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Document 52011XC1028(04)

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2011 to 31 August 2011 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )

OJ C 316, 28.10.2011, p. 18–193 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

28.10.2011   

EN

Official Journal of the European Union

C 316/18


Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2011 to 31 August 2011

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

2011/C 316/02

—   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

24.8.2011

Clavudale

See Annex I

See Annex I

25.8.2011

20.7.2011

Kytril

See Annex II

See Annex II

22.7.2011

13.7.2011

Doxycycline 50 % WSP and associated names

See Annex III

See Annex III

14.7.2011

13.7.2011

Doxyfar 50 % and associated names

See Annex IV

See Annex IV

14.7.2011

13.7.2011

alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid and tiludronic acid

See Annex V

See Annex V

15.7.2011

13.7.2011

Dianeal PD4 and Extraneal and associated names

See Annex VI

See Annex VI

15.7.2011

7.7.2011

Docetaxel Teva Generics and associated names

See Annex VII

See Annex VII

8.7.2011


—   Refusal 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

5.8.2011

Combimox Lactating Cow Intramammary Suspension and associated names

See Annex VIII

See Annex VIII

9.8.2011

5.8.2011

Combisyn Lactating Cow Intramammary suspension

See Annex IX

See Annex IX

9.8.2011

5.8.2011

Nisamox Lactating Cow Intramammary Suspension

See Annex X

See Annex X

8.8.2011


—   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

5.8.2011

Combimox Lactating Cow Intramammary Suspension and associated names

See Annex VIII

See Annex VIII

9.8.2011

5.8.2011

Combisyn Lactating Cow Intramammary suspension

See Annex IX

See Annex IX

9.8.2011

5.8.2011

Nisamox Lactating Cow Intramammary Suspension

See Annex X

See Annex X

8.8.2011


(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I

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

Member State EU/EEA

Applicant/Marketing Authorisation Holder

Name

Pharmaceutical form

Strengths

Animal species

Frequency and route of administration

Recommended dose

Austria

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

Belgium

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

Czech Republic

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

Denmark

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

Finland

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

France

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

Germany

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

Greece

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

Hungary

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

Iceland

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

Ireland

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

Luxembourg

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

The Netherlands

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

Norway

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

Poland

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

Portugal

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

Slovak Republic

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

Spain

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

Sweden

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight

United Kingdom

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Tablet

Amoxicillin 40 mg

Clavulanic acid 10 mg

Cats and dogs

Oral administration, twice daily for 5-7 days

Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight


ANNEX II

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

Roche Austria GmbH, Engelhorngasse 3, 1211 Wien

Austria

Kytril 3 mg - Injektionslösung

3 mg/3 ml

Solution for injection

Intravenous use

3 ml

Austria

Roche Austria GmbH, Engelhorngasse 3, 1211 Wien

Austria

Kytril 2 mg - Filmtabletten

2 mg

Film-coated tablet

Oral use

 

Belgium

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Kytril 1 mg/1 ml solution injectable

1 mg

Solution for injection

Intravenous use

1 mg/1 ml

Belgium

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Kytril 3 mg/3 ml solution injectable

3 mg

Solution for injection

Intravenous use

3 mg/3 ml

Belgium

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Kytril 1 mg comprimés pelliculés

1 mg

Film-coated tablet

Oral use

 

Bulgaria

Roche Bulgaria EOOD,

16 Bialo Pole Str.

1618 Sofia

Bulgaria

Kytril

1 mg/ml

Solution for injection/infusion

Intravenous use

1 ml (1 mg/ml)

3 ml (1 mg/ml)

Bulgaria

Roche Bulgaria EOOD,

16 Bialo Pole Str.

1618 Sofia

Bulgaria

Kytril

2 mg

Film-coated tablet

Oral use

 

Czech Republic

Roche s.r.o.,

Dukelských hrdinů 52

170 00 Praha 7

Czech Republic

Kytril 2 mg

2 mg

Film-coated tablet

Oral use

 

Czech Republic

Roche s.r.o.,

Dukelských hrdinů 52

170 00 Praha 7

Czech Republic

Kytril inj./inf

1 mg/ml

Solution for injection/infusion

Intravenous use

1 mg/1 ml

Estonia

Roche Eesti OÜ

Lõõtsa 2, 11415

Tallinn

Estonia

Kytril

1 mg/ml

Concentrate for solution for injection/infusion

Intravenous use

1 mg/ml (1 ml and 3 ml)

Estonia

Roche Eesti OÜ

Lõõtsa 2, 11415

Tallinn

Estonia

Kytril

1 mg

Film-coated tablet

Oral use

 

Finland

Roche Oy

PL 12

02181 Espoo

Finland

Kytril

1 mg

Film-coated tablet

Oral use

 

Finland

Roche Oy

PL 12

02181 Espoo

Finland

Kytril

2 mg

Film-coated tablet

Oral use

 

Finland

Roche Oy

PL 12

02181 Espoo

Finland

Kytril

1 mg/ml

Solution for injection

Intravenous use

5 × 1 ml and 5 × 3 ml

France

ROCHE

52 Boulevard du Parc

92521 NEUILLY SUR SEINE cedex

France

Kytril 3 mg/3 ml solution injectable pour voie intraveineuse

3 mg/3 ml

Solution for injection

Intravenous use

3 mg/3 ml

France

ROCHE

52 Boulevard du Parc

92521 NEUILLY SUR SEINE cedex

France

Kytril 1 mg/comprimé pelliculé

1 mg

Film-coated tablet

Oral use

 

France

ROCHE

52 Boulevard du Parc

92521 NEUILLY SUR SEINE cedex

France

Kytril 2 mg comprimé pelliculé

2 mg

Film-coated tablet

Oral use

 

Germany

Roche Pharma AG

Emil-Barell-Straße 1

79639 Grenzach-Wyhlen

Germany

Kevatril

1 mg/1 ml Injektionslösung

1 mg

Solution for injection

Intravenous use

1 ml

Germany

Roche Pharma AG

Emil-Barell-Straße 1

79639 Grenzach-Wyhlen

Germany

Kevatril

Filmtabletten 2 mg

2 mg

Film-coated tablet

Oral use

 

Germany

Roche Pharma AG

Emil-Barell-Straße 1

79639 Grenzach-Wyhlen

Germany

Kevatril

3 mg/3 ml Injektionslösung

3 mg

Solution for injection

Intravenous use

3 ml

Greece

Roche (Hellas )

A.E.

Alamanas 4 & Delfon, 15125 Maroussi

Greece

Kytril

1 mg

Film-coated tablet

Oral use

 

Greece

Roche (Hellas )

A.E.

Alamanas 4 & Delfon, 15125 Maroussi

Greece

Kytril

2 mg

Film-coated tablet

Oral use

 

Greece

Roche (Hellas )

A.E.

Alamanas 4 & Delfon, 15125 Maroussi

Greece

Kytril

1 mg/1 ml

Solution for injection

Intravenous use

1 mg/1 ml

Greece

Roche (Hellas )

A.E.

Alamanas 4 & Delfon, 15125 Maroussi

Greece

Kytril

3 mg/3 ml

Solution for injection

Intravenous use

3 mg/3 ml

Hungary

Roche (Hungary) Ltd

H-2040 Budaörs

Edison u. 1.

Hungary

Kytril

1 mg

Film-coated tablet

Oral use

 

Hungary

Roche (Hungary) Ltd

H-2040 Budaörs

Edison u. 1.

Hungary

Kytril

3 mg/3 ml

Solution for injection

Intravenous use

3 mg/3 ml

Ireland

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW, United Kingdom

Kytril Tablets 1 mg

1 mg

Film-coated tablet

Oral use

 

Ireland

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW, United Kingdom

Kytril Tablets 2 mg

2 mg

Film-coated tablet

Oral use

 

Ireland

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW, United Kingdom

Kytril Ampoules 1 mg/1 ml concentrate for solution for infusion or injection

1 mg/1 ml

Concentrate for solution for infusion/injection

Intravenous use

1 ml contains 1 mg granisetron (hydrochloride)

1 mg contains 9 mg sodium chloride = 3.54 mg sodium

Ireland

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW, United Kingdom

Kytril Infusion 3 mg/3 ml concentrate for solution for infusion or injection

3 mg/3 ml

Concentrate for solution for infusion/injection

Intravenous use

3 ml contains 3 mg granisetron (hydrochloride)

3 ml contains 27 mg sodium chloride = 10.62 mg sodium

Italy

Roche S.p.A.

Piazza Durante 11

20131 Milano

Italy

Kytril

3 mg/3 ml

Solution for injection

Intravenous use

3 mg/3 ml

Italy

Roche S.p.A.

Piazza Durante 11

20131 Milano

Italy

Kytril

1 mg/1 ml

Solution for injection

Intravenous use

1 mg/1 ml

Italy

Roche S.p.A.

Piazza Durante 11

20131 Milano

Italy

Kytril

3 mg/5 ml

Solution for injection

Intravenous use

3 mg/5 ml

Italy

Roche S.p.A.

Piazza Durante 11

20131 Milano

Italy

Kytril

1 mg

Film-coated tablet

Oral use

 

Italy

Roche S.p.A.

