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Document 52013XC1129(07)

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 31 October 2013 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

OJ C 350, 29.11.2013, p. 30–75 (BG, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
OJ C 350, 29.11.2013, p. 30–62 (ES)

29.11.2013   

EN

Official Journal of the European Union

C 350/30

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 31 October 2013

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

2013/C 350/03

—   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

2.10.2013

Suifertil 4 mg/ml

See Annex I

See Annex I

3.10.2013

9.10.2013

Methylphenidate Hexal

See Annex II

See Annex II

11.10.2013

9.10.2013

Methylphenidate Sandoz

See Annex III

See Annex III

10.10.2013

18.10.2013

Dexadreson 2 mg/ml

See Annex IV

See Annex IV

21.10.2013

18.10.2013

Micotil 300

See Annex V

See Annex V

21.10.2013

31.10.2013

Sandimmun

See Annex VI

See Annex VI

4.11.2013

31.10.2013

Sandimmun Neoral

See Annex VII

See Annex VII

4.11.2013


—   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

11.10.2013

Ketoconazole

See Annex VIII

See Annex VIII

14.10.2013

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

ANNEX I

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, 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

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Suifertil 4 mg/ml Lösung zum Eingeben für Schweine

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

France

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Synchroplan 4 mg/ml solution buvable porcins

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

Germany

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Suifertil 4 mg/ml Oral Solution for Pigs

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

Hungary

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Suifertil 4 mg/ml belsőleges oldat sertések részére A.U.V.

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

The Netherlands

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Suifertil 4 mg/ml orale oplossing voor varkens

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

Poland

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Suifertil 4 mg/ml Oral Solution for Pigs

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

Romania

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Suifertil 4 mg/ml Oral Solution for Pigs

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

Spain

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Suifertil 4 mg/ml solución oral para porcino

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

United Kingdom

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Suifertil 4 mg/ml Oral Solution for Pigs

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

ANNEX II

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

Member State EU/EEA

Marketing authorisation holder company name, address

Applicant company name, address

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Denmark

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

 

Methylphenidate ‘Hexal’

18 mg

Prolonged-release tablet

Oral use

Denmark

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

 

Methylphenidate ‘Hexal’

36 mg

Prolonged-release tablet

Oral use

Denmark

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

 

Methylphenidate ‘Hexal’

54 mg

Prolonged-release tablet

Oral use

Germany

 

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid HEXAL 18 mg Retardtabletten

18 mg

Prolonged-release tablet

Oral use

Germany

 

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid HEXAL 36 mg Retardtabletten

36 mg

Prolonged-release tablet

Oral use

Germany

 

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid HEXAL 54 mg Retardtabletten

54 mg

Prolonged-release tablet

Oral use

Ireland

Rowex Ltd

Bantry

Co. Cork

Ireland

 

Metidate XL 54 mg Prolonged-Release Tablets

54 mg

Prolonged-release tablet

Oral use

Ireland

Rowex Ltd

Bantry

Co. Cork

Ireland

 

Metidate XL 18 mg Prolonged-Release Tablets

18 mg

Prolonged-release tablet

Oral use

Ireland

Rowex Ltd

Bantry

Co. Cork

Ireland

 

Metidate XL 36 mg Prolonged-Release Tablets

36 mg

Prolonged-release tablet

Oral use

ANNEX III

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

Member State EU/EEA

Marketing authorisation holder company name, address

Applicant company name, address

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Belgium

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 18 mg tabletten met verlengde afgifte

18 mg

Prolonged-release tablet

Oral use

Belgium

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 36 mg tabletten met verlengde afgifte

36 mg

Prolonged-release tablet

Oral use

Belgium

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 54 mg tabletten met verlengde afgifte

54 mg

Prolonged-release tablet

Oral use

Cyprus

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

 

Methylphenidate Sandoz

18 mg

Prolonged-release tablet

Oral use

Cyprus

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

 

Methylphenidate Sandoz

36 mg

Prolonged-release tablet

Oral use

Cyprus

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

 

Methylphenidate Sandoz

54 mg

Prolonged-release tablet

Oral use

Denmark

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

 

Methylphenidate ‘Sandoz’

18 mg

Prolonged-release tablet

Oral use

Denmark

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

 

Methylphenidate ‘Sandoz’

36 mg

Prolonged-release tablet

Oral use

Denmark

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

 

Methylphenidate ‘Sandoz’

54 mg

Prolonged-release tablet

Oral use

Finland

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

 

Methylphenidate Sandoz

18 mg

Prolonged-release tablet

Oral use

Finland

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

 

Methylphenidate Sandoz

36 mg

Prolonged-release tablet

Oral use

Finland

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

 

