61352 Bad Homburg v. d. H.

Germany

Flupivil 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

Vitapharma Generics GmbH

Benzstr. 1

61352 Bad Homburg v. d. H.

Germany

Flupirtinmaleat Viatris 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Flupirtinmaleat Winthrop 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Flupimal 100 mg Hertkapseln

100 mg

capsule, hard

oral use

Germany

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Flupsadim 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Miphaflumix 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Fluporol 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Germany

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Flupirtinmaleat Winthrop 100 mg Hartkapseln

100 mg

capsule, hard

oral use

Hungary

ZENTIVA k.s.

Ul. kabelovny 130, Dolní Mecholupy

10237 Prague 10

Czeh Republic

Flupizen 100 mg kemény kapszula

100 mg

capsule, hard

oral use

Italy

MEDA PHARMA S.p.A.,

Viale Brenta 18, 20139 Milano

Italy

EFIRET

100 mg

capsule, hard

oral use

Latvia

Teva Pharma B.V.,

Computerweg 10,

3542 DR Utrecht

The Netherlands

Katadolon 100 mg hard capsules

100 mg

capsule, hard

oral use

Lithuania

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Katadolon

100 mg

capsule, hard

oral use

Poland

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warsaw

Poland

Katadolon

100 mg

capsule, hard

oral use

Portugal

Midas Pharma GmbH

Rheinstrasse, 49

55218 Ingelheim

Germany

Flupirtina Midas

100 mg

capsule, hard

oral use

Portugal

Sanofi-Aventis - Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park,

Edifício 7 - 3o Piso

2740-244 Porto Salvo

Portugal

Flupirtina Winthrop

100 mg

capsule, hard

oral use

Portugal

Meda Pharma - Produtos Farmacêuticos, S.A.

Rua do Centro Cultural, 13

1749-066 Lisboa

Portugal

Metanor

100 mg

capsule, hard

oral use

Romania

Zentiva k.s.

U Kabelovny 130, Dolní Měcholupy

102 37, Praga 10,

Czech Republic

FLUPIZEN 100 mg

100 mg

capsule

oral use

Slovak Republic

Zentiva k.s.

U Kabelovny 130

102 37 Praha 10

Czech Republic

Flupizen 100 mg tvrdé kapsuly

100 mg

capsule, hard

oral use

Slovak Republic

TEVA Pharmaceuticals Slovakia, s.r.o.

Teslova 26

821 02 Bratislava

Slovak Republic

Katadolon

100 mg

capsule, hard

oral use


ANNEX VIII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA

Applicant/marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Route of administration

Animal species

Austria

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1,

1210 Wien

AUSTRIA

Dectomax 1 % - Injektionslösung für Rinder und Schafe

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep

Austria

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1,

1210 Wien

AUSTRIA

Dectomax S 10 mg/ml Injektionslösung für Schweine

Doramectin

10 mg/ml

Solution for injection

intramuscular

Pigs

Austria

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1,

1210 Wien

AUSTRIA

Dectomax Pour-On 5 mg/ml Lösung für Rinder

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Belgium

Eli Lilly Benelux S.A.

Division Elanco Animal Health

Stoofstraat 52

1000 Brussel

BELGIUM

DECTOMAX

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep

Belgium

Eli Lilly Benelux S.A.

Division Elanco Animal Health

Stoofstraat 52

1000 Brussel

BELGIUM

DECTOMAX POUR-ON

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Belgium

Eli Lilly Benelux S.A.

Division Elanco Animal Health

Stoofstraat 52

1000 Brussel

BELGIUM

DECTOMAX SOLUTION INJECTABLE POUR PORCS

Doramectin

10 mg/ml

Solution for injection

intramuscular

Pigs

Bulgaria

Pfizer S.A.,

Z.l. De Poce-sur-Cisse, B.P. 109

37401 Amboise Cedex,

FRANCE

Дектомакс 1 % инжективен разтвор

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Bulgaria

BIOVET AD

39 Petar Rakov str.

Peshtera 4550

BULGARIA

Ендектовет 1 % инжекционен разтвор за говеда, овце и свине

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Cyprus

PFIZER HELLAS AE

243 Av Mesogeion

15451, Athens

GREECE

DECTOMAX 1 % ενέσιμο διάλυμα για βοοειδή, χοίρους και πρόβατα

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Czech republic

Pfizer s.r.o.

Stroupežnického 17

150 00 Praha

CZECH REPUBLIC

DECTOMAX 10 mg/ml injekční roztok

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Czech republic

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

Prontax 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Denmark

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Dectomax Pour-On Vet.

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Denmark

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Dectomax Vet.

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, pigs

Denmark

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Denmark

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax

Doramectin

10 mg/ml

Solution for injection

subcutaneous

Cattle

Estonia

Pfizer Animal Health S.A.,

Rue Laid Burniat 1,

1348 Louvain-la-Neuve,

BELGIUM

Dectomax

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Estonia

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

Prontax 10 mg/ml Solution for injection for Cattle, Sheep and Pigs

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Finland

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

DECTOMAX vet 10 mg/ml injektioneste, liuos

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, reindeer, pigs

Finland

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax 5 mg/ml kertavaleluliuos

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Finland

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax 10 mg/ml injektioneste, liuos

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

France

Lilly France

13 Rue Pages

92158 Suresnes Cedex

FRANCE

ZEARL

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep

France

Lilly France

13 Rue Pages

92158 Suresnes Cedex

FRANCE

ZEARL POUR ON

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

France

Lilly France

13 Rue Pages

92158 Suresnes Cedex

FRANCE

ZEARL PORCS

Doramectin

10 mg/ml

Solution for injection

intramuscular

Pigs

France

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

PRONTAX 5 MG/ML SOLUTION POUR POUR ON POUR BOVINS

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

France

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

PRONTAX 10 MG/ML SOLUTION INJECTABLE POUR BOVINS OVINS ET PORCINS

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Germany

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

GERMANY

Dectomax

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep

Germany

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

GERMANY

Dectomax Pour-On

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Germany

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

GERMANY

Dectomax-S Injektionslösung

Doramectin

10 mg/ml

Solution for injection

intramuscular

Pigs

Greece

PFIZER HELLAS AE

243 Av Mesogeion

15451, Athens

GREECE

DECTOMAX ing sol

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Hungary

Pfizer Kft.

Alkotás u. 53.

1123 Budapest

HUNGARY

Dectomax injekció A.U.V.

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Iceland

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Dectomax, vet.

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Iceland

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Iceland

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Ireland

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

UNITED KINGDOM

Zearl Pour-On Solution for Cattle 5 mg/ml

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Ireland

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

UNITED KINGDOM

Zearl 10 mg/ml Solution for Injection for Cattle and Sheep

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep

Ireland

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

UNITED KINGDOM

Zearl 10 mg/ml Solution for Injection for Pigs

Doramectin

10 mg/ml

Solution for injection

intramuscular

Pigs

Ireland

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

Dectomax 5 mg/ml Pour-On Solution for Cattle

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Ireland

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Italy

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

ITALY

DECTOMAX 10 mg/ml soluzione iniettabile per bovini, ovini e suini

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Italy

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

ITALY

DECTOMAX POUR ON 5 mg/ml

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Latvia

Pfizer Animal Health S.A.,

Rue Laid Burniat, 1,

1348 Louvain-la-Neuve,

BELGIUM

Dectomax

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Latvia

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

Dectomax

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Lithuania

Pfizer S.A.,

Z.l. De Poce-sur-Cisse, B.P. 109

37401 Amboise Cedex,

FRANCE

DECTOMAX, injekcinis tirpalas galvijams, avims ir kiaulėms

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Lithuania

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

PRONTAX 10 mg/ml, injekcinis tirpalas galvijams, avims ir kiaulėms

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

The Netherlands

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

THE NETHERLANDS

Dectomax Pour-On Oplossing voor Rundvee 5 mg/ml

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

The Netherlands

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

THE NETHERLANDS

DECTOMAX oplossing voor injectie 10 mg/ml voor rundvee, varkens en schapen

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Norway

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Dectomax Pour-On vet

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Norway

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Dectomax vet

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Norway

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Norway

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Poland

Pfizer Trading Polska s.p. z o.o.

ul. Postępu 17 B

02-676 Warszawa

POLAND

Dectomax 10 mg/ml, roztwór do wstrzykiwań dla bydła, świń i owiec

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Portugal

LABORATÓRIOS PFIZER, LDA.

Lagoas Park - Edifício 10

2740-244 Porto Salvo

PORTUGAL

Dectomax Pour-on

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Portugal

LABORATÓRIOS PFIZER, LDA.

Lagoas Park - Edifício 10

2740-244 Porto Salvo

PORTUGAL

Dectomax solução injectável

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Romania

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

DECTOMAX

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Romania

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

PRONTAX 10 mg/ml Injectable Solution for Cattle, Sheep and Pigs

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Romania

Pfizer Limited

Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

UNITED KINGDOM

PRONTAX 5 mg/ml Pour On Solution for Cattle

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Slovakia

Pfizer Luxemburg SARL, o.z.

Pfizer AH

Pribinova 25

811 09 Bratislava

SLOVAK REPUBLIC

Dectomax 10 mg/ml injekčný roztok

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Slovenia

Pfizer Luxembourg SARL

51, Avenue J.F. Kennedy

L-1855 Luxembourg

LUXEMBOURG

DECTOMAX 10 mg/ml raztopina za injiciranje

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Spain

PFIZER S.A.

Avda. de Europa 20 B.

Parque Empresarial La Moraleja

28108 - Alcobendas

Madrid

SPAIN

DECTOMAX 10 MG/ML SOLUCIÓN INYECTABLE PARA PORCINO

Doramectin

10 mg/ml

Solution for injection

intramuscular

Pigs

Spain

PFIZER S.A.

Avda. de Europa 20 B.

Parque Empresarial La Moraleja

28108 - Alcobendas

Madrid

SPAIN

DECTOMAX POUR-ON SOLUCION 5 MG/ML PARA BOVINO

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Spain

PFIZER S.A.

Avda. de Europa 20 B.

Parque Empresarial La Moraleja

28108 - Alcobendas

Madrid

SPAIN

DECTOMAX SOLUCION INYECTABLE

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep

Sweden

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Dectomax vet.

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, reindeer

Sweden

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Dectomax Suis vet.

Doramectin

10 mg/ml

Solution for injection

intramuscular

Pigs

Sweden

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep, pigs

Sweden

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Dectomax pour-on vet.

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

Sweden

Pfizer Oy, Animal Health,

Tietokuja 4

00330 Helsinki

FINLAND

Prontax

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle

United Kingdom

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

UNITED KINGDOM

Dectomax 10 mg/ml Solution for Injection for Cattle and Sheep

Doramectin

10 mg/ml

Solution for injection

subcutaneous, intramuscular

Cattle, sheep

United Kingdom

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

UNITED KINGDOM

Dectomax 10 mg/ml Solution for Injection for Pigs

Doramectin

10 mg/ml

Solution for injection

intramuscular

Pigs

United Kingdom

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke, Hampshire

RG24 9NL

UNITED KINGDOM

Dectomax Pour-on Solution for Cattle 5 mg/ml

Doramectin

5 mg/ml

Pour-on solution

topical - on the back of the animal

Cattle


ANNEX IX

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State

(in EEA)

Marketing authorisation holder

INN

Invented name

Strengths

Pharmaceutical forms

Routes of administration

Austria

Pfizer Corporation Austria Ges.m.b.H

Floridsdorfer Hauptstraße 1,

1210 Vienna

Austria

Diclofenac sodium

Misoprostol

Arthrotec forte - Manteltabletten

75 mg

0,2 mg

Coated tablet

Oral use

Austria

Pfizer Corporation Austria Ges.m.b.H

Floridsdorfer Hauptstraße 1,

1210 Vienna

Austria

Diclofenac sodium

Misoprostol

Arthrotec - Manteltabletten

50 mg

0,2 mg

Coated tablet

Oral use

Austria

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Dedolor akut 75 mg – Kapseln

75 mg

Gastro-resistant capsule, hard

Oral use

Austria

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Dedolor DRS 100 mg – Kapseln

100 mg

Capsule, hard

Oral use

Austria

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Deflamat DRS 75 mg – Kapseln

75 mg

Capsule, hard

Oral use

Austria

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Deflamat 75 mg - Ampullen

75 mg/3 ml

Solution for injection/infusion

Intramuscular use, Intravenous use

Austria

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Deflamat 50 mg – Kapseln

50 mg

Capsule, hard

Oral use

Austria

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Deflamat 100 mg – Suppositorien

100 mg

Suppository

Rectal use

Austria

Astellas Pharma GmbH

Linzer Straße 221/E02

1140 Vienna

Austria

Diclofenac sodium

Deflamat retard 100 mg – Kapseln

100 mg

Capsule, hard

Oral use

Austria

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

DiclacHexal 50 mg - Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

DiclacHexal rapid 50 mg - lösbare Tabletten

50 mg

Soluble tablet

Oral use

Austria

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

DiclacHexal retard 150 mg - Tabletten

150 mg

Prolonged-release tablet

Oral use

Austria

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

DiclacHexal retard 75 mg - Tabletten

75 mg

Prolonged-release tablet

Oral use

Austria

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene 75 mg – Ampullen

75 mg/2 ml

Solution for injection/infusion

Intramuscular use, Intravenous use

Austria

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene 25 mg – Filmtabletten

25 mg

Film-coated tablet

Oral use

Austria

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene 50 mg – Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene 100 mg – Zäpfchen

100 mg

Suppository

Rectal use

Austria

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene 50 mg – Zäpfchen

50 mg

Suppository

Rectal use

Austria

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene retard 100 mg - Kapseln

100 mg

Capsule, hard

Oral use

Austria

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac sodium

Diclobene uno 150 mg - Retardtabletten

150 mg

Prolonged-release tablet

Oral use

Austria

1A Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Diclofenac akut 1A Pharma 50 mg - lösbare Tabletten

50 mg

Soluble tablet

Oral use

Austria

Genericon Pharma Gesellschaft m.b.H.

Hafnerstraße 211

8054 Graz

Austria

Diclofenac sodium

Diclofenac Genericon 75 mg - Ampullen

75 mg/3 ml

Solution for injection/infusion

Intramuscular use, Intravenous use

Austria

Genericon Pharma Gesellschaft m.b.H.

Hafnerstraße 211

8054 Graz

Austria

Diclofenac sodium

Diclofenac "Genericon" 50 mg - Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

Genericon Pharma Gesellschaft m.b.H.

Hafnerstraße 211

8054 Graz

Austria

Diclofenac sodium

Diclofenac Genericon retard 100 mg Filmtabletten

100 mg

Film-coated tablet

Oral use

Austria

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

Diclofenac sodium

DICLOFENAC "S.Med" 25 mg-Filmtabletten

25 mg

Film-coated tablet

Oral use

Austria

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

Diclofenac sodium

DICLOFENAC "S.Med" 50 mg - Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

Diclofenac sodium

Diclofenac ”S.Med“ 75 mg/3 ml - Ampullen

75 mg/3 ml

Solution for injection

Intramuscular use

Austria

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

Diclofenac sodium

DICLOFENAC "S.Med" retard 100 mg - Tabletten

100 mg

Tablet

Oral use

Austria

S.MED Handels GmbH

Zachgasse 1

1220 Vienna

Austria

Diclofenac sodium

DICLOFENAC "S.Med" retard 75 mg - Tabletten

75 mg

Tablet

Oral use

Austria

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac sodium

Diclofenac G.L. 50 mg - Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

1A Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Diclofenac 1A Pharma retard 150 mg - Tabletten

150 mg

Prolonged-release tablet

Oral use

Austria

1A Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Diclofenac 1A Pharma retard 75 mg - Tabletten

75 mg

Prolonged-release tablet

Oral use

Austria

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac sodium

Diclofenac G.L. retard 100 mg - Filmtabletten

100 mg

Film-coated tablet

Oral use

Austria

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclofenac Sandoz 75 mg – Ampullen

75 mg/3 ml

Solution for injection/infusion

Intramuscular use, Intravenous use

Austria

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclofenac Sandoz 50 mg – Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclofenac Sandoz 150 mg - Retardtabletten

150 mg

Prolonged-release tablet

Oral use

Austria

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclofenac Sandoz 75 mg - Retardtabletten

75 mg

Prolonged-release tablet

Oral use

Austria

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diclofenac "Sandoz" retard 100 mg – Filmtabletten

100 mg

Film-coated tablet

Oral use

Austria

Lannacher Heilmittel Ges.m.b.H

Schlossplatz 1

8502 Lannach

Austria

Diclofenac sodium

Diclo-B „Lannacher“-Kapseln

50 mg

Capsule, hard

Oral use

Austria

Lannacher Heilmittel Ges.m.b.H

Schlossplatz 1

8502 Lannach

Austria

Diclofenac sodium

Diclo-B G.L.

50 mg

Capsule, hard

Oral use

Austria

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

Diclofenac sodium

Diclostad Ampullen

75 mg/3 ml

Solution for injection/infusion

Intramuscular use, Intravenous use

Austria

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

Diclofenac Sodium

Diclostad 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

Diclofenac sodium

Diclostad retard 100 mg Filmtabletten

100 mg

Film-coated tablet

Oral use

Austria

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac sodium

Diclovit-Kapseln

50 mg

Capsule, hard

Oral use

Austria

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Dolpasse 75 mg – Infusionslösung

75 mg/250 ml

Solution for Infusion

Intravenous use

Austria

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Dolpasse retard 100 mg - Filmtabletten

100 mg

Film-coated tablet

Oral use

Austria

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Orphenadrine citrate

Neodolpasse – Infusionslösung

75 mg/250 ml

30 mg/250 ml

Solution for Infusion

Intravenous use

Austria

MERCK GesmbH

Zimbagasse 5

1147 Vienna

Austria

Diclofenac sodium

Neurofenac - Kapseln

50 mg

Capsule, hard

Oral use

Austria

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenac sodium

Tratul retard 100 mg - Filmtabletten

100 mg

Film-coated tablet

Oral use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 25 mg - Filmtabletten

25 mg

Film-coated tablet

Oral use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 50 mg - Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 75 mg/3 ml - Injektionslösung

75 mg/3 ml

Solution for injection/infusion

Intramuscular use, Intravenous use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 25 mg - Zäpfchen

25 mg

Suppository

Rectal use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 100 mg - Zäpfchen für Erwachsene

100 mg

Suppository

Rectal use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren 50 mg - Zäpfchen für Erwachsene

50 mg

Suppository

Rectal use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac sodium

Voltaren retard 100 mg - Filmtabletten

100 mg

Film-coated tablet

Oral use

Austria

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenac Acid

Tratul 50 mg - Kapseln

50 mg

Gastro-resistant capsule, soft

Oral use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac Acid

Voltaren dispers - lösliche Tabletten

46,5 mg

Soluble tablet

Oral use

Austria

ratiopharm Arzneimittel VertriebsGmbH

Albert-Schweitzer-Gasse 3

1140 Vienna

Austria

Diclofenac potassium

Diclobene rapid 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac potassium

Voltaren 50 mg Pulver zur Herstellung einer Lösung zum Einnehmen

50 mg

Powder for oral solution

Oral use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Vienna

Austria

Diclofenac potassium

Voltaren rapid 50 mg - Dragees

50 mg

Coated tablet

Oral use

Belgium

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

Diclofenac sodium

Misoprostol

ARTHROTEC 50

50 mg

0,2 mg

Modified-release tablet

Oral use

Belgium

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

Diclofenac sodium

Misoprostol

ARTHROTEC 75

75 mg

0,2 mg

Modified-release tablet

Oral use

Belgium

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac potassium

CATAFLAM 50 MG

50 mg

Coated tablet

Oral use

Belgium

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac potassium

CATAFLAM 50 MG

50 mg

Powder for oral solution

Oral use

Belgium

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac

CATAFLAM DISPERSIBLE

46,5 mg

Dispersible tablet

Oral use

Belgium

APOTEX NV

Av. du Bourg. Etienne Demunter 5, box 8

1090 Jette

Belgium

Diclofenac sodium

DICLOFENAC APOTEX 100 MG

100 mg

Prolonged-release tablet

Oral use

Belgium

APOTEX NV

Av. du Bourg. Etienne Demunter 5, box 8

1090 Jette

Belgium

Diclofenac sodium

DICLOFENAC APOTEX 75 MG

75 mg

Prolonged-release tablet

Oral use

Belgium

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG 100 MG

100 mg

Suppository

Rectal use

Belgium

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG 25 MG

25 mg

Coated tablet

Oral use

Belgium

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG 50 MG

50 mg

Coated tablet

Oral use

Belgium

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG 75 MG

75 mg/3 ml

Solution for injection

Intramuscular use

Belgium

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG RETARD 100 MG

100 mg

Prolonged-release tablet

Oral use

Belgium

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

DICLOFENAC EG RETARD 75 MG

75 mg

Prolonged-release tablet

Oral use

Belgium

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

Diclofenac sodium

DICLOFENAC RETARD MYLAN 100 MG

100 mg

Prolonged-release tablet

Oral use

Belgium

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

Diclofenac sodium

DICLOFENAC RETARD MYLAN 75 MG

75 mg

Prolonged-release tablet

Oral use

Belgium

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

Diclofenac sodium

DICLOFENAC SANDOZ 50 MG

50 mg

Gastro-resistant tablet

Oral use

Belgium

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

Diclofenac sodium

DICLOFENAC SANDOZ 75 MG

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Belgium

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

Diclofenac sodium

DICLOFENAC SANDOZ RETARD 100 MG

100 mg

Modified-release tablet

Oral use

Belgium

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

Diclofenac sodium

DICLOFENAC SANDOZ RETARD 75 MG

75 mg

Modified-release tablet

Oral use

Belgium

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac sodium

DICLOFENAC TEVA 100

100 mg

Suppository

Rectal use

Belgium

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac sodium

DICLOFENAC TEVA 100 MG RETARD

100 mg

Prolonged-release tablet

Oral use

Belgium

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac sodium

DICLOFENAC TEVA 50 MG

50 mg

Gastro-resistant tablet

Oral use

Belgium

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac sodium

DICLOFENAC TEVA 75 MG / 3 ML

75 mg/3 ml

Solution for injection

Intramuscular use

Belgium

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac sodium

DICLOFENAC TEVA 75 MG RETARD

75 mg

Prolonged-release tablet

Oral use

Belgium

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Diclofenac potassium

DICLOFENAC-K-TEVA 50 MG COMPR

50 mg

Film-coated tablet

Oral use

Belgium

RATIOPHARM BELGIUM S.A.

Rue Saint-Lambert 141

1200 Woluwé-saint-lambert

Belgium

Diclofenac sodium

DICLOFENAC-RATIOPHARM 50 MG GASTRO-

50 mg

Gastro-resistant tablet

Oral use

Belgium

LABORATORIA QUALIPHAR N.V/S.A

Rijksweg 9

2880 Bornem

Belgium

Diclofenac sodium

DICLOFENACUM NATRI QUALIPHAR 50 MG

50 mg

Gastro-resistant tablet

Oral use

Belgium

SOCOBOM N.V.

Louizalaan 149 box 24

1050 Ixelles

Belgium

Diclofenac sodium

FLAMPHAR 50 MG

50 mg

Tablet

Oral use

Belgium

Daiichi Sankyo Belgium SA

Rue Fond Jean Pâques 5

B-1348 Louvain-la-Neuve

Belgium

Diclofenac sodium

MOTIFENE 75 MG

75 mg

Modified-release capsule

Oral use

Belgium

SOCOBOM N.V.

Louizalaan 149 box 24

1050 Ixelles

Belgium

Diclofenac sodium

POLYFLAM 75 MG

75 mg

Prolonged-release tablet

Oral use

Belgium

SOCOBOM N.V.

Louizalaan 149 box 24

1050 Ixelles

Belgium

Diclofenac sodium

POLYFLAM EX RUFIMAX EX ALGIRHUMA 50 MG

50 mg

Coated tablet

Oral use

Belgium

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN 100

100 mg

Suppository

Rectal use

Belgium

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN 25

25 mg

Gastro-resistant tablet

Oral use

Belgium

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN 50

50 mg

Gastro-resistant tablet

Oral use

Belgium

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN 75 MG/3 ML

75 mg/3 ml

Solution for injection

Intramuscular use

Belgium

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN RETARD 100

100 mg

Tablet

Oral use

Belgium

NOVARTIS PHARMA N.V.

Medialaan, 40, box 1

1800 Vilvoorde

Belgium

Diclofenac sodium

VOLTAREN RETARD 75 MG

75 mg

Tablet

Oral use

Belgium

Novartis Consumer Health S.A.