Piazza Durante 11

20131 Milano

Italy

Kytril

2 mg

Film-coated tablet

Oral use

 

Latvia

Roche Latvija SIA

G. Astras 8b

Riga, LV-1082

Latvia

Kytril 1 mg/ml solution for injection

1 mg/ml

Solution for injection

Intravenous use

1 mg/ml

Latvia

Roche Latvija SIA

G. Astras 8b

Riga, LV-1082

Latvia

Kytril 1 mg film-coated tablets

1 mg

Film-coated tablet

Oral use

 

Lithuania

UAB ‘Roche Lietuva’

J. Jasinskio 16b, LT-01112 Vilnius

Lithuania

Kytril

1 mg

Film-coated tablet

Oral use

 

Lithuania

UAB ‘Roche Lietuva’

J. Jasinskio 16b, LT-01112 Vilnius

Lithuania

Kytril

1 mg/ml

Solution for injection/infusion

Intravenous use

1 mg/1 ml

Lithuania

UAB ‘Roche Lietuva’

J. Jasinskio 16b, LT-01112 Vilnius

Lithuania

Kytril

3 mg/3 ml

Solution for injection/infusion

Intravenous use

3 mg/3 ml

Luxembourg

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Kytril 1 mg/1 ml solution injectable

1 mg

Solution for injection

Intravenous use

1 mg/1 ml

Luxembourg

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Kytril 3 mg/3 ml solution injectable

3 mg

Solution for injection

Intravenous use

3 mg/3 ml

Luxembourg

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Kytril 1 mg comprimés pelliculés

1 mg

Film-coated tablet

Oral use

 

Malta

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW, United Kingdom

Kytril Tablets 1 mg

1 mg

Film-coated tablet

Oral use

 

Malta

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW, United Kingdom

Kytril Injection 3 mg/3 ml

3 mg/3 ml

Concentrate for solution for infusion/injection

Intravenous use

1 ml contains 1 mg granisetron (hydrochloride)

Netherlands

Roche Nederland B.V., Postbus 44, 3440 AA Woerden

Netherlands

Kytril i.v. 3 mg = 3 ml, oplossing voor injectie 1 mg/ml

1 mg/ml

Solution for injection

Intravenous use

1 mg/ml

Netherlands

Roche Nederland B.V., Postbus 44, 3440 AA Woerden

Netherlands

Kytril i.v. 1 mg = 1 ml, oplossing voor injectie 1 mg/ml

1 mg/ml

Solution for injection

Intravenous use

1 mg/ml

Netherlands

Roche Nederland B.V., Postbus 44, 3440 AA Woerden

Netherlands

Kytril 1 mg tabletten, omhulde tabletten

1 mg

Film-coated tablet

Oral use

 

Netherlands

Roche Nederland B.V., Postbus 44, 3440 AA Woerden

Netherlands

Kytril 2 mg tabletten, omhulde tabletten

2 mg

Film-coated tablet

Oral use

 

Portugal

Roche Farmacêutica Química, Lda

Estrada nacional 249-1, 2720-413, Amadora

Portugal

Kytril

1 mg

Film-coated tablet

Oral use

 

Portugal

Roche Farmacêutica Química, Lda

Estrada nacional 249-1, 2720-413, Amadora

Portugal

Kytril

2 mg

Film-coated tablet

Oral use

 

Portugal

Roche Farmacêutica Química, Lda

Estrada nacional 249-1, 2720-413, Amadora

Portugal

Kytril

1 mg/1 ml

Solution for injection

Intravenous use

1 ml (1 mg/1 ml)

Portugal

Roche Farmacêutica Química, Lda

Estrada nacional 249-1, 2720-413, Amadora

Portugal

Kytril

3 mg/3 ml

Solution for injection

Intravenous use

3 ml (3 mg/3 ml)

Romania

Roche Romania SRL

9-9A Dimitrie Pompei Street, Building 19, Entrance B, 3rd Floor, Sector (District) 2, Bucharest

Romania

Kytril 1 mg

1 mg

Film-coated tablet

Oral use

 

Romania

Roche Romania SRL

9-9A Dimitrie Pompei Street, Building 19, Entrance B, 3rd Floor, Sector (District) 2, Bucharest

Romania

Kytril

3 mg/3 ml

Solution for injection

Intravenous use

3 mg/3 ml (1 mg/ml)

Slovak Republic

Roche Slovensko s.r.o.

Cintorínska 3/A

Bratislava

Slovak Republic

Kytril 1 mg

1 mg

Film-coated tablet

Oral use

 

Slovak Republic

Roche Slovensko s.r.o.

Cintorínska 3/A

Bratislava

Slovak Republic

Kytril 2 mg

2 mg

Film-coated tablet

Oral use

 

Slovak Republic

F.Hoffmann-La Roche Ltd.

Basel, Switzerland

Kytril INJ/INF

1 mg/1 ml

Concentrate for solution for infusion/injection

Intravenous use

1 mg/1 ml

Slovenia

Roche farmacevtska družba d.o.o.

Vodovodna cesta 109

1000 Ljubljana

Slovenia

Kytril 2 mg filmsko obložene tablete

2 mg

Film-coated tablet

Oral use

 

Slovenia

Roche farmacevtska družba d.o.o.

Vodovodna cesta 109

1000 Ljubljana

Slovenia

Kytril 1 mg/1 ml raztopina za injiciranje

1 mg/1 ml

Solution for injection

Intravenous use

1 mg/ml

Slovenia

Roche farmacevtska družba d.o.o.

Vodovodna cesta 109

1000 Ljubljana

Slovenia

Kytril 3 mg/3 ml raztopina za injiciranje

3 mg/3 ml

Solution for injection

Intravenous use

1 mg/ml

Spain

Roche Farma S.A.

C/Eucalipto 33

28016 Madrid

Spain

Kytril 1 mg comprimidos recubiertos con película

1 mg

Film-coated tablet

Oral use

 

Spain

Roche Farma S.A.

C/Eucalipto 33

28016 Madrid

Spain

Kytril 1 mg/1 ml solución inyectable

1 mg/1 ml

Solution for injection

Intravenous use

1 mg/ml

Spain

Roche Farma S.A.

C/Eucalipto 33

28016 Madrid

Spain

Kytril 3 mg/3 ml solución inyectable

3 mg/3 ml

Solution for injection

Intravenous use

1 mg/ml

Sweden

Roche AB

Box 47327

100 74 Stockholm

Sweden

Kytril

1 mg

Film-coated tablet

Oral use

 

Sweden

Roche AB

Box 47327

100 74 Stockholm

Sweden

Kytril

2 mg

Film-coated tablet

Oral use

 

Sweden

Roche AB

Box 47327

100 74 Stockholm

Sweden

Kytril

1 mg/ml

Solution for injection

Intravenous use

5 × 1 ml

5 × 3 ml

United Kingdom

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

Kytril Tablets 1 mg

1 mg

Film-coated tablet

Oral use

 

United Kingdom

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

Kytril Tablets 2 mg

2 mg

Film-coated tablet

Oral use

 

United Kingdom

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

Kytril Ampoule 1 mg/1 ml

1 mg/1 ml

Concentrate for solution for infusion/injection

Intravenous use

1 ml contains 1 mg granisetron (hydrochloride

United Kingdom

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

Kytril Infusion 3 mg/ml

3 mg/3 ml

Concentrate for solution for infusion/injection

Intravenous use

1 mg of granisetron per 1 ml solution


ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

Member State EU/EEA

Applicant/Marketing Authorisation Holder

Name

INN & Strength

Pharmaceutical form

Animal species

Belgium

Dopharma Research BV

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Doxycycline 50 % Dopharma

Doxycycline hyclate

500 mg/g

Water Soluble Powder

Non-ruminating calves

Pigs

Non-laying poultry

Bulgaria

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Doxycycline 50 %

WSP

Doxycycline hyclate

500 mg/g

Water Soluble Powder

Calves, pigs, poultry

Denmark

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Doxylin Vet.

Doxycycline hyclate

500 mg/g

Water Soluble Powder

Pigs

Greece

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Doxycycline 50 % Dopharma

Doxycycline hyclate

500 mg/g

Water Soluble Powder

Chickens (broilers)

Calves

Pigs

Hungary

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Doxycycline 50 % WSP

Doxycycline hyclate

500 mg/g

Powder for oral solution

Calves, pigs, chicken

Lithuania

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Doxycycline 50 %

Doxycycline hyclate

500 mg/g

Powder for oral solution

Calves, pigs and poultry

The Netherlands

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Doxycycline 50 % WSP

Doxycycline hyclate

500 mg/g

Powder for administration in drinking water

Non-egg laying chickens

Poland

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Doxymed 50

Doxycycline hyclate

500 mg/g

Water Soluble Powder

Calves, chicken, pigs

Portugal

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Vetadoxi 50

Doxycycline hyclate

500 mg/g

Water Soluble Powder

Cattle (calves), swine, birds

Romania

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Doxycycline 50 % WSP

Doxycycline hyclate

500 mg/g

Water Soluble Powder

Poultry

(not for use in animals from which eggs are produced for human consumption)

Calves

Pig


ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

Member State EU/EEA

Applicant/Marketing Authorisation Holder

Name

INN & Strength

Pharmaceutical form

Animal species

Austria

Eurovet Animal Health B.V.,

Handelsweg 25, 5531 AE Bladel,

The Netherlands

Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Hühner

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Chicken

Austria

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Pigs

Belgium

Eurovet N.V.

Poorthoevestraat 4, 3

550 Heusen-Zolder

Belgium

Soludox 50 %

Doxycycline hyclate

500 mg/g

Water Soluble Powder for oral administration

Pigs

Chickens

Czech Republic

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g prášek pro podání v pitné vodě pro prasata

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Pigs

Denmark

Eurovet Animal Health B.V.,

P.O. 179,

Handelsweg 25,

NL-5531 AE Bladel,

The Netherlands

Soludox Vet.

Doxycycline hyclate

500 mg/g

Water Soluble Powder

Pigs

Estonia

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox, 500 mg/g, suukaudse lahuse pulber sigadele

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Pigs

Estonia

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox, 500 mg/g, suukaudse lahuse pulber kanadele

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Chickens

Finland

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi sioille

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Pig

Finland

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi kanoille

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Chicken

France

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 433 mg/g poudre pour administration dans l'eau de boisson pour poulets

Doxycycline (as hyclate)

433 mg/g

Powder for use in drinking water

Chicken

France

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 433 mg/g poudre pour administration dans l'eau de boisson pour porcs.

Doxycycline (as hyclate)

433 mg/g

Powder for use in drinking water

Pigs

Germany

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g Pulver zum Eingeben

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Chicken

Germany

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Pigs

Greece

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g κόνις για χρήση στο πόσιμο νερό για όρνιθες.

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Chicken

Hungary

Eurovet Animal Health B.V.,

P.O. 179,

Handelsweg 25,

NL-5531 AE Bladel,

The Netherlands

Soludox 50 % pulvis A.U.V.

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chicken

Italy

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g polvere per uso in acqua di bevanda per suini

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Pigs

Italy

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g polvere per uso in acqua di bevanda per polli.

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Chicken

Latvia

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g pulveris lietošanai ar dzeramo ūdeni cūkām

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Pigs

Latvia

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g pulveris lietošanai ar dzeramo ūdeni vistām

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Chicken

Lithuania

Eurovet Animal Health B.V.