Methylphenidate Sandoz

54 mg

Prolonged-release tablet

Oral use

France

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Méthylphénidate Sandoz LP 18 mg, comprimé à liberation prolongée

18 mg

Prolonged-release tablet

Oral use

France

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Méthylphénidate Sandoz LP 36 mg, comprimé à libération prolongée

36 mg

Prolonged-release tablet

Oral use

France

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Méthylphénidate Sandoz LP 54 mg, comprimé à librétaion prolongée

54 mg

Prolonged-release tablet

Oral use

Germany

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid - 1 A Pharma 18 mg Retardtabletten

18 mg

Prolonged-release tablet

Oral use

Germany

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid - 1 A Pharma 36 mg Retardtabletten

36 mg

Prolonged-release tablet

Oral use

Germany

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid - 1 A Pharma 54 mg Retardtabletten

54 mg

Prolonged-release tablet

Oral use

Iceland

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

 

Methylphenidate Sandoz, 18 mg, forðatöflur

18 mg

Prolonged-release tablet

Oral use

Iceland

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

 

Methylphenidate Sandoz, 36 mg, forðatöflur

36 mg

Prolonged-release tablet

Oral use

Iceland

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

 

Methylphenidate Sandoz, 54 mg, forðatöflur

54 mg

Prolonged-release tablet

Oral use

Luxembourg

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 18 mg comprimé à libération prolongée

18 mg

Prolonged-release tablet

Oral use

Luxembourg

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 36 mg comprimé à libération prolongée

36 mg

Prolonged-release tablet

Oral use

Luxembourg

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 54 mg comprimé à libération prolongée

54 mg

Prolonged-release tablet

Oral use

Malta

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 18 mg Prolonged-release Tablets

18 mg

Prolonged-release tablet

Oral use

Malta

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 36 mg Prolonged-release Tablets

36 mg

Prolonged-release tablet

Oral use

Malta

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 54 mg Prolonged-release Tablets

54 mg

Prolonged-release tablet

Oral use

Norway

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

 

Methylphenidate Sandoz 18 mg depottabletter

18 mg

Prolonged-release tablet

Oral use

Norway

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

 

Methylphenidate Sandoz 36 mg depottabletter

36 mg

Prolonged-release tablet

Oral use

Norway

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

 

Methylphenidate Sandoz 54 mg depottabletter

54 mg

Prolonged-release tablet

Oral use

Poland

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

 

Difumenil

18 mg

Prolonged-release tablet

Oral use

Poland

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

 

Difumenil

36 mg

Prolonged-release tablet

Oral use

Poland

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

 

Difumenil

54 mg

Prolonged-release tablet

Oral use

Portugal

Sandoz Farmacêutica Lda.

Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15

2710-693 Sintra

Portugal

 

Metilfenidato Sandoz

18 mg

Prolonged-release tablet

Oral use

Portugal

Sandoz Farmacêutica Lda.

Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15

2710-693 Sintra

Portugal

 

Metilfenidato Sandoz

36 mg

Prolonged-release tablet

Oral use

Portugal

Sandoz Farmacêutica Lda.

Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15

2710-693 Sintra

Portugal

 

Metilfenidato Sandoz

54 mg

Prolonged-release tablet

Oral use

Spain

Sandoz Farmacéutica, S.A.

Centro Empresarial Osa Mayor

Avda Osa Mayor no 4

28023 – Aravaca, Madrid

Spain

 

Metilfenidato Sandoz 18 mg comprimidos de liberación prolongada EFG

18 mg

Prolonged-release tablet

Oral use

Spain

Sandoz Farmacéutica, S.A.

Centro Empresarial Osa Mayor

Avda Osa Mayor no 4

28023 – Aravaca, Madrid

Spain

 

Metilfenidato Sandoz 36 mg comprimidos de liberación prolongada EFG

36 mg

Prolonged-release tablet

Oral use

Spain

Sandoz Farmacéutica, S.A.

Centro Empresarial Osa Mayor

Avda Osa Mayor no 4

28023 – Aravaca, Madrid

Spain

 

Metilfenidato Sandoz 54 mg comprimidos de liberación prolongada EFG

54 mg

Prolonged-release tablet

Oral use

Sweden

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz

18 mg

Prolonged-release tablet

Oral use

Sweden

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz

36 mg

Prolonged-release tablet

Oral use

Sweden

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz

54 mg

Prolonged-release tablet

Oral use

The Netherlands

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat HCl Sandoz retard 18 mg, tabletten met verlengde afgifte

18 mg

Prolonged-release tablet

Oral use

The Netherlands

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat HCl Sandoz retard 36 mg, tabletten met verlengde afgifte

36 mg

Prolonged-release tablet

Oral use

The Netherlands

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat HCl Sandoz retard 54 mg, tabletten met verlengde afgifte