Medialaan, 40

B-1800 Vilvoorde

Belgium

Diclofenac potassium

VOLTATABS 12,5 MG(EX:ZYMAMED)

12,5 mg

Coated tablet

Oral use

Bulgaria

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

Almiral

50 mg

Gastro-resistant tablet

Oral use

Bulgaria

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

Almiral

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Bulgaria

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenac sodium

Diclofenac Duo

75 mg

Prolonged-release capsule, hard

Oral use

Bulgaria

Tchaikapharma Highquality Medicines

1 G. M. Dimitrov Blvd.

Sofia 1172

Bulgaria

Diclofenac sodium

Diclofenac-Tchaikapharma

50 mg

Gastro-resistant tablet

Oral use

Bulgaria

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Bulgaria

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac

75 mg

Modified-release tablet

Oral use

Bulgaria

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac

150 mg

Modified-release tablet

Oral use

Bulgaria

Sopharma Pharmaceuticals

5 Lachezar Stanchev Str.

Sofia 1220

Bulgaria

Diclofenac sodium

Feloran

100 mg

Suppository

Rectal use

Bulgaria

Actavis EAD

29 Atanas Dukov Str.

Sofia 1407

Bulgaria

Diclofenac sodium

Feloran Actavis

100 mg

Prolonged-release tablet

Oral use

Bulgaria

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

Naklofen SR

100 mg

Prolonged-release tablet

Oral use

Bulgaria

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

Naklofen DUO

75 mg

Modified-release capsule, hard

Oral use

Bulgaria

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

Naklofen

75 mg/3 ml

Solution for injection

Intramuscular use

Bulgaria

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac sodium

Naklofen

50 mg

Gastro-resistant tablet

Oral use

Bulgaria

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Orphenadrine citrate

Neodolpasse

75 mg/250 ml

30 mg/250 ml

Solution for infusion

Intravenous use

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

25 mg

Gastro-resistant tablet

Oral use

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

100 mg

Suppository

Rectal use

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

50 mg

Suppository

Rectal use

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac potassium

Voltfast

50 mg

Powder for oral solution

Oral use

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

50 mg

Gastro-resistant tablet

Oral use

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren Retard

100 mg

Prolonged-release tablet

Oral use

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Bulgaria

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassium

Voltaren Dolo

12,5 mg

Capsule, soft

Oral use

Bulgaria

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassium

Voltaren Dolo

12,5 mg

Film-coated tablet

Oral use

Bulgaria

Sopharma Pharmaceuticals

5 Lachezar Stanchev Str.

Sofia 1220

Bulgaria

Diclofenac sodium

Feloran

25 mg/ml

solution for injection

Intramuscular use, Intravenous use

Cyprus

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ALMIRAL INJECTION 75 MG/3 ML

75 mg/3 ml

Injection

Intramuscular use

Cyprus

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ALMIRAL SUPPOSITORY 100 MG

100 mg

Suppository

Rectal use

Cyprus

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ALMIRAL SUPPOSITORY 50 MG

50 mg

Suppository

Rectal use

Cyprus

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ALMIRAL GASTRO-RESISTANT TABLET 25 MG

25 mg

Tablet

Oral use

Cyprus

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ALMIRAL GASTRO-RESISTANT TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

ARESTON TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac potassium

CATAFLAM ORAL DROPS 1,5 %

15 mg/ml

Oral drops, solution

Oral use

Cyprus

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac potassium

CATAFLAM COATED TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

P.T.Hadjigeorgiou CO ltd,

P.O.Box 53158

3301 Lemesos

Cyprus

Diclofenac sodium

DICLAC INJECTION 75 MG/3 ML

75 mg/3 ml

Injection

Intramuscular use

Cyprus

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

DICLAC 50 HEXAL GASTRO-RESISTANT TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

DICLAC 75 ID HEXAL SUSTAINED RELEASE TABLET 75 MG

75 mg

Tablet

Oral use

Cyprus

Medlink Pharmaceuticals ltd

30 Armenias Str.

P.O.Box 26576

Strovolos

Cyprus

Diclofenac sodium

DIFENE DUAL CAPSULE 100 MG

100 mg

Capsule

Oral use

Cyprus

Medlink Pharmaceuticals ltd

30 Armenias Str.

P.O.Box 26576

Strovolos

Cyprus

Diclofenac sodium

DIFENE DUAL CAPSULE 75 MG

75 mg

Capsule

Oral use

Cyprus

Interpak ltd

Aharnon st

Industrial Estate

P.O. Box 51166

3502 Lemesos

Cyprus

Diclofenac sodium

NERITAN GASTRO RESISTANT TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

Interpak ltd

Aharnon st

Industrial Estate

P.O. Box 51166

3502 Lemesos

Cyprus

Diclofenac sodium

NERITAN GASTRO RESISTANT TABLET 25 MG

25 mg

Tablet

Oral use

Cyprus

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

Diclofenac sodium

REMETHAN SUPPOSITORY 100 MG

100 mg

Suppository

Rectal use

Cyprus

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

Diclofenac sodium

REMETHAN SUSTAINED RELEASE TABLET 100 MG

100 mg

Tablet

Oral use

Cyprus

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

Diclofenac sodium

REMETHAN GASTRO RESISTANT TABLET 25 MG

25 mg

Tablet

Oral use

Cyprus

Remedica ltd

Aharnon str.

P.O. Box 51706

Lemesos

Cyprus

Diclofenac sodium

REMETHAN GASTRO RESISTANT TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

Codal Synto ltd

33 Theklas Lysioti str.

P.O. Box 51785

Lemesos

Cyprus

Diclofenac sodium

TAKS INJECTION 75 MG/3 ML

75 mg/3 ml

Injection

Intramuscular use

Cyprus

Codal Synto ltd

33 Theklas Lysioti str.

P.O. Box 51785

Lemesos

Cyprus

Diclofenac sodium

TAKS GASTRO RESISTANT TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN INJECTION 75 MG/3 ML

75 mg/3 ml

Injection

Intramuscular use

Cyprus

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN SUPPOSITORY 100 MG

100 mg

Suppository

Rectal use

Cyprus

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN SUPPOSITORY 50 MG

50 mg

Suppository

Rectal use

Cyprus

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN GASTRO RESISTANT TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN D DISPERSIBLE TABLET 50 MG

50 mg

Tablet

Oral use

Cyprus

Novartis Hellas S.A.C.I.

12th km

National Road No1

Metamorfosi Attiki

Athens

Greece

Diclofenac sodium

VOLTAREN DOLO FILM COATED TABLET 12,5 MG

12,5 mg

Tablet

Oral use

Cyprus

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN FOR CHILDREN SUPPOSITORY 12,5 MG

12,5 mg

Suppository

Rectal use

Cyprus

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN RETARD SUSTAINED RELEASE TABLET 100 MG

100 mg

Tablet

Oral use

Cyprus

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

VOLTAREN SR SUSTAINED RELEASE TABLET 75 MG

75 mg

Tablet

Oral use

Czech Republic

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenacum natricum

ALMIRAL

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Czech Republic

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenacum natricum

ALMIRAL 50

50 mg

Gastro-resistant tablet

Oral use

Czech Republic

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenacum natricum

APO-DICLO SR 100

100 mg

Modified-release tablet

Oral use

Czech Republic

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenacum natricum

APO-DICLO 25 MG

25 mg

Gastro-resistant tablet

Oral use

Czech Republic

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenacum natricum

APO-DICLO 50 MG

50 mg

Gastro-resistant tablet

Oral use

Czech Republic

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenacum natricum

DICLOFENAC AL RETARD

100 mg

Prolonged-release tablet

Oral use

Czech Republic

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenacum natricum

DICLOFENAC AL 25

25 mg

Film-coated tablet

Oral use

Czech Republic

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenacum natricum

DICLOFENAC AL 50

50 mg

Film-coated tablet

Oral use

Czech Republic

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenacum natricum

DICLOFENAC DUO PHARMASWISS 75 MG

75 mg

Modified-release capsule, hard

Oral use

Czech Republic

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum natricum

DICLOREUM

25 mg/ml

Solution for injection

Intramuscular use

Czech Republic

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum natricum

DICLOREUM RETARD

100 mg

Prolonged-release tablet

Oral use

Czech Republic

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum natricum

DICLOREUM 100

100 mg

Suppository

Rectal use

Czech Republic

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum natricum

DICLOREUM 50

50 mg

Suppository

Rectal use

Czech Republic

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum natricum

DICLOREUM 50

50 mg

Gastro-resistant tablet

Oral use

Czech Republic

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

DICUNO 25 MG POTAHOVANÉ TABLETY

25 mg

Film-coated tablet

Oral use

Czech Republic

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

DICUNO 50 MG POTAHOVANÉ TABLETY

50 mg

Film-coated tablet

Oral use

Czech Republic

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10 - Dolní Měcholupy

Czech Republic

Diclofenacum natricum

DOLMINA INJ

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Czech Republic

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10 - Dolní Měcholupy

Czech Republic

Diclofenacum natricum

DOLMINA 100 SR

100 mg

Prolonged-release tablet

Oral use

Czech Republic

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10 - Dolní Měcholupy

Czech Republic

Diclofenacum natricum

DOLMINA 50

50 mg

Film-coated tablet

Oral use

Czech Republic

IBSA Slovakia s.r.o.

Mytna 42

811 05 Bratislava

Slovak Republic

Diclofenacum epolaminum

FLECTOR EP RAPID 50 MG

50 mg

Granules for oral solution

Oral use

Czech Republic

Winthrop Arzneimittel GmbH

Industriestrasse 26

Mülheim-Kärlich

Germany

Diclofenacum natricum

MONOFLAM 100 MG

100 mg

Suppository

Rectal use

Czech Republic

Winthrop Arzneimittel GmbH

Industriestrasse 26

Mülheim-Kärlich

Germany

Diclofenacum natricum

MONOFLAM 50 MG

50 mg

Gastro-resistant tablet

Oral use

Czech Republic

Dr. R. Pfleger Chemische Fabrik GmbH

Dr.Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenacum natricum

MYOGIT 25

25 mg

Gastro-resistant tablet

Oral use

Czech Republic

Dr. R. Pfleger Chemische Fabrik GmbH

Dr.Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenacum natricum

MYOGIT 50

50 mg

Gastro-resistant tablet

Oral use

Czech Republic

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenacum natricum

NAKLOFEN DUO TOBOLKY

75 mg

Modified-release capsule, hard

Oral use

Czech Republic

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Orphenadrine citrate

Neodolpasse

75 mg/250 ml

30 mg/250 ml

Solution for infusion

Intravenous use

Czech Republic

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

OLFEN-100 SR

100 mg

Prolonged-release capsule, hard

Oral use

Czech Republic

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

OLFEN-50

50 mg

Film-coated tablet

Oral use

Czech Republic

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

OLFEN-75

37,5 mg/ml

Solution for injection

Intramuscular use

Czech Republic

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum natricum

UNO

150 mg

Prolonged-release tablet

Oral use

Czech Republic

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenacum natricum

VERAL 100 MG

100 mg

Suppository

Rectal use

Czech Republic

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenacum natricum

VERAL 100 RETARD

100 mg

Modified-release tablet

Oral use

Czech Republic

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenacum natricum

VERAL 25 MG

25 mg

Gastro-resistant tablet

Oral use

Czech Republic

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenacum natricum

VERAL 50 MG

50 mg

Gastro-resistant tablet

Oral use

Czech Republic

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenacum natricum

VERAL 75

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Czech Republic

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenacum natricum

VERAL 75 RETARD

75 mg

Modified-release tablet

Oral use

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenacum natricum

VOLTAREN

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenacum natricum

VOLTAREN RETARD

100 mg

Prolonged-release tablet

Oral use

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenacum natricum

VOLTAREN 50

50 mg

Gastro-resistant tablet

Oral use

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac potassium

VOLTAREN RAPID 50 MG TABLETY

50 mg

Coated tablet

Oral use

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac potassium

VOLTAREN ACTIGO

12,5 mg

Film-coated tablet

Oral use

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac potassium

VOLTAREN ACTIGO EXTRA

25 mg

Coated tablet

Oral use

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac potassium

VOLTAREN RAPID 12,5 MG

12,5 mg

Capsule, soft

Oral use

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle

Czech Republic

Diclofenac potassium

VOLTAREN RAPID 25 MG

25 mg

Capsule, soft

Oral use

Denmark

PharmaCoDane ApS

Marielundvej 46 A

DK-2730 Herlev

Denmark

Diclofenac

Diclodan

50 mg

Suppository

Rectal use

Denmark

PharmaCoDane ApS

Marielundvej 46 A

DK-2730 Herlev

Denmark

Diclofenac

Diclodan

100 mg

Suppository

Rectal use

Denmark

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Købenahvn S

Denmark

Diclofenac

Diclon

100 mg

Suppository

Rectal use

Denmark

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Købenahvn S

Denmark

Diclofenac

Diclon Rapid

50 mg

Film-coated tablet

Oral use

Denmark

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Købenahvn S

Denmark

Diclofenac

Diclon Rapid

25 mg

Film-coated tablet

Oral use

Denmark

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenac

Diklofenak "Mylan"

50 mg

Gastro-resistant tablet

Oral use

Denmark

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac

Diklofenak "Orifarm"

25 mg

Gastro-resistant tablet

Oral use

Denmark

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac

Diklofenak "Orifarm"

50 mg

Gastro-resistant tablet

Oral use

Denmark

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac

Modifenac

75 mg

Modified-release capsule

Oral use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren

25 mg

Gastro-resistant tablet

Oral use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren

50 mg

Gastro-resistant tablet

Oral use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren

100 mg

Suppository

Rectal use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren

25 mg/ml

Solution for injection

Intramuscular use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren

50 mg

Suppository

Rectal use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Dolo

12,5 mg

Film-coated tablet

Oral use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Dolo

12,5 mg

Capsule, soft

Oral use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Dolo

12,5 mg

Tablet

Oral use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Rapid

50 mg

Tablet

Oral use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Retard

100 mg

Prolonged-release tablet

Oral use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Denmark

Diclofenac

Voltaren Retard

75 mg

Prolonged-release tablet

Oral use

Denmark

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenac

Diclofenac "BMM Pharma"

50 mg

Gastro-resistant tablet

Oral use

Denmark

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenac

Diclofenac "BMM Pharma"

25 mg

Gastro-resistant tablet

Oral use

Denmark

Actavis Nordic A/S

Ørnegårdsvej 16

DK-2820 Gentofte

Denmark

Diclofenac

Diclofenac Rapid "Actavis"

50 mg

Film-coated tablet

Oral use

Denmark

Actavis Nordic A/S

Ørnegårdsvej 16

DK-2820 Gentofte

Denmark

Diclofenac

Diclofenac Rapid "Actavis"

25 mg

Film-coated tablet

Oral use

Denmark

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac

Diclofenac Rapid "Orifarm"

50 mg

Film-coated tablet

Oral use

Denmark

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac

Diclofenac Rapid "Orifarm"

25 mg

Film-coated tablet

Oral use

Denmark

Teva Denmark A/S

Parallelvej 10-12

DK-2800 Kongens Lyngby

Denmark

Diclofenac

Diclofenac Rapid "Teva"

50 mg

Film-coated tablet

Oral use

Denmark

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac

Diclon

50 mg

Gastro-resistant tablet

Oral use

Denmark

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac

Diclon

100 mg

Prolonged-release tablet

Oral use

Denmark

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac

Diclon

75 mg

Prolonged-release tablet

Oral use

Denmark

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac

Diclon

25 mg

Gastro-resistant tablet

Oral use

Denmark

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac

Diclopax

25 mg

Film-coated tablet

Oral use

Denmark

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac

Diclopax

50 mg

Film-coated tablet

Oral use

Denmark

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac

Diklotab

25 mg

Film-coated tablet

Oral use

Denmark

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac

Diklotab

50 mg

Film-coated tablet

Oral use

Denmark

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenac

Eeze

25 mg

Film-coated tablet

Oral use

Denmark

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac

Fenacta

12,5 mg

Film-coated tablet

Oral use

Denmark

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno

50 mg

Film-coated tablet

Oral use

Denmark

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno

25 mg

Film-coated tablet

Oral use

Denmark

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Diclofenac

Misoprostol

Arthrotec

50 mg

0,2 mg

Tablet

Oral use

Denmark

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Diclofenac

Misoprostol

Arthrotec Forte

75 mg

0,2 mg

Tablet

Oral use

Estonia

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac

DICLOBERL 75 MG/3 ML

25 mg/ml

Solution for injection

Intramuscular use

Estonia

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac

DICLOBERL RETARD

100 mg

Prolonged-release capsule, hard

Oral use

Estonia

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

DICLOMELAN 50 MG

50 mg

Gastro-resistant tablet

Oral use

Estonia

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

DICLOMELAN

100 mg

Suppository

Rectal use

Estonia

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

DICLOMELAN RETARD 100 MG

100 mg

Prolonged-release tablet

Oral use

Estonia

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

NAKLOFEN

50 mg

Gastro-resistant tablet

Oral use

Estonia

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

NAKLOFEN

50 mg

Suppository

Rectal use

Estonia

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

NAKLOFEN

25 mg/ml

Solution for injection

Intramuscular use

Estonia

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

NAKLOFEN SR

100 mg

Prolonged-release tablet

Oral use

Estonia

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac

ALMIRAL

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Estonia

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

OLFEN DEPOCAPS

100 mg

Prolonged-release capsule, hard

Oral use

Estonia

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

OLFEN DEPOCAPS

75 mg

Prolonged-release tablet

Oral use

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

CATAFLAM

50 mg

Coated tablet

Oral use

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

VOLTAREN

25 mg/ml

Solution for injection

Intramuscular use

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

VOLTAREN RETARD

100 mg

Prolonged-release tablet

Oral use

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

VOLTAREN AKTI

12,5 mg

Film-coated tablet

Oral use

Estonia

Pfizer Enterprises SARL

Round-Point du Kirchberg

51, Avenue J.F.Kennedy

L-1855 Luxembourg

Luxembourg

Diclofenac

Misoprostol

ARTHROTEC

50 mg

0,2 mg

Modified-release tablet

Oral use

Estonia

Pharmaswiss Eesti OÜ

Tammsaare tee 47

11316 Tallinn

Estonia

Diclofenac

DICLORAPID

75 mg

Gastro-resistant capsule, hard

Oral use

Estonia

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

DICLOFENAC- RATIOPHARM 50 MG

50 mg

Gastro-resistant tablet

Oral use

Estonia

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

DICLOFENAC-RATIOPHARM 50 MG

50 mg

Suppository

Rectal use

Estonia

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

DICLOFENAC-RATIOPHARM 100 MG

100 mg

Suppository

Rectal use

Estonia

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

DICLOFENAC-RATIOPHARM 75 MG/2 ML

75 mg/2 ml

Solution for injection

Intramuscular use

Estonia

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

DICLOFENAC-RATIOPHARM UNO

150 mg

Modified-release tablet

Oral use

Estonia

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

DICLAC 100

100 mg

Suppository

Rectal use

Estonia

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

DICLAC

25 mg/ml

Solution for injection

Intramuscular use

Estonia

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

DICLAC ID 75 MG

75 mg

Modified-release tablet

Oral use

Estonia

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

DICLAC ID 150 MG

150 mg

Modified-release tablet

Oral use

Estonia

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

DICLAC 100 MG

100 mg

Prolonged-release tablet

Oral use

Estonia

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

DICUNO

25 mg

Film-coated tablet

Oral use

Estonia

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

DICUNO

50 mg

Film-coated tablet

Oral use

Finland

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenacum kalium

Diclofenac Rapid Orifarm

50 mg

Film-coated tablet

oral use

Finland

ratiopharm Oy

P.O.Box 67

02631 Espoo

Finland

Diclofenacum kalium

Diclomex Rapid

50 mg

Film-coated tablet

oral use

Finland

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenacum kalium

Dicuno

25 mg

Film-coated tablet

oral use

Finland

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenacum kalium

Dicuno

50 mg

Film-coated tablet

oral use

Finland

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenacum kalium

Eeze

25 mg

Film-coated tablet

oral use

Finland

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum kalium

Voltaren Rapid

25 mg

Coated tablet

oral use

Finland

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum kalium

Voltaren Rapid

50 mg

Coated tablet

oral use

Finland

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum kalium

Voltfast

50 mg

Powder for oral solution

oral use

Finland

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Diclofenacum natricum

Misoprostolum

Arthrotec

50 mg

0,2 mg

Tablet

oral use

Finland

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Diclofenacum natricum

Misoprostolum

Arthrotec Forte

75 mg

0,2 mg

Prolonged-release tablet

oral use

Finland

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenacum natricum

Diclofenac BMM Pharma

25 mg

Gastro-resistant tablet

oral use

Finland

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenacum natricum

Diclofenac BMM Pharma

50 mg

Gastro-resistant tablet

oral use

Finland

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum natricum

Diclomex

25 mg

Gastro-resistant tablet

oral use

Finland

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum natricum

Diclomex

50 mg

Gastro-resistant tablet

oral use

Finland

Oy Stada Pharma Ab

P.O.Box 1310

00101 Helsinki

Finland

Diclofenacum natricum

Motifene Dual

75 mg

Prolonged-release capsule

oral use

Finland

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum natricum

Voltaren

100 mg

Suppository

rectal use

Finland

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum natricum

Voltaren

25 mg

Gastro-resistant tablet

oral use

Finland

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum natricum

Voltaren

25 mg/ml

Solution for injection /concentrate for solution for infusion

Intramuscular use, Intravenous use

Finland

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum natricum

Voltaren

50 mg

Gastro-resistant tablet

oral use

Finland

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum natricum

Voltaren Retard

100 mg

Prolonged-release tablet

oral use

Finland

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum natricum

Voltaren Retard

75 mg

Prolonged-release tablet

oral use

France

Laboratoires Genevrier

280, rue de Goa

Les Trois Moulins - Parc de Sophia Antipolis

06600 Antibes

France

Diclofenac epolamine

FLECTOR 25 mg, granulés pour solution buvable en sachet-dose

25 mg

Granules for oral solution

Oral use

France

Laboratoires Genevrier

280, rue de Goa

Les Trois Moulins - Parc de Sophia Antipolis

06600 Antibes

France

Diclofenac epolamine

FLECTOR 50 mg, granulés pour solution buvable en sachet-dose

50 mg

Granules for oral solution

Oral use

France

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

DICLOFENAC ACTAVIS 12,5 mg, comprimé pelliculé

12,5 mg

Film-coated tablet

Oral use

France

NOVARTIS SANTE FAMILIALE

14, boulevard Richelieu

92500 Rueil-Malmaison

France

Diclofenac potassium

VOLTARENDOLO 12,5 mg, comprimé enrobé

12,5 mg

Coated tablet

Oral use

France

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

Diclofenac sodium

DICLOFENAC ARROW 50 mg, comprimé gastro-résistant

50 mg

Gastro-resistant tablet

Oral use

France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

Diclofenac sodium

DICLOFENAC BIOGARAN 50 mg, comprimé pelliculé gastrorésistant

50 mg

Film-coated gastro-resistant tablet

Oral use

France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

Diclofenac sodium

DICLOFENAC BIOSTABILEX 50 mg, comprimé gastro-résistant

50 mg

Gastro-resistant tablet

Oral use

France

CRISTERS

22 quai Gallieni

92150 Suresnes

France

Diclofenac sodium

DICLOFENAC CRISTERS 50 mg, comprimé gastro-résistant

50 mg

Gastro-resistant tablet

Oral use

France

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

Diclofenac sodium

DICLOFENAC EG 50 mg, comprimé gastro-résistant

50 mg

Gastro-resistant tablet

Oral use

France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

Diclofenac sodium

DICLOFENAC MYLAN 25 mg, comprimé gastro-résistant

25 mg

Gastro-resistant tablet

Oral use

France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

Diclofenac sodium

DICLOFENAC MYLAN 50 mg, comprimé gastro-résistant

50 mg

Gastro-resistant tablet

Oral use

France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

Diclofenac sodium

DICLOFENAC SANDOZ 50 mg, comprimé enrobé gastro-résistant

50 mg

Gastro-resistant coated tablet

Oral use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

Diclofenac sodium

DICLOFENAC TEVA 25 mg, comprimé enrobé gastro-résistant

25 mg

Gastro-resistant coated tablet

Oral use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

Diclofenac sodium

DICLOFENAC TEVA 50 mg, comprimé enrobé gastro-résistant

50 mg

Gastro-resistant coated tablet

Oral use

France

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE 100 mg, suppositoire

100 mg

Suppository

Rectal use

France

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE 25 mg, comprimé gastro-résistant

25 mg

Gastro-resistant tablet

Oral use

France

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE 50 mg, comprimé enrobé gastro-résistant

50 mg

Gastro-resistant coated tablet

Oral use

France

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE 75 mg/3 ml, solution injectable

75 mg/3 ml

Solution for injection

Intramuscular use

France

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE ENFANT, suppositoire

25 mg

Suppository

Rectal use

France

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE LP 100 mg, comprimé enrobé à libération prolongée

100 mg

Prolonged-release coated tablet

Oral use

France

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

France

Diclofenac sodium

VOLTARENE LP 75 mg, comprimé enrobé à libération prolongée

75 mg

Prolonged-release coated tablet

Oral use

France

Pfizer Holding France

23-25, avenue du Docteur Lannelongue

75014 Paris

France

Diclofenac sodium

Misoprostol

ARTOTEC 50 mg/0,2 mg, comprimé gastro-résistant

50 mg

0,2 mg

Gastro-resistant tablet

Oral use

France

Pfizer Holding France

23-25, avenue du Docteur Lannelongue

75014 Paris

France

Diclofenac sodium

Misoprostol

ARTOTEC 75 mg/0,2 mg, comprimé gastro-résistant

75 mg

0,2 mg

Gastro-resistant tablet

Oral use

France

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Diclofenac sodium

Xelaran Brausetablette 25 mg

25 mg

Effervescent tablet

oral use

Germany

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclo 100 retard - 1 A Pharma

100 mg

Prolonged-release tablet

Oral use

Germany

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclo 25 - 1 A Pharma

25 mg

Gastro-resistant tablet

Oral use

Germany

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclo 50 - 1 A Pharma

50 mg

Gastro-resistant tablet

Oral use

Germany

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclo 75 SL - 1 A Pharma

75 mg

Prolonged-release tablet

Oral use

Germany

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclofenac- 1 A Pharma 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

1 A Pharma

Keltenring 1+3

82041 Oberhaching

Germany

Diclofenac sodium

Diclofenac- 1 A Pharma 50 mg Zäpfchen

50 mg

Suppository

Rectal use

Germany

AbZ-Pharma GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclofenac AbZ 25 mg Tabletten

25 mg

Gastro-resistant tablet

Oral use

Germany

AbZ-Pharma GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclofenac AbZ 50 mg Tabletten

50 mg

Gastro-resistant tablet

Oral use

Germany

AbZ-Pharma GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclofenac AbZ 50 mg Trinktabletten

50 mg

Dispersible tablet

Oral use

Germany

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

Diclofenac sodium

Diclo Divido

75 mg

Prolonged-release capsule, hard

Oral use

Germany

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

Diclofenac sodium

Diclo-Divido long

75 mg

Prolonged-release capsule, hard

Oral use

Germany

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

Diclofenac sodium

Diclofenac-Actavis 100 mg

100 mg

Prolonged-release capsule

Oral use

Germany

Actavis Deutschland GmbH & Co. KG

Willy-Brandt-Allee 2

81829 München

Germany

Diclofenac sodium

Diclofenac-Actavis 50 mg

50 mg

Gastro-resistant capsule

Oral use

Germany

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac kalium

Diclo AL akut 12,5 mg

12,5 mg

Film-coated tablet

Oral use

Germany

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL 100

100 mg

Suppository

Rectal use

Germany

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL 25

25 mg

Gastro-resistant tablet

Oral use

Germany

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL 50

50 mg

Gastro-resistant tablet

Oral use

Germany

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL 50 Supp.