Handelsveg 25 - PO Box 179,

5530 AD Bladel

The Netherlands

SOLUDOX 500 mg/g, geriamieji milteliai,

Doxycycline hyclate

500 mg/g

Powder for oral solution

Pigs and chicken

The Netherlands

Eurovet Animal Health B.V.

Handelsveg 25 - PO Box 179,

5530 AD Bladel

The Netherlands

DOXY ORT 50 %

Poeder voor toediening aan het drinkwater van varkens en kippen

Doxycycline hyclate

500 mg/g

Powder for administration in the drinking water

Pigs and non-egg laying chickens.

The Netherlands

Eurovet Animal Health B.V.

Handelsveg 25 - PO Box 179,

5530 AD Bladel

The Netherlands

DOXYFAR 50 %

Poeder voor toediening aan het drinkwater van varkens en kippen

Doxycycline hyclate

500 mg/g

Powder for administration in the drinking water

Pigs and non-egg laying chickens.

The Netherlands

Eurovet Animal Health B.V.

Handelsveg 25 - PO Box 179

5530 AD Bladel

The Netherlands

SOLUDOX 50 %, poeder voor toediening via het drinkwater aan varkens en kippen

Doxycycline hyclate

500 mg/g

Powder for administration in the drinking water

Pigs and non-egg laying chickens.

The Netherlands

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg per gram voor gebruik in drinkwater voor kippen

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Chicken

Poland

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 50 %; 500 mg/g proszek do podawania w wodzie do picia dla swiń i kur

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

pigs, chickens (non-egg laying)

Slovakia

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g prášok pre užívanie s pitnou vodou pre ošípané

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Pigs

Spain

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g polvo para administración en agua de bebida para porcino

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Pigs

Spain

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g polvo para administración en agua de bebida para pollos.

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Chickens

UK

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox, 500 mg/g, Water Soluble Powder for Pigs

Doxycycline hyclate

500 mg/g

Water Soluble Powder

Pigs

UK

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g powder for use in drinking water for chickens

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Chickens

UK

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g powder for use in drinking water for pigs

Doxycycline hyclate

500 mg/g

Powder for use in drinking water

Pigs


ANNEX V

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

Alendronic acid 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

AB-Consult Handels- und Betriebsberatungs GmbH, Eichenstraße 32, A-1120 Wien, Austria

Alemol 70 mg - einmal wöchentlich Tabletten

70 mg

tablet

Oral Use

AT - Austria

AB-Consult Handels- und Betriebsberatungs GmbH, Eichenstraße 32, A-1120 Wien, Austria

Alenat 70 mg - einmal wöchentlich Tabletten

70 mg

tablet

Oral Use

AT - Austria

Hexal Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria

Alendrohexal 70 mg - einmal wöchentlich Filmtabletten

70 mg

film-coated tablet

Oral Use

AT - Austria

Genericon Pharma GmbH, Hafnerstraße 211, A-8054 Graz, Austria

Alendronorm 70 mg - einmal wöchentlich Tabletten

70 mg

tablet

Oral Use

AT - Austria

Accord Healthcare Ltd, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, UK

Alendronsäure Accord 70 mg einmal wöchentlich Tabletten

70 mg

tablet

Oral Use

AT - Austria

Accord Healthcare Ltd, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, UK

Alendronsäure Accord 10 mg Tabletten

10 mg

tablet

Oral Use

AT - Austria

Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjördur, Iceland

Alendronsäure Actavis 70 mg einmal wöchentlich Tabletten

70 mg

tablet

Oral Use

AT - Austria

Arcana Arzneimittel GmbH,

Hütteldorfer Straße 299,

A-1140 Wien,

Austria

Alendronsäure ‧Arcana‧ 70 mg - einmal wöchentlich - Tabletten

70 mg

tablet

Oral Use

AT - Austria

Bluefish Pharmaceuticals AB, Torsgatan 11, 111 23 Stockholm, Sweden

Alendronsäure Bluefish 70 mg einmal wöchentlich Tabletten

70 mg

tablet

Oral Use

AT - Austria

Interpharm Produktions GmbH, Effingergasse 21, A-1160 Wien, Austria

Alendronsäure ‧Interpharm‧ 70 mg einmal wöchentlich - Tabletten

70 mg

tablet

Oral Use

AT - Austria

Interpharm Produktions GmbH, Effingergasse 21, A-1160 Wien, Austria

Alendronsäure ‧Interpharm‧ 10 mg - Tabletten

10 mg

tablet

Oral Use

AT - Austria

1A Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria

Alendronsäure 1A Pharma 70 mg - einmal wöchentlich Filmtabletten

70 mg

film-coated tablet

Oral Use

AT - Austria

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer Gasse 3

A-1140 Wien

Austria

Alendronsäure ‧ratiopharm‧ 70 mg - einmal wöchentlich Tabletten

70 mg

tablet

Oral Use

AT - Austria

Sandoz GmbH, Biochemiestraße 10 A-6250 Kundl, Austria

Alendronsäure Sandoz 70 mg - einmal wöchentlich Filmtabletten

70 mg

film-coated tablet

Oral Use

AT - Austria

Stada Arzneimittel GmbH

Muthgasse 36

A-1190 Wien

Austria

Alendronstad 70 mg einmal wöchentlich Tabletten

70 mg

tablet

Oral Use

AT - Austria

Merck Sharp & Dohme GmbH, EURO PLAZA Gebäude G, 5.Stock, Am Euro Platz 2, A-1120 Wien, Austria

Fosamax einmal wöchentlich 70 mg Tabletten

70 mg

tablet

Oral Use

AT - Austria

Merck Sharp & Dohme GmbH, EURO PLAZA Gebäude G, 5.Stock, Am Euro Platz 2, A-1120 Wien, Austria

Fosamax 10 mg - Tabletten

10 mg

tablet

Oral Use

BE - Belgium

Arrow Generics Limited

2 Eastman Way, Stevenage,

Hertfordshire, SG1 4SZ, United Kingdom

Alendronate Arrow Generics

10 mg

Tablets

Oral Use

BE - Belgium

Arrow Generics Limited

2 Eastman Way, Stevenage,

Hertfordshire, SG1 4SZ, United Kingdom

Alendronate Arrow Generics

70 mg

Tablets

Oral Use

BE - Belgium

Eurogenerics N.V.

Heizel Esplanade b22

1020 Brussels

Belgium

Alendronate EG

10 mg

Tablets

Oral Use

BE - Belgium

Eurogenerics N.V.

Heizel Esplanade b22

1020 Brussels

Belgium

Alendronate EG

70 mg

Tablets

Oral Use

BE - Belgium

Mylan BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

Alendronate Mylan

10 mg

Tablets

Oral Use

BE - Belgium

Mylan BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

Alendronate Mylan

70 mg

Tablets

Oral Use

BE - Belgium

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Alendronate teva

70 mg

Tablets

Oral Use

BE - Belgium

Merck Sharp & Dohme B.V.

Clos du Lynx, 5- 1200 Brussels, Belgium

Fosamax hebdomadaire

70 mg

Tablets

Oral Use

BE - Belgium

Merck Sharp & Dohme B.V.

Clos du Lynx, 5- 1200 Brussels, Belgium

Fosamax

10 mg

Tablets

Oral Use

BG - Bulgaria

Tchaikapharma

1172 Sofia

1 G. M. Dimitrov Blvd

Sofia

Bulgaria

Fosanate

70 mg

film-coated tablets

Oral Use

BG - Bulgaria

Betapharm Arzneimittel GmbH, Kobelweg 95, 86156 Augsburg, Germany

Instrel

70 mg

tablets

Oral Use

BG - Bulgaria

Smarjeska cesta 6, 8501 Novo mesto –

Slovenia

Lindron

10 mg

tablets

Oral Use

BG - Bulgaria

Teva Pharmaceuticals

N.V.Gogol 15

ЕООД

Sofia

Bulgaria

Tevanate

70 mg

tablets

Oral Use

BG - Bulgaria

Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220, Hafnarfjordur

Alendronat Actavis

70 mg

tablets

Oral Use

BG - Bulgaria

Sandoz GmbH, 10 Biochemie strasse, A-6250 Kundl, Austria

Forosa

70 mg

film - coated tablets

Oral Use

BG - Bulgaria

Merck Sharp & Dohme Bulgaria

55, Nicola Vaptzarov blvd. EXPO 2000 1st floor-east wing, sections B1&B2

Sofia 1407 Bulgaria.

Fosamax OW

70 mg

tablets

Oral Use

CY - Cyprus

Merck Sharp & Dohme BV, Waarderweg 39, 2031 bn Haarlem, The Netherlands

Fosamax tablet 70 mg

70 mg

tablets

Oral Use

CY - Cyprus

Pharmanel Pharmaceuticals SA, 106 Marathons Avenue, Athens, Greece

Difonate tablet 70 mg

70 mg

tablets

Oral Use

CY - Cyprus

Farmanic-Chemipharma SA, 137 Filis Avenue, 13451 Kamatero, Attikis, Greece

Ledronin tablet 70 mg

70 mg

tablets

Oral Use

CY - Cyprus

Arrow Generics Limited, Unit 2 Eastman Way,Hertfordshire, SG1 4SZ, Stevenage, UK

Alendronic -Acid Arrow tablet 10 mg

10 mg

tablets

Oral Use

CY - Cyprus

Arrow Generics Limited, Unit 2 Eastman Way,Hertfordshire, SG1 4SZ, Stevenage, UK

Alendronic -Acid Arrow tablet 70 mg

70 mg

tablets

Oral Use

CY - Cyprus

Aurobindo Pharma (Malta) Limited, 46/2 South street, Valetta, Malta

Alendronic Acid Aurobindo tablet 70 mg

70 mg

tablets

Oral Use

CZ - Czech Republic

Orion Corporation, Orionintie 1A, FI-02200 Espoo, Finland

Aldrion 70 mg

70 mg

Tablet

Oral Use

CZ - Czech Republic

Generics Ltd., Mylan

Albany Gate, Darkes Lane,

Potters Bar

Hertfordshire

EN6 1AG

United Kingdom

Alendrogen 70 mg

70 mg

Tablet

Oral Use

CZ - Czech Republic

Actavis Group hf.