54 mg

Prolonged-release tablet

Oral use

United Kingdom

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 18 mg Prolonged-release Tablets

18 mg

Prolonged-release tablet

Oral use

United Kingdom

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 36 mg Prolonged-release Tablets

36 mg

Prolonged-release tablet

Oral use

United Kingdom

 

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 54 mg Prolonged-release Tablets

54 mg

Prolonged-release tablet

Oral use

ANNEX IV

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

Member State EU/EEA

Applicant/marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Animal species

Austria

Intervet GmbH

Siemensstraße 107

AT-1210 Wien

AUSTRIA

Hexadreson 2 mg/ml Injektionslösung für Pferde, Rinder, Schweine, Hunde

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Austria

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon 2 mg/ml Injektionslösung für Pferde, Rinder, Schweine, Katzen und Hunde

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Belgium

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

RAPIDEXON 2 MG/ML SOLUTION INJECTABLE

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Belgium

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

DEXA-JECT 2 MG/ML oplossing voor injectie voor runderen, paarden, varkens, honden en katten

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Cyprus

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

DEXADRESON INJECTION 2 MG/ML

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Czech republic

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

Dexadreson, 2 mg/ml Injekční roztok

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Czech republic

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

RAPIDEXON 2 mg/ml injekční roztok

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Denmark

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

Dexadreson Vet

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses

Denmark

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexaject

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Denmark

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Finland

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon vet

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

France

Intervet

Rue Olivier De Serres

Angers Technopole

49071 Beaucouze Cedex

FRANCE

Dexadreson

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, goat, pigs, dogs and cats.

France

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon 2 mg/ml solution injectable

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

France

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

Cortadex 2 mg/ml solution injectable pour bovins, porcins, chiens et chats

Dexamethasone

2 mg/ml

Solution for injection

Cattle, pigs, dogs and cats

France

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexa-ject 2 mg/ml solution injectable pour bovins, chevaux, porcins, chiens et chats

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Germany

Intervet Deutschland GmbH

Feldstr. 1a

D-85716 Unterschleißheim

GERMANY

Hexadreson

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Germany

Albrecht GmbH

Hauptstr. 6-8

88326 Aulendorf

GERMANY

Rapidexon Albrecht 2 mg/ml

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Germany

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexa-ject 2 mg/ml

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Greece

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

DEXADRESON

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Greece

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

RAPIDEXON

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Hungary

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

Dexadreson injekció A.U.V.

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Hungary

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexa-ject 2 mg/ml injekció szarvasmarhák, lovak, sertések, kutyák és macskák részére A.U.V.

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Hungary

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon 2 mg/ml injekció A.U.V.

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Iceland

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexaject

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Ireland

Intervet Ireland Ltd.

Magna Drive, Magna Business Park

Citywest Road

Dublin 24

IRELAND

Dexadresson 2 mg/ml solution for injection

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Ireland

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon 2 mg/ml solution for injection

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Ireland

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexa-ject 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Italy

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

Dexadreson

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, goat, pigs, dogs and cats.

Latvia

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

Dexacortin

Dexamethasone

2 mg/ml

Solution for injection

Cattle, pigs, dogs and cats

Lithuania

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

DEXACORTIN 2 mg/ml solution for injection for cattle, swine, dogs and cats

Dexamethasone

2 mg/ml

Solution for injection

Cattle, pigs, dogs and cats

Lithuania

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

RAPIDEXON 2 mg/ml, solution for injection

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Lithuania

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

DEXA-JECT 2 mg/ml solution for injection for cattle, horse, pigs, dogs and cats

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

The Netherlands

Intervet Nederland B.V.

p.o. box 50

5830 AB Boxmeer

THE NETHERLANDS

Dexadreson

Dexamethasone

2 mg/ml

Solution for injection

Cattle

The Netherlands

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon

Dexamethasone

2 mg/ml

Solution for injection

Cattle

The Netherlands

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

The Netherlands

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexa-ject

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Norway

Intervet AB

Box 7121

192 07 Sollentuna

SWEDEN

Dexadreson vet.

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Poland

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

DEXACORTIN 2 mg/ml roztwór do wstrzykiwań dla bydła, świń, psów i kotów

Dexamethasone

2 mg/ml

Solution for injection

Cattle, pigs, dogs and cats.