50 mg

Suppository

Rectal use

Germany

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL i.m.

75 mg

Solution for injection

Intramuscular use

Germany

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac sodium

Diclofenac AL retard

100 mg

Prolonged-release tablet

Oral use

Germany

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac kalium

Diclofenac-Kalium AL 25 mg Filmtabletten

25 mg

Film-coated tablet

Oral use

Germany

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Diclofenac sodium

Rewodina 25 mg

25 mg

Gastro-resistant tablet

Oral use

Germany

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Diclofenac sodium

Rewodina 50 mg

50 mg

Gastro-resistant tablet

Oral use

Germany

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Diclofenac sodium

Rewodina dual 75 Kaps

75 mg

Capsule

Oral use

Germany

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Diclofenac sodium

Rewodina uno 100

100 mg

Capsule

Oral use

Germany

AWD.pharma GmbH & Co. KG

Wasastr. 50

01445 Radebeul

Germany

Diclofenac sodium

Xelaran Brausetablette 50 mg

50 mg

Effervescent tablet

Oral use

Germany

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac sodium

Dicloberl 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac sodium

Dicloberl 50 mg

Tabletten

50 mg

Gastro-resistent tablet

Oral use

Germany

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac sodium

Dicloberl N 75

75 mg

Solution for injection

Intramuscular use

Germany

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Diclofenac sodium

Diclo dispers

50 mg

Dispersible tablet

Oral use

Germany

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Diclofenac sodium

Diclofenbeta 100

100 mg

Suppository

Rectal use

Germany

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Diclofenac sodium

Diclofenbeta 100 retard

100 mg

Prolonged-release tablet

Oral use

Germany

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Diclofenac sodium

Diclofenbeta 25

25 mg

Gastro-resistant tablet

Oral use

Germany

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Diclofenac sodium

Diclofenbeta 50

50 mg

Gastro-resistant tablet

Oral use

Germany

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Muehlstr. 50

66386 Sankt Ingbert

Germany

Diclofenac sodium

Diclo-saar 100 mg Retardtablette

100 mg

Prolonged-release tablet

Oral use

Germany

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Muehlstr. 50

66386 Sankt Ingbert

Germany

Diclofenac sodium

Diclo-saar 50 mg magensaftresistente Tabletten

50 mg

Gastro-resistant tablet

Oral use

Germany

Chephasaar Chemisch-Pharmazeutische Fabrik GmbH

Muehlstr. 50

66386 Sankt Ingbert

Germany

Diclofenac sodium

Diclo-saar 75 mg SF Injektionslösung

75 mg

Solution for injection

Intramuscular use

Germany

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 100 mg Supp.

100 mg

Suppository

Rectal use

Germany

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 25 mg Tabletten

25 mg

Gastro-resistant tablet

Oral use

Germany

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 50 mg Trinktabletten

50 mg

Dispersible tablet

Oral use

Germany

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 50 mg Supp.

50 mg

Suppository

Rectal use

Germany

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 50 mg Tabletten

50 mg

Gastro-resistant tablet

Oral use

Germany

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac sodium

Diclo-CT 75 mg/2 ml Ampullen

75 mg

Solution for injection

Intramuscular use

Germany

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenac kalium

Diclo-CT akut 12,5 mg Filmtabletten

12,5 mg

Film-coated tablet

Oral use

Germany

Denk Pharma GmbH & Co. KG

Prinzregentenstr. 79

81675 München

Germany

Diclofenac sodium

Diclo-Denk 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

Denk Pharma GmbH & Co. KG

Prinzregentenstr. 79

81675 München

Germany

Diclofenac sodium

DICLO-DENK 100 mg RETARD

100 mg

Prolonged-release tablet

Oral use

Germany

Dexcel Pharma GmbH

Carl-Zeiss-Str. 2

63755 Alzenau

Germany

Diclofenac sodium

Diclofenac Atid 50 mg

50 mg

Gastro-resistant tablet

Oral use

Germany

Dexcel Pharma GmbH

Carl-Zeiss-Str. 2

63755 Alzenau

Germany

Diclofenac sodium

Diclofenac Atid retard

100 mg

Prolonged-release tablet

Oral use

Germany

DOCPHARM Arzneimittelvertrieb GmbH & Co.

Kommanditgesellschaft auf Aktien

Greschbachstr. 7

76229 Karlsruhe

Germany

Diclofenac sodium

Diclafenac PB retard 100 mg

100 mg

Prolonged-release tablet

Oral use

Germany

Dolorgiet GmbH & Co. KG

Otto-von-Guericke-Str. 1

53757 Sankt Augustin

Germany

Diclofenac sodium

Dolgit-Diclo 100

100 mg

Prolonged-release tablet

Oral use

Germany

Dolorgiet GmbH & Co. KG

Otto-von-Guericke-Str. 1

53757 Sankt Augustin

Germany

Diclofenac sodium

Dolgit-Diclo 50

50 mg

Gastro-resistant tablet

Oral use

Germany

Dr. R. Pfleger Chemische Fabrik GmbH

Dr.Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenac sodium

Myogit 100

100 mg

Suppository

Rectal use

Germany

Dr. R. Pfleger Chemische Fabrik GmbH

Dr.Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenac sodium

Myogit 25

25 mg

Gastro-resistant tablet

Oral use

Germany

Dr. R. Pfleger Chemische Fabrik GmbH

Dr.Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenac sodium

Myogit 50

50 mg

Gastro-resistant tablet

Oral use

Germany

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Diclofenac sodium

Diclo KD 100

100 mg

Suppository

Rectal use

Germany

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Diclofenac sodium

Diclo KD 50

50 mg

Suppository

Rectal use

Germany

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Diclofenac sodium

Diclo KD 50

50 mg

Gastro-resistant tablet

Oral use

Germany

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Diclofenac sodium

Diclo KD 75 akut

75 mg

Modified-release capsule, hard

Oral use

Germany

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

12277 Berlin

Germany

Diclofenac sodium

Diclo KD retard

100 mg

Prolonged-release tablet

Oral use

Germany

hameln pharma plus gmbh

Langes Feld 13

31789 Hameln

Germany

Diclofenac sodium

Diclo-Weimer

75 mg

Solution for injection

Intramuscular use

Germany

Hermes Arzneimittel GmbH

Georg-Kalb-Str. 5-8

82049 Großhesselohe

Germany

Diclofenac sodium

Diclofenac Natrium HERMES 25 mg Brausetabletten

25 mg

Effervescent tablet

Oral use

Germany

Hermes Arzneimittel GmbH

Georg-Kalb-Str. 5-8

82049 Großhesselohe

Germany

Diclofenac sodium

Diclofenac Natrium HERMES 50 mg Brausetabletten

50 mg

Effervescent tablet

Oral use

Germany

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

Diclofenac sodium

Diclofenac 100 Heumann Supp.

100 mg

Suppository

Rectal use

Germany

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

Diclofenac sodium

Diclofenac 100 retard Heumenn

100 mg

Prolonged-release tablet

Oral use

Germany

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

Diclofenac sodium

Diclofenac 25 Heumenn

25 mg

Gastro-resistant tablet

Oral use

Germany

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

Diclofenac sodium

Diclofenac 50 Heumann

50 mg

Gastro-resistant tablet

Oral use

Germany

Heumann Pharma GmbH & Generica Co. KG

Südwestpark 50

90449 Nürnberg

Germany

Diclofenac sodium

Diclofenac 50 Heumenn Supp.

50 mg

Suppository

Rectal use

Germany

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac

75 mg

Solution for injection

Intramuscular use

Germany

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 150 mg ID

150 mg

Prolonged-release tablet

Oral use

Germany

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 25

25 mg

Gastro-resistant tablet

Oral use

Germany

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 50

50 mg

Gastro-resistant tablet

Oral use

Germany

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 50 mg Zäpfchen

50 mg

Suppository

Rectal use

Germany

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 75 mg ID

75 mg

Prolonged-release tablet

Oral use

Germany

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac Dispers

50 mg

dispersible tablet

Oral use

Germany

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac potassium

Diclac Dolo 12,5 mg

12,5 mg

Film-coated tablet

Oral use

Germany

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac potassium

Diclac Dolo 25 mg

25 mg

Coated tablet

Oral use

Germany

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac retard

100 mg

Prolonged-release tablet

Oral use

Germany

HIKMA Farmaceutica (Portugal), S.A.

Estrada do Rio da Mo, 8, 8 A e 8 B - Fervenca

2705-906 Terrugem SNT

Portugal

Diclofenac sodium

Diclofenac Hikma 75 mg

75 mg

Solution for injection

Intramuscular use

Germany

Juta Pharma GmbH

Gutenbergstr. 13

24941 Flensburg

Germany

Diclofenac sodium

Jutafenac 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

Germany

Kappler Pharma Consult GmbH

Fonyoder Str. 18

89340 Leipheim

Germany

Diclofenac potassium

Diclofen Kalium KPC 25 mg Filmtabletten

25 mg

Film-coated tablet

Oral use

Germany

KSK-Pharma Vertriebs AG

Finkenstr. 1

76327 Pfinztal-Berghausen

Germany

Diclofenac sodium

Diclo KSK 50 mg

50 mg

Gastro-resistant tablet

Oral use

Germany

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Diclofenac sodium

Diclofenac MEDA 25 mg Brausetabletten

25 mg

Effervescent tablet

Oral use

Germany

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Diclofenac sodium

Diclofenac MEDA 50 mg Brausetabletten

50 mg

Effervescent tablet

Oral use

Germany

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Diclofenac sodium

Diclofenac dura 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

Germany

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Diclofenac sodium

Diclofenac dura 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Diclofenac sodium

Diclofenac dura 25 mg

25 mg

Gastro-resistant tablet

Oral use

Germany

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Diclofenac sodium

Diclofenac dura 50 mg

50 mg

Gastro-resistant tablet

Oral use

Germany

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Diclofenac sodium

Diclofenac Mylan 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

Germany

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassium

Diclofenac NCH 25 mg

25 mg

Coated tablet

Oral use

Germany

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassium

Optalidon Zahnschmerz mit Diclofenac 25 mg

25 mg

Coated tablet

Oral use

Germany

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassium

Voltaren Dolo 12,5 mg

12,5 mg

Film-coated tablet

Oral use

Germany

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassium

Voltaren Dolo 25 mg

25 mg

Coated tablet

Oral use

Germany

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassium

Voltaren Dolo 25 mg

25 mg

Coated tablet

Oral use

Germany

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 München

Germany

Diclofenac potassium

Voltaren Dolo Liquid 12,5 mg

12,5 mg

Capsule, soft

Oral use

Germany

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Codein phosphate hemihydrate

Combaren 50 mg/50 mg Filmtabletten

50 mg

50 mg

Film-coated tablet

Oral use

Germany

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 100 mg retard

100 mg

Prolonged-release tablet

Oral use

Germany

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 25 mg

25 mg

Gastro-resistant tablet

Oral use

Germany

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 25 mg Zäpfchen

25 mg

Suppository

Rectal use

Germany

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 50 mg

50 mg

Gastro-resistant tablet

Oral use

Germany

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren 50 mg Zäpfchen

50 mg

Suppository

Rectal use

Germany

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Voltaren Dispers

50 mg

Dispersible tablet

Oral use

Germany

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac potassium

Voltaren K Migräne 50 mg

50 mg

Coated tablet

Oral use

Germany

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac sodium

Codeine phosphate hemihydrate

Voltaren Plus 50 mg/50 mg Filmtabletten

50 mg

50 mg

Film-coated tablet

Oral use

Germany

Novartis Pharma GmbH

Roonstrasse 25

90426 Nuernberg

Germany

Diclofenac colestyramin

Voltaren Resinat

140 mg

Capsule, hard

Oral use

Germany

Pharmacia GmbH

Linkstrasse 10

10785 Berlin

Germany

Diclofenac sodium

Misoprostol

Arthotec

50 mg

0,2 mg

Coated tablet

Oral use

Germany

Pharmacia GmbH

Linkstrasse 10

10785 Berlin

Germany

Diclofenac sodium

Misoprostol

Arthotec forte

75 mg

0,2 mg

Coated tablet

Oral use

Germany

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 100 mg Retardkapseln

100 mg

Prolonged-release capsule

Oral use

Germany

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 25 mg magensaftresistente Tabletten

25 mg

Gastro-resistant tablet

Oral use

Germany

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 50 mg Disperstabletten

50 mg

Dispersible tablet

Oral use

Germany

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 50 mg magensaftresistente Tabletten

50 mg

Gastro-resistant tablet

Oral use

Germany

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 50 mg Zäpfchen

50 mg

Suppository

Rectal use

Germany

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 75 mg SL Retardkapseln

75 mg

Prolonged-release capsule

Oral use

Germany

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac-ratiopharm 75 mg/2 ml Injektionslösung

75 mg/2 ml

Solution for injection

Intramuscular use

Germany

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac potassium

Diclofenac-ratiopharm Lösung bei Migräne

50 mg/1 ml

Oral drops, solution

Oral use

Germany

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac potassium

Diclofenac-ratiopharm Schmerztabletten 12,5 mg

12,5 mg

Film-coated tablet

Oral use

Germany

Rotexmedica GmbH Arzneimittelwerk

Bunsenstr. 4

22946 Trittau

Germany

Diclofenac sodium

Diclofenac SF-Rotexmedica

75 mg/3 ml

Solution for injection

Intramuscular use

Germany

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

Germany

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz 25 mg magensaftresistente Tabletten

25 mg

Gastro-resistant tablet

Oral use

Germany

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz 50 mg magensaftresistente Tabletten

50 mg

Gastro-resistant tablet

Oral use

Germany

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz 50 mg Zäpfchen

50 mg

Suppository

Rectal use

Germany

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz parenteral 75 mg Injektionslösung

75 mg

Solution for injection

Intramuscular use

Germany

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Diclofenac sodium

Diclofenac Sandoz Uno 150 mg Retardtabletten

150 mg

Prolonged-release tablet

Oral use

Germany

sigapharm GmbH

Temmlerstr. 2

35039 Marburg/Lahn

Germany

Diclofenac sodium

Sigafenac 50 mg Zäpfchen

50 mg

Suppository

Rectal use

Germany

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac STADA 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

Germany

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac STADA 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac STADA 25 mg magensaftresistente Tabletten

25 mg

Gastro-resistant tablet

Oral use

Germany

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac STADA 50 mg magensaftresistente Tabletten

50 mg

Gastro-resistant tablet

Oral use

Germany

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac Stada 50 mg Zäpfchen

50 mg

Suppository

Rectal use

Germany

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac sodium

Diclofenac STADA N 75 mg/3 ml Injektionslösung

75 mg/3 ml

Solution for injection

Intramuscular use

Germany

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac potassium

Diclofenac-Kalium STADA 12,5 mg Filmtabletten

12,5 mg

Film-coated tablet

Oral use

Germany

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Diclofenac potassium

Diclofenac-Kalium STADA 25 mg Filmtabletten

25 mg

Film-coated tablet

Oral use

Germany

T & D Pharma GmbH

Kleine Knopheide 4

32657 Lemgo

Germany

Diclofenac sodium

Allvoran 100 mg Retard

100 mg

Prolonged-release tablet

Oral use

Germany

T & D Pharma GmbH

Kleine Knopheide 4

32657 Lemgo

Germany

Diclofenac sodium

Allvoran SF

75 mg/3 ml

Solution for injection

Intramuscular use

Germany

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Diclofenac sodium

Allvoran 25 mg

25 mg

Gastro-resistant tablet

Oral use

Germany

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Diclofenac sodium

Allvoran 50 mg

50 mg

Gastro-resistant tablet

Oral use

Germany

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Diclofenac sodium

Allvoran S 100 mg

100 mg

Suppository

Rectal use

Germany

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Diclofenac sodium

Allvoran S 50 mg

50 mg

Suppository

Rectal use

Germany

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Diclofenac sodium

Allvoran uno

100 mg

Prolonged-release tablet

Oral use

Germany

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclo-Klinge 75 mg magensaftresistente Hartkapsel

75 mg

Prolonged-release capsule, hard

Oral use

Germany

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclo-Klinge 75 mg spezial

75 mg

Prolonged-release capsule, hard

Oral use

Germany

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclofenac spezial 100 mg Klinge

100 mg

Prolonged-release capsule, hard

Oral use

Germany

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclofenac spezial 75 mg Klinge

75 mg

Prolonged-release capsule, hard

Oral use

Germany

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclofenac Temmler 25 mg Hartkapseln

25 mg

Gastro-resistant capsule, hard

Oral use

Germany

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclofenac Temmler SL 100 mg Retardkapseln

100 mg

Prolonged-release capsule

Oral use

Germany

Temmler Werke GmbH

Weihenstephaner Str. 28

81673 München

Germany

Diclofenac sodium

Diclofenac Temmler SL 75 mg Retardkapseln

75 mg

Prolonged-release capsule

Oral use

Germany

TEOFARMA S.R.L.

Via F.Iii Cervi 8

I-27010 VALLE SALIMBENE (PV)

Italy

Diclofenac sodium

Effekton 100 mg Retardtabletten

100 mg

Prolonged-release tablet

Oral use

Germany

TEOFARMA S.R.L.

Via F.Iii Cervi 8

I-27010 VALLE SALIMBENE (PV)

Italy

Diclofenac sodium

Effekton 100 mg Zäpfchen

100 mg

Suppository

Rectal use

Germany

TEOFARMA S.R.L.

Via F.Iii Cervi 8

I-27010 VALLE SALIMBENE (PV)

Italy

Diclofenac sodium

Effekton 25 mg magensaftresistente Tabletten

25 mg

Gastro-resistant tablet

Oral use

Germany

TEOFARMA S.R.L.

Via F.Iii Cervi 8

I-27010 VALLE SALIMBENE (PV)

Italy

Diclofenac sodium

Effekton 50 mg magensaftresistente Tabletten

50 mg

Gastro-resistant tablet

Oral use

Germany

TEOFARMA S.R.L.

Via F.Iii Cervi 8

I-27010 VALLE SALIMBENE (PV)

Italy

Diclofenac sodium

Effekton 75 mg/3 ml Injektionslösung

75 mg/3 ml

Solution for injection

Intramuscular use

Germany

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Diclofenac sodium

Xelaran Brausetablette 25 mg

25 mg

Effervescent tablet

Oral use

Germany

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Diclotin 25 mg Filmtabletten

25 mg

Film-coated tablet

Oral use

Germany

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Diclotin 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

Germany

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

Diclofenac sodium

Diclowal 100 mg retard

100 mg

Prolonged-release tablet

Oral use

Germany

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

Diclofenac sodium

DICLOWAL 50

50 mg

Gastro-resistant tablet

Oral use

Germany

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

Diclofenac sodium

DICLOWAL 75 mg

75 mg

Solution for injection

Intramuscular use

Germany

Walter Ritter GmbH & Co.

Spaldingstr. 110 B

20097 Hamburg

Germany

Diclofenac sodium

DICLOWAL Supp.

100 mg

Suppository

Rectal use

Germany

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

Diclofenac sodium

Monoflam 100 mg

100 mg

Suppository

Rectal use

Germany

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

Diclofenac sodium

Monoflam 50 mg

50 mg

Gastro-resistant tablet

Oral use

Germany

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

Diclofenac sodium

Monoflam 50 mg

50 mg

Suppository

Rectal use

Germany

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

Diclofenac sodium

Monoflam retard N

100 mg

Prolonged-release capsule, hard

Oral use

Germany

Wörwag Pharma GmbH & Co.KG

Calwer Str. 7

71034 Böblingen

Germany

Diclofenac sodium

Dignofenac 100 mg

100 mg

Prolonged-release tablet

Oral use

Germany

Wörwag Pharma GmbH & Co.KG

Calwer Str. 7

71034 Böblingen

Germany

Diclofenac sodium

Dignofenac 25 mg

25 mg

Gastro-resistant tablet

Oral use

Germany

Wörwag Pharma GmbH & Co.KG

Calwer Str. 7

71034 Böblingen

Germany

Diclofenac sodium

Dignofenac 50 mg

50 mg

Gastro-resistant tablet

Oral use

Greece

PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS

Dilou 9, Peristeri

Attikis, 12134

Greece

Diclofenac sodium

BATAFIL

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

PHARMATHEN International S.A. Greece

Dervenakiwn 4, Pallini

Attikis 15351

Greece

Diclofenac sodium

DELIMON

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Diclofenac sodium

VURDON

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

Diclofenac sodium

EVINOPON

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

DEMO ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

Diclofenac sodium

URIGON

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

Diclofenac sodium

RUVOMINOX

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines

Achaias & Trizinias

Nea Kifissia 14564

Greece

Diclofenac sodium

RHEUMAVEK

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

MEDICUS S.A

Valaoritou 10

Metamorfosi 14452

Greece

Diclofenac sodium

DIFEND

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Greece

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

25 mg

Enteric film-coated tablet

Oral use

Greece

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

50 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

100 mg

Film-coated sustained release tablet

Oral use

Greece

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

75 mg

Film-coated sustained release tablet

Oral use

Greece

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

50 mg

Dispersible tablet

Oral use

Greece

PHARMATHEN International S.A. Greece

Dervenakiwn 4, Pallini

Attikis 15351

Greece

Diclofenac sodium

DELIMON

25 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

PHARMATHEN International S.A. Greece

Dervenakiwn 4, Pallini

Attikis 15351

Greece

Diclofenac sodium

DELIMON

50 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

D.A.S.T. BIOTECH Pharmaceutical Ltd

Larissis 10

Pallini 15351

Greece

Diclofenac sodium

FLEFARMIN

50 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Diclofenac sodium

VURDON

25 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Diclofenac sodium

VURDON

100 mg

Film-coated sustained release tablet

Oral use

Greece

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

Diclofenac sodium

EVINOPON

25 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

Diclofenac sodium

EVINOPON

50 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

DEMO ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

Diclofenac sodium

URIGON

25 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

DEMO ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

Diclofenac sodium

URIGON

50 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

Diclofenac sodium

RUVOMINOX

50 mg

Coated tablet

Oral use

Greece

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

Diclofenac sodium

RUVOMINOX

25 mg

Coated tablet

Oral use

Greece

ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines

Achaias & Trizinias

Nea Kifissia 14564

Greece

Diclofenac sodium

RHEUMAVEK

25 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines

Achaias & Trizinias

Nea Kifissia 14564

Greece

Diclofenac sodium

RHEUMAVEK

50 mg

(Enteric coated) gastroresistant tablet

Oral use

Greece

Pfizer Hellas A.E.

Messoghion Ave. 243

Neo Psychiko 15451

Greece

Diclofenac sodium

Misoprostol

ARTHROTEC

50 mg

0,2 mg

Controlled release tablet

Oral use

Greece

PHARMANEL COMMERCE PHARMACEUTICAL S.A.