Reykavikurvegi 76-78

220 Hafnarfirdi

Iceland

Alendronat Actavis 70 mg

70 mg

Tablet

Oral Use

CZ - Czech Republic

Accord Healthcare Ltd

Sage House

Pinner Road

Harrow

Middlesex

HA1 4HF

United Kingdom

Alendronát Natrium Accord 10 mg

10 mg

Tablet

Oral Use

CZ - Czech Republic

Accord Healthcare Ltd

Sage House

Pinner Road

Harrow

Middlesex

HA1 4HF

United Kingdom

Alendronát Natrium Accord 70 mg

70 mg

Tablet

Oral Use

CZ - Czech Republic

Sandoz GmbH, Biochemiestraße 10

6250 Kundl, Austria

Alendronat Sandoz 70

70 mg

Tablet

Oral Use

CZ - Czech Republic

Ratiopharm GmbH, Graf-Arco-Straße 3

89079 Ulm, Germany

Alendronat-Ratiopharm 70 mg

70 mg

Tablet

Oral Use

CZ - Czech Republic

Teva Pharmaceuticals CR, s.r.o., Radlická 3185/1c

150 00 Praha 5

Cezch Republic

Alendronate_Teva 70 mg

70 mg

Tablet

Oral Use

CZ - Czech Republic

Arrow Generics Ltd

2 Eastman Way, Stevenage,

Hertfordshire, SG1 4SZ, United Kingdom

Alenwin 70

70 mg

Tablet

Oral Use

CZ - Czech Republic

Apotex Nederland BV

Bio Science Park

Archimedesweg 2

2333 CN Leiden, Netherlands

Apo-Alendronat 70 mg

70 mg

Tablet

Oral Use

CZ - Czech Republic

Merck Sharp & Dohme BV

Waarderweg 39, 2031 BN Haarlem, Netherlands

Fosamax 70 mg 1xtýdně

70 mg

Tablet

Oral Use

CZ - Czech Republic

Arrow Generics Ltd

2 Eastman Way, Stevenage,

Hertfordshire, SG1 4SZ, United Kingdom

Fosteofos 70

70 mg

Tablet

Oral Use

CZ - Czech Republic

Bentley Pharmaceuticals Ireland Ltd, 25/28 North Wall Quay, Dublin 1, Ireland

Gendron 70 mg

70 mg

Tablet

Oral Use

CZ - Czech Republic

Richter Gedeon Nyrt.

Gyömrői út 19-21.

H-1103 Budapest

Hungary

Siranin 70 mg potahované tablety

70 mg

Tablet

Oral Use

DE - Germany

TEVA Deutschland GmbH

Wasastr. 50

D-01445 Radebeul

Tevanate 10 mg Tabletten

10 mg

Tablet

Oral Use

DE - Germany

TEVA Deutschland GmbH

Wasastr. 50

D-01445 Radebeul

Tevanate 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

TEVA Deutschland GmbH

Wasastr. 50

D-01445 Radebeul

Tevabone-4 70 mg Tabletten und 1 Mikrogramm Weichkapseln

70 mg

1 μ

Tablet and Capsule soft

Oral Use

DE - Germany

TEVA Deutschland GmbH

Wasastr. 50

D-01445 Radebeul

Tevabone-5 70 mg Tabletten und 1 Mikrogramm Weichkapseln

70 mg

1 μ

Tablet and Capsule soft

Oral Use

DE - Germany

TEVA Deutschland GmbH

Wasastr. 50

D-01445 Radebeul

Tevabone-3 70 mg Tabletten und 1 Mikrogramm Weichkapseln

70 mg

1 μ

Tablet and Capsule soft

Oral Use

DE - Germany

TEVA Deutschland GmbH

Wasastr. 50

D-01445 Radebeul

Tevabone-2 70 mg Tabletten und 1 Mikrogramm Weichkapseln

70 mg

1 μ

Tablet and Capsule soft

Oral Use

DE - Germany

TEVA Deutschland GmbH

Wasastr. 50

D-01445 Radebeul

Tevabone 70 mg Tabletten und 1 Mikrogramm Weichkapseln

70 mg

1 μ

Tablet and Capsule soft

Oral Use

DE - Germany

1 A Pharma GmbH

Keltenring 1 + 3

D-82041 Oberhaching

Alendronsäure - 1 A Pharma 70 mg Filmtabletten

70 mg

Film-coated tablet

Oral Use

DE - Germany

AbZ-Pharma GmbH

Dr.Georg-Spohn-Str. 7

D-89143 Blaubeuren

Alendronsäure AbZ 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

Accord Healthcare Limited

Sage House, 319, Pinner Road

GB-HA1 4HF NORTH HARROW, MIDDLESEX

Alendronsäure Accord 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

Accord Healthcare Limited

Sage House, 319, Pinner Road

GB-HA1 4HF NORTH HARROW, MIDDLESEX

Alendronsäure Accord 10 mg Tabletten

10 mg

Tablet

Oral Use

DE - Germany

acis Arzneimittel GmbH

Lil-Dagover-Ring 7

D-82031 Grünwald

Alendronat acis 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

Actavis Group PTC ehf

Reykjavikurvegur 76 - 78

IS-220 Hafnarfjördur

Alendronsäure-Actavis 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

ALIUD PHARMA GmbH

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Alendronsäure AL 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

AWD.pharma GmbH & Co.KG

Wasastr. 50

D-01445 Radebeul

Alendronsäure AWD 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

AWD.pharma GmbH & Co.KG

Wasastr. 50

D-01445 Radebeul

Alendronsäure AWD 10 mg Tabletten

10 mg

Tablet

Oral Use

DE - Germany

axcount Generika AG

Max-Planck-Str. 36b

D-61381 Friedrichsdorf

Alendronsäure axcount 70 mg

70 mg

Tablet

Oral Use

DE - Germany

Basics GmbH

Hemmelrather Weg 201

D-51377 Leverkusen

ALENDRONSÄURE BASICS einmal wöchentlich 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Alendron beta einmal wöchentlich 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Alendron 10 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

biomo pharma GmbH

Josef-Diezgen-Str 3

D-53773 Hennef

Alendronsäure-biomo 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

Bluefish Pharmaceuticals AB

Torsgatan 11

S-111 23 Stockholm

Alendronsäure Bluefish 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

CT Arzneimittel GmbH

Lengeder Str. 42a

D-13407 Berlin

Alendronsäure-CT 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

esparma GmbH

Seepark 7

D-39116 Magdeburg

Alendron esparma 70 mg einmal wöchentlich Tabletten

70 mg

Tablet

Oral Use

DE - Germany

Gedeon Richter Plc.

Gyömröi ut 19 - 21

H-1103 Budapest

Alendronate Richter 70 mg Filmtabletten

70 mg

Film-coated tablet

Oral Use

DE - Germany

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Alendronsäure Heumann 10 mg Tabletten

10 mg

Tablet

Oral Use

DE - Germany

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Alendronsäure Heumann 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Alendron-Hexal 10 mg Tabletten

10 mg

Tablet

Oral Use

DE - Germany

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Alendron-Hexal 10 einmal wöchentlich 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

Juta Pharma GmbH

Gutenbergstr. 13

D-24941 Flensburg

Alendro-Q 70 mg Tablette

70 mg

Tablet

Oral Use

DE - Germany

Juta Pharma GmbH

Gutenbergstr. 13

D-24941 Flensburg

Alendro-Q 10 mg Tabletten

10 mg

Tablet

Oral Use

DE - Germany

KSK-Pharma Vertriebs AG

Finkenstr. 1

D-76327 Pfinztal-Berghausen

Alendro-KSK 70 mg

70 mg

Tablet

Oral Use

DE - Germany

mibe GmbH Arznzemittel

Münchener Str. 15

D-06796 Brehna

Alendromed 70 mg

70 mg

Tablet

Oral Use

DE - Germany

MSD Sharp & Dohme GmbH

Lindenplatz 1

D-85540 Haar

FOSAMAX 10 mg Tabletten

10 mg

Tablet

Oral Use

DE - Germany

MSD Sharp & Dohme GmbH

Lindenplatz 1

D-85540 Haar

FOSAMAX einmal wöchentlich 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

Mylan dura GmbH

Wittichstr. 6

D-64295 Darmstadt

Alendronsäure Mylan 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

Mylan dura GmbH

Wittichstr. 6

D-64295 Darmstadt

Alendrosäure dura 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

Mylan dura GmbH

Wittichstr. 6

D-64295 Darmstadt

Alendrossa 10 mg

10 mg

Tablet

Oral Use

DE - Germany

Orion Corporation

Orionintie 1

FIN-=2200 ESPOO

Alendronsäure Orion 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

Ovamex Limited

118 larch crescent

GB-UB4 9EB HAYES, MIDDLESEX

Alendronsäure Ovamex 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

Ovamex Limited

118 larch crescent

GB-UB4 9EB HAYES, MIDDLESEX

Alendronsäure Ovamex 10 mg Tabletten

10 mg

Tablet

Oral Use

DE - Germany

ratiopharm GmbH

Graf-Arco-STr. 3

D-89079 Ulm

Alendronsäure-ratiopharm 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Alendron-Sandoz einmal wöchentlich 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

Stadapharm GmbH

Stadastr. 2 - 18

D-61118 Bad Vilbel

Alendronsäure STADA 10 mg Tabletten

10 mg

Tablet

Oral Use

DE - Germany

Stadapharm GmbH

Stadastr. 2 - 18

D-61118 Bad Vilbel

Alendronsäure STADA 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

D-56218 Mülheim-Kärlich

Alendron Winthrop einmal wöchentlich 70 mg Tabletten

70 mg

Tablet

Oral Use

DE - Germany

Mylan dura GmbH

Wittichstr. 6

D-64295 Darmstadt

Alendrokit dura

91,36 mg

1 495,5 mg

4 mg

Tablet and film-coated tablet

Oral Use

DE - Germany

TECNIMEDE - Sociedade Técnico-Medicinal, S.A. (BS 2)

Rua da Tapada Grande, n2

P-2710-089 ABRUNHEIRA, SINTRA

Alendronsäure Tecnimede 70 mg Filmtabletten

70 mg

Film-coated tablet

Oral Use

DE - Germany

Volkspharma GmbH

August-Wessels-Str. 5

D-86154 Augsburg

Alendronsäure 70 mg Volkspharma Tabletten

70 mg

Tablet

Oral Use

DK - Denmark

1A Farma, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark

Alendronat "1A Farma"