Poland

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

RAPIDEXON 2 mg/ml roztwór do wstrzykiwań

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Poland

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexa-ject 2 mg/ml roztwór do wstrzykiwań dla bydła, koni, świń, psów i kotów

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Portugal

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon 2 mg/ml, solução injectável

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Portugal

Intervet Portugal – Saúde Animal, Lda

Rua Agualva dos Açores n.o 16

2735-557 Agualva-Cacém,

PORTUGAL

Dexacortin 2 mg/ml solução injectável para bovinos, suínos, cães e gatos

Dexamethasone

2 mg/ml

Solution for injection

Cattle, pigs, dogs and cats

Romania

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

DEXADRESON

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, goat, pigs, dogs and cats

Slovakia

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

Dexadreson 2 mg/ml injekčný roztok

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Slovakia

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon 2 mg/ml injekčný roztok

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Slovenia

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

RAPIDEXON 2 mg/ml raztopina za injiciranje

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Slovenia

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

DEXACORTIN 2 mg/ml, raztopina za injiciranje za govedo, prašiče, pse in mačke

Dexamethasone

2 mg/ml

Solution for injection

Cattle, pigs, dogs and cats

Spain

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon 2 mg/ml solución inyectable

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Spain

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, Km 4,1

43330 Riudoms, Tarragona

SPAIN

Dexavex

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Spain

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexa-ject 2 mg/ml

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Sweden

Intervet AB

Box 7121

192 07 Sollentuna

SWEDEN

Dexadreson vet.

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

United Kingdom

Intervet UK Ltd

Walton Manor, Walton

Milton Keynes MK7 7AJ

UNITED KINGDOM

Dexadreson 2 mg/ml Solution for Injection

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

United Kingdom

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexa-ject 2 mg/ml Solution for Injection for Cattle, Horses, Pigs, Dogs and Cats

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

United Kingdom

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon 2 mg/ml Solution for Injection

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

ANNEX V

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

Member State EU/EEA

Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Richter Pharma AG

Feldgasse 19

4600 Wels

AUSTRIA

Micotil 300 mg/ml - Injektionslösung für Rinder

Tilmicosin

300 mg/ml

Solution for injection

Cattle

Subcutaneous injection

Belgium

ELI LILLY BENELUX N.V.

Division Elanco Animal Health

Stoofstraat 52

1000 Brussel

BELGIUM

Micotil 300 mg/ml

Tilmicosin

300 mg/ml

Solution for injection

Cattle, sheep

Subcutaneous injection

Czech Republic

EIi Lílly Regional Operations GmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Wien

AUSTRIA

Micotil 300 mg/ml injekční roztok pro skot (telata, mladý skot)

Tilmicosin

300 mg/ml

Solution for injection

Cattle

Subcutaneous injection

Germany

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

GERMANY

Micotil 300

Tilmicosin

300 mg/ml

Solution for injection

Cattle

Subcutaneous injection

France

LILLY FRANCE

13 Rue Pages

92158 Suresnes Cedex

FRANCE

MICOTIL 300

Tilmicosin

300 mg/ml

Solution for injection

Cattle

Subcutaneous injection

Greece

Eli Lilly Regional Operations GesmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

AUSTRIA

MICOTIL 300

Tilmicosin

300 mg/ml

Solution for injection

Cattle, sheep

Subcutaneous injection

Spain

ELANCO VALQUÍMICA S.A,

Avenida de la Industria 30

28108 Alcobendas

Madrid

SPAIN

Micotil 300

Tilmicosin

300 mg/ml

Solution for injection

Cattle

Subcutaneous injection

Hungary

Eli Lilly Regional Operations GmbH

Elanco Animal Health Kölblgasse 8-10

1030 Vienna

AUSTRIA

Micotil 300 injekció

Tilmicosin

300 mg/ml

Solution for injection

Cattle

Subcutaneous injection

Ireland

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

UNITED KINGDOM

Micotil 300 mg/ml Solution for Injection

Tilmicosin

300 mg/ml

Solution for injection

Cattle, sheep

Subcutaneous injection

Italy

ELI LILLY ITALIA S.p.A.

Via A. Gramsci, 731/733 Sesto Fiorentino

ITALY

Micotil 300

Tilmicosin

300 mg/ml

Solution for injection

Cattle, sheep rabbit

Subcutaneous injection

The Netherlands

Eli Lilly Nederland B.V./Elanco AnimalHealth

Grootslag 1-5

3991 RA Houten

THE NETHERLANDS

MICOTIL 300 INJECTIE

Tilmicosin

300 mg/ml

Solution for injection

Cattle, sheep

Subcutaneous injection

Portugal

Lilly Portugal – Produtos Farmacêuticos, Lda.

Rua Cesário Verde, 5 – piso 4

Linda-a-Pastora

2790-326 QUEIJAS

PORTUGAL

Micotil 300 mg/ml solução injectável

Tilmicosin

300 mg/ml

Solution for injection

Cattle

Subcutaneous injection

United Kingdom

Eli Lilly & Company Ltd

Elanco Animal Health

Lilly House

Priestley Road

Basingstoke

RG24 9NL

UNITED KINGDOM

Micotil 300 mg/ml Solution for Injection

Tilmicosin

300 mg/ml

Solution for injection

Cattle, sheep

Subcutaneous injection

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

Invented Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun

50 mg – Konzentrat zur Infusionsbereitung

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

B-1800 Vilvoorde

Belgium

SANDIMMUN

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Finland

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

France

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

25 mg

Capsule, soft

Oral use

 

France

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

50 mg

Capsule, soft

Oral use

 

France

Novartis Pharma S.A.S.