Marathonos Avenue 106, Gerakas 15344

Greece

Diclofenac sodium

FENOCLOF

75 mg

Controlled release capsule

Oral use

Greece

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac potassium

VOLTAREN ACTI-GO

25 mg

Coated tablet

Oral use

Greece

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac potassium

VOLTAREN ACTI-GO

50 mg

Coated tablet

Oral use

Greece

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac potassium

VOLTAREN ACTI-GO

12,5 mg

Coated tablet

Oral use

Greece

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac potassium

VOLTAREN FAST

50 mg

Powder for oral solution

Oral use

Greece

PHARMASWISS HELLAS A.E.

Pentelis Avenue 53

Vrilissia 15235

Greece

Diclofenac sodium

DICLO DUO

75 mg

Controlled release capsule

Oral use

Greece

PHARMASWISS HELLAS A.E.

Pentelis Avenue 53

Vrilissia 15235

Greece

Diclofenac sodium

COUNTERFLAME

75 mg

Gastro-resistant capsule

Oral use

Greece

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

50 mg

Suppository

Rectal use

Greece

NOVARTIS (HELLAS) A.E.B.E.

12th Km National Highway No 1,

Metamorfosi Attikis 144 51

Greece

Diclofenac sodium

VOLTAREN

100 mg

Suppository

Rectal use

Greece

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Diclofenac sodium

VURDON

50 mg

Suppository

Rectal use

Greece

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Diclofenac sodium

VURDON

100 mg

Suppository

Rectal use

Greece

BROS EPE

Avgis & Gallinis 15

N. Kifissia, 14564

Greece

Diclofenac sodium

EVINOPON

50 mg

Suppository

Rectal use

Greece

RAFARM AEBE

Korinthou 12

N. Psychiko, 15451

Greece

Diclofenac sodium

RUVOMINOX

50 mg

Suppository

Rectal use

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

CATAFLAM belsőleges szuszpenziós cseppek

15 mg/ml

Oral drops, suspension

Oral use

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

CATAFLAM 50 mg bevont tabletta

50 mg

Coated tablet

Oral use

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

CATAFLAM-V 50 mg tabletta

50 mg

Tablet

Oral use

Hungary

Sandoz Hungária Kft.,

Bartók Béla út 43.-47.

Budapest, 1114

Hungary

Diclofenac

DICLAC 75 mg retard tabletta

75 mg

Prolonged-release tablet

Oral use

Hungary

Sandoz Hungária Kft.,

Bartók Béla út 43.-47.

Budapest, 1114

Hungary

Diclofenac

DICLAC 150 mg retard tabletta

150 mg

Prolonged-release tablet

Oral use

Hungary

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

DICLOFENAC AL 50 mg végbélkúp

50 mg

Suppository

Rectal use

Hungary

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

DICLOFENAC AL 50 mg gyomornedv-ellenálló filmtabletta

50 mg

Gastro-resistant film-coated tablet

Oral use

Hungary

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

DICLOFENAC AL 100 mg végbélkúp

100 mg

Suppository

Rectal use

Hungary

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

DICLOFENAC AL 75 mg/3 ml oldatos injekció

75 mg/3 ml

Solution for injection

Parenteral use,

Intramuscular use

Hungary

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenac

DICLOFENAC DUO PHARMAVIT 75 mg kemény kapszula

75 mg

Capsule, hard

Oral use

Hungary

STADA Arzneimittel AG

Stadastrasse 2-18

Bad Vilbel 61118

Germany

Diclofenac

DICLOFENAC STADA 100 mg retard filmtabletta

100 mg

Prolonged-release film-coated tablet

Oral use

Hungary

ratiopharm Hungária

Kereskedelmi Kft. Uzsoki u. 36/a

Budapest, 1145

Hungary

Diclofenac

DICLOFENAC-RATIOPHARM 25 mg filmtabletta

25 mg

Film-coated tablet

Oral use

Hungary

ratiopharm Hungária

Kereskedelmi Kft. Uzsoki u. 36/a

Budapest, 1145

Hungary

Diclofenac

DICLOFENAC-RATIOPHARM 100 mg retard kemény kapszula

100 mg

Prolonged-release capsule, hard

Oral use

Hungary

ratiopharm Hungária

Kereskedelmi Kft. Uzsoki u. 36/a

Budapest, 1145

Hungary

Diclofenac

DICLOFENAC-RATIOPHARM 50 mg filmtabletta

50 mg

Film-coated tablet

Oral use

Hungary

ratiopharm Hungária

Kereskedelmi Kft. Uzsoki u. 36/a

Budapest, 1145

Hungary

Diclofenac

DICLOFENAC-RATIOPHARM retard tabletta

150 mg

Prolonged-release tablet

Oral use

Hungary

TEVA Gyógyszergyár zRt.

Pallagi út 13

Debrecen 4042

Hungary

Diclofenac

DICLOFENAC-TEVA 100 mg végbélkúp

100 mg

Suppository

Rectal use

Hungary

PANNONPHARMA Gyógyszergyártó Kft.

PannonPharma út 1.

Pécsvárad 7720

Hungary

Diclofenac

DICLOMEL SR 100 mg retard tabletta

100 mg

Prolonged-release tablet

Oral use

Hungary

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Orphenadrine citrate

NEODOLPASSE oldatos infúzió

75 mg/250 ml

30 mg/250 ml

Solution for infusion

Parenteral use,

Intravenous use

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 100 mg retard filmtabletta

100 mg

Prolonged-release film-coated tablet

Oral use

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 25 mg gyomornedv-ellenálló filmtabletta

25 mg

Gastro-resistant film-coated tablet

Oral use

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 50 mg gyomornedv-ellenálló filmtabletta

50 mg

Gastro-resistant film-coated tablet

Oral use

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 50 mg végbélkúp

50 mg

Suppository

Rectal use

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 75 mg retard filmtabletta

75 mg

Prolonged-release film-coated tablet

Oral use

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN 75 mg/3 ml oldatos injekció

75 mg/3 ml

Solution for injection

Parenteral use; Intramuscular injection or intravenous infusion. Not applicable for bolus intravenous injection

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN DOLO 12,5 mg filmtabletta

12,5 mg

Film-coated tablet

Oral use

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN DOLO 12,5 mg lágy kapszula

12,5 mg

Capsule, soft

Oral use

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac

VOLTAREN DOLO 25 mg bevont tabletta

25 mg

Coated tablet

Oral use

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

Budapest, 1114

Hungary

Diclofenac potassium

VOLTAREN DOLO 25 mg lágy kapszula

25 mg

Capsule, soft

Oral use

Hungary

IBSA Pharma Információs és Szolgáltató Kft.

Fodor u. 54/B.

Budapest 1124,

Hungary

Diclofenac

FLECTOR RAPID 50 mg granulátum

50 mg

Granules

Oral use

Hungary

TEVA Gyógyszergyár zRt.

Pallagi út 13

Debrecen 4042

Hungary

Diclofenac

FORTEDOL 50 mg filmtabletta

50 mg

Film-coated tablet

Oral use

Iceland

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Diclofenacum natrium

Misoprostolum

Arthrotec

50 mg

0,2 mg

Tablet

Oral use

Iceland

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Denmark

Diclofenacum natrium

Misoprostolum

Arthrotec Forte

75 mg

0,2 mg

Tablet

Oral use

Iceland

ratiopharm GmbH

Graf-Arco Strasse 3

89079 Ulm

Germany

Diclofenacum INN natríum

Diclomex

50 mg

Gastro-resistant tablet

Oral use

Iceland

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenacum natrium

Diklofenak Mylan

50 mg

Gastro-resistant tablet

Oral use

Iceland

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenacum natrium

Klofen L

100 mg

Prolonged-release capsule, hard

Oral use

Iceland

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenacum natrium

Modifenac

75 mg

Modified-release capsule, hard

Oral use

Iceland

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum natrium

Voltaren

100 mg

Suppository

Rectal use

Iceland

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum natrium

Voltaren

25 mg

Gastro-resistant tablet

Oral use

Iceland

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum natrium

Voltaren

25 mg/ml

Solution for injection

Intramuscular use

Iceland

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum natrium

Voltaren

50 mg

Suppository

Rectal use

Iceland

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum natrium

Voltaren

50 mg

Gastro-resistant tablet

Oral use

Iceland

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum kalium

Voltaren Dolo

12,5 mg

Film-coated tablet

Oral use

Iceland

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum kalium

Voltaren Dolo

12,5 mg

Capsule, soft

Oral use

Iceland

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum kalium

Voltaren Dolo

25 mg

Coated tablet

Oral use

Iceland

Novaris Healthcare A/S

Lyngbyvej 172

DK-2100 Københawn Ø

Denmark

Diclofenacum kalium

Voltaren Rapid

50 mg

Coated tablet

Oral use

Iceland

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenacum kalium

Vóstar-S

25 mg

Film-coated tablet

Oral use

Iceland

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenacum kalium

Vóstar-S

50 mg

Film-coated tablet

Oral use

Ireland

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol 25 mg Gastro-Resistant Tablets

25 mg

Gastro-resistant tablet

Oral use

Ireland

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol 50 mg Gastro-Resistant Tablets

50 mg

Gastro-resistant tablet

Oral use

Ireland

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol 12,5 mg Suppositories

12,5 mg

Suppository

Rectal use

Ireland

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol 100 mg Suppositories

100 mg

Suppository

Rectal use

Ireland

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol Ampoules 75 mg/3 ml, solution for injection

75 mg/3 ml

Solution for injection

Intramuscular use

Ireland

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol Retard 100 mg Film-coated Prolonged Release Tablets

100 mg

Film-coated prolonged release tablet

Oral use

Ireland

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac sodium

Voltarol Retard 75 mg Film-coated Prolonged-release Tablets

75 mg

Film-coated prolonged release tablet

Oral use

Ireland

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac potassium

Cataflam 25 mg Coated Tablets

25 mg

Coated tablet

Oral use

Ireland

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac potassium

Cataflam 50 mg Coated Tablets

50 mg

Coated tablet

Oral use

Ireland

Novarits Pharmacetucials UK Ltd

Frimley Business Park

Frimley

Camberley, GU16 7SR

Surrey

United Kingdom

Diclofenac potassium

Voltfast Sachets 50 mg Powder for Oral Solution

50 mg

Powder for oral solution

Oral use

Ireland

Novartis Consumer Health UK Limited

Park View, Riverside Way

Watchmoor Park, Camberley

Surrey GU15 3YL

United Kingdom

Diclofenac potassium

Diclofenac potassium NCH 12,5 mg Film-coated tablets

12,5 mg

Film-coated tablet

Oral use

Ireland

Novartis Consumer Health UK Limited

Park View, Riverside Way

Watchmoor Park, Camberley

Surrey GU15 3YL

United Kingdom

Diclofenac potassium

Otriflu 12,5 mg Film-coated Tablets

12,5 mg

Film-coated tablet

Oral use

Ireland

Pinewood Laboratories Ltd

(T/A Pinewood Heathcare) Ballymacarbry

Clonmel, Co. Tipperary

Ireland

Diclofenac sodium

Diclo 75 mg prolonged release tablets.

75 mg

Prolonged-release tablet

Oral use

Ireland

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac 75 mg Prolonged -Release Tablets

75 mg

Prolonged-release tablet

Oral use

Ireland

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac Retard 100 mg Prolonged-release Tablets

100 mg

Prolonged-release tablet

Oral use

Ireland

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac 25 mg Gastro-resistant Tablets

25 mg

Gastro-resistant tablet

Oral use

Ireland

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac 50 mg Gastro-resistant Tablets

50 mg

Gastro-resistant tablet

Oral use

Ireland

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac 100 mg Suppositories

100 mg

Suppository

Rectal use

Ireland

Rowex Ltd

Bantry, Co. Cork

Ireland

Diclofenac sodium

Diclac 25 mg/ml Solution for Injection 3 ml Ampoule

25 mg

Solution for injection

Intramuscular use

Ireland

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

Diclofenac sodium

Arthrotec 50 modified release tablets

50 mg

Modified-release tablet

Oral use

Ireland

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

Diclofenac sodium

Arthrotec 75 modified-release tablets

75 mg

Modified-release tablet

Oral use

Ireland

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene 25 mg Capsules

25 mg

Capsule

Oral use

Ireland

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene 50 mg Capsules

50 mg

Capsule

Oral use

Ireland

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene 75 mg Dual Release Capsules

75 mg

Dual release capsule

Oral use

Ireland

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene 100 mg Dual Release Capsules

100 mg

Dual release capsule

Oral use

Ireland

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene ampoules 75 mg/3 ml Solution for Injection or Concentrate for Solution for Infusion

75 mg/3 ml

Solution for injection or concentrate for solution for infusion

Intramuscular use, Intravenous use

Ireland

Astellas Pharma Co. Ltd

5 Waterside

Citywest Busniess Campus Naas Road

Dublin 24

Ireland

Diclofenac sodium

Difene 100 mg Suppositories

100 mg

Suppository

Rectal use

Ireland

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

Kyflam 50 mg Film Coated Tablet

50 mg

Film-coated tablet

Oral use

Ireland

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

Diclofenac Sodium

Misoprostol

Diclofenac 50 mg/Misoprostol 200 micrograms modified release tablets

50 mg

0,2 mg

Modified Release Tablet

Oral use

Ireland

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

Diclofenac Sodium

Misoprostol

Diclofenac 75 mg/Misoprostol 200 micrograms modified release tablets

75 mg

0,2 mg

Modified Release Tablet

Oral use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

50 mg

Soluble tablet

Oral use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

50 mg

Gastro-resistant tablet

Oral use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

75 mg

Prolonged-release tablet

Oral use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

100 mg

Prolonged-release tablet

Oral use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

100 mg

Suppository

Rectal use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac

VOLTAREN

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

Industria Farmaceutica Galenica Senese S.r.l.

Via Cassia Nord

351 Darvia - 53014 Siena

Italy

Diclofenac sodico

ALGOSENAC

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

Bayer S.p.a.

Viale Certosa, 130

Milano - 20156

Italy

Diclofenac hydroxyethylpyrrolidine

BAIFENAC

50 mg

Granules

Oral use

Italy

CostanzaFarma srl

Via Taranto 4

20142 Milano

Italy

Diclofenac sodico

DEALGIC

75 mg

Prolonged-release capsule, hard

Oral use

Italy

CostanzaFarma srl

Via Taranto 4

20142 Milano

Italy

Diclofenac sodico

DEALGIC

100 mg

Prolonged-release capsule, hard

Oral use

Italy

DAICHI SANKYO Italia S.p.a.

Via Paolo Di Dono 73

00142, Rome

Italy

Diclofenac sodico

DEFLAMAT

25 mg/ml

Solution for injection

Intramuscular use

Italy

DAICHI SANKYO Italia S.p.a.

Via Paolo Di Dono 73

00142, Rome

Italy

Diclofenac sodico

DEFLAMAT

75 mg

Prolonged-release capsule, hard

Oral use

Italy

DAICHI SANKYO Italia S.p.a.

Via Paolo Di Dono 73

00142, Rome

Italy

Diclofenac sodico

DEFLAMAT

100 mg

Prolonged-release capsule, hard

Oral use

Italy

Crinos S.p.a.

Via Pavia, 6

Milano - 20136

Italy

Diclofenac sodico

DICLOFAN

100 mg

Prolonged-release tablet

Oral use

Italy

Crinos S.p.a.

Via Pavia, 6

Milano - 20136

Italy

Diclofenac sodico

DICLOFAN

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

Sandoz S.p.a.

Largo Umberto Boccioni, 1

Origgio, Varese - 21040

Italy

Diclofenac sodico

DICLOFENAC

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

Sandoz S.p.a.

Largo Umberto Boccioni, 1

Origgio, Varese - 21040

Italy

Diclofenac sodico

DICLOFENAC

100 mg

Suppository

Rectal use

Italy

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodico

DICLOFENAC ALPHA BIOTECH

50 mg

Suppository

Rectal use

Italy

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodico

DICLOFENAC ALPHA BIOTECH

100 mg

Suppository

Rectal use

Italy

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodico

DICLOFENAC ALPHA BIOTECH

25 mg

Tablet

Oral use

Italy

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodico

DICLOFENAC ALPHA BIOTECH

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodico

DICLOFENAC ALPHA BIOTECH

50 mg

Tablet

Oral use

Italy

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodico

DICLOFENAC ALPHA BIOTECH

100 mg

Prolonged-release tablet

Oral use

Italy

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodico

DICLOFENAC ALPHA BIOTECH

150 mg

Prolonged-release capsule

Oral use

Italy

Alpha Biotech S.r.l.

Via Ragazzi del 99

5, Bologna - 40133

Italy

Diclofenac sodico

DICLOFENAC ALPHA BIOTECH

25 mg/ml

Oral drops, solution

Oral use

Italy

Almus S.r.l.

Via Cesarea, 11/10

Genova - 16121

Italy

Diclofenac sodico

DICLOFENAC ALMUS

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

Diclofenac sodico

DICLOFENAC ANGENERICO

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

Diclofenac sodico

DICLOFENAC ANGENERICO

100 mg

Suppository

Rectal use

Italy

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

Diclofenac sodico

DICLOFENAC ANGENERICO

50 mg

Gastro-resistant tablet

Oral use

Italy

Angenerico S.p.a.

Via Nocera Umbra 75

Roma - 00181

Italy

Diclofenac sodico

DICLOFENAC ANGENERICO

25 mg

Gastro-resistant tablet

Oral use

Italy

Doc Generici S.r.l.

Via Manuzio 7

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC DOC

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

Doc Generici S.r.l.

Via Manuzio 7

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC DOC GENERICI

75 mg

Prolonged-release tablet

Oral use

Italy

Doc Generici S.r.l.

Via Manuzio 7

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC DOC GENERICI

100 mg

Prolonged-release tablet

Oral use

Italy

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC EG

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC EG

50 mg

Gastro-resistant tablet

Oral use

Italy

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC EG

100 mg

Prolonged-release tablet

Oral use

Italy

EG S.p.a

Via Scarlatti, 31

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC EG

100 mg

Suppository

Rectal use

Italy

Germed Pharma S.p.a.

Via Cantu, 11, Balsamo

Milano, 20092

Italy

Diclofenac sodico

DICLOFENAC GERMED

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

HEXAL S.p.a.

Centro Direzionale Colleoni

Palazzo Andromeda

Via Paracelso, 16

Brianza, Milano, 20041

Italy

Diclofenac sodico

DICLOFENAC HEXAL

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

HEXAL S.p.a.

Centro Direzionale Colleoni

Palazzo Andromeda

Via Paracelso, 16

Brianza, Milano, 20041

Italy

Diclofenac sodico

DICLOFENAC HEXAL

100 mg

Suppository

Rectal use

Italy

HEXAL S.p.a.

Centro Direzionale Colleoni

Palazzo Andromeda

Via Paracelso, 16

Brianza, Milano, 20041

Italy

Diclofenac sodico

DICLOFENAC HEXAL

50 mg

Gastro-resistant tablet

Oral use

Italy

HEXAL S.p.a.

Centro Direzionale Colleoni

Palazzo Andromeda

Via Paracelso, 16

Brianza, Milano, 20041

Italy

Diclofenac sodico

DICLOFENAC HEXAL

25 mg

Gastro-resistant tablet

Oral use

Italy

Mylan S.p.a.

Via Vittor Pisani, 20

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC MYLAN GENERICS

100 mg

Prolonged-release tablet

Oral use

Italy

Mylan S.p.a.

Via Vittor Pisani, 20

Milano - 20124

Italy

Diclofenac sodico

DICLOFENAC MYLAN GENERICS

100 mg

Suppository

rectal use

Italy

Sandoz S.p.a.

Largo Umberto Boccioni, 1

Origgio, Varese - 21040

Italy

Diclofenac sodico

DICLOFENAC SODICO

100 mg

Prolonged-release tablet

Oral use

Italy

Biologici Italia Laboratories S.r.l.

Via Serpero, 2

Masate, Milano - 20060

Italy

Diclofenac sodico

DICLOFENAC SODICO BIL

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

50 mg

Suppository

rectal use

Italy

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

100 mg

Suppository

rectal use

Italy

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

100 mg

Prolonged-release tablet

Oral use

Italy

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

150 mg

Prolonged-release capsule, hard

Oral use

Italy

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

50 mg

Granules

Oral use

Italy

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

50 mg

Gastro-resistant tablet

Oral use

Italy

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

25 mg/ml

Oral drops, solution

Oral use

Italy

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac sodico

DICLOREUM

46,5 mg/ml

Oral drops, solution

Oral use

Italy

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac hydroxyethylpyrrolidine

DIEP

25 mg

Gastro-resistant tablet

Oral use

Italy

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac hydroxyethylpyrrolidine

DIEP

25 mg

Granules for oral suspension

Oral use

Italy

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac potassico

EMINOCS

50 mg

Oral drops, solution

Oral use

Italy

Proge Farm S.r.l.

Largo Donegani 4/a

Novara - 28100

Italy

Diclofenac sodico

FENADOL

100 mg

Prolonged-release tablet

Oral use

Italy

Wellington Street Development Pharma Limited

47 Oaklands Drive Rathgar

Dublin 6

Ireland

Diclofenac sodico

FENDER

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

Wellington Street Development Pharma Limited

47 Oaklands Drive Rathgar

Dublin 6

Ireland

Diclofenac sodico

FENDER

100 mg

Prolonged-release tablet

Oral use

Italy

Bayer S.p.a.

Viale Certosa, 130

Milano - 20156

Italy

Diclofenac hydroxyethylpyrrolidine

FLECTOR DOLORE

25 mg

Granules for oral solution

Oral use

Italy

Menarini Industrie Farmaceutiche Riunite S.r.l.

Via Sette Santi 3,

Firenze 50131- Italy

Diclofenac sodico

FLOGOFENAC

100 mg

Prolonged-release capsule, hard

Oral use

Italy

FIDIA Farmaceutici S.p.a.

Via Ponte della Fabbrica

3/a, Abano Terme

Padova - 35031

Italy

Diclofenac potassico

ITAMIFAST

25 mg

Film-coated tablet

Oral use

Italy

FIDIA Farmaceutici S.p.a.

Via Ponte della Fabbrica

3/a, Abano Terme

Padova - 35031

Italy

Diclofenac potassico

ITAMIFAST

50 mg

Film-coated tablet

Oral use

Italy

Scandinavian Regulatory Services, AB

Svardvagen 3B

Stockholm SE-182 33

Sweden

Diclofenac potassico

KAPPADI

25 mg

Film-coated tablet

Oral use

Italy

Scandinavian Regulatory Services, AB

Svardvagen 3B

Stockholm SE-182 33

Sweden

Diclofenac potassico

KAPPADI

50 mg

Film-coated tablet

Oral use

Italy

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac sodico

NOVAPIRINA

25 mg

Coated tablet

Oral use

Italy

O. P. PHARMA S.r.l.

Via Torino 51

Milano - 20123

Italy

Diclofenac sodico

TRAULEN

100 mg

Film-coated tablet

Oral use

Italy

O. P. PHARMA S.r.l.

Via Torino 51

Milano - 20123

Italy

Diclofenac sodico

TRAULEN

75 mg/3 ml

Solution for injection

Intramuscular use

Italy

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac sodico

VOLTADVANCE

25 mg

Powder for oral solution

Oral use

Italy

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac sodico

VOLTADVANCE

25 mg

Film-coated tablet

Oral use

Italy

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac potassico

VOLTFAST

50 mg

Coated tablet

Oral use

Italy

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac potassico

VOLTFAST

25 mg

Coated tablet

Oral use

Italy

Novartis Pharma S.p.A.

Largo Umberto Boccioni, 1

Origgio - 21040 Varese

Italy

Diclofenac potassico

VOLTFAST

50 mg

Granules for oral solution

Oral use

Italy

Altergon Italia S.r.l.

Via Dell'Industria

Pietradefusi - 83030 Avellino

Italy

Diclofenac

INFORCE

75 mg/ml

Solution for injection

Intramuscular use, Subcutaneous use

Italy

Altergon Italia S.r.l.

Via Dell'Industria

Pietradefusi - 83030 Avellino

Italy

Diclofenac sodico

INDICAM

75 mg/ml

Solution for injection

Intramuscular use, Subcutaneous use

Italy

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

Diclofenac sodico

Misoprostolo

MISOFENAC

50 mg

0,2 mg

Tablet

Oral use

Italy

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

Diclofenac sodico

Misoprostolo

MISOFENAC

75 mg

0,2 mg

Modified-release tablet

Oral use

Italy

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

Diclofenac sodico

Misoprostolo

ARTROTEC

50 mg

0,2 mg

Tablet

Oral use

Italy

Pfizer Italia S.r.l.

Via Isonzo 71

Latina 04100

Italy

Diclofenac sodico

Misoprostolo

ARTROTEC

75 mg

0,2 mg

Modified-release tablet

Oral use

Italy

HEXAL AG S.p.a.