70 mg

Film-coated tablets

Oral Use

DK - Denmark

Actavis Group PTC ehf., Reykjavikurvegi 76-78, P.O. 425, IS-220 Hafnarfjördur, Iceland

Alendronat "Actavis"

70 mg

Tablets

Oral Use

DK - Denmark

Arrow Generics Limited, Unit 2, Eastman Way Stevenage, SG1 4SZ Hertfordshire, England

Alendronat "Arrow"

10 mg

Tablets

Oral Use

DK - Denmark

Arrow Generics Limited, Unit 2, Eastman Way Stevenage, SG1 4SZ Hertfordshire, England

Alendronat "Arrow"

70 mg

Tablets

Oral Use

DK - Denmark

BLUEFISH PHARMACEUTICALS AB, Torsgatan 11, 111 23 Stockholm, Sweden

Alendronat "Bluefish"

70 mg

Tablets

Oral Use

DK - Denmark

Mylan AB, P.O.box 23033, Ynglingagatan 14, SE-104 35 Stockholm; Sweden

Alendronat "Mylan"

10 mg

Tablets

Oral Use

DK - Denmark

Mylan AB, P.O.box 23033, Ynglingagatan 14, SE-104 35 Stockholm; Sweden

Alendronat "Mylan"

70 mg

Tablets

Oral Use

DK - Denmark

Orifarm Generics A/S, Energivej 15, DK-5260 Odense S., Denmark

Alendronat "Orifarm"

70 mg

Tablets

Oral Use

DK - Denmark

Orion Corporation Orion Pharma, Orionintie 1, FI-02200 Espoo, Finland

Alendronat "Orion"

70 mg

Tablets

Oral Use

DK - Denmark

Pharmachemie B.V., PO Box 552, Swensweg 5, NL-2031 GA Haarlem, Nederlands

Alendronat "PCH"

10 mg

Tablets

Oral Use

DK - Denmark

Ranbaxy (UK) Ltd., 20 Balderton Street, W1K 6TL London, UK

Alendronat "Ranbaxy"

70 mg

Tablets

Oral Use

DK - Denmark

Sandoz A/S, C.F. Tietgens Boulevard 40, DK-5220 Odense SØ, Denmark

Alendronat "Sandoz"

70 mg

Film-coated tablets

Oral Use

DK - Denmark

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany

Alendronat "Stada"

70 mg

Tablets

Oral Use

DK - Denmark

Teva Denmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark

Alendronat "Teva"

70 mg

Tablets

Oral Use

DK - Denmark

ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany

Alendronat "ratiopharm"

70 mg

Tablets

Oral Use

DK - Denmark

Merck Sharp & Dohme B.V., PO Box 581, Waarderweg 39, NL-2031 BN Haarlem, Nederlands

Fasamax Ugetablet

70 mg

Tablets

Oral Use

DK - Denmark

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany

Alendronat "Stada"

10 mg

Tablets

Oral Use

DK - Denmark

Teva Denmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark

Alendronat "Teva"

10 mg

Tablets

Oral Use

EL - Greece

VIANEX S.A.

TATIOIOU STREET

Nea Erythrea 14671

FOSAMAX

10 MG/TAB

TABLET

Oral Use

EL - Greece

VIANEX S.A.

TATIOIOU STREET

Nea Erythrea 14671

FOSAMAX

5 MG/TAB

TABLET

Oral Use

EL - Greece

VIANEX S.A.

TATIOIOU STREET

Nea Erythrea 14671

FOSAMAX ONCE WEEKLY

70 MG/TAB

TABLET

Oral Use

EL - Greece

FARAN ABEE PRODUCTION AND COMMERCE OF MEDICINAL PRODUCTS

ACHAIAS AND TROIZINIAS, KIFISSIA 14564

OSASTON

70 MG/TAB

TABLET

Oral Use

EL - Greece

BIOMEDICA-CHEMICA S.A.

G. LYRA 25

KATW KIFISSIA

AMPINE

70 MG/TAB

TABLET

Oral Use

EL - Greece

KLEVA AFBEE

PARNITHOS AVENUE 189

ACHARNES ATTIKIS 13675

DARGOL

70 MG/TAB

TABLET

Oral Use

EL - Greece

MED-ONE AFBEE

AGIOU PETROU 30 & EPAMEINONDA

ACHARNES 13675

DEBENAL

70 MG/TAB

TABLET

Oral Use

EL - Greece

GENERICS PHARMA HELLAS ΕΠΕ

VOULIAGMENIS AVENUE 577A

16451 ARGYROUPOLI

P.O. BOX 72571

ALENDRONATE / GENERICS

70 MG/TAB

TABLET

Oral Use

EL - Greece

GENERICS PHARMA HELLAS ΕΠΕ

VOULIAGMENIS AVENUE 577A

16451 ARGYROUPOLI

P.O. BOX 72572

ALENDRONATE / GENERICS

10 MG/TAB

TABLET

Oral Use

EL - Greece

ALAPIS ABEE

AUTOKRATOROS NIKOLAOU 2

ATHENS 17671

MELDOZ

70 MG/TAB

TABLET

Oral Use

EL - Greece

VELKA HELLAS AEBE

KAPODISTRIOU AND KORINTHOU 12

NEO PSYCHIKO 15451

OSTAVEN

70 MG/TAB

TABLET

Oral Use

EL - Greece

ARROW GENERICS LIMITED, HERTS, UNITED KINGDOM

Unit 2, Eastman Way,

Stevenage,

Herts

United Kingdom

ALENDRONIC ACID/ARROW

10 MG/TAB

TABLET

Oral Use

EL - Greece

ARROW GENERICS LIMITED, HERTS, UNITED KINGDOM

Unit 2, Eastman Way,

Stevenage,

Herts

United Kingdom

ALENDRONIC ACID/ARROW

70 MG/TAB

TABLET

Oral Use

EL - Greece

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

OSTEONAT

70 MG/TAB

TABLET

Oral Use

EL - Greece

MEDARTE PHARMACEUTICALS ΑΒΕΕ

SPYROU VRETTOU 10

METAMORFOSI 14452

OSTALERT

70 MG/TAB

TABLET

Oral Use

EL - Greece

VOCATE PHARMACEUTICALS S.A.

GOUNARI 150,

GLYFADA 16674

FOSAZOM

70 MG/TAB

TABLET

Oral Use

EL - Greece

GENEPHARM S.A.

18km MARATHONOS AVENUE

PALLINI ATTIKIS 15351

FOSALEN

70 MG/TAB

TABLET

Oral Use

EL - Greece

SANTA PHARMA S.A.

ASKLIPIOU 4

KRYONERI ATTIKIS 14568

ALEFOS

70 MG/TAB

TABLET

Oral Use

EL - Greece

IASIS PHARMAC.HELLAS

137 FYLIS AVENUE

KAMATERO 13451

LEDRONIN

70 MG/TAB

TABLET

Oral Use

EL - Greece

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

DIFONATE

70 MG/TAB

TABLET

Oral Use

EL - Greece

ANFARM HELLAS S.A.

PERIKLEOUS 53-57

GERAKAS ATTIKIS 15344

RIDON

70 MG/TAB

TABLET

Oral Use

EL - Greece

AURORA PHARMACEUTICALS S.A.

EVROU 4 & MESSINIAS 2

GERAKAS 15344

AURODREN

70 MG/TAB

TABLET

Oral Use

EL - Greece

VIOFAR LTD

ETHNIKIS ANTISTASEWS & TRIZINIAS

ACHARNES 13671

DEPAREX

70 MG/TAB

TABLET

Oral Use

EL - Greece

BIOSPRAY ABEE

18KM MARATHONOS AVENUE

PALLINI 15344

ALENDRAL

70 MG/TAB

TABLET

Oral Use

EL - Greece

FARMATHEN HELLAS ABEE

MARATHONOS AVENUE 144

PALLINI 15351

POROCALM

70 MG/TAB

TABLET

Oral Use

EL - Greece

SANDOZ GMBH, KUNDL, AUSTRIA

Biochemiestrasse 10,

A-6250, Kundl

Tirol, Austria

FOROSA

70 MG/TAB

TABLET

Oral Use

EL - Greece

RAFARM AEBE

KORINTHOU 12

NEO PSYCHIKO 15451

MOSMASS

70 MG/TAB

TABLET

Oral Use

EL - Greece

ROTTAPHARM HELLAS S.A.

PRDUCTION AND COMMERCE OF PHARMACEUTICALS

ACHAIAS AND TRIZINIAS

NEA KIFISSIA 14564

LOZOSTUN

70 MG/TAB

TABLET

Oral Use

EL - Greece

DELEGANT HOLDINGS LTD, CYPRUS

AGIAS ELENIS 36

COMMERCIAL CENTRE GALAXY 401

NICOSIA 1061

CYPRUS

DELFOZA

70 MG/TAB

TABLET

Oral Use

EL - Greece

SPECIFAR ABEE

28TH OCTOBER 1

AGIA VARVARA 123 51

DROFAZ

70 MG/TAB

TABLET

Oral Use

EL - Greece

EVANGELOS KALOFOLIAS & CO IAPHARM

MENANDROU 54

ATHENS 10431

FOSANDRON

70 MG/TAB

TABLET

Oral Use

EL - Greece

TARGET PHARMA LTD

MENANDROU 54

ATHENS 10431

ARTHROPLUS

70 MG/TAB

TABLET

Oral Use

EL - Greece

VIVAX PHARMACEUTICALS LTD,

DERVENAKION 38

GERAKAS ATTIKIS 15344

EN-POR

70 MG/TAB

TABLET

Oral Use

EL - Greece

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

MORALEN

70 MG/TAB

TABLET

Oral Use

EL - Greece

FARMEX S.A.

KIFISSOU AVENUE 132

ATHENS 12131

ENIMON

70 MG/TAB

TABLET

Oral Use

EL - Greece

ALET PHARMACEUTICALS ABEE

AIDINIOU 26,

CHALANDRI 12461

ALEDROLET

70 MG/TAB

TABLET

Oral Use

EL - Greece

PHARMA LINE S.A.

TH. PETALA 41

NEA CHALKIDONA 14343

ZULGAR

70 MG/TAB

TABLET

Oral Use

EL - Greece

VERISFIELD (UK) LTD, U.K.