2- 4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

100 mg

Capsule, soft

Oral use

 

France

Novartis Pharma S.A.S.

2- 4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

100 mg/ml

Oral solution

Oral use

100 mg/ml

France

Novartis Pharma S.A.S.

2- 4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

50 mg/ml

Solution for infusion

Intravenous use

50 mg/ml

Germany

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 25 mg Weichkapseln

25 mg

Capsule, soft

Oral use

 

Germany

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg Weichkapseln

100 mg

Capsule, soft

Oral use

 

Germany

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg/ml Lösung zum Einnehmen

100 mg/ml

Oral solution

Oral use

100 mg/ml

Germany

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 50 mg/ml Konzentrat zur Herstellung einer Infusionslösung

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Germany

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Immunosporin 25 mg Weichkapseln

25 mg

Capsule, soft

Oral use

 

Germany

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Immunosporin 50 mg Weichkapseln

50 mg

Capsule, soft

Oral use

 

Germany

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Immunosporin 100 mg Weichkapseln

100 mg

Capsule, soft

Oral use

 

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN

250 mg/5 ml amp

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN

50 mg/ml amp

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun 50 mg/ml koncentrátum oldatos infúzióhoz

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Iceland

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003

Köbenhavn S

Denmark

Sandimmun

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Ireland

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

25 mg

Capsule, soft

Oral use

 

Ireland

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

50 mg

Capsule, soft

Oral use

 

Ireland

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

100 mg

Capsule, soft

Oral use

 

Ireland

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

100 mg/ml

Oral Solution

Oral use

100 mg/ml

Ireland

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

50 mg/1 ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Italy

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

25 mg

Capsule, soft

Oral use

 

Italy

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

50 mg

Capsule, soft

Oral use

 

Italy

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

100 mg

Capsule, soft

Oral use

 

Italy

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

100 mg/ml

Oral solution

Oral use

100 mg/ml

Italy

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 25 mg Weichkapseln

25 mg

Capsule, soft

Oral use

 

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg Weichkapseln

100 mg

Capsule, soft

Oral use

 

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg/ml Lösung zum Einnehmen

100 mg/ml

Oral solution

Oral use

100 mg/ml

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 50 mg/ml Konzentrat zur Herstellung einer Infusionslösung

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Netherlands

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Sandimmune, concentraat voor oplossing voor intraveneuze infusie 50 mg/ml

50 mg/ml

Concentrate for solution for intravenous infusion

Intravenous use

50 mg/ml

Norway

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Poland

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun

50 mg/ml

Concentrate for solution for infusion

Intravenous

50 mg/ml

Portugal

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Slovak Republic

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun 50 mg/ml

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 50 mg/ml koncentrat za raztopino za infundiranje

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Spain

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun 50 mg/ml concentrado para solución para perfusión

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Spain

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun 250 mg/5 ml concentrado para solución para perfusión

250 mg/5 ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Sweden

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

United Kingdom

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Soft Gelatin Capsules 25 mg

25 mg

Capsule, soft

Oral use

 

United Kingdom

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Soft Gelatin Capsules 50 mg

50 mg

Capsule, soft

Oral use

 

United Kingdom

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Soft Gelatin Capsules 100 mg

100 mg

Capsule, soft

Oral use

 

United Kingdom

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Oral Solution

100 mg/ml

Oral solution

Oral use

100 mg/ml

United Kingdom

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Concentrate for Solution for Infusion 50 mg/ml

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/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 EU/EEA

Marketing authorisation holder

Invented Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 10 mg Kapseln

10 mg

Capsule, soft

Oral use

 

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 25 mg Kapseln

25 mg

Capsule, soft

Oral use

 

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 50 mg Kapseln

50 mg

Capsule, soft

Oral use

 

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 100 mg Kapseln

100 mg

Capsule, soft

Oral use

 

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 100 mg/ml - Trinklösung

100 mg/ml

Oral solution

Oral use

100 mg/ml

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral - Sandimmun 10 mg

10 mg

Capsule

Oral use

 

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral-Sandimmun 100 mg

100 mg

Capsule

Oral use

 

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral - Sandimmun 25 mg

25 mg

Capsule

Oral use

 

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral - Sandimmun 50 mg

50 mg

Capsule

Oral use

 