Industriestrasse, 25, D-83607

HOLZKIRCHEN

Germany

Diclofenac sodico

DICLOFENAC HEXAL AG

100 mg

Prolonged-release tablet

oral use

Italy

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodico

DICLOFENAC RATIOPHARM

50 mg

Gastro-resistant tablet

oral use

Italy

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodico

DICLOFENAC RATIOPHARM

75 mg/3 ml

solution for injection

Intramuscular use

Latvia

Cipla (UK) Ltd

The Old Post House

Heath Road, Weybridge

Surrey KT138TS

United Kingdom

Diclofenacum natricum

Profenac 75 mg/3 ml solution for injection

75 mg/3 ml

Solution for injection

Intramuscular use

Latvia

Cipla (UK) Ltd

The Old Post House

Heath Road, Weybridge

Surrey KT138TS

United Kingdom

Diclofenacum natricum

Profenac SR 100 mg prolonged-release tablets

100 mg

Prolonged-release tablet

Oral use

Latvia

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum natricum

Diclofenac-ratiopharm 50 mg gastro-resistant tablets

50 mg

Gastro-resistant tablet

Oral use

Latvia

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum natricum

Diclofenac-ratiopharm 25 mg gastro-resistant tablets

25 mg

Gastro-resistant tablet

Oral use

Latvia

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum natricum

Diclofenac-ratiopharm uno 150 mg prolonged-release tablets

150 mg

Prolonged-release tablet

Oral use

Latvia

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum natricum

Diclofenac-ratiopharm 75 mg/2 ml solution for injection

75 mg/2 ml

Solution for injection

Intramuscular use

Latvia

Cipla (UK) Ltd

The Old Post House

Heath Road, Weybridge

Surrey KT138TS

United Kingdom

Diclofenacum natricum

Diclogen 50 mg suppositories

50 mg

Suppository

Rectal use

Latvia

Cipla (UK) Ltd

The Old Post House

Heath Road, Weybridge

Surrey KT138TS

United Kingdom

Diclofenacum natricum

Diclogen 100 mg suppositories

100 mg

Suppository

Rectal use

Latvia

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenacum natricum

Diclac 75 mg/3 ml solution for injection/infusion

75 mg/3 ml

Solution for injection and infusion

Intramuscular use, Intravenous use

Latvia

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenacum natricum

Diclac 100 mg modified release tablets

100 mg

Modified-release tablet

Oral use

Latvia

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenacum natricum

Diclac ID 75 mg modified release tablets

75 mg

Modified-release tablet

Oral use

Latvia

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenacum natricum

Diclac ID 150 mg modified release tablets

150 mg

Modified-release tablet

Oral use

Latvia

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenacum natricum

Diclomelan retard 100 mg sustained-release tablets

100 mg

Prolonged-release tablet

Oral use

Latvia

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenacum natricum

Diclomelan 50 mg gastro-resistant tablets

50 mg

Gastro-resistant tablet

Oral use

Latvia

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenacum natricum

Diclomelan 100 mg suppositories

100 mg

Suppository

Rectal use

Latvia

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenacum natricum

Thiamini hydrochloridum

Pyridoxini hydrochloridum

Cyanocobalaminum

Diclovit hard capsules

50 mg

50 mg

50 mg

0,25 mg

Capsule, hard

Oral use

Latvia

SIA Briz

Rasas iela 5

Riga, LV-1057

Latvia

Diclofenacum natricum

Feloran 75 mg/3 ml solution for injection

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Latvia

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Lidocainum hydrochloridum

Olfen 75 mg/20 mg/2 ml solution for injection

75 mg/2 ml

20 mg/2 ml

Solution for injection

Intramuscular use

Latvia

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen Lactab 50 mg gastro-resistant tablets

50 mg

Gastro-resistant tablet

Oral use

Latvia

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen Depocaps 100 mg prolonged-release capsules, hard

100 mg

Prolonged-release capsule, hard

Oral use

Latvia

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen Rectocaps 100 mg rectal capsules

100 mg

Rectal capsule

Rectal use

Latvia

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen Depotabs 75 mg prolonged release tablets

75 mg

Prolonged-release tablet

Oral use

Latvia

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Dicuno 25 mg film-coated tablets

25 mg

Film-coated tablet

Oral use

Latvia

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Dicuno 50 mg film-coated tablets

50 mg

Film-coated tablet

Oral use

Latvia

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenacum natricum

Dicloberl 75 mg/3 ml solution for injection

75 mg/3 ml

Solution for injection

Intramuscular use

Latvia

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenacum natricum

Dicloberl 100 mg suppositories

100 mg

Suppository

rectal use

Latvia

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenacum natricum

Dicloberl 50 mg gastro-resistant tablets

50 mg

Gastro-resistant tablet

Oral use

Latvia

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenacum natricum

Dicloberl retard 100 mg prolonged release capsules

100 mg

Prolonged-release capsule

Oral use

Latvia

Pharmaceutical Works POLPHARMA SA

ul. Pelplińska 19

83-200 Starogard Gdański

Poland

Diclofenacum natricum

Majamil retard 100 mg prolonged-release tablets

100 mg

Prolonged-release tablet

Oral use

Latvia

A/S “Olainfarm”

Rupnicu iela 5

Olaine, LV – 2114

Latvia

Diclofenac potassium

Dikloferol 50 mg coated tablets

50 mg

Coated tablet

Oral use

Latvia

SIA PharmaSwiss Latvia

Gertrudes iela 54 – 5

Riga, LV 1011

Latvia

Diclofenacum natricum

Diclorapid 75 mg gastro-resistant capsules, hard

75 mg

Gastro-resistant capsule, hard

Oral use

Latvia

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum natricum

Voltaren 75 mg/3 ml solution for injection

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Latvia

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac potassium

Voltaren Akti 12,5 mg film-coated tablets

12,5 mg

Film-coated tablet

Oral use

Latvia

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac potassium

Voltaren Akti 25 mg soft capsules

25 mg

Capsule, soft

Oral use

Latvia

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenacum natricum

Voltaren Retard 100 mg modified-release film-coated tablets

100 mg

Modified-release tablet

Oral use

Latvia

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac potassium

Cataflam 50 mg film-coated tablets

50 mg

Film-coated tablet

Oral use

Latvia

GlaxoSmithKline Latvia SIA

Duntes iela 11

Riga LV - 1013

Latvia

Diclofenacum natricum

Diclofenac 50 mg suppositories

50 mg

Suppository

Rectal use

Latvia

GlaxoSmithKline Latvia SIA

Duntes iela 11

Riga LV - 1013

Latvia

Diclofenacum natricum

Diclofenac 100 mg suppositories

100 mg

Suppository

Rectal use

Latvia

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenacum natricum

Naklofen SR 100 mg prolonged-release tablets

100 mg

Prolonged-release tablet

Oral use

Latvia

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenacum natricum

Naklofen 75 mg/3 ml solution for injection

75 mg/3 ml

Solution for injection

Intramuscular use

Latvia

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenacum natricum

Naklofen 50 mg gastro-resistant tablets

50 mg

Gastro-resistant tablet

Oral use

Latvia

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenacum natricum

Almiral 25 mg/ml solution for injection and infusion

25 mg/ml

Solution for injection and infusion

Intramuscular use, Intravenous use

Latvia

CT Arzneimittel GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Diclofenacum natricum

Diclo CT 75 mg/2 ml solution for injection

75 mg/2 ml

Solution for injection

Intramuscular use

Lithuania

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

Diclac

75 mg/3 ml

Solution for injection/infusion

Intramuscular use, Intravenous use

Lithuania

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

Diclac

100 mg

Prolonged-release tablet

Oral use

Lithuania

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

Diclac ID

75 mg

Modified-release tablet

Oral use

Lithuania

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Diclofenac

Diclac ID

150 mg

Modified-release tablet

Oral use

Lithuania

UAB „PharmaSwiss“

Šeimyniškių g. 21B

LT-09200, Vilnius

Lithuania

Diclofenac

DicloRapid

75 mg

Gastro-resistant capsule, hard

Oral use

Lithuania

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac

Dicloberl

75 mg/3 ml

Solution for injection

Intramuscular use

Lithuania

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac

Dicloberl

50 mg

Gastro-resistant tablet

Oral use

Lithuania

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenac

Dicloberl

100 mg

Suppository

Rectal use

Lithuania

UAB „BERLIN CHEMIE MENARINI BALTIC“

Jasinskio g. 16 a,

01112 Vilnius

Lithuania

Diclofenac

Dicloberl retard

100 mg

Prolonged-release capsule, hard

Oral use

Lithuania

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm

50 mg

Gastro-resistant tablet

Oral use

Lithuania

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm

100 mg

Suppository

Rectal use

Lithuania

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm

50 mg

Suppository

Rectal use

Lithuania

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm

75 mg/2 ml

Solution for injection

Intramuscular use

Lithuania

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm

100 mg

Prolonged-release capsule, hard

Oral use

Lithuania

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclofenac-ratiopharm uno

150 mg

Modified-release tablet

Oral use

Lithuania

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

Diclomelan

100 mg

Suppository

Rectal use

Lithuania

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

Diclomelan

50 mg

Gastro-resistant tablet

Oral use

Lithuania

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

Diclomelan retard

100 mg

Prolonged-release tablet

Oral use

Lithuania

UAB Corpus Medica

Sukilėlių pr. 61

LT-49333 Kaunas

Lithuania

Diclofenac

FELORAN

75 mg/3 ml

Solution for injection

Intramuscular use

Lithuania

Actavis Nordic A/S

Ørnegårdsvej 16

DK-2820 Gentofte

Denmark

Diclofenac

Feloran

100 mg

Prolonged-release tablet

Oral use

Lithuania

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen

75 mg/3 ml

Solution for injection

Intramuscular use

Lithuania

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen

50 mg

Gastro-resistant tablet

Oral use

Lithuania

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen

50 mg

Suppository

Rectal use

Lithuania

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen SR

100 mg

Prolonged-release tablet

Oral use

Lithuania

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Olfen Depocaps

100 mg

Prolonged-release capsule, hard

Oral use

Lithuania

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Olfen Depotabs

75 mg

Prolonged-release tablet

Oral use

Lithuania

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Olfen Lactab

50 mg

Gastro-resistant coated tablet

Oral use

Lithuania

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Olfen Rectocaps

100 mg

Rectal capsule

Rectal use

Lithuania

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren

75 mg/3 ml

Solution for injection/infusion

Intramuscular use, Intravenous use

Lithuania

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren

100 mg

Suppository

Rectal use

Lithuania

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren Akti

25 mg

Coated tablet

Oral use

Lithuania

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren Akti

12,5 mg

Film-coated tablet

Oral use

Lithuania

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren Retard

100 mg

Prolonged-release tablet

Oral use

Lithuania

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Voltaren Akti

25 mg

Capsule, soft

Oral use

Lithuania

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Diclofenac

Cataflam

50 mg

Coated tablet

Oral use

Lithuania

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno

25 mg

Film-coated tablet

Oral use

Lithuania

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno

50 mg

Film-coated tablet

Oral use

Lithuania

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Lidocaine

Olfen

75 mg/2 ml

20 mg/2 ml

Solution for injection

Intramuscular use

Lithuania

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Diclofenac

Thiamine

Pyridoxine

Cyanocobalamin

Diclovit

50 mg

50 mg

50 mg

0,25 mg

Capsule, hard

Oral use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac potassium

Cataflam

50 mg

Coated tablet

Oral use

Luxembourg

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac retard 100

100 mg

Prolonged-release tablet

Oral use

Luxembourg

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac 75 mg/3 ml Injektionslösung

75 mg

solution for injection

Intramuscular use

Luxembourg

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac-100 Zäpfchen

100 mg

suppository

Rectal use

Luxembourg

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac-25

25 mg

Gastro-resistant coated tablet

Oral use

Luxembourg

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac-50

50 mg

Gastro-resistant coated tablet

Oral use

Luxembourg

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac sodium

Diclac-50 Zäpfchen

50 mg

suppository

Rectal use

Luxembourg

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG-25

25 mg

Coated tablet

Oral use

Luxembourg

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG-50

50 mg

Coated tablet

Oral use

Luxembourg

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG retard 75

75 mg

Prolonged-release tablet

Oral use

Luxembourg

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG retard 100

100 mg

Prolonged-release tablet

Oral use

Luxembourg

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG 75 mg/3 ml solution injectable

75 mg

solution for injection

Intramuscular use, Intravenous use

Luxembourg

N.V. Eurogenerics S.A

Esplanade Heysel b 22

B-1020 Bruxelles

Belgium

Diclofenac sodium

Diclofenac EG 100 suppositoire

100 mg

suppository

Rectal use

Luxembourg

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

Diclofenac sodium

Diclofenac Mylan-75 Retard

75 mg

Prolonged-release tablet

Oral use

Luxembourg

Mylan bvba

Rozendal Businesspark

Terhulpsesteenweg 6A

B-1560 Hoeilaart

Belgium

Diclofenac sodium

Diclofenac Mylan-100 Retard

100 mg

Prolonged-release tablet

Oral use

Luxembourg

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac Ratiopharm-100 Zäpfchen

100 mg

suppository

Rectal use

Luxembourg

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac Ratiopharm-25

25 mg

Gastro-resistant coated tablet

Oral use

Luxembourg

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac Ratiopharm-50

50 mg

Gastro-resistant coated tablet

Oral use

Luxembourg

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac Ratiopharm 75 mg/2 ml Injektionslösung

75 mg

solution for injection

Intramuscular use

Luxembourg

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac Retard Ratiopharm-100

100 mg

Prolonged-release capsule, hard

Oral use

Luxembourg

Daiichi Sankyo Belgium SA

Rue Fond Jean Pâques 5

B-1348 Louvain-la-Neuve

Belgium

Diclofenac sodium

Motifene-75

75 mg

Modified- release capsule, hard

Oral use

Luxembourg

Socobom S.A

Avenue Louise 149 b24

B-1050 Bruxelles

Belgium

Diclofenac sodium

Polyflam-50

50 mg

Gastro-resistant coated tablet

Oral use

Luxembourg

Socobom S.A

Avenue Louise 149 b24

B-1050 Bruxelles

Belgium

Diclofenac sodium

Polyflam-75

75 mg

Prolonged-release tablet

Oral use

Luxembourg

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

Diclofenac sodium

Misoprostol

Arthrotec-50

50 mg

0,2 mg

Modified-release capsule, hard

Oral use

Luxembourg

Continental Pharma

Rijksweg, 12

B-2870 Puurs

Belgium

Diclofenac sodium

Misoprostol

Arthrotec-75

75 mg

0,2 mg

Modified-release capsule, hard

Oral use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren-100 Zäpfchen

100 mg

suppository

Rectal use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren-25

25 mg

Gastro-resistant coated tablet

Oral use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren-50

50 mg

Gastro-resistant coated tablet

Oral use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren injekt

75 mg

solution for injection

Intramuscular use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac colestyramine

Voltaren resinat

145,6 mg

Capsule, hard

Oral use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac sodium

Voltaren Retard-100

100 mg

Prolonged-release tablet

Oral use

Luxembourg

Novartis Consumer Health S.A.

Medialaan, 40

B-1800 Vilvoorde

Belgium

Diclofenac potassium

Voltatabs

12,5 mg

Coated tablet

Oral use

Malta

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac potassium

Cataflam

25 mg

Coated tablet

Oral use

Malta

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac potassium

Cataflam

50 mg

Coated tablet

Oral use

Malta

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac potassium

Catafast

50 mg

Powder for oral solution

Oral use

Malta

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

12,5 mg

Suppository

Rectal use

Malta

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

50 mg

Suppository

Rectal use

Malta

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

100 mg

Suppository

Rectal use

Malta

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

25 mg

Gastro-resistant tablet

Oral use

Malta

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

50 mg

Gastro-resistant tablet

Oral use

Malta

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

75 mg/3 ml

Solution for injection

Intramuscular use, intravenous use

Malta

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

50 mg

Dispersible tablet

Oral use

Malta

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

75 mg

Modified-release tablet

Oral use

Malta

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltaren

100 mg

Modified-release tablet

Oral use

Malta

Proge Farm S.r.l.

Largo Donegani 4/a

Novara - 28100

Italy

Diclofenac sodium

Fenadol

100 mg

Suppository

Rectal use

Malta

Proge Farm S.r.l.

Largo Donegani 4/a

Novara - 28100

Italy

Diclofenac sodium

Fenadol

100 mg

Modified-release tablet

Oral use

Malta

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac potassium

Areston

50 mg

Film-coated tablet

Oral use

Malta

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

Almiral 25 mg tablets

25 mg

Gastro-resistant tablet

Oral use

Malta

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

Almiral 50 mg tablets

50 mg

Gastro-resistant tablet

Oral use

Malta

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac sodium

Almiral injection

75 mg/3 ml

Solution for Injection or Infusion

Intramuscular use, intravenous use

Malta

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-75 Ampoules

75 mg/2 ml

Solution for injection

Intramuscular use

Malta

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-25 Lactab

25 mg

Film-coated, gastro-resistant tablet

Oral use

Malta

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-50 Lactab

50 mg

Film-coated, gastro-resistant tablet

Oral use

Malta

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-100 Rectocaps

100 mg

Suppository

Rectal use

Malta

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-75 SR Depotabs

75 mg

Modified-release tablet

Oral use

Malta

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac sodium

Olfen-100 SR Depocaps

100 mg

Modified-release capsule

Oral use

Malta

Remedica Ltd

Limassol Industrial Estate

Aharnon Street

PO Box 51706

CY-3508 Limassol

Cyprus

Diclofenac sodium

Remethan 25 mg Tablets

25 mg

Gastro-resistant tablet

Oral use

Malta

DEMO SA Pharmaceutical Industry

21st km National Road

Athens-Lamia 14568

Athens

Greece

Diclofenac sodium

Urigon 75 mg/3 ml solution for injection

75 mg/3 ml

Solution for injection

Intramuscular use

Norway

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac potassium

Diclofenackalium Orifarm

25 mg

Film-coated tablet

Oral use

Norway

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac potassium

Diclofenackalium Orifarm

50 mg

Film-coated tablet

Oral use

Norway

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassium

Voltarol

12,5 mg

Capsule, soft

Oral use

Norway

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassium

Voltarol

25 mg

Capsule, soft

Oral use

Norway

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassium

Voltarol

12,5 mg

Film-coated tablet

Oral use

Norway

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassium

Voltarol

25 mg

Coated tablet

Oral use

Norway

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassium

Cataflam

12,5 mg

Coated tablet

Oral use

Norway

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassium

Cataflam

50 mg

Coated tablet

Oral use

Norway

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac potassium

Cataflam

50 mg

Powder for oral solution

Oral use

Norway

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Dicuno

25 mg

Film-coated tablet

Oral use

Norway

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Dicuno

50 mg

Film-coated tablet

Oral use

Norway

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Difenassium

25 mg

Film-coated tablet

Oral use

Norway

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Difenassium

50 mg

Film-coated tablet

Oral use

Norway

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

Diclofenac Actavis

12,5 mg

Film-coated tablet

Oral use

Norway

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac sodium

Modifenac

75 mg

Modified- release capsule, hard

Oral use

Norway

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac potassium

DiclofenacKalium ratiopharm

50 mg

Film-coated tablet

Oral use

Norway

Pfizer AS

Lilleakerveien 2B

1324 Lysaker

Norway

Diclofenac sodium

Misoprostol

Arthrotec

50 mg

0,2 mg

Modified-release tablet

Oral use

Norway

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac ratiopharm

25 mg

Gastro-resistant tablet

Oral use

Norway

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac sodium

Diclofenac ratiopharm

50 mg

Gastro-resistant tablet

Oral use

Norway

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

25 mg

Gastro-resistant tablet

Oral use

Norway

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

50 mg

Gastro-resistant tablet

Oral use

Norway

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

25 mg/ml

Solution for infusion /Concentrate for solution for infusion

Parenteral use

Norway

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenac sodium

Diclofenac BMM Pharma

25 mg

Gastro-resistant tablet

Oral use

Norway

BMM Pharma AB

Blasieholmsgatan 2

SE-111 48 Stockholm

Sweden

Diclofenac sodium

Diclofenac BMM Pharma

50 mg

Gastro-resistant tablet

Oral use

Norway

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

25 mg

Suppository

Rectal use

Norway

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

50 mg

Suppository

Rectal use

Norway

Novartis Norge AS

Nydalen Alle 37 A

0484 Oslo

Norway

Diclofenac sodium

Voltaren

100 mg

Suppository

Rectal use

Poland

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

Vostar

12,5 mg

Film-coated tablet

Oral use

Poland

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum natricum

Dicloreum

50 mg

Gastro-resistant film-coated tablet

Oral use

Poland

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum natricum

Dicloreum

25 mg/ml

Solution for injection

Intramuscular use

Poland

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum natricum

Dicloreum retard

100 mg

Prolonged-release capsule

Oral use

Poland

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenacum natricum

Dicloberl retard

100 mg

Prolonged-release capsule

Oral use

Poland

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Diclofenacum natricum

Dicloberl 50

50 mg

Suppository

Rectal use

Poland

GlaxoSmithKline Pharmaceuticals S.A.

Grunwaldzka 189

Poznań 60-322

Poland

Diclofenacum natricum

Diclofenac GSK

50 mg

Suppository

Rectal use

Poland

GlaxoSmithKline Pharmaceuticals S.A.

Grunwaldzka 189

Poznań 60-322

Poland

Diclofenacum natricum

Diclofenac GSK

100 mg

Suppository

Rectal use

Poland

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenacum natricum

Naklofen

25 mg/ml

Solution for injection

Intramuscular use

Poland

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenacum natricum

Naklofen Duo

75 mg

Prolonged-release capsule

Oral use

Poland

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen 100

100 mg

Rectal capsule

Rectal use

Poland

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen 50

50 mg

Rectal capsule

Rectal use

Poland

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Lidocaini hydrochloridum

Olfen 75

37,5 mg/ml

10 mg/ml

Solution for injection

Intramuscular use

Poland

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen 100 SR

100 mg

Prolonged-release capsule

Oral use

Poland

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen 25

25 mg

Film-coated tablet

Oral use

Poland

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenacum natricum

Olfen 50

50 mg

Film-coated tablet

Oral use

Poland

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassium

Voltaren Acti

12,5 mg

Film-coated tablet

Oral use

Poland

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassium

Voltaren Express

12,5 mg

Capsule, soft

Oral use

Poland

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassium

Voltaren Acti Forte

25 mg

Film-coated tablet

Oral use

Poland

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac potassium

Voltaren Express Forte

25 mg

Capsule, soft

Oral use

Poland

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenac potassium

Cataflam 50

50 mg

Film-coated tablet

Oral use

Poland

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum natricum

Voltaren

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Poland

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum natricum

Voltaren

50 mg

Gastro-resistant tablet

Oral use

Poland

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum natricum

Voltaren SR 100

100 mg

Prolonged-release tablet

Oral use

Poland

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum natricum

Voltaren SR 75

75 mg

Prolonged-release tablet

Oral use

Poland

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum natricum

Voltaren

50 mg

Suppository

Rectal use

Poland

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum natricum

Voltaren

25 mg

Suppository

Rectal use

Poland

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum natricum

Voltaren

100 mg

Suppository

Rectal use

Poland

Pfizer Europe MA EEIG

Ramsgate Road

Kent, Sandwich CT13 9NJ

United Kingdom

Diclofenacum

Misoprostolum

Arthrotec Forte

75 mg

0,2 mg

Tablet

Oral use

Poland

Pfizer Europe MA EEIG

Ramsgate Road

Kent, Sandwich CT13 9NJ

United Kingdom

Diclofenacum natricum

Misoprostolum

Arthrotec

50 mg

0,2 mg

Tablet

Oral use

Poland

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenacum natricum

DicloDuo

75 mg

Modified-release capsule

Oral use

Poland

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Dicloratio Retard 100

100 mg

Prolonged-release capsule

Oral use

Poland

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Dicloratio 25

25 mg

Gastro-resistant tablet

Oral use

Poland

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Lidocainum

Dicloratio

75 mg/2 ml

20 mg/2 ml

Solution for injection

Intramuscular use

Poland

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Dicloratio 50

50 mg

Gastro-resistant tablet

Oral use

Poland

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Olfen UNO

150 mg

Prolonged-release capsule

Oral use

Poland

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Dicloratio 100

100 mg

Suppository

Rectal use

Poland

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenacum

Dicloratio 50

50 mg

Suppository

Rectal use

Poland

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenacum natricum

Diclac

75 mg/3 ml

Solution for injection

Intramuscular use

Poland

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenacum natricum

Diclac 75 Duo

75 mg

Modified-release tablet

Oral use

Poland

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenacum natricum

Diclac 150 Duo

150 mg

Modified-release tablet

Oral use

Poland

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenacum natricum

Diclac 100

100 mg

Suppository

Rectal use

Poland

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenacum natricum

Diclac 50

50 mg

Suppository

Rectal use

Poland

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Dicuno

25 mg

Film-coated tablet

Oral use

Poland

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Dicuno

50 mg

Film-coated tablet

Oral use

Poland

Warszawskie Zakłady Farmaceutyczne POLFA S.A.

ul. Karolkowa 22/24

Warszawa 01-207

Poland

Diclofenacum natricum

Difadol

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Poland

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19

Starogard Gdański 83-200

Poland

Diclofenacum natricum

Majamil prolongatum

100 mg

Prolonged-release capsule

Oral use

Poland

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19

Starogard Gdański 83-200

Poland

Diclofenacum natricum

Majamil PPH

25 mg

Gastro-resistant tablet

Oral use

Poland

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19

Starogard Gdański 83-200

Poland

Diclofenacum natricum

Majamil PPH

50 mg

Gastro-resistant tablet

Oral use

Portugal

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Diclofenac

Misoprostol

Arthrotec

50 mg

0,2 mg

Tablet

Oral use

Portugal

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Diclofenac

Misoprostol

Arthrotec 75

75 mg

0,2 mg

Modified-release tablet

Oral use

Portugal

Alter, S.A.