41 Chalton street,

London, NW1 1JD,

United Kingdom

ZEMAROS

70 MG/TAB

TABLET

Oral Use

EL - Greece

HELP ΑΒΕΕ

VALAORITOU 10

METAMORFOSI ATTIKIS 14452

OSTEOS

70 MG/TAB

TABLET

Oral Use

EL - Greece

FARMEDIA AE

ATHINAS 22 & APOLLONOS

GERAKAS ATTIKIS 15344

FARMEMAX

70 MG/TAB

TABLET

Oral Use

EL - Greece

FARMAZAK S.A.

NAOUSSIS 31

VOTANIKOS 10447

ZAKODRONATE

70 MG/TAB

TABLET

Oral Use

EL - Greece

TEVA PHARMA B.V., UTRECHT, THE NETHERLANDS

Computerweg 10,

3542 DR, Utrecht,

The Netherlands

TEVANATE

70 MG/TAB

TABLET

Oral Use

ES - Spain

MERCK SHARP AND DOHME DE ESPAÑA, S.A.Josefa Valcarcel, 38 28027 MADRID

FOSAMAX Semanal 70 mg comprimidos

70 mg

Film coated tablet

Oral Use

ES - Spain

MERCK SHARP AND DOHME DE ESPAÑA, S.A.Josefa Valcarcel, 38 28027 MADRID

FOSAMAX 10 mg Comprimidos

10 mg

tablets

Oral Use

ES - Spain

MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5o Planta 08038 Barcelona

ÁCIDO ALENDRÓNICO SEMANAL MYLAN 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

LABORATORIOS ALTER, S.A. Mateo Inurria, 30 28036 Madrid

ÁCIDO ALENDRÓNICO SEMANAL ALTER 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

MERCK S.L.María de Molina, 40 28006 Madrid

CALBION SEMANAL 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

LABORATORIOS ALTER, S.A. Mateo Inurria, 30 28036 Madrid

BIFOAL SEMANAL 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

LABORATORIO STADA, S.L. Frederic Mompou, 5 08960 Sant Just Desvern

Barcelona

ÁCIDO ALENDRÓNICO SEMANAL STADA 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

RATIOPHARM ESPAÑA, S.A. Avda. de Burgos, 16 D - 5a Planta 28036 Madrid

ACIDO ALENDRONICO SEMANAL RATIOPHARM 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

LABORATORIOS EDIGEN, S.A Chile 8, 2o Oficina 203.Edificio Euromadrid 28290 Las Matas

Madrid

ÁCIDO ALENDRÓNICO EDIGEN 10 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

LABORATORIOS EDIGEN, S.A Chile 8, 2o Oficina 203.Edificio Euromadrid 28290 Las Matas

Madrid

ÁCIDO ALENDRÓNICO EDIGEN 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

TEVA GENERICOS ESPAÑOLA, S.L. Guzmán el Bueno 133, Edificio Britania 4oIzq.28003 Madrid

ACIDO ALENDRONICO TEVA 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

MABO FARMA, S.A Carretera M-300 Km 30,500. 28802 Alcalá de Henares

ÁCIDO ALENDRÓNICO SEMANAL MABO 70 mg COMPRIMIDOS

70 mg

tablets

Oral Use

ES - Spain

CANTABRIA PHARMA, S.L.c/Ribera del Loira, 46 edificio 2 28042 Madrid

Spain

ALENDROCARE SEMANAL 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

SANDOZ FARMACEUTICA, S.A. Avda. Osa Mayor, 4Aravaca 28023 (Madrid)

ÁCIDO ALENDRÓNICO SEMANAL SANDOZ 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos

ACIDO ALENDRONICO SEMANAL NORMON 70 mg Comprimidos

70 mg

tablets

Oral Use

ES - Spain

TECNIMEDE ESPAÑA, INDUSTRIA FARMACEUTICA, S.A. Avda. Pio XII, 92, Edificio Ural A, Planta 16-4 28036 Madrid

ACIDO ALENDRONICO SEMANAL TECNIGEN 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

PHARMAGENUS, S.A. Avda. Camí Real, 51-57 08184 Palau-solita i Plegamans

Barcelona

ACIDO ALENDRONICO SEMANAL PHARMAGENUS 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

LABORATORIOS RANBAXY, S.L. Passeig de Gracia, 9 08007 Barcelona

ÁCIDO ALENDRÓNICO SEMANAL RANBAXY 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

TEVA PHARMA S.L.U. C/ Anabel Segura, 11, Edificio Albatros B, 1a planta 28108 Alcobendas

SEMANDROL SEMANAL 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

QUALIGEN, S.L.Avda. Barcelona, 69 08970 Sant Joan Despi

ACIDO ALENDRÓNICO SEMANAL QUALIGEN 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

LABORATORIOS DAVUR, S.L.Teide, 4-planta baja. Poligono Empresarial La Marina 28703 San Sebastian de los Reyes

ÁCIDO ALENDRÓNICO SEMANAL DAVUR 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

RIMAFAR, S.L.Pol. Ind. Malpica Calle C, No 4 50016 Zaragoza

ÁCIDO ALENDRÓNICO SEMANAL RIMAFAR 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

KERN PHARMA, S.L.Venus, 72. Poligono Industrial Colon II.08228 Tarrasa

ÁCIDO ALENDRÓNICO SEMANAL KERN PHARMA 70 mg Comprimidos

70 mg

tablets

Oral Use

ES - Spain

KORHISPANA S.L.Carretera de Castellvell, 24 43206 Reus

ACIDO ALENDRONICO SEMANAL KORHISPANA 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

GERVASI FARMACIA, S.L.Juan XXIII, 15-19 08950 Esplugues de Llobregat

LEFOSAN SEMANAL 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

LABORATORIOS ALACAN INDUSTRIAS QUIMICO FARMACEUTICAS, S.A.Sagitario, 14 03006 Alicante

ADELAN SEMANAL 70 mg Comprimidos

70 mg

tablets

Oral Use

ES - Spain

FARMALIDER, S.A.Aragoneses, 15 28108 Alcobendas

ACIDO ALENDRONICO SEMANAL FARMALIDER 70 mg comprimidos recubiertos con película

70 mg

Film coated tablets

Oral Use

ES - Spain

SINTEXLINE S.A.Polígono Industrial La Red, Calle 11 no 2 41500 Alcalá de Guadaira

ALENDROGYN 70 mg comprimidos recubiertos con película

70 mg

Film coated tablets

Oral Use

ES - Spain

FARMALIDER, S.A.Aragoneses, 15 28108 Alcobendas

ALENDROFARM 70 mg comprimidos recubiertos con pelicula

70 mg

Film coated tablets

Oral Use

ES - Spain

LABORATORIOS COMBIX, S.L.San Rafael, 3. Pol. Industrial Alcobendas 28108 Alcobendas

ACIDO ALENDRONICO SEMANAL COMBIX 70 mg comprimidos recubiertos con película

70 mg

Film coated tablets

Oral Use

ES - Spain

ALMUS FARMACEUTICA, S.A.Avda. Verge de Montserrat, 6 08820 El Prat de Llobregat

ACIDO ALENDRONICO SEMANAL ALMUS 70 mg comprimidos recubiertos con película

70 mg

Film coated tablets

Oral Use

ES - Spain

PENSA PHARMA, S.A.U Jorge Comín (médico pediatra), 3 - bajos 46015 Valencia

ÁCIDO ALENDRÓNICO SEMANAL PENSA 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

LABORATORIOS RANBAXY, S.L.Passeig de Gracia, 9 08007 Barcelona

ACIDO ALENDRONICO SEMANAL RANBAXYGEN 70 mg Comprimidos

70 mg

tablets

Oral Use

ES - Spain

LABORATORIOS RANBAXY, S.L.Passeig de Gracia, 9 08007 Barcelona

ÁCIDO ALENDRÓNICO SEMANAL CINFA 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

LAREQ PHARMA S.L Laguna, 66-68-70. Poligono Industrial Urtinsa II 28923 Alcorcón

ACIDO ALENDRONICO SEMANAL LAREQ 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

LABORATORIOS PEREZ GIMENEZ, S.A.Pol. Ind. Los Mochos. Polígono 8 - Parcela 20. Crta. A-431, Km 19 14720 Almodovar del Río

ÁCIDO ALENDRÓNICO SEMANAL CUVE 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.Laguna, 66-68-70. Poligono Industrial Urtinsa II 28923 Alcorcón

ACIDO ALENDRONICO SEMANAL VIR 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4 - Area B Aravaca (Madrid)

ACIDO ALENDRONICO SEMANAL BEXAL 70 mg comprimidos recubiertos con película

70 mg

tablets

Oral Use

ES - Spain

ACOST COMERCIAL GENERIC-PHARMA, S.L.Centro Empresarial Osa Mayor. Osa Mayor, 4 Area B Aravaca (Madrid)

ACIDO ALENDRONICO SEMANAL ACOST 70 mg comprimidos recubiertos con película

70 mg

tablets

Oral Use

ES - Spain

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.Laguna, 66-68-70. Poligono Industrial Urtinsa II 28923 Alcorcón

ALENVIR SEMANAL 70 mg comprimidos

70 mg

tablets

Oral Use

ES - Spain

Apotex Europe BV

Darwinweg 20

2333 CR Leiden Netherlands

ÁCIDO ALENDRÓNICO APOTEX 70 mg comprimidos

70 mg

tablets

Oral Use

ET - Estonia

Merck Sharp & Dohme OÜ Peterburi tee 46

11415 Tallinn ESTONIA

FOSAMAX 70 MG

70 mg

Tablet

Oral Use

ET - Estonia

Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow HA1 4HF, Middlesex UNITED KINGDOM

ALENDRONIC ACID ACCORD 70 MG

70 mg

Tablet

Oral Use

ET - Estonia

Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow HA1 4HF, Middlesex UNITED KINGDOM