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral-Sandimmun 100 mg/ml

100 mg/ml

Oral solution

Oral use

100 mg/ml

Bulgaria

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 25 mg capsule

25 mg

Capsule, soft

Oral use

 

Bulgaria

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 50 mg capsule

50 mg

Capsule, soft

Oral use

 

Bulgaria

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 100 mg capsule

100 mg

Capsule, soft

Oral use

 

Bulgaria

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 100 mg/ml oral solution

100 mg/ml

Oral solution

Oral use

100 mg/ml – 50 ml

Cyprus

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral 25 mg

25 mg

Capsule, soft

Oral use

 

Cyprus

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral 50 mg

50 mg

Capsule, soft

Oral use

 

Cyprus

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral 100 mg

100 mg

Capsule, soft

Oral use

 

Cyprus

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral Oral Solution 100 mg/ ml

100 mg/ml

Oral Solution

Oral use

100 mg/ml

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun Neoral 25 mg

25 mg

Capsule, soft

Oral use

 

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun Neoral 50 mg

50 mg

Capsule, soft

Oral use

 

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun Neoral 100 mg

100 mg

Capsule, soft

Oral use

 

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun Neoral 100 mg/ml

100 mg/ml

Oral solution

Oral use

100 mg/ml

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

10 mg

Capsule, soft

Oral use

 

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

 

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

 

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

 

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

 

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

 

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

 

Finland

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

 

Finland

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

 

Finland

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

 

Finland

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

France

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

10 mg

Capsule, soft

Oral use

 

France

Novartis Pharma S.A.S.

2- 4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

25 mg

Capsule, soft

Oral use

 

France

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

50 mg

Capsule, soft

Oral use

 

France

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

100 mg

Capsule, soft

Oral use

 

France

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

100 mg/ml

Oral solution

Oral use

100 mg/ml

Germany

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 10 mg Weichkapseln

10 mg

Capsule, soft

Oral use

 

Germany

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 25 mg Weichkapseln

25 mg

Capsule, soft

Oral use

 

Germany

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 50 mg Weichkapseln

50 mg

Capsule, soft

Oral use

 

Germany

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 100 mg Weichkapseln

100 mg

Capsule, soft

Oral use

 

Germany

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 100 mg/ml Lösung zum Einnehmen

100 mg/ml

Oral solution

Oral use

100 mg/ml

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN NEORAL

25 mg/cap

Capsule, soft

Oral use

 

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN NEORAL

50 mg/cap

Capsule, soft

Oral use

 

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN NEORAL

100 mg/cap

Capsule, soft

Oral use

 

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN NEORAL

500 mg/5 ml

Oral solution

Oral use

100 mg/ml

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 10 mg lágy kapszula

10 mg

Capsule, soft

Oral use

 

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 25 mg lágy kapszula

25 mg

Capsule, soft

Oral use

 

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 50 mg lágy kapszula

50 mg

Capsule, soft

Oral use

 

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 100 mg lágy kapszula

100 mg

Capsule, soft

Oral use

 

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 100 mg/ml belsőleges oldat

100 mg/ml

Oral solution

Oral use

100 mg/ml

Iceland

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003 Köbenhavn S Denmark

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

 

Iceland

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003 Köbenhavn S Denmark

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

 

Iceland

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003 Köbenhavn S Denmark

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

 

Iceland

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003 Köbenhavn S Denmark

Sandimmun Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

Ireland

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral

25 mg

Capsule, soft

Oral use

 

Ireland

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral

50 mg

Capsule, soft

Oral use

 

Ireland

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral

100 mg

Capsule, soft

Oral use

 

Ireland

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

Italy

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

10 mg

Capsule, soft

Oral use

 

Italy

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

 

Italy

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

 

Italy

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

 

Italy

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

Latvia

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral 25 mg mīkstās kapsulas

25 mg

Capsule, soft

Oral use

 

Latvia

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral 50 mg mīkstās kapsulas

50 mg

Capsule, soft

Oral use

 

Latvia

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral 100 mg mīkstās kapsulas

100 mg

Capsule, soft

Oral use

 

Lithuania

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

 

Lithuania

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo,

Finland

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

 

Lithuania

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

 

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 10 mg Weichkapseln

10 mg

Capsule, soft

Oral use

 

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 25 mg Weichkapseln

25 mg

Capsule, soft

Oral use

 

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 50 mg Weichkapseln

50 mg

Capsule, soft

Oral use

 

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 100 mg Weichkapseln

100 mg

Capsule, soft

Oral use

 

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 100 mg/ml Lösung zum Einnehmen

100 mg/ml

Oral solution

Oral use

100 mg/ml

Malta

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

 

Malta

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

 