Estrada Marco do Grilo - Zemouto

2830 Coina

Portugal

Diclofenac

Diclofenac Alter 50 mg Comprimidos

50 mg

Coated tablet

Oral use

Portugal

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Diclofenac

Diclofenac Generis 50 mg Comprimidos Revestidos

50 mg

Coated tablet

Oral use

Portugal

Labesfal - Laboratórios Almiro S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Diclofenac

Diclofenac Labesfal

100 mg

Suppository

Rectal use

Portugal

Labesfal - Laboratórios Almiro S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Diclofenac

Diclofenac Labesfal

100 mg

Prolonged-release capsule, hard

Oral use

Portugal

Labesfal - Laboratórios Almiro S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Diclofenac

Diclofenac Labesfal

50 mg

Gastro-resistant tablet

Oral use

Portugal

Labesfal - Laboratórios Almiro, S.A.

Campo de Besteiros

3465-051 Santiago de Besteiros

Portugal

Diclofenac

Diclofenac Labesfal 75 mg/3 ml Solução injectável

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Portugal

Mylan, Lda.

Rua Doutor António Loureiro Borges

Edíficio Arquiparque 1

R/C Esqo

1499-016 Algés

Portugal

Diclofenac

Diclofenac Mylan

100 mg

Prolonged-release capsule, hard

Oral use

Portugal

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda

Rua Quinta do Pinheiro

Edifício Tejo - 6o Piso

2790-143 Carnaxide

Portugal

Diclofenac

Diclofenac Ratiopharm

50 mg

Gastro-resistant tablet

Oral use

Portugal

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda

Rua Quinta do Pinheiro

Edifício Tejo - 6o Piso

2790-143 Carnaxide

Portugal

Diclofenac

Diclofenac Ratiopharm 100 mg Supositórios

100 mg

Suppository

Rectal use

Portugal

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda

Rua Quinta do Pinheiro

Edifício Tejo - 6o Piso

2790-143 Carnaxide

Portugal

Diclofenac

Diclofenac Retard Ratiopharm

100 mg

Prolonged-release capsule, hard

Oral use

Portugal

Sandoz Farmacêutica, Lda.

Alameda da Beloura

Edifício 1, 2o - Escritório 15

2710-693 Sintra

Portugal

Diclofenac

Diclofenac Sandoz 50 mg Comprimidos revestidos

50 mg

Coated tablet

Oral use

Portugal

Labesfal - Laboratórios Almiro S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Diclofenac

Dolacen

75 mg/2 ml

Solution for injection

Intramuscular use

Portugal

Laboratório B. A. Farma, Lda.

Rua Prof. Sousa da Câmara, 207 - 211

1074-803 Lisboa

Portugal

Diclofenac

Dorcalor

50 mg

Gastro-resistant tablet

Oral use

Portugal

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 - Venda Nova

2700-327 Amadora

Portugal

Diclofenac

Fenil-V

75 mg/2 ml

Solution for injection

Intramuscular use

Portugal

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 - Venda Nova

2700-327 Amadora

Portugal

Diclofenac

Fenil-V

100 mg

Suppository

Rectal use

Portugal

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 - Venda Nova

2700-327 Amadora

Portugal

Diclofenac

Fenil-V

50 mg

Gastro-resistant tablet

Oral use

Portugal

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 - Venda Nova

2700-327 Amadora

Portugal

Diclofenac

Fenil-V Retard

100 mg

Prolonged-release capsule, hard

Oral use

Portugal

Laboratório Normal - Produtos Farmacêuticos, Lda.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Flameril

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Portugal

Laboratório Normal - Produtos Farmacêuticos, Lda.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Flameril

100 mg

Suppository

Rectal use

Portugal

Laboratório Normal - Produtos Farmacêuticos, Lda.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Flameril

50 mg

Gastro-resistant tablet

Oral use

Portugal

Laboratório Normal - Produtos Farmacêuticos, Lda.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Flameril Retard

100 mg

Prolonged-release tablet

Oral use

Portugal

Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Diclofenac

Olfen

50 mg

Gastro-resistant tablet

Oral use

Portugal

Confar - Consórcio Farmacêutico, Lda.

Rua Félix Correia, 1-B

1500-271 Lisboa

Portugal

Diclofenac

Painex 25

25 mg

Coated tablet

Oral use

Portugal

Confar - Consórcio Farmacêutico, Lda.

Rua Félix Correia, 1-B

1500-271 Lisboa

Portugal

Diclofenac

Painex 50

50 mg

Coated tablet

Oral use

Portugal

Confar - Consórcio Farmacêutico, Lda.

Rua Félix Correia, 1-B

1500-271 Lisboa

Portugal

Diclofenac

Painex R

100 mg

Prolonged-release capsule, hard

Oral use

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren

100 mg

Suppository

Rectal use

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren

50 mg

Gastro-resistant tablet

Oral use

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren 75

75 mg

Prolonged-release tablet

Oral use

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren Retard

100 mg

Prolonged-release tablet

Oral use

Portugal

Laboratório Normal - Produtos Farmacêuticos, Lda.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Cataflam

50 mg

Coated tablet

Oral use

Portugal

Novartis Consumer Health

Produtos Farmacêuticos e Nutrição, Lda.

Rua do Centro Empresarial,

Edf 8, Quinta da Beloura

2710-693 Sintra

Portugal

Diclofenac

Otriflu

12,5 mg

Coated tablet

Oral use

Portugal

Novartis Consumer Health

Produtos Farmacêuticos e Nutrição, Lda.

Rua do Centro Empresarial,

Edf 8, Quinta da Beloura

2710-693 Sintra

Portugal

Diclofenac

Voltaren 12,5

12,5 mg

Film-coated tablet

Oral use

Portugal

Novartis Consumer Health

Produtos Farmacêuticos e Nutrição, Lda.

Rua do Centro Empresarial,

Edf 8, Quinta da Beloura

2710-693 Sintra

Portugal

Diclofenac

Voltaren 12,5

12,5 mg

Capsule, soft

Oral use

Portugal

Novartis Consumer Health

Produtos Farmacêuticos e Nutrição, Lda.

Rua do Centro Empresarial,

Edf 8, Quinta da Beloura

2710-693 Sintra

Portugal

Diclofenac

Voltaren 25

25 mg

Capsule, soft

Oral use

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

2710-444 Sintra

Portugal

Diclofenac

Voltaren Rapid

50 mg

Coated tablet

Oral use

Portugal

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 - Venda Nova

2700-327 Amadora

Portugal

Diclofenac

Fenil-V Dispersivel

46,5 mg

Dispersible tablet

Oral use

Romania

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenacum

DICLOFENAC DUO PHARMASWISS 75 mg

75 mg

Prolonged-release capsule, hard

Oral use

Romania

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenacum

DICLOREUM 150 mg

150 mg

Prolonged-release capsule, hard

Oral use

Romania

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenacum

TRATUL 50 mg

50 mg

Gastro-resistant capsule, soft

Oral use

Romania

S.C. TERAPIA S.A.

Str. Fabricii nr. 124

Cluj-Napoca 400 632

România

Diclofenacum

DICLOTARD® 100 mg

100 mg

Prolonged-release tablet

Oral use

Romania

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenacum

DICLAC® 75 ID

75 mg

Modified-release tablet

Oral use

Romania

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN® RETARD

100 mg

Prolonged-release tablet

Oral use

Romania

STADA HEMOFARM S.R.L.

Str. Zugrav Nedelcu nr. 3, Timișoara

Județul Timiș

România

Diclofenacum

REFEN® RETARD

100 mg

Prolonged-release tablet

Oral use

Romania

S.C. AC HELCOR PHARMA SRL

Str. Victor Babeș nr. 50

Baia-Mare

Jud. Maramureș 430092

România

Diclofenacum

DICLOFENAC 50 mg

50 mg

Gastro-resistant tablet

Oral use

Romania

SC ANTIBIOTICE SA

Str. Valea Lupului nr. 1

6600-Iași

România

Diclofenacum

CLAFEN 50 mg

50 mg

Gastro-resistant tablet

Oral use

Romania

FARAN LABORATORIES S.A.

17 km Athens-Lamia

Achaias și Trizinas

145 64 Nea Kifisia

Greece

Diclofenacum

RHEUMAVEK

25 mg

Gastro-resistant tablet

Oral use

Romania

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN® 50

50 mg

Gastro-resistant tablet

Oral use

Romania

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN® 25

25 mg

Gastro-resistant tablet

Oral use

Romania

S.C. TERAPIA S.A.

Str. Fabricii nr. 124

Cluj-Napoca 400 632

România

Diclofenacum

DICLOFENAC 50 mg

50 mg

Gastro-resistant tablet

Oral use

Romania

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN RAPID®

50 mg

Coated tablet

Oral use

Romania

S.C. ARENA GROUP S.A.

Str. Stefan Mihaileanu

nr. 31, sector 2;

Bucuresti

România

Diclofenacum

DICLOFENAC ARENA 50 mg

25 mg

Coated tablet

Oral use

Romania

S.C. ARENA GROUP S.A.

Str. Stefan Mihaileanu

nr. 31, sector 2;

Bucuresti

România

Diclofenacum

DICLOFENAC ARENA 50 mg

50 mg

Coated tablet

Oral use

Romania

S.C. MEDUMAN S.A.

Str. Aleea Eroilor nr. 28

Vișeu de Sus

Județul Maramureș 435700

România

Diclofenacum

N - DICLOFENAC

50 mg

Coated tablet

Oral use

Romania

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN®

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Romania

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenacum

DICLOFENAC AL I.M.

75 mg/3 ml

Solution for injection

Intramuscular use

Romania

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenacum

TRATUL®

30 mg/ml

Solution for injection

Intramuscular use

Romania

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenacum

ALMIRAL

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Romania

S.C. TERAPIA S.A.

Str. Fabricii nr. 124

Cluj-Napoca 400 632

România

Diclofenacum

DICLOFENAC 75 mg

75 mg/3 ml

Solution for injection

Intramuscular use

Romania

STADA HEMOFARM S.R.L.

Str. Zugrav Nedelcu nr. 3, Timișoara

Județul Timiș

România

Diclofenacum

REFEN 75 mg

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

Romania

FARAN LABORATORIES S.A.

17 km Athens-Lamia

Achaias și Trizinas

145 64 Nea Kifisia

Greece

Diclofenacum

RHEUMAVEK

25 mg/ml

Solution for injection

Intramuscular use

Romania

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenacum

TRATUL 120 mg

120 mg

Suppository

Rectal use

Romania

Gerot Pharmazeutika GmbH

Arnethgasse 3

A-1160 Vienna

Austria

Diclofenacum

TRATUL 60 mg

60 mg

Suppository

Rectal use

Romania

SC ANTIBIOTICE SA

Str. Valea Lupului nr. 1

6600-Iași

România

Diclofenacum

CLAFEN 100 mg

100 mg

Suppository

Rectal use

Romania

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN®

100 mg

Suppository

Rectal use

Romania

Novartis Pharma GmbH

Roonstrasse 25

Nuernberg D-90429

Germany

Diclofenacum

VOLTAREN®

50 mg

Suppository

Rectal use

Romania

S.C. MAGISTRA C&C S.R.L.

B-dul Aurel Vlaicu nr. 82A

Constanța 900055

România

Diclofenacum

DICLOFENAC SODIC 100 mg

100 mg

Suppository

Rectal use

Romania

S.C. MAGISTRA C&C S.R.L.

B-dul Aurel Vlaicu nr. 82A

Constanța 900055

România

Diclofenacum

DICLOFENAC 100 mg

100 mg

Suppository

Rectal use

Romania

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac sodium

Orphenadrine citrate

Neodolpasse

75 mg/250 ml

30 mg/250 ml

Solution for infusion

Intravenous use

Romania

PFIZER EUROPE MA EEIG

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Diclofenacu

Misoprostolum

ARTHROTEC 75

75 mg

0,2 mg

Gastro –

resistant tablet

Oral use

Romania

Lannacher Heilmittel Ges.m.b.H

Schlossplatz 1

8502 Lannach

Austria

Diclofenac sodium

Thiamine hydrochloride

Pyridoxine hydrochloride

Cyanocobalamin

TRATUL PLUS

50 mg

50 mg

50 mg

0,25 mg

Gastro –

resistant tablet

Oral use

Slovak Republic

MEDOPHARM s.r.o., Lehárova 1808/11

143 00, Praha 4

Czech Republic

Diclofenac

ALMIRAL

75 mg/3 ml

Solution for injection

Intramuscular use, Intravenous use

Slovak Republic

Medochemie Ltd

1-10 Constantinoupoleos str

P.O. Box 51409

Limassol 3505

Cyprus

Diclofenac

ALMIRAL 50 mg

50 mg

Gastro-resistant tablet

Oral use

Slovak Republic

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Germany

Diclofenac

Diclac retard

100 mg

Prolonged-release tablet

Oral use

Slovak Republic

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclobene 150 mg retard

150 mg

Prolonged-release tablet

Oral use

Slovak Republic

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclobene 25 mg

25 mg

Gastro-resistant tablet

Oral use

Slovak Republic

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac

Diclobene 50 mg

50 mg

Gastro-resistant tablet

Oral use

Slovak Republic

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

Diclofenac AL 25

25 mg

Gastro-resistant tablet

Oral use

Slovak Republic

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

Diclofenac

Diclofenac AL 50

50 mg

Gastro-resistant tablet

Oral use

Slovak Republic

ALIUD PHARMA GmbH & Co. KG

Gottlieb Daimler Strasse 19

D-89150 Laichingen

Germany

diclofenac

Diclofenac AL retard

100 mg

Prolonged-release tablet

Oral use

Slovak Republic

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c

170 00 Praha 7 - Holešovice

Czech Republic

Diclofenac

Diclofenac Duo PharmaSwiss 75 mg

75 mg

Modified-release capsule

Oral use

Slovak Republic

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac

DICLOREUM 25 mg

25 mg

Gastro-resistant tablet

Oral use

Slovak Republic

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac

DICLOREUM 50 mg

50 mg

Gastro-resistant tablet

Oral use

Slovak Republic

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac

DICLOREUM 50 mg

50 mg

Suppository

Rectal use

Slovak Republic

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac

DICLOREUM 100 mg

100 mg

Suppository

Rectal use

Slovak Republic

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

diclofenac

DICLOREUM 75 mg

75 mg/3 ml

Solution for injection

Intramuscular use

Slovak Republic

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac

DICLOREUM retard

100 mg

Prolonged-release tablet

Oral use

Slovak Republic

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno 25 mg filmom obalené tablety

25 mg

Film-coated tablet

Oral use

Slovak Republic

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno 50 mg filmom obalené tablety

50 mg

Film-coated tablet

Oral use

Slovak Republic

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10 - Dolní Měcholupy

Czech Republic

Diclofenac

Dolmina 50

50 mg

Film-coated tablet

Oral use

Slovak Republic

Zentiva, k.s.

U kabelovny 130

102 37 Praha 10 - Dolní Měcholupy

Czech Republic

Diclofenac

DOLMINA INJ

75 mg/3 ml

Solution for injection

Intramuscular use

Slovak Republic

IBSA Slovakia s.r.o.

Mytna 42

811 05 Bratislava

Slovak Republic

Diclofenac

Flector EP Rapid 50 mg

50 mg

Granules

Oral use

Slovak Republic

Dr. R. Pfleger Chemische Fabrik GmbH

Dr. Robert Pfleger Strasse 12

D-96045 Bamberg

Germany

Diclofenac

Myogit 50

50 mg

Gastro-resistant tablet

Oral use

Slovak Republic

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 100 mg

100 mg

Suppository

Rectal use

Slovak Republic

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 100 retard

100 mg

Prolonged-release tablet

Oral use

Slovak Republic

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 25 mg

25 mg

Gastro-resistant tablet

Oral use

Slovak Republic

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 50 mg

50 mg

Gastro-resistant tablet

Oral use

Slovak Republic

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 75

75 mg/3 ml

Solution for injection

Intramuscular use

Slovak Republic

Herbacos Recordati s.r.o.

Štrossova 239

53003 Pardubice

Czech Republic

Diclofenac

VERAL 75 retard

75 mg

Prolonged-release tablet

Oral use

Slovak Republic

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren 100

100 mg

Suppository

Rectal use

Slovak Republic

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren 50

50 mg

Gastro-resistant tablet

Oral use

Slovak Republic

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren 75 mg/3 ml

75 mg/3 ml

Solution for injection

Intramuscular use

Slovak Republic

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Actigo Extra 25 mg

25 mg

Coated tablet

Oral use

Slovak Republic

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Rapid 12,5 mg

12,5 mg

Capsule, soft

Oral use

Slovak Republic

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Rapid 25 mg

25 mg

Capsule, soft

Oral use

Slovak Republic

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Rapid 50 mg

50 mg

Coated tablet

Oral use

Slovak Republic

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Rapid Sachets

50 mg

Powder for oral solution

Oral use

Slovak Republic

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren Retard 100

100 mg

Prolonged-release tablet

Oral use

Slovak Republic

Novartis s.r.o.

Na Pankraci 1724/129

140 00 Praha 4

Czech Republic

Diclofenac

Voltaren SR 75

75 mg

Prolonged-release tablet

Oral use

Slovak Republic

Pfizer Europe MA EEIG

Ramsgate Road

Kent, Sandwich CT13 9NJ

United Kingdom

Diclofenac

Misoprostol

ARTHROTEC FORTE

75 mg

0,2 mg

Film-coated tablet

Oral use

Slovak Republic

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

Graz A-8055

Austria

Diclofenac

Orphenadrine

Neodolpasse

75 mg/250 ml

30 mg/250 ml

Solution for infusion

Intravenous use

Slovenia

PharmaSwiss d.o.o.

Wolfova 1

1000 Ljubljana

Slovenia

Diclofenac

Diclo Duo 75 mg trde gastrorezistentne kapsule

75 mg

Gastro-resistant capsule, hard

Oral use

Slovenia

PharmaSwiss d.o.o.

Wolfova 1

1000 Ljubljana

Slovenia

Diclofenac

DicloJet 75 mg trde gastrorezistentne kapsule

75 mg

Gastro-resistant capsule, hard

Oral use

Slovenia

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno 25 mg filmsko obložene tablete

25 mg

Film-coated tablet

Oral use

Slovenia

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac

Dicuno 50 mg filmsko obložene tablete

50 mg

Film-coated tablet

Oral use

Slovenia

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen 25 mg/ml raztopina za injiciranje

25 mg/ml

Solution for injection

Intramuscular use

Slovenia

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

diclofenac

Naklofen 50 mg gastrorezistentne tablete

50 mg

Gastro-resistant tablet

Oral use

Slovenia

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen 50 mg svečke

50 mg

Suppository

Rectal use

Slovenia

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen duo 75 mg trde kapsule

75 mg

Capsule, hard

Oral use

Slovenia

Krka, d.d.

Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Diclofenac

Naklofen SR 100 mg tablete s podaljšanim sproščanjem

100 mg

Prolonged-release tablet

Oral use

Slovenia

Medias International d.o.o.

Leskoškova cesta 9D

1000 Ljubljana

Slovenia

Diclofenac

Neodolpasse 75 mg/30 mg raztopina za infundiranje

2,5 mg/ml

Solution for infusion

Intravenous use

Slovenia

Pliva Ljubljana d.o.o.

pot k sejmišču 35

1231 Ljubljana Črnuče

Slovenia

Diclofenac

Olfen 100 mg trde kapsule s podaljšanim sproščanjem

100 mg

Prolonged-release capsule, hard

Oral use

Slovenia

Pliva Ljubljana d.o.o.

pot k sejmišču 35

1231 Ljubljana Črnuče

Slovenia

Diclofenac

Voltaren 12,5 mg svečke

12,5 mg

Suppository

Rectal use

Slovenia

Pliva Ljubljana d.o.o.

pot k sejmišču 35

1231 Ljubljana Črnuče

Slovenia

Diclofenac

Voltaren 25 mg svečke

25 mg

Suppository

Rectal use

Slovenia

Novartis Consumer Health GmbH

Zielstattstrasse 40

Munchen 81379

Germany

Diclofenac

Voltaren Dolo 12,5 mg filmsko obložene tablete

12,5 mg

Film-coated tablet

Oral use

Spain

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

VOLTAREN 100 mg supositorios

100 mg

Suppository

Rectal use

Spain

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

VOLTAREN 50 mg comprimidos gastrorresistentes

50 mg

Gastro-resistant tablet

Oral use

Spain

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

DOLO-VOLTAREN 50 mg comprimidos dispersables

50 mg

Orodispersible tablet

Oral use

Spain

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

VOLTAREN RETARD 75 mg comprimidos de liberación modificada

75 mg

Modified-release tablet

Oral use

Spain

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

VOLTAREN RETARD 100 mg comprimidos de liberación modificada

100 mg

Modified-release tablet

Oral use

Spain

NOVARTIS FARMACEUTICA, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Diclofenac sodium

VOLTAREN 75 mg/3 ml solución inyectable

75 mg/3 ml

Solution for injection

Intramuscular use

Spain

LABORATORIOS ALDO-UNION, S.A.

Baronesa de Malda, 73

08950 Esplugues de Llobregat (Barcelona)

Spain

Diclofenac sodium

DICLOFENACO ALDO-UNION comprimidos EFG

50 mg

Tablet

Oral use

Spain

BEXAL FARMACEUTICA, S.A.

Centro Empresarial Osa Mayor

Avda. Osa Mayor, 4 - Area B

28023 Aravaca (Madrid)

Spain

Diclofenac sodium

DICLOFENACO BEXAL 50 mg comprimidos gastrorresistentes EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

LABORATORIOS STADA, S.L

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Diclofenac sodium

DICLOFENACO RETARD STADA 100 mg comprimidos EFG

100 mg

Film-coated tablet

Oral use

Spain

LABORATORIOS STADA, S.L

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Diclofenac sodium

DICLOFENACO STADA 50 mg comprimidos EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos (Madrid)

Spain

Diclofenac sodium

DICLOFENACO NORMON 50 mg comprimidos dispersables EFG

50 mg

Orodispersible tablet

Oral use

Spain

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos (Madrid)

Spain

Diclofenac sodium

DICLOFENACO NORMON 50 mg comprimidos entéricos EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

Diclofenac sodium

DOLOTREN 50 mg comprimidos gastrorresistentes

50 mg

Gastro-resistant tablet

Oral use

Spain

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

Diclofenac sodium

DOLOTREN RETARD 100 mg cápsulas duras de liberación prolongada

100 mg

Modified-release hard capsule

Oral use

Spain

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

Diclofenac sodium

DOLOTREN DISPERSABLE comprimidos

50 mg

Orodispersible tablet

Oral use

Spain

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

Diclofenac sodium

DOLOTREN supositorios

100 mg

Suppository

Rectal use

Spain

FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Lamiaco-Lejona (Vizcaya)

Spain

Diclofenac sodium

DOLOTREN ampollas

75 mg/3 ml

Solution for injection

Intramuscular use

Spain

SIGMA TAU ESPAÑA, S.A.

Bolivia, 15

Polígono Industrial Azque

28806 Alcalá de Henares (Madrid)

Spain

Diclofenac sodium

LUASE 50 mg comprimidos

50 mg

Gastro-resistant tablet

Oral use

Spain

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

Diclofenac sodium

DICLOFENACO LLORENS 50 mg comprimidos entéricos EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

Diclofenac sodium

DICLOFENACO LLORENS 75 mg solución inyectable EFG

75 mg/3 ml

Solution for injection

Intramuscular use

Spain

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

Diclofenac sodium

DI-RETARD 100 mg comprimidos de liberación modificada

100 mg

Modified-release tablet

Oral use

Spain

LABORATORIOS LLORENS, S.A.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

Diclofenac sodium

DICLOFENACO LLORENS 100 mg supositorios EFG

100 mg

Suppository

Rectal use

Spain

RATIOPHARM ESPAÑA, S.A.

Avda. de Burgos, 16 D

5a planta

28036 Madrid

Spain

Diclofenac sodium

DICLOFENACO RATIOPHARM 50 mg comprimidos

50 mg

Coated tablet

Oral use

Spain

LABORATORIOS ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Diclofenac sodium

DICLOFENACO ALTER 50 mg comprimidos EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

PENSA PHARMA, S.A.U.