ALENDRONIC ACID ACCORD 10 MG

10 mg

Tablet

Oral Use

ET - Estonia

Actavis Group PTC ehf Reykjavikurvegi 76-78

220 Hafnarfjördur ICELAND

LENDRATE

70 mg

Tablet

Oral Use

ET - Estonia

Gedeon Richter Plc. Gyömrõi ut 19-21

1103 Budapest HUNGARY

SEDRON

70 mg

Film-coated tablet

Oral Use

ET - Estonia

KRKA d.d., Novo Mesto Shmarjeshka cesta 6,

8501 Novo Mesto SLOVENIA

LINDRON

10 mg

Tablet

Oral Use

ET - Estonia

MEPHA Lda. Lagoas Park Edifico 5-A, Piso 2, 2740-298 Porto Salvo PORTUGAL

DENSIDRON

70 mg

Film-coated tablet

Oral Use

ET - Estonia

Orion Corporation Orionintie 1

FIN-02200 Espoo FINLAND

ALENDROONHAPE ORION

70 mg

Tablet

Oral Use

ET - Estonia

Ranbaxy (UK) Limited 20 Balderton Street, London W1K 6TL UNITED KINGDOM

RALENOST 70 MG

70 mg

Tablet

Oral Use

ET - Estonia

Teva Pharma B.V. Computerweg 10

3542 DR Utrecht THE NETHERLANDS

ALENOTOP

70 mg

Tablet

Oral Use

ET - Estonia

Teva Pharma B.V. Computerweg 10

3542 DR Utrecht THE NETHERLANDS

TEVANATE 70 MG

70 mg

Tablet

Oral Use

FI - Finland

Ranbaxy UK Ltd, 20 Balderton Street, LONDON W1K 6TL, United Kingdom

Alendronat Ranbaxy

70 mg

tablet

Oral Use

FI - Finland

Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 HAFNARFJORDUR, Iceland

Alendronat Actavis

70 mg

tablet

Oral Use

FI - Finland

Arrow Generics Limited, Unit 2, Eastman Way Stevenage, HERTS SG14SZ, United Kingdom

Alendronat Arrow

10 mg

tablet

Oral Use

FI - Finland

Arrow Generics Limited, Unit 2, Eastman Way Stevenage, HERTS SG14SZ, United Kingdom

Alendronat Arrow

70 mg

tablet

Oral Use

FI - Finland

Bluefish Pharmaceuticals AB, Torsgatan 11, 11123 STOCKHOLM, Sweden

Alendronat Bluefish

70 mg

tablet

Oral Use

FI - Finland

Hexal A/S, Kanalholmen 8-12, 2650 HVIDOVRE, Denmark

Alendronat Hexal

70 mg

film-coated tablet

Oral Use

FI - Finland

Mylan AB, BOX 23033, 10435 STOCKHOLM, Sweden

Alendronat Mylan

70 mg

tablet

Oral Use

FI - Finland

Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark

Alendronat Orifarm

70 mg

tablet

Oral Use

FI - Finland

Orion Corporation, Orion Pharma, Orionintie 1, 02200 Espoo, Finland

Alendronat Orion

70 mg

tablet

Oral Use

FI - Finland

ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany

Alendronat ratiopharm

70 mg

film-coated tablet

Oral Use

FI - Finland

Sandoz A/S, C. F. Tietgens Boulevard 40, 5220 ODENSE SØ, Denmark

Alendronat Sandoz

70 mg

film-coated tablet

Oral Use

FI - Finland

Merck Sharp & Dohme B.V., Waarderweg 39, P.O.BOX 581, 2031 BN HAARLEM, Netherlands

Fosamax

10 mg

tablet

Oral Use

FI - Finland

Merck Sharp & Dohme B.V., Waarderweg 39, P.O.BOX 581, 2031 BN HAARLEM, Netherlands

Fosamax

70 mg

tablet

Oral Use

FR - France

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

FRANCE

ACIDE ALENDRONIQUE ALMUS 10 mg, comprimé

10 mg

tablet

Oral Use

FR - France

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

FRANCE

ACIDE ALENDRONIQUE ALMUS 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

ALTER

3, avenue de la Baltique

ZI de Courtaboeuf

91140 Villebon Sur Yvette

FRANCE

ACIDE ALENDRONIQUE ALTER 70 mg, comprimé pelliculé

70 mg

tablet

Oral Use

FR - France

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

FRANCE

ACIDE ALENDRONIQUE ARROW 10 mg, comprimé

10 mg

tablet

Oral Use

FR - France

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

FRANCE

ACIDE ALENDRONIQUE ARROW 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

FRANCE

ACIDE ALENDRONIQUE BIOGARAN 10 mg, comprimé

10 mg

tablet

Oral Use

FR - France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

FRANCE

ACIDE ALENDRONIQUE BIOGARAN 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

FRANCE

ACIDE ALENDRONIQUE EG 10 mg, comprimé

10 mg

tablet

Oral Use

FR - France

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

FRANCE

ACIDE ALENDRONIQUE EG 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

FRANCE

ACIDE ALENDRONIQUE MYLAN, 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

FRANCE

ACIDE ALENDRONIQUE PHR LAB 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

KROMME RIJN APOTHEEK

Langstraat 4C

3981 EV BUNNIK

PAYS-BAS

ACIDE ALENDRONIQUE QUALIHEALTH 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

QUALIMED (LYON)

117, allée des Parcs

69800 Saint-Priest

FRANCE

ACIDE ALENDRONIQUE QUALIMED 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

RATIOPHARM (ALLEMAGNE)

Graf Arco Strasse 3

89079 Ulm

ALLEMAGNE

ACIDE ALENDRONIQUE RATIOPHARM 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

FRANCE

ACIDE ALENDRONIQUE SANDOZ 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

ACIDE ALENDRONIQUE WINTHROP 10 mg, comprimé

10 mg

tablet

Oral Use

FR - France

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

ACIDE ALENDRONIQUE WINTHROP 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

ZYDUS FRANCE

25, rue des Peupliers

ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers

92000 Nanterre

FRANCE

ACIDE ALENDRONIQUE ZYDUS 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

PHARMEMMA

Unit 2, Ashbourne Manufacturing Park

Ashbourne County Meath

IRLANDE

ARONADE 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

THERAMEX

6, avenue Albert II

Zone F - Bloc B

98000 Monaco

MONACO

AURENA 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

PHARMEMMA

Unit 2, Ashbourne Manufacturing Park

Ashbourne County Meath

IRLANDE

DRONACID 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

MERCK SHARP & DOHME CHIBRET

3, avenue Hoche

75114 Paris Cedex 08

FRANCE

FOSAMAX 10 mg, comprimé

70 mg

tablet

Oral Use

FR - France

MERCK SHARP & DOHME CHIBRET

3, avenue Hoche

75114 Paris Cedex 08

FRANCE

FOSAMAX 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

MERCK SHARP & DOHME CHIBRET

3, avenue Hoche

75114 Paris Cedex 08

FRANCE

FOSATROL 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

FRANCE

ACIDE ALENDRONIQUE BIOGALENIQUE 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES

4, place Louis Armand

75012 Paris

FRANCE

ACIDE ALENDRONIQUE RANBAXY 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

FRANCE

ACIDE ALENDRONIQUE RPG 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

FRANCE

ACIDE ALENDRONIQUE TEVA 70 mg, comprimé

70 mg

tablet

Oral Use

FR - France

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

FRANCE

ALENDRONATE TEVA 10 mg, comprimé

10 mg

tablet

Oral Use

HU - Hungary

Generics (UK) Ltd.

Albany Gate, Darkes Lane, Potters bar

EN61AG Hertfordshire

UK

ALENDIS 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,37 mg sodium alendronate]

tablet

Oral Use

HU - Hungary

Arrow Generics Ltd.

Stevenage

SG14SZ Hertfordshire

UK

ALENDROMAX 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,36 mg sodium alendronate trihydrate]

tablet

Oral Use

HU - Hungary

Sandoz Hungária Kft.,

1114 Budapest, Bartók Béla út 43-47.

Hungary

ALENDRON HEXAL 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,36 mg sodium alendronate trihydrate]

tablet

Oral Use

HU - Hungary

Bluefish Pharmaceuticals ABTorsgatan 11

111 23 Stockholm

Sweden

ALENDRONAT BLUEFISH 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,37 mg sodium alendronate trihydrate]

tablet

Oral Use

HU - Hungary

Orion Corporation

Orionintie 1.

2200 Espoo

Finland

ALENDRONAT ORION 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,36 mg sodium alendronate trihydrate]

tablet

Oral Use

HU - Hungary

Pliva Hungária Kft.

Galagonya u. 5.

1036 Budapest

Hungary (The company is the member of TEVA Group Teva Magyarország zRt, 1134budapest, Róbert Károly krt.59))

ALENDRONAT PLIVA 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,36 mg alendronate trihydrate]

tablet

Oral Use

HU - Hungary

Ratiopharm Hungária Kft.

Uzsoki u. 36/A

1145 Budapest

Hungary

ALENDRONAT-RATIOPHARM 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,36 mg sodium alendronate trihydrate]

tablet

Oral Use

HU - Hungary

Richter Gedeon nyrt.

Gyömrői út 19-21.

1103 Budapest

Hungary

ALENDRONAT-RICHTER 70 mg filmtabletta

70,0 mg Alendronic acid

[in the form of 91,35 mg sodium alendronate trihydrate]

film coated tablet

Oral Use

HU - Hungary

Sandoz Hungária Kft.,

1114 Budapest, Bartók Béla út 43-47.

Hungary

ALENDRONAT-SANDOZ 70 mg filmtabletta

70,0 mg Alendronic acid

[in the form of 91,35 mg sodium alendronate]

film coated tablet

Oral Use

HU - Hungary

Apotex Europe B.V.

Darwinweg 20.

2333 CR Leiden

Holland

ALENDRONSAV APOTEX 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,35 mg sodium alendronate trihydrate]

tablet

Oral Use

HU - Hungary

Richter Gedeon nyrt.

Gyömrői út 19-21.

1103 Budapest

Hungary

Calcisedron-D filmtabletta

70,0 mg Alendronic acid

[in the form of 91,35 mg sodium alendronate trihydrate]

film-coated tablet

Oral Use

HU - Hungary

Richter Gedeon nyrt.

Gyömrői út 19-21.

1103 Budapest

Hungary

Calcisedron-D Trio filmtabletta

70,0 mg Alendronic acid

[in the form of 91,35 mg sodium alendronate trihydrate]

film-coated tablet

Oral Use

HU - Hungary

Aramis Pharma Kft.

Mester u. 28. III/5.

1095 Budapest

Hungary

DRONAVIC 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,37 mg sodium alendronate trihydrate]

tablet

Oral Use

HU - Hungary

Apotex Europe B.V.

Darwinweg 20.