Malta

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral

100 mg/ml

Oral Solution

Oral use

100 mg/ml

Netherlands

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Neoral 25 mg, capsules

25 mg

Capsule, soft

Oral use

 

Netherlands

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Neoral 100 mg, capsules

100 mg

Capsule, soft

Oral use

 

Netherlands

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Neoral 100 mg/ml, drank

100 mg/ml

Oral Solution

Oral use

100 mg/ml

Norway

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

 

Norway

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

 

Norway

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

 

Norway

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

Poland

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

10 mg

Capsule, soft

Oral use

 

Poland

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

 

Poland

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

 

Poland

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

 

Poland

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

Portugal

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

 

Portugal

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

 

Portugal

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

 

Portugal

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

Romania

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

SANDIMMUN NEORAL capsule moi, 25 mg

25 mg

Capsule, soft

Oral use

 

Romania

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

SANDIMMUN NEORAL,capsule moi, 50 mg

50 mg

Capsule, soft

Oral use

 

Romania

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

SANDIMMUN NEORAL, solutie orala, 100 mg/ml

100 mg/ml

Oral solution

Oral use

100 mg/ml

Slovak Republic

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun Neoral 25 mg

25 mg

Capsule, soft

Oral use

 

Slovak Republic

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun Neoral 50 mg

50 mg

Capsule, soft

Oral use

 

Slovak Republic

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun Neoral 100 mg

100 mg

Capsule, soft

Oral use

 

Slovak Republic

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun Neoral 100 mg/ml

100 mg/ml

Oral solution

Oral use

100 mg/ml

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral 25 mg mehke kapsule

25 mg

Capsule, soft

Oral use

 

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral 50 mg mehke kapsule

50 mg

Capsule, soft

Oral use

 

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral 100 mg mehke kapsule

100 mg

Capsule, soft

Oral use

 

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral 100 mg/ml peroralna raztopina

100 mg/ml

Oral solution

Oral use

100 mg/ml

Spain

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun Neoral 25 mg cápsulas blandas

25 mg

Capsule, soft

Oral use

 

Spain

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun Neoral 50 mg cápsulas blandas

50 mg

Capsule, soft

Oral use

 

Spain

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun Neoral 100 mg cápsulas blandas

100 mg

Capsule, soft

Oral use

 

Spain

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun Neoral 100 mg/ml solución oral

100 mg/ml

Oral solution

Oral use

100 mg/ml

Sweden

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

10 mg

Capsule, soft

Oral use

 

Sweden

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

 

Sweden

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

 

Sweden

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

 

Sweden

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

United Kingdom

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Soft Gelatin Capsules 10 mg

10 mg

Capsule, soft

Oral use

 

United Kingdom

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Soft Gelatin Capsules 25 mg

25 mg

Capsule, soft

Oral use

 

United Kingdom

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Soft Gelatin Capsules 50 mg

50 mg

Capsule, soft

Oral use

 

United Kingdom

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Soft Gelatin Capsules 100 mg

100 mg

Capsule, soft

Oral use

 

United Kingdom

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Oral solution

100 mg/ml

Oral Solution

Oral use

100 mg/ml

ANNEX VIII

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

Invented name

Strength

Pharmaceutical Form

Route of administration

Belgium

Janssen-Cilag NV

Antwerpseweg 15-17

2340 Beerse

Belgium

Nizoral 200 mg tabletten

200 mg

Tablet

Oral use

Bulgaria

Jonson & Jonson D.O.O.,

Smartinska cesta 53,

1000 Ljubljana,

Slovenia

NIZORAL

200 mg

Tablet

Oral use

Cyprus

Aegis Ltd

17 Athinon street

2081 Lefkosia

Cyprus

KETOZAL TABLETS 200 mg

200 mg

Tablet

Oral use

Cyprus

Remedica ltd

Aharnon street

3508 Lemesos

Cyprus

KETROZOL TABLETS 200 mg

200 mg

Tablet

Oral use

Cyprus

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beers

Belgium

NIZORAL TABLETS 200 mg

200 mg

Tablet

Oral use

Cyprus

Medochemie ltd

1-10 Constantinoupoleos street

3505 Lemesos

Cyprus

TINUVIN TABLETS 200 mg

200 mg

Tablet

Oral use

Cyprus

CDL Pharmaceutical Products ltd

Agiou Spyridonos 12

7102 Larnaca

Cyprus

VAFLUSON TABLETS 200 mg

200 mg

Tablet

Oral use

Czech Republic

Janssen-Cilag s.r.o.