Jorge Comín (médico pediatra), 3-bajos

46015 Valencia

Spain

Diclofenac sodium

DICLOFENACO PENSA 50 mg comprimidos EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

LABORATORIOS CINFA, S.A.

Olaz-Chipi, 10

Polígono Industrial Areta

31620 Huarte-Pamplona (Navarra)

Spain

Diclofenac sodium

DICLOFENACO CINFA 50 mg comprimidos gastrorresistentes EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

SANDOZ FARMACEUTICA, S.A.

Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

Spain

Diclofenac sodium

DICLOFENACO SANDOZ 50 mg comprimidos gastrorresistentes EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

SANDOZ FARMACEUTICA, S.A.

Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

Spain

Diclofenac sodium

DICLOFENACO SANDOZ 100 mg supositorios EFG

100 mg

Suppository

Rectal use

Spain

SANDOZ FARMACEUTICA, S.A.

Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

Spain

Diclofenac sodium

DICLOFENACO SANDOZ RETARD 100 mg comprimidos de liberación modificada EFG

100 mg

Modified-release tablet

Oral use

Spain

LABORATORIOS RANBAXY, S.L.

Passeig de Gracia, 9

08007 Barcelona

Spain

Diclofenac sodium

DICLOFENACO MUNDOGEN 50 mg comprimidos EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

GERMED FARMACEUTICA, S.L.

Chile, 8-2a planta. Oficina 203

28290 Las Matas (Madrid)

Spain

Diclofenac sodium

DICLOFENACO EDIGEN 50 mg comprimidos EFG

50 mg

Gastro-resistant tablet

Oral use

Spain

Pfizer S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Diclofenac sodium

Misoprostol

ARTROTEC

50 mg

0,2 mg

Film-coated tablet

Oral use

Spain

Pfizer S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Diclofenac sodium

Misoprostol

NORMULEN

50 mg

0,2 mg

Film-coated tablet

Oral use

Sweden

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

25 mg

Gastro-resistant tablet

Oral use

Sweden

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

50 mg

Gastro-resistant tablet

Oral use

Sweden

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac potassium

Voltaren® T

12,5 mg

Film-coated tablet

Oral use

Sweden

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

25 mg/ml

Solution for injection

Parenteral use

Sweden

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac potassium

Voltaren® T

25 mg

Coated tablet

Oral use

Sweden

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac potassium

Voltaren® T

50 mg

Coated tablet

Oral use

Sweden

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac potassium

Voltaren® T

12,5 mg

Capsule, soft

Oral use

Sweden

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac potassium

Voltaren® T

25 mg

Capsule, soft

Oral use

Sweden

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenac sodium

Diklofenak Mylan

25 mg

Gastro-resistant tablet

Oral use

Sweden

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenac sodium

Diklofenak Mylan

50 mg

Gastro-resistant tablet

Oral use

Sweden

Pfizer AB

Vetenskapsvägen 10

191 90 Sollentuna

Sweden

Diclofenac

Misoprostol

Arthrotec

50 mg

0,2 mg

Modified-release tablet

Oral use

Sweden

Pfizer AB

Vetenskapsvägen 10

191 90 Sollentuna

Sweden

Diclofenac natrium

Misoprostol

Arthrotec forte

75 mg

0,2 mg

Modified-release tablet

Oral use

Sweden

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diklofenak Sandoz

25 mg

Gastro-resistant tablet

Oral use

Sweden

Sandoz GmbH

Biochemiestraße 10

Kundl A-6250

Austria

Diclofenac sodium

Diklofenak Sandoz

50 mg

Gastro-resistant tablet

Oral use

Sweden

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac potassium

Diclofenac T ratiopharm

25 mg

Film-coated tablet

Oral use

Sweden

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Diclofenac potassium

Diclofenac T ratiopharm

50 mg

Film-coated tablet

Oral use

Sweden

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac sodium

Diklofenak Orifarm

25 mg

Gastro-resistant tablet

Oral use

Sweden

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac sodium

Diklofenak Orifarm

50 mg

Gastro-resistant tablet

Oral use

Sweden

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenac potassium

Eeze

25 mg

Film-coated tablet

Oral use

Sweden

Evolan Pharma AB

Box: 120

182 12 Danderyd

Sweden

Diclofenac potassium

Diklofenak T Evolan

50 mg

Film-coated tablet

Oral use

Sweden

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac sodium

Diklofenak T Orifarm

25 mg

Film-coated tablet

Oral use

Sweden

Orifarm Generics A/S

PO 69, Energivej 15

DK-5260 Odense S

Denmark

Diclofenac sodium

Diklofenak T Orifarm

50 mg

Film-coated tablet

Oral use

Sweden

Actavis A/S

Ornegardsvej 16

2820 Gentofte

Denmark

Diclofenac potassium

Diklofenak T Actavis

25 mg

Film-coated tablet

Oral use

Sweden

Actavis A/S

Ornegardsvej 16

2820 Gentofte

Denmark

Diclofenac potassium

Diklofenak T Actavis

50 mg

Film-coated tablet

Oral use

Sweden

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenac sodium

Diclofenac BMM Pharma

25 mg

Gastro-resistant tablet

Oral use

Sweden

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenac sodium

Diclofenac BMM Pharma

50 mg

Gastro-resistant tablet

Oral use

Sweden

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Diclofenac potassium

Instantin

50 mg

Powder for oral solution

Oral use

Sweden

Meda OTC AB

Östermalmsgatan 19

11426 Stockholm

Sweden

Diclofenac potassium

Eezeneo

25 mg

Film-coated tablet

Oral use

Sweden

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Eezeneo

50 mg

Film-coated tablet

Oral use

Sweden

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Eeze

12,5 mg

Film-coated tablet

Oral use

Sweden

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Dicuno

25 mg

Film-coated tablet

Oral use

Sweden

Vitabalans OY

Varastokatu 8

FI-135 000 Hämeenlinna

Finland

Diclofenac potassium

Dicuno

50 mg

Film-coated tablet

Oral use

Sweden

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Diklotab

25 mg

Film-coated tablet

Oral use

Sweden

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Diklotab

50 mg

Film-coated tablet

Oral use

Sweden

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Diklok

25 mg

Film-coated tablet

Oral use

Sweden

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Diklok

50 mg

Film-coated tablet

Oral use

Sweden

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Kappadi

25 mg

Film-coated tablet

Oral use

Sweden

Mimer Medical

Svärdvägen 3B

SE-182 33 Danderyd

Sweden

Diclofenac potassium

Kappadi

50 mg

Film-coated tablet

Oral use

Sweden

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

100 mg

Suppository

Rectal use

Sweden

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

50 mg

Suppository

Rectal use

Sweden

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Diclofenac sodium

Voltaren®

25 mg

Suppository

Rectal use

Sweden

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenac sodium

Diklofenak Mylan

100 mg

Suppository

Rectal use

Sweden

Mylan AB

PO 230 33

Ynglingagatan 14

SE-104 35 Stockholm

Sweden

Diclofenac sodium

Diklofenak Mylan

50 mg

Suppository

Rectal use

The Netherlands

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis 25 mg, maagsapresistente tabletten

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis 50 mg, maagsapresistente tabletten

50 mg

Gastro-resistant tablet

Oral use

The Netherlands

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis Retard 75 mg, tabletten met gereguleerde afgifte

75 mg

Modified-release tablet

Oral use

The Netherlands

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis Retard 100 mg, tabletten met gereguleerde afgifte

100 mg

Modified-release tablet

Oral use

The Netherlands

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis 25 mg, zetpillen

25 mg

Suppository

Rectal use

The Netherlands

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis 50 mg, zetpillen

50 mg

Suppository

Rectal use

The Netherlands

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Diclofenac sodium

Diclofenacnatrium Actavis 100 mg, zetpillen

100 mg

Suppository

Rectal use

The Netherlands

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

Diclofenac Kalium Actavis 12,5 mg, filmomhulde tabletten

12,5 mg

Film-coated tablet

Oral use

The Netherlands

Alfa Wassermann S.p.A.

Via Enrico Fermi 1

Alanno (PE) 65020

Italy

Diclofenac potassium

Eminocs 50 mg/ml, drank

50 mg

Oral drops, solution

Oral use

The Netherlands

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex 25 mg, maagsapresistente tabletten

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex 50 mg, maagsapresistente tabletten

50 mg

Gastro-resistant tablet

Oral use

The Netherlands

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex retard 100 mg, tabletten met gereguleerde afgifte

100 mg

Modified-release tablet

Oral use

The Netherlands

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex 25 mg, zetpillen

25 mg

Suppository

Rectal use

The Netherlands

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex 50 mg, zetpillen

50 mg

Suppository

Rectal use

The Netherlands

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Diclofenac sodium

Diclofenacnatrium Apotex 100 mg, zetpillen

100 mg

Suppository

Rectal use

The Netherlands

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na CF 25 mg/ml, oplossing voor injectie

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

The Netherlands

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na CF 25 mg, maagsapresistente tabletten

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na CF 50 mg, maagsapresistente tabletten

50 mg

Gastro-resistant tablet

Oral use

The Netherlands

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na zetpil CF 50 mg, zetpillen

50 mg

Suppository

Rectal use

The Netherlands

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na zetpil CF 100 mg, zetpillen

100 mg

Suppository

Rectal use

The Netherlands

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na retard CF 75 mg, tabletten met gereguleerde afgifte

75 mg

Modified-release tablet

Oral use

The Netherlands

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten Leur

The Netherlands

Diclofenac sodium

Diclofenac Na retard CF 100 mg, tabletten met gereguleerde afgifte

100 mg

Modified-release tablet

Oral use

The Netherlands

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar EC 25, maagsapresistente tabletten 25 mg

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar EC 50, maagsapresistente tabletten 50 mg

50 mg

Gastro-resistant tablet

Oral use

The Netherlands

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar Retard 75, tabletten met gereguleerde afgifte 75 mg

75 mg

Modified-release tablet

Oral use

The Netherlands

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar Retard 100, tabletten met gereguleerde afgifte 100 mg

100 mg

Modified-release tablet

Oral use

The Netherlands

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar 25, zetpillen 25 mg

25 mg

Suppository

Rectal use

The Netherlands

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar 50, zetpillen 50 mg

50 mg

Suppository

Rectal use

The Netherlands

Disphar International B.V.

Winkelskamp 6

7255 PZ Hengelo

The Netherlands

Diclofenac sodium

Diclofenacnatrium Disphar 100, zetpillen 100 mg

100 mg

Suppository

Rectal use

The Netherlands

Manston Pharma Limited

3 Montpelier Avenue, Bexley

DA5 3AP Kent

United Kingdom

Diclofenac sodium

Diclofenacnatrium Manston 25 mg, maagsapresistente tabletten

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

Manston Pharma Limited

3 Montpelier Avenue, Bexley

DA5 3AP Kent

United Kingdom

Diclofenac sodium

Diclofenacnatrium Manston 50 mg, maagsapresistente tabletten

50 mg

Gastro-resistant tablet

Oral use

The Netherlands

Manston Pharma Limited

3 Montpelier Avenue, Bexley

DA5 3AP Kent

United Kingdom

Diclofenac sodium

Diclofenacnatrium retard Manston 100 mg, maagsapresistente tabletten

100 mg

Gastro-resistant tablet

Oral use

The Netherlands

Marel B.V.

Archimedesweg 2

2333 CN Leiden

The Netherlands

Diclofenac potassium

Kruidvat Diclofenac kalium 12,5 mg, filmomhulde tabletten

12,5 mg

Film-coated tablet

Oral use

The Netherlands

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

Diclofenac sodium

Diclofenacnatrium 50 mg, zetpillen

50 mg

Suppository

Rectal use

The Netherlands

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

Diclofenac sodium

Diclofenacnatrium 100 mg, zetpillen

100 mg

Suppository

Rectal use

The Netherlands

Novartis Consumer Health B.V.

Claudius Prinselaan 142

4818 CP Breda

The Netherlands

Diclofenac potassium

Voltaren K 12,5 mg, filmomhulde tabletten

12,5 mg

Film-coated tablet

Oral use

The Netherlands

Novartis Consumer Health B.V.

Claudius Prinselaan 142

4818 CP Breda

The Netherlands

Diclofenac potassium

Voltaren K 25 mg, omhulde tabletten

25 mg

Coated tablet

Oral use

The Netherlands

Novartis Consumer Health B.V.

Claudius Prinselaan 142

4818 CP Breda

The Netherlands

Diclofenac potassium

Otriflu, omhulde tabletten 12,5 mg

12,5 mg

Coated tablet

Oral use

The Netherlands

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Diclofenac sodium

Voltaren 25 mg, maagsapresistente tabletten

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Diclofenac sodium

Voltaren 75 mg/3 ml, oplossing voor injectie 25 mg/ml

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

The Netherlands

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Diclofenac potassium

Cataflam 50, omhulde tabletten 50 mg

50 mg

Coated tablet

Oral use

The Netherlands

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Diclofenac sodium

Voltaren Retard 75 mg, tabletten met verlengde afgifte

75 mg

Prolonged-release tablet

Oral use

The Netherlands

Pfizer B.V.

Rivium Westlaan 142

2909 LD Capelle aan den IJssel

The Netherlands

Diclofenac sodium

Misoprostol

Arthrotec 50, tabletten

50 mg

Modified-release tablet

Oral use

The Netherlands

Pfizer B.V.

Rivium Westlaan 142

2909 LD Capelle aan den IJssel

The Netherlands

Diclofenac sodium

Misoprostol

Arthrotec 75, tabletten 75 mg

75 mg

Modified-release tablet

Oral use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 25 PCH, maagsapresistente tabletten

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 50 PCH, maagsapresistente tabletten

50 mg

Gastro-resistant tablet

Oral use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 25 PCH, zetpillen 25 mg

25 mg

Suppository

Rectal use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 50 PCH, zetpillen 50 mg

50 mg

Suppository

Rectal use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 100 PCH, zetpillen 100 mg

100 mg

Suppository

Rectal use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenac Na retard 75 PCH, tabletten met gereguleerde afgifte 75 mg

75 mg

Modified-release tablet

Oral use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenac Na Retard 100 PCH tabletten met gereguleerde afgifte 100 mg

100 mg

Modified-release tablet

Oral use

The Netherlands

Pharmacin B.V.

Molenvliet 103

3335 LH Zwijndrecht

The Netherlands

Diclofenac sodium

Diclofenacnatrium Pharmacin 25 mg, maagsapresistente tabletten

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

Pharmacin B.V.

Molenvliet 103

3335 LH Zwijndrecht

The Netherlands

Diclofenac sodium

Diclofenacnatrium Pharmacin 50 mg, maagsapresistente tabletten

50 mg

Gastro-resistant tablet

Oral use

The Netherlands

Pharmacin B.V.

Molenvliet 103

3335 LH Zwijndrecht

The Netherlands

Diclofenac sodium

Diclofenac Na Pharmacin 100 mg, tabletten met gereguleerde afgifte

100 mg

Modified-release tablet

Oral use

The Netherlands

ratiopharm Nederland B.V.

Florapark 4

2012 HK Haarlem

The Netherlands

Diclofenac sodium

Diclofenac Na ratiopharm retard 75 mg, tabletten met gereguleerde afgifte

75 mg

Modified-release tablet

Oral use

The Netherlands

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Diclofenac sodium

Diclofenacnatrium Sandoz retard 75, tabletten met gereguleerde afgite 75 mg

75 mg

Modified-release tablet

Oral use

The Netherlands

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Diclofenac sodium

Diclofenacnatrium Sandoz retard 100, tabletten met gereguleerde afgite 100 mg

100 mg

Modified-release tablet

Oral use

The Netherlands

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Diclofenac sodium

Diclofenacnatrium Sandoz 25, maagsapresistente tabletten 25 mg

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Diclofenac sodium

Diclofenacnatrium Sandoz 50, maagsapresistente tabletten 50 mg

50 mg

Gastro-resistant tablet

Oral use

The Netherlands

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Diclofenac sodium

Diclofenacnatrium Sandoz injectie 75 mg/3 ml, oplossing voor injectie 25 mg/ml

25 mg/ml

Solution for injection

Intramuscular use, Intravenous use

The Netherlands

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 25 mg Teva, zetpilen

25 mg

Suppository

Rectal use

The Netherlands

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 50 mg Teva, zetpilen

50 mg

Suppository

Rectal use

The Netherlands

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Diclofenac sodium

Diclofenacnatrium 100 mg Teva, zetpilen

100 mg

Suppository

Rectal use

The Netherlands

Wise Pharmaceuticals Ltd.

Hamwells Business Park Unit No. 7, Hardicker Street

M19 2RB Manchester

United Kingdom

Diclofenac sodium

Diclofenacnatrium 25 mg, maagsapresistente tabletten

25 mg

Gastro-resistant tablet

Oral use

The Netherlands

Wise Pharmaceuticals Ltd.

Hamwells Business Park Unit No. 7, Hardicker Street

M19 2RB Manchester

United Kingdom

Diclofenac sodium

Diclofenacnatrium 50 mg, maagsapresistente tabletten

50 mg

Gastro-resistant tablet

Oral use

United Kingdom

Novartis Consumer Health UK Limited

Park View, Riverside Way

Watchmoor Park, Camberley

Surrey GU15 3YL

United Kingdom

Diclofenac potassium

Voltarol Pain-Eze Extra Strength Tablets

25 mg

Coated tablet

Oral use

United Kingdom

Novartis Consumer Health UK Limited

Park View, Riverside Way

Watchmoor Park, Camberley

Surrey GU15 3YL

United Kingdom

Diclofenac potassium

Voltarol Pain-Eze Tablets

12,5 mg

Coated tablet

Oral use

United Kingdom

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Diclofenac sodium

Arthrotec 50 Modified-Release tablets

50 mg

Modified-release tablet

Oral use

United Kingdom

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Diclofenac sodium

Arthrotec 75 Modified-Release tablets

75 mg

Modified-release tablet

Oral use

United Kingdom

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Injection 75 mg/3 ml

75 mg

Solution for Injection

Intramuscular use, Intravenous use

United Kingdom

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac free acid

Voltarol Dispersible Tablets 50 mg

46,5 mg

Tablet for oral solution

Oral use

United Kingdom

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Retard Tablets 100 mg

100 mg

Modified-release tablet

Oral use

United Kingdom

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol SR Tablets

75 mg

Modified-release tablet

Oral use

United Kingdom

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Suppositories 12,5 mg

12,5 mg

Suppository

Rectal use

United Kingdom

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Suppositories 25 mg

25 mg

Suppository

Rectal use

United Kingdom

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Suppositories 50 mg

50 mg

Suppository

Rectal use

United Kingdom

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Suppositories 100 mg

100 mg

Suppository

Rectal use

United Kingdom

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Tablets 25 mg

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Tablets 50 mg

50 mg

Gastro-resistant tablet

Oral use

United Kingdom

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Rapid Tablets 25 mg

25 mg

Coated tablet

Oral use

United Kingdom

Novartis Pharmaceuticals UK ltd.

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Diclofenac sodium

Voltarol Rapid Tablets 50 mg

50 mg

Coated tablet

Oral use

United Kingdom

Actavis UK Limited

Whiddon Valley

Barnstaple

North Devon EX32 8NS

United Kingdom

Diclofenac sodium

Flamatak MR Tablets 75 mg

75 mg

Modified-release tablet

Oral use

United Kingdom

Teva UK Limited

Brampton Road

Hampden Park

Eastbourne

E Sussex BN22 9AG

United Kingdom

Diclofenac sodium

Teva UK Diclofenac Sodium Tablets 25 mg

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

Teva UK Limited

Brampton Road

Hampden Park

Eastbourne

E Sussex BN22 9AG

United Kingdom

Diclofenac sodium

Teva UK Diclofenac Sodium Tablets 50 mg

50 mg

Gastro-resistant tablet

Oral use

United Kingdom

Chatfield Pharmaceuticals Limited

Kramer Mews

London SW5 9JL

United Kingdom

Diclofenac sodium

Chatfield Pharms Diclofenac Sodium Tablets 25 mg

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

Mercury Pharma International Limited

4045 Kingswood Road

City West Business Park

Co Dublin, Ireland

Diclofenac sodium

Antigen Diclofenac Sodium Injection 2,5 % w/v

75 mg

Solution for injection

Intramuscular use

United Kingdom

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Sandoz Ltd Rhumalgan CR75 Modified Release Tablets 75 mg

75 mg

Modified-release tablet

Oral use

United Kingdom

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Sandoz Ltd Rhumalgan CR100 Modified Release Tablet 100 mg

100 mg

Modified-release tablet

Oral use

United Kingdom

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Lagap Pharms Diclofenac Tablets 25 mg

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Lagap Pharms Diclofenac Tablets 50 mg

50 mg

Gastro-resistant tablet

Oral use

United Kingdom

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Sandoz Ltd Diclovol SR Modified Release Tablet 75 mg

75 mg

Modified-release tablet

Oral use

United Kingdom

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Sandoz Ltd Rhumalgan SR Modified Release Capsules 75 mg

75 mg

Modified-Release Capsule, Hard

Oral use

United Kingdom

Sandoz Limited

Frimley Business Park

Frimley

Camberley, GUI16 7SR

United Kingdom

Diclofenac sodium

Sandoz Ltd Rhumalgan XL Modified Release Capsules 100 mg

100 mg

Modified-Release Capsule, Hard

Oral use

United Kingdom

Generics (UK) Limited

Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom

Diclofenac sodium

Generics UK Diclofenac Sodium Tablets 25 mg

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

Generics (UK) Limited

Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom

Diclofenac sodium

Generics UK Diclofenac Sodium Tablets 50 mg

50 mg

Gastro-resistant tablet

Oral use

United Kingdom

Waymade Plc

Regency House

Miles Gray Road

Basildon, Essex SS14 3RF

United Kingdom

Diclofenac sodium

Rheumatac Retard Tablets 75 mg

75 mg

Modified-release tablet

Oral use

United Kingdom

Daichi-Sankyo UK Limited

Chiltern Place

Chalfont Park

Gerrards Cross

Buckinghamshire SL9 0BG

United Kingdom

Diclofenac sodium

Motifene Capsules 75 mg

75 mg

Modified-release capsule

Oral use

United Kingdom

Chiesi Limited

Cheadle Royal Business Park

Highfield, Cheadle

Cheshire SK8 3GY

United Kingdom

Diclofenac sodium

Volsaid Retard Tablets 75 mg

75 mg

Modified-release tablet

Oral use

United Kingdom

Chiesi Limited

Cheadle Royal Business Park

Highfield, Cheadle

Cheshire SK8 3GY

United Kingdom

Diclofenac sodium

Volsaid Retard Tablets 100 mg

100 mg

Modified-release tablet

Oral use

United Kingdom

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Econac Suppositories 100 mg

100 mg

Suppository

Rectal use

United Kingdom

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Econac Injection 75 mg/3 ml

75 mg

Solution for injection

Intramuscular use

United Kingdom

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Mercury Pharms Diclofenac Solution for Injection 75 mg/3 ml

75 mg

Solution for injection

Intramuscular use, Intravenous use

United Kingdom

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Mercury Pharms Econac SR Prolonged Release Tablet 75 mg

75 mg

Prolonged-release tablet

Oral use

United Kingdom

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Mercury Pharms Econac XL Prolonged Release Tablet 100 mg

100 mg

Prolonged-release tablet

Oral use

United Kingdom

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Mercury Pharms Diclofenac Sodium Tablets 25 mg

25 mg

Tablet

Oral use

United Kingdom

Mercury Pharma Group Limited

No. 1 Croydon

12-16 Addiscombe Road

Croydon, Surrey CR0 0XT

United Kingdom

Diclofenac sodium

Mercury Pharms Diclofenac Sodium Tablets 75 mg

50 mg

Tablet

Oral use

United Kingdom

Co-Pharma Limited

Unit 4, Metro Centre

Tolpits Lane, Watford

Hertfordshire WD18 9SS

United Kingdom

Diclofenac sodium

Diclo-XL 100

100 mg

Modified-release tablet

Oral use

United Kingdom

Co-Pharma Limited

Unit 4, Metro Centre

Tolpits Lane, Watford

Hertfordshire WD18 9SS

United Kingdom

Diclofenac sodium

Diclo-SR 75

75 mg

Modified-release tablet

Oral use

United Kingdom

Dexcel Pharma Limited

7 Sopwith Way

Drayton Fields

Industrial Estate, Daventry

Northamptonshire NN11 8PB

United Kingdom

Diclofenac sodium

Dexcel-Pharma Dicloflex Retard Prolonged Release Tablet 100 mg

100 mg

Modified-release tablet

Oral use

United Kingdom

Dexcel Pharma Limited

7 Sopwith Way

Drayton Fields

Industrial Estate, Daventry

Northamptonshire NN11 8PB

United Kingdom

Diclofenac sodium

Dexcel-Pharma Dicloflex SR Prolonged Release Tablet 75 mg

75 mg

Modified-release tablet

Oral use

United Kingdom

Dexcel Pharma Limited

7 Sopwith Way

Drayton Fields

Industrial Estate, Daventry

Northamptonshire NN11 8PB

United Kingdom

Diclofenac sodium

Dexcel-Pharma Diclofenac Sodium Tablets 25 mg

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

Dexcel Pharma Limited

7 Sopwith Way

Drayton Fields

Industrial Estate, Daventry

Northamptonshire NN11 8PB

United Kingdom

Diclofenac sodium

Dexcel-Pharma Diclofenac Sodium Tablets 75 mg

75 mg

Gastro-resistant tablet

Oral use

United Kingdom

Bristol Laboratories Limited

Unit 3, Canal side

Northbridge Road, Berkhamsted

Hertfordshire HP4 1EG

United Kingdom

Diclofenac sodium

Volraman 25 mg Gastro-resistant tablets

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

Bristol Laboratories Limited

Unit 3, Canal side

Northbridge Road, Berkhamsted

Hertfordshire HP4 1EG

United Kingdom

Diclofenac sodium

Volraman 50 mg Gastro-resistant tablets

50 mg

Gastro-resistant tablet

Oral use

United Kingdom

Focus Pharmaceuticals Limited

Unit 5, Faraday court

First Avenue, Centrum 100

Burton upon trent

Staffordshire, DE14 2WX

United Kingdom

Diclofenac potassium

Adacium Rapid 50 mg Tablets

50 mg

Film-coated tablet

Oral use

United Kingdom

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

Diclofenac sodium

Misoprostol

Misofen 50 mg/200 mcg modified released tablets

50 mg

0,2 mg

Modified-release tablet

Oral use

United Kingdom

Morningside Healthcare Limited

115 Narborough Road

Leicester, LE3 0PA

United Kingdom

Diclofenac sodium

Misoprostol

Misofen 75 mg/200 mcg modified released tablets

75 mg

0,2 mg

Modified-release tablet

Oral use

United Kingdom

Crescent Pharma Limited

Unit 3&4

Quidhampton Business Units

Polhampton Lane, Overton

Hampshire, RG25 3ED

United Kingdom

Diclofenac

Crescent Pharma Diclofenac Tablets BP 25 mg

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

Crescent Pharma Limited

Unit 3&4

Quidhampton Business Units

Polhampton Lane, Overton

Hampshire, RG25 3ED

United Kingdom

Diclofenac

Crescent Pharma Diclofenac Tablets BP 50 mg

50 mg

Gastro-resistant tablet

Oral use

United Kingdom

Therabel pharma UK Limited

Compass House, vision Park

Chivers, Histon

Cambridge CB24 9AD

United Kingdom

Diclofenac sodium

Dyloject 75 mg/2 ml solution for injection

75 mg/2 ml

solution for injection

Intramuscular use, Intravenous use

United Kingdom

Galen Limited

Seagoe Industrial Estate

Craigavon

Armagh BT 63 5AU

United Kingdom

Diclofenac sodium

Diclomax SR

75 mg

Modified-release capsule

Oral use

United Kingdom

Galen Limited

Seagoe Industrial Estate

Craigavon

Armagh BT 63 5AU

United Kingdom

Diclofenac sodium

Diclomax Retard

100 mg

Modified-release capsule

Oral use

United Kingdom

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

Doble action pain relief

12,5 mg

Tablet

Oral use

United Kingdom

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

Diclofenac potassium 12,5 mg Tablets

12,5 mg

Tablet

Oral use

United Kingdom

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

Diclofenac potassium 25 mg Tablets

25 mg

Film-coated tablet

Oral use

United Kingdom

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceæand

Diclofenac potassium

Diclofenac potassium 50 mg Tablets

50 mg

Film-coated tablet

Oral use

United Kingdom

Chelonia Healthcare Limited

Boumpoulinas 11

3rd, Nicosia

CY-1060

Cyprus

Diclofenac sodium

Diclofenac sodium 25 mg Tablets

25 mg

Gastro-resistant tablet

Oral use

United Kingdom

RI Pharma Limited

First floor, 6 St John's Court

Upper Fforest Way

Swansea Enterprise Park

Swansea SA6 8QQ

United Kingdom

Diclofenac sodium

Slofenac 75 mg SR

75 mg

Modified-release tablet

Oral use

United Kingdom

RI Pharma Limited

First floor, 6 St John's Court

Upper Fforest Way

Swansea Enterprise Park

Swansea SA6 8QQ

United Kingdom

Diclofenac sodium

Slofenac 100 mg SR

100 mg

Modified-release tablet

Oral use

United Kingdom

Ennogen Pharma Limited

Unit G4, Riverside Way

Dartford, DA1 5BS

United Kingdom

Diclofenac sodium

Enstar SR 75 mg Tablets

75 mg

Prolonged-release tablet

Oral use

United Kingdom

Ennogen Pharma Limited

Unit G4, Riverside Way

Dartford, DA1 5BS

United Kingdom

Diclofenac sodium

Enstar XL 100 mg Tablets

100 mg

Modified-release tablet

Oral use

United Kingdom

Aptil Pharma limited

9th Floor

CP House

97-107 Uxbridge Road

London W5 5TL

United Kingdom

Diclofenac potassium

Diclofenac potassium 12,5 mg Tablets

12,5 mg

Film-coated tablet

Oral use

United Kingdom

Aptil Pharma limited

9th Floor

CP House

97-107 Uxbridge Road

London W5 5TL

United Kingdom

Diclofenac potassium

Diclofenac potassium 25 mg Tablets

25 mg

Film-coated tablet

Oral use

United Kingdom

Aptil Pharma limited

9th Floor

CP House

97-107 Uxbridge Road

London W5 5TL

United Kingdom

Diclofenac potassium

Diclofenac potassium 50 mg Tablets

50 mg

Film-coated tablet

Oral use


ANNEX X

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES

Member State (in EEA)

Marketing Authorisaton Holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

WABOSAN

Arzneimittelvertriebs

GmbH, Anton Anderer

Platz 6/1, A-1210 Vienna

Austria

Ergomed retard - Kapseln

2.5 mg (1:1:1)

prolonged-release capsule, soft

oral use

Austria

WABOSAN

Arzneimittelvertriebs

GmbH, Anton Anderer

Platz 6/1, A-1210 Vienna

Austria

Ergomed - Tropfen

1 mg/ml (1:1:1)

oral drops, solution

oral use

Czech Republic

TEVA Czech Industries s.r.o.

Ostravská 29

747 70 Opava-Komárov

Czech Republic

ERSILAN

1mg/ml

Oral drops, solution

oral use

France

PIERRE FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

France

ISKEDYL FORT, comprimé

2.40 mg/19.20 mg

tablet

oral use

France

PIERRE FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

France

ISKEDYL, comprimé

0.60 mg / 4.80 mg

tablet

oral use

France

PIERRE FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

France

ISKEDYL, solution buvable en flacon

0.10 g / 0.80 g

oral solution

oral use

France

PIERRE FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

France

ISKEDYL, solution injectable en ampoule

0.3125 mg /6.25 mg

solution for injection

IV/IM

Greece

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

Greece

DIERTINA

3mg/cap

capsules, soft

oral use

Greece

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

Greece

DIERTINA

6MG/SINGLE DOSE

powder for oral solution for single dose

oral use

Greece

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

Greece

DIERTINA

6MG/TAB

tablet

oral use

Greece

VOCATE PHARMAKEFTIKI A.E.

GOUNARI 150,

GLYFADA, 16674

Greece

ERGOFIL

6MG/TAB

tablet

oral use

Greece

GENEPHARM A.E.

18TH Km MARATHONOS

AVENUE, PALLINI,

ATTIKIS, 15351

Greece

MEMOTIL / GENEPHARM

6MG/TAB

tablet

oral use

Greece

ANTOR LTD

P. MAVROMIHALI 1

VRILISSIA 15235

Greece

THRIOLAN

6MG/TAB

tablet

oral use

Greece

LEOVAN, M. LEWN & SIA EE

ARGONAFTWN 22,

ARGYROUPOLI, 16452

Greece

FENITINA

6MG/TAB

tablet

oral use

Greece

PHARMACEUTICAL INDUSTRY PROEL EPAM.

G. KORONIS

DILOU 9, PERISTERI,

ATTIKIS, 12134

Greece

BEYTINA

6MG/TAB

tablet

oral use

Greece

FINIXFARM EPE

DERVENAKION 38 & SAHINI,

GERAKAS, 15344

Greece

CRISTIL

6MG/TAB

tablet

oral use

Greece

S.J.A. PHARM O.E.

ARKOLEON 11, KATO

PATISSIA, 10445

Greece

AGIOBITA

6MG/TAB

tablet

oral use

Luxembourg

Pierre Fabre Médicaments

45, PLACE ABEL GANCE

F 92654 BOULOGNE

CEDEX

France

Iskedyl Fort

2.40 mg/19.20 mg

tablets

oral use

Portugal

Daiichi Sankyo

Portugal,Lda. PRT

Lagoas Park, Edifício 11

2740-270 Porto Salvo

Portugal

Diertina

3 mg

Capsule hard

oral use

Spain

LABORATORIOS DAVUR, S.L.

Teide, 4 - planta baja Polígono Empresarial La Marina

28703 San Sebastian de los Reyes (Madrid)

Spain

ERGODAVUR GOTAS

1 mg (monodose suchet)

oral drops, solution

oral use

Spain

TORA LABORATORIES

S.L. Ferraz 80, 5o

28008 Madrid

Spain

DIERTINE FORTE

2 mg/ ml

oral drops, solution

oral use


ANNEX XI

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES

Member State

(in EEA)

Marketing Authorisaton Holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

France

CHIESI

11, avenue Dubonnet

92400 Courbevoie

France

VASOBRAL, comprimé sécable

4 mg/40 mg

tablet

oral use

France

CHIESI

11, avenue Dubonnet

92400 Courbevoie

France

VASOBRAL, solution buvable en flacon

0,10 g/1 g per 100 ml

oral solution

oral use


ANNEX XII

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES

Member State (in EEA)

Marketing Authorisaton Holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

Kwizda Pharma GmbH

Effingergasse 21

1160 Vienna

Austria

Ergotop 10 mg - Tabletten

10 mg

tablet

oral use

Austria

Kwizda Pharma GmbH

Effingergasse 21

1160 Vienna

Austria

Ergotop 20 mg - Filmtabletten

20 mg

film-coated tablet

oral use

Austria

Kwizda Pharma GmbH

Effingergasse 21

1160 Vienna

Austria

Ergotop 30 mg - Filmtabletten

30 mg

film-coated tablet

oral use

Austria

Rösch & Handel

Scheringgasse 2/Objekt 2

1140 Vienna

Austria

Nicergin - Filmtabletten

30 mg

film-coated tablet

oral use

Austria

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

1210 Vienna

Austria

Sermion 30 mg - Filmtabletten

30 mg

film-coated tablet

oral use

Bulgaria

Pfizer Enterprises SARL

Avenue J.F.Kennedy 51

L-1855

Luxembourg

Sermion

4 mg/4 ml

powder and solvent for solution for injection

intramuscular and intravenous use

Bulgaria

Pfizer Enterprises SARL

Avenue J.F.Kennedy 51

L-1855

Luxembourg

Sermion

30 mg

film-coated tablets

oral use

Czech Republic

Pfizer, spol. s r.o., Praha

Stroupežnického 17

150 00 Prague 5

Czech Republic

SERMION

30 mg

Film-coated tablet

oral use

France

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

France

SERMION 10 mg, gélule

10 mg

capsule, hard

oral use

France

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

France

SERMION 5 mg, gélule

5 mg

capsule, hard

oral use

France

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

France

SERMION 5 mg, poudre pour solution pour perfusion

5 mg

powder for solution for infusion

intravenous use

France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

NICERGOLINE BIOGARAN 10 mg, gélule

10 mg

capsule, hard

oral use

France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

NICERGOLINE BIOGARAN 5 mg, gélule

5 mg

capsule, hard

oral use

France

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

NICERGOLINE EG 10 mg, gélule

10 mg

capsule, hard

oral use

France

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

NICERGOLINE EG 5 mg, gélule

5 mg

capsule, hard

oral use

France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

NICERGOLINE MYLAN 10 mg, gélule

10 mg

capsule, hard

oral use

France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

NICERGOLINE MYLAN 5 mg, gélule

5 mg

capsule, hard

oral use

France

QUALIMED (LYON)

117, allée des Parcs

69800 Saint-Priest

France

NICERGOLINE QUALIMED 10 mg, gélule

10 mg

capsule, hard

oral use

France

QUALIMED (LYON)

117, allée des Parcs

69800 Saint-Priest

France

NICERGOLINE QUALIMED 5 mg, gélule

5 mg

capsule, hard

oral use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

NICERGOLINE TEVA 10 mg, gélule

10 mg

capsule, hard

oral use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

NICERGOLINE TEVA 5 mg, gélule

5 mg

capsule, hard

oral use

Hungary

Pfizer Kft.

Alkotás u. 53., MOM Park F épület

1123 Budapest

Hungary

SERMION 30 mg filmtabletta

30 mg

film-coated tablet

oral use

Italy

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italy

SERMION

10 mg/ml

powder and solvent per oral solution

oral use

Italy

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italy

SERMION

5 mg

coated tablet

oral use

Italy

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italy

SERMION

10 mg

coated tablet

oral use

Italy

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italy

SERMION

30 mg

film coated tablet

oral use

Italy

Pfizer Italia srl

Via Isonzo, 71

04100 Latina

Italy

SERMION

30 mg

soluble tablet

oral use

Italy

Angenerico spa

Via Nocera Umbra,

75 00181 Roma

Italy

NICERGOLINA ANGENERICO

10 mg/ml

powder and solvente per oral solution

oral use

Italy

Angenerico spa

Via Nocera Umbra,

75 00181 Roma

Italy

NICERGOLINA ANGENERICO

30 mg

tablet

oral use

Italy

Sandoz spa

Largo Umberto Boccioni,

1 21040 Origgio - Varese

Italy

NICERGOLINA SANDOZ

30 mg

effervescent tablet

oral use

Italy

Sandoz spa

Largo Umberto Boccioni,

1 21040 Origgio - Varese

Italy

NICERGOLINA SANDOZ

30 mg

tablet

oral use

Italy

EG spa

Via Scarlatti Domenico,

31 20124 Milano

Italy

NICERGOLINA EG

30 mg

tablet

oral use

Latvia

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenia

Nicerium

10 mg

film-coated tablets

oral use

Latvia

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenia

Nicerium

30 mg

capsules, hard

oral use

Latvia

Pfizer Italia S.r.l.,

Via Isonzo 71,

04100 Latina,

Italy

Sermion

5 mg

film-coated tablets

oral use

Latvia

Pfizer Italia S.r.l.,

Via Isonzo 71,

04100 Latina,

Italy

Sermion

10 mg

film-coated tablets

oral use

Lithuania

Pfizer Italia S.r.l.,

Borgo San Michele S.S. 156 Km. 50

Latina (LT),

Italy

Sermion

4 mg

Powder and solvent for solution for injection

intramuscular use intravenous use

Lithuania

Pfizer Italia S.r.l.,

Borgo San Michele S.S. 156 Km. 50

Latina (LT)

Italy

Sermion

5 mg

Coated tablet

oral use

Lithuania

Pfizer Italia S.r.l.,

Borgo San Michele S.S. 156 Km. 50

Latina (LT),

Italy

Sermion

10 mg

Coated tablet

oral use

Lithuania

Pfizer Italia S.r.l.,

Borgo San Michele S.S. 156 Km. 50

Latina (LT),

Italy

Sermion

30 mg

Film-coated tablet

oral use

Lithuania

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenia

Nicerium

30 mg

Capsule, hard

oral use

Lithuania

Sandoz d.d.,

Verovškova 57,

1000 Ljubljana,

Slovenia

Nicerium

10 mg

Film-coated tablet

oral use

Poland

Farmaceutyczna Spółdzielnia Pracy FILOFARM

ul. Pułaskiego 39

85-619 Bydgoszcz

Poland

Nicergolin

10 mg

tablet

oral use

Poland

Pfizer Europe MA EEIG

Ramsgate Road

CT13 9 NJ Kent, Sandwich

United Kingdom

Nicergolin

10 mg

coated tablet

oral use

Poland

Pfizer Italia S.r.l.

Borgo San Michele SS 156 Km 50

Latina

Italy

Nicergolin

4 mg

powder and solvent for solution for injection

intramuscular use intravenous use

Portugal

Laboratórios Pfizer,

Lda. PRT Lagoas Park,

Edifício 10 Porto Salvo

Portugal

Sermion 30

30 mg

Film-coated tablet

oral use

Romania

S.C. LABORMED PHARMA S.A.

Bd. Theodor Pallady nr. 44 B,

sector 3, București,

Romania

NICERGOLINA LPH 5 mg

5 mg

Film – coated tablet

oral use

Romania

S.C. LABORMED PHARMA S.A.

Bd. Theodor Pallady nr. 44 B,

sector 3, București,

Romania

NICERGOLINA LPH 10 mg

10 mg

Film – coated tablet

oral use

Romania

S.C. LABORMED PHARMA S.A.

Bd. Theodor Pallady nr. 44 B,

sector 3, București,

Romania

NICERGOLINA LPH 30 mg

30 mg

Film – coated tablet

oral use

Romania

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București,

Romania

GRALIN 5 mg

5 mg

Film – coated tablet

oral use

Romania

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București,

Romania

GRALIN 10 mg

10 mg

Film – coated tablet

oral use

Romania

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București,

Romania

GRALIN 30 mg

30 mg

Film – coated tablet

oral use

Romania

HEXAL AG

Industriestrasse 25,

D-83607 Holzkirchen,

Germany

NICERIUM® 10

10 mg

Coated tablet

oral use

Romania

Hexal AG,

Industriestrasse 25,

D-83607 Holzkirchen,

Germany

NICERIUM® 15

15 mg

Modified – release capsule, hard

oral use

Romania

HEXAL AG,

Industriestrasse 25,

D-83607 Holzkirchen,

Germany

NICERIUM® 30 UNO

30 mg

Modified – release capsule, hard

oral use

Spain

PFIZER, S.L.

Avenida de Europa,

20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid)

Spain

SERMION 5 mg

5 mg

coated tablet

oral use


ANNEX XIII

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES

Member State

(in EEA)

Marketing Authorisaton Holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

Boehringer Ingelheim

RCV GmbH & Co KG,

Dr. Boehringer-Gasse 5-11,

A-1121 Vienna

Austria

Effortil comp. - Tropfen

2 mg/ml, 10 mg/ml

oral drops, solution

oral use

Austria

ratiopharm Arzneimittel

Vertriebs-GmbH,

Albert-Schweitzer-Gasse 3,

A-1140 Vienna

Austria

DHE "ratiopharm" 2,5 mg - Kapseln

2,5 mg

prolonged-release capsule, hard

oral use

Austria

ratiopharm Arzneimittel

Vertriebs-GmbH,

Albert-Schweitzer-Gasse 3,

A-1140 Vienna

Austria

DHE "ratiopharm" 5 mg - Kapseln

5 mg

prolonged-release capsule, hard

oral use

Austria

Amdipharm Ltd.

3, Burlington Road,

Temple Chambers,

Dublin 4

Ireland

Dihydergot 2,5 mg - Tabletten

2,5 mg

tablet

oral use

Austria

WABOSAN

Arzneimittelvertriebs

GmbH, Anton Anderer

Platz 6/1,

A-1210 Vienna

Austria

Ergovasan 2 mg/ml - Tropfen

2 mg/ml

oral drops, solution

oral use

Austria

WABOSAN

Arzneimittelvertriebs

GmbH, Anton Anderer

Platz 6/1,

A-1210 Vienna

Austria

Ergovasan 2,5 mg retard - Kapseln

2,5 mg

prolonged-release capsule, hard

oral use

Austria

WABOSAN

Arzneimittelvertriebs

GmbH, Anton Anderer

Platz 6/1,

A-1210 Vienna

Austria

Ergovasan 5 mg retard - Kapseln

5 mg

prolonged-release capsule, hard

oral use

Belgium

Amdipharm Limited

Burlington Road, 3

Dublin 4

Ireland

Dihydergot Forte

2,5 mg

Tablet

oral use

Belgium

Laboratoires Belges

PHARMACOBEL SA

Avenue de Scheut 46-50

1070 Brussels

Belgium

Dystonal

2,5 mg

Tablet

oral use

Finland

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

ORSTANORM

2,5 mg

tablet

oral use

France

PIERRE FABRE

MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

France

IKARAN L.P. 5 mg, comprimé à libération prolongée

5 mg

prolonged-release tablet

oral use

France

PIERRE FABRE

MEDICAMENT

45, place Abel Gance

92100 Boulogne

Billancourt

France

IKARAN, solution buvable en gouttes

0.20 g /100 ml

oral drops, solution

oral use

France

UCB PHARMA

420 Avenue Estienne d'Orves

Défense Ouest

92700 Colombes

France

SEGLOR 2 mg/ml, solution buvable en gouttes

2 mg/ml

oral solution

oral use

France

UCB PHARMA

420 Avenue Estienne d'Orves

Défense Ouest

92700 Colombes

France

SEGLOR 5 mg, gélule

5 mg

hard capsule

oral use

France

UCB PHARMA

420 Avenue Estienne d'Orves

Défense Ouest

92700 Colombes

France

SEGLOR LYOC 5 mg, lyophilisat oral

5 mg

oral lyophilisate

oral use

France

Alfa Wasserman Pharma SAS

67 rue Anatole France,

92300 Levallois Perret

France

TAMIK, capsule

3 mg

soft capsule

oral use

France

AMDIPHARM

Temple Chambers

3, Burlington Road

DUBLIN 4

IRELAND

DIHYDROERGOTAMINE AMDIPHARM 2 mg/ml, solution buvable

2 mg/ml

oral solution

oral use

France

AMDIPHARM

Temple Chambers

3, Burlington Road

DUBLIN 4

Ireland

DIHYDROERGOTAMINE AMDIPHARM 3 mg, comprimé

3 mg

tablet

oral use

Germany

Amdipharm Limited

Temple Chamcers, 3

Burlington Road

IRL-Dublin 4

Ireland

Dihydergot plus Lösung zum Einnehmen

2 mg/ 1 ml

10 mg/ 1 ml

Solution

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co.KG

Binger Str. 173

D-55216 Ingelheim

Germany

Effortil plus

0.2 g/ 100 ml

1 g/ 100 ml

Solution

oral use

Germany

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

DET MS Tropflösung

2 mg/ 1 ml

Solution

oral use

Germany

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Ergotam-CT 2,5mg Retardkapseln

2,5 mg

Prolonged-released capsule

oral use

Germany

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Ergotam-CT 5,0mg Retardkapseln

5 mg

Prolonged-released capsule

oral use

Germany

UCB Pharma GmbH

Alfred-Nobel-Str. 10

D-40789 Monheim

Germany

Agit depot sanol

5 mg

Prolonged-released capsule, hard

oral use

Germany

Verla-Pharm Arzneimittel GmbH & Co.KG Hauptstr. 98

D-82327 Tutzing

Germany

Verladyn

2 mg/ 1 ml

solution

oral use

Greece

Amdipharm Ltd.

3 Burlington Road,

Temple Chambers,

Dublin 4

Ireland

Dihydergot

2,5 mg

tablet

oral use

Italy

Teofarma srl

Via Fratelli Cervi, 8

27010 Valle Salimbene

Pavia

Italy

DIIDERGOT

2 mg/ml

oral solution

oral use

Italy

Teofarma srl

Via Fratelli Cervi, 8

27010 Valle Salimbene

Pavia

Italy

DIIDERGOT

3 mg

tablet

oral use

Italy

Acarpia - Servicos

Farmaceuticos LDA

Rua dos Murcas, 88

Funchal Madeira -

Portugal

SEGLOR

5 mg

modified-releasecapsule, hard

oral use

Luxembourg

Pierre Fabre

Médicaments

45, PLACE ABEL GANCE

F 92654 BOULOGNE CEDEX

France

Ikaran

0.20 g /100 ml

oral solution

oral use

Luxembourg

Pierre Fabre

Médicaments

45, PLACE ABEL GANCE

F 92654 BOULOGNE CEDEX

France

Ikaran L.P.

5 mg

tablets

oral use

Poland

Farmaceutyczna

Spółdzielnia Pracy

FILOFARM

ul. Pułaskiego 39

85-619 Bydgoszcz

Poland

Dihydroergotaminum Filofarm

2 mg/g

oral solution

oral use

Poland

Farmaceutyczna

Spółdzielnia Pracy

FILOFARM

ul. Pułaskiego 39

85-619 Bydgoszcz

Poland

DHE - tar

1 mg

tablet

oral use

Portugal

Laboratórios Azevedos –

Indústria Farmacêutica,

S.A. PRT

Edifícios Azevedos –

Estrada Nacional 117-2, Alfragide

2614-504 Amadora

Portugal

Seglor Retard

5 mg

Prolonged-release capsule, hard

oral use

Slovenia

LEK farmacevtska

družba d.d.,

Verovskova 57,

SI-1526 Ljubljana,

Slovenia

Ditamin 2,5 mg tablete

2,5 mg

tablet

oral use

Spain

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

DIHYDERGOT COMPRIMIDOS

1 mg

tablet

oral use

Sweden

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Orstanorm

2,5 mg

Tablets

oral use

Sweden

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Orstanorm

5 mg

Tablets

oral use


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