Karla Engliše 3201/6

15000 Praha 5

Czech Republic

NIZORAL

200 mg

Tablet

Oral use

Estonia

UAB Johnson & Johnson

Gelezinio Vilko g. 18A

08104 Vilnius

Lithuania

NIZORAL

200 mg

Tablet

Oral use

Finland

Janssen-Cilag Oy

Vaisalantie 2

02130 Espoo

Finland

NIZORAL

200 mg

Tablet

Oral use

France

Janssen Cilag

1, rue Camille Desmoulins TSA

91003 92787 Issy-les-Moulineaux

Cedex 9

France

NIZORAL 200 mg, comprimé

200 mg

Tablet

Oral use

Greece

Coup ABEE

Agias Barbaras 53-55

Dafni 15235

Greece

MYCOFEBRIN

200 mg

Tablet

Oral use

Greece

Demo ABEE

21ST Km National Highway

Athens - Lamia

Kryoneri 14568

Greece

AQUARIUS

200 mg

Tablet

Oral use

Greece

Rafarm AEBE

Korinthou 12

Neo Psychiko 15451

Greece

ILGEM

200 mg

Tablet

Oral use

Greece

Angelini Pharma Hellas ABEE

Achaias & Trizinias

Nea Kifissia 14564

Athens

Greece

SOSTATIN

200 mg

Tablet

Oral use

Greece

Bros ltd

Avgis & Galinis 15

Nea Kifissia

Athens

Greece

EBERSEPT

200 mg

Tablet

Oral use

Hungary

Janssen-Cilag Kft.

West Gate Business Park

Tó Park

2045, Törökbálint

Hungary

NIZORAL 200 mg tabletta

200 mg

Tablet

Oral use

Iceland

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Fungoral

200 mg

Tablet

Oral use

Latvia

UAB Johnson & Johnson

Gelezinio Vilko g. 18A

08104 Vilnius

Lithuania

Nizoral 200 mg tablets

200 mg

Tablet

Oral use

Lithuania

UAB Johnson & Johnson

Gelezinio Vilko g. 18A

08104 Vilnius

Lithuania

Nizoral

200 mg

Tablet

Oral use

Luxembourg

Janssen Cilag NV

15-17 Antwerpseweg

B-2340 Beerse

Belgium

Nizoral 200 mg comprimés

200 mg

Tablet

Oral use

Norway

Janssen-Cilag AS

Postboks 144

1325 Lysaker

Norway

Fungoral

200 mg

Tablet

Oral use

Poland

Polfarmex S.A.

Józefów 9

99-300 Kutno

Poland

Ketokonazol

200 mg

Tablet

Oral use

Portugal

Janssen Farmacêutica Portugal, Lda.

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

2734-503 Barcarena

Portugal

Nizale

200 mg

Tablet

Oral use

Romania

S.C. Arena Group S.A.

Str. Ștefan Mihăileanu nr. 31 Sector 2, București

România

KETOCONAZOL ARENA 200 mg

200 mg

Tablet

Oral use

Romania

Terapia SA

Str. Fabricii nr. 124

Cluj-Napoca

Romania

NIZORAL 200 mg

200 mg

Tablet

Oral use

Romania

S.C. Magistra C&C

Str. Aurel Vlaicu nr. 82A

8700 Constanța

România

KETOCONAZOL 200 mg

200 mg

Tablet

Oral use

Romania

S.C. Slavia Pharm S.R.L.

Bd.Theodor Pallady nr. 44C

Sector 3

București

România

KETOCONAZOL 200 mg

200 mg

Tablet

Oral use

Romania

A.C. Helcor s.r.l.

Str. Dr. Victor Babeș nr. 50

Baia Mare

România

KETOSTIN 200 mg

200 mg

Tablet

Oral use

Slovak Republic

Johnson & Johnson s.r.o.

Karadžičova 12

821 08 Bratislava

Slovak Republic

NIZORAL

200 mg

Tablet

Oral use

Spain

Zeus, S.L.

Collado mediano, s/n

28230 Las Rozas

Madrid

Spain

FUNGO ZEUS 200 mg comprimidos

200 mg

Tablet

Oral use

Spain

Janssen-Cilag, S.A.

Po de Las Doce Estrellas 5-7

28042 Madrid

Spain

FUNGAREST comprimidos

200 mg

Tablet

Oral use

Spain

Ratiopharm Espana, S.A.

C/ Anabel Segura, 11

Edificio Albatros B 1a planta

28108 Alcobendas (Madrid)

Spain

Ketoconazol ratiopharm 200 mg comprimidos

200 mg

Tablet

Oral use

Sweden

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Fungoral®

200 mg

Tablet

Oral use

The Netherlands

Janssen-Cilag B.V.

Dr. Paul Janssenweg 150

5026 RH TILBURG

The Netherlands

Nizoral tabletten 200 mg

200 mg

Tablet

Oral use

United Kingdom

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire HP12 4EG

United Kingdom

Nizoral 200 mg tablets

200 mg

Tablet

Oral use
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