2333 CR Leiden

Holland

EPOLAR 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,35 mg sodium alendronate]

tablet

Oral Use

HU - Hungary

Apotex Europe B.V.

Darwinweg 20.

2333 CR Leiden

Holland

EPOLAR Trio 70 mg tabletta és rágótabletta

70,0 mg Alendronic acid

[in the form of 91,35 mg sodium alendronate]

tablet and chewing tablet

Oral Use

HU - Hungary

Actavis Group PTC ehf.

Reykjavikurvegur 76-78.

220 Hafnarfjordur

Iceland

FLADOR 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,37 mg sodium alendronate trihydrate]

tablet

Oral Use

HU - Hungary

Medico Uno Pharma Kft.

Viadukt u. 12.

2051 Biatorbágy

Hungary

FORTIMAX tabletta

70,0 mg Alendronic acid

[in the form of 91,37 mg sodium alendronate trihydrate]

tablet

Oral Use

HU - Hungary

Merck Sharp & Dohme Magyarország Kft.

Alkotás u. 48-50.

1123 Budapest

Hungary

FOSAMAX 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,37 mg sodium alendronate]

tablet

Oral Use

HU - Hungary

Richter Gedeon nyrt.

Gyömrői út 19-21.

1103 Budapest

Hungary

HANTRUX 70 mg filmtabletta

70,0 mg Alendronic acid

[in the form of 91,35 mg sodium alendronate trihydrate]

film coated tablet

Oral Use

HU - Hungary

Vera Pharma Kft.

Rákos köz 22.

1028 Budapest

Hungary

MASSIDRON 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 81,2 mg mg sodium alendronate monohydrate]

tablet

Oral Use

HU - Hungary

Richter Gedeon nyrt.

Gyömrői út 19-21.

1103 Budapest

Hungary

MATEKIT 70 mg filmtabletta

70,0 mg Alendronic acid

[in the form of 91,35 mg sodium alendronate trihydrate]

film coated tablet

Oral Use

HU - Hungary

Richter Gedeon nyrt.

Gyömrői út 19-21.

1103 Budapest

Hungary

SEDRON 70 mg filmtabletta

70,0 mg Alendronic acid

[in the form of 91,35 mg sodium alendronate trihydrate]

film coated tablet

Oral Use

HU - Hungary

Teva Magyarország Zrt.

2100 Gödöllő, Repülőtéri út 5.

TRABECAN-TEVA 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 81,2 mg mg sodium alendronate monohydrate]

tablet

Oral Use

HU - Hungary

Teva Magyarország Zrt.

2100 Gödöllő, Repülőtéri út 5.

TRABECAN Duo TEVA tabletta és lágy kapszula

70,0 mg Alendronic acid

[in the form of 81,2 mg mg sodium alendronate monohydrate]

tablet and soft capsules

Oral Use

HU - Hungary

Richter Gedeon nyrt.

Gyömrői út 19-21.

1103 Budapest

Hungary

UTERITRIN 70 mg filmtabletta

70,0 mg Alendronic acid

[in the form of 91,35 mg sodium alendronate trihydrate]

film coated tablet

Oral Use

IE - Ireland

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

Fosamax

10 mg

Tablet

Oral Use

IE - Ireland

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

Fosamax

70 mg

Tablet

Oral Use

IE - Ireland

Clonmel Healthcare Limited

Waterford Road

Clonmel

Co. Tipperary

Ireland

Osteomel Once weekly

70 mg

Tablet

Oral Use

IE - Ireland

PLIVA Pharma Ltd.

Vision House

Bedford Road

Petersfield

Hants, GU32 3QB

United Kingdom

Fosalen Once Weekly 70 mg Tablets

70 mg

Tablet

Oral Use

IE - Ireland

Rowex Ltd

Bantry

Co. Cork

Romax Once Weekly 70 mg Tablets

70 mg

Tablet

Oral Use

IE - Ireland

Laboratorios Davur S.L.U.

C/Anabel Segura 11

Edificio Albatros B

1a planta

Alcobendas

28108 Madrid

Spain

Alendronic Acid Once Weekly 70 mg Tablets

70 mg

Tablet

Oral Use

IE - Ireland

McDermott Laboratories Ltd. t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Fostepor 10 mg Tablets

10 mg

tablets

Oral Use

IE - Ireland

McDermott Laboratories Ltd. t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Fostepor Once Weekly 70 mg Tablets

10 mg

tablets

Oral Use

IE - Ireland

PLIVA Pharma Ltd. Vision House, Bedford Road, Petersfield, Hants, GU32 3QB, United Kingdom

Fosalen 10 mg Tablets

10 mg

tablets

Oral Use

IE - Ireland

PLIVA Pharma Ltd. Vision House, Bedford Road, Petersfield, Hants, GU32 3QB, United Kingdom

Fosalen Once Weekly 70 mg Tablets

70 mg

tablets

Oral Use

IE - Ireland

Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, The Netherlands

Tevanate Once Weekly 70 mg Tablets

70 mg

Tablets

Oral Use

IE - Ireland

Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, The Netherlands

Fosalen Once Weekly 70 mg Tablets

70 mg

tablets

Oral Use

IE - Ireland

Bluefish Pharmaceuticals AB, Torsgatan 11, 111 23 Stockholm, Sweden.

Alendronic Acid Bluefish Once weekly 70 mg Tablets

70 mg

tablets

Oral Use

IE - Ireland

Actavis Group PTC ehf; Reykjavikurvegi 76-78,

220 Hafnarfjordur

Iceland

Fostolin Once Weekly 70 mg Tablets

70 mg

tablets

Oral Use

IS - Iceland

Arrow Generics Ltd., Unit 2 Eastman Way Stevenage, Hertz SG1 4SZ U.K

Alendroarrow

10 mg

Tablet

Oral Use

IS - Iceland

Arrow Generics Ltd., Unit 2 Eastman Way Stevenage, Hertz SG1 4SZ U.K

Alendroarrow week tablet

70 mg

Tablet

Oral Use

IS - Iceland

Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland

Alendronat Actavis

70 mg

Tablet

Oral Use

IS - Iceland

Ranbaxy (UK) Limited, C.P. House 97-107 Uxbridge Road, Ealing Londo W5 5TL U.K

Alendronat Ranbaxy

70 mg

Tablet

Oral Use

IS - Iceland

Merck Sharp & Dohme B.V., Waaderveg 39, PC Haarlem, The Netherlands

Fosamax week tablet

70 mg

Tablet

Oral Use

IS - Iceland

Williams & Halls ehf, Hverfisgata 105 101 Reykjavík, Iceland

Ostacid

70 mg

film-coated tablet

Oral Use

IT - Italy

ABIOGEN PHARMA SpA

Via Meucci, 36 - 56014

Ospedaletto (PI)

ALENDROS

10 mg

tablets

Oral Use

IT - Italy

ABIOGEN PHARMA SpA

Via Meucci, 36 - 56014

Ospedaletto (PI)

ALENDROS

70 mg

tablets

Oral Use

IT - Italy

ACCORD HEALTHCARE LIMITED

Sage House,319

Pinner Road

North Harrow Middlesex

ALENDRONATO AHCL

10 mg

tablets

Oral use

IT - Italy

ACTAVIS GROUP PTC EHF

Reykjavikurvegi 76-78

ALENDRONATO ACTAVIS

70 mg

tablets

Oral use

IT - Italy

AGIPS FARMACEUTICI Srl

Via Amendola 4 - 16035

Rapallo (GE)

GLAMOR

70 mg

film coated tablets

Oral use

IT - Italy

ALMUS Srl

Via Cesarea, 11/10 - 16121

Genova

ALENDRONATO ALMUS

70 mg

film coated tablets

Oral use

IT - Italy

ARROW GENERICS LTD

Unit 2, Eastman way

Stevenage, Herts SG1 4SZ

ALENDRONATO ARROW

10 MG

tablets

Oral use

IT - Italy

ARROW GENERICS LTD

Unit 2, Eastman way

Stevenage, Herts SG1 4SZ

ALENDRONATO ARROW

70 mg

tablets

Oral use

IT - Italy

BENTLEY PHARMACEUTICALS IRELAND LTD

25-28 North Wall Uay

Dublin 1 – Ireland

ALENDRONATO BENTLEY PHARMACEUTICALS IRELAND

70 mg

tablets

Oral use

IT - Italy

BIOHEALTH PHARMACEUTICALS Srl

Via Bolognese, 250

Pistoia – Italy

ASTON

70 mg

film coated tablets

Oral use

IT - Italy

BIOMEDICA FOSCAMA INDUSTRIA CHIMICA FARMACEUTICA SpA

Via Morolense, 87 - 03013

Ferentino (FR)

ALOST

70 mg

tablets

Oral use

IT - Italy

LABORATORIO PRODOTTI FARMACEUTICI BONISCONTRO & GAZZONE Srl

Via Pavia, 6 - 20136

Milano – Italy

DORYX

70 mg

tablets

Oral use

IT - Italy

DOC GENERICI Srl

Via Manuzio, 7 - 20124

Milano

ALENDRONATO DOC GENERICI

70 mg

tablets

Oral use

IT - Italy

DOC GENERICI Srl

Via Manuzio, 7 - 20124

Milano

ALENDRONATO DOC

70 mg

tablets

Oral use

IT - Italy

DR REDDY'S Srl

Via Fernanada Wittgens, 6 - 20123

Milano

ALENDRONATO DR REDDY'S

70 mg

tablets

Oral use

IT - Italy

EG SpA

Via Pavia, 6 - 20136

Milano - Italy

ALENDRONATO EG

10 mg

tablets

Oral use

IT - Italy

EG SpA

Via Pavia, 6 - 20136

Milano - Italy

ALENDRONATO EG

70 mg

tablets

Oral use

IT - Italy

EPIFARMA Srl

Via San Rocco, 6 - 85033

Episcopia (PZ)

ALENIC

70 mg

tablets

Oral use

IT - Italy

EPIFARMA Srl

Via San Rocco, 6 - 85033

Episcopia (PZ)

ACIDO ALENDRONICO EPIFARMA

70 mg

tablets

Oral use

IT - Italy

FG Srl

Via San Rocco, 6 - 85033

Episcopia (PZ)

ACIDO ALENDRONICO FG

70 mg

tablets

Oral use

IT - Italy

FIDIA FARMACEUTICI SpA

Via Ponte D/Fabbrica, 3/A - 25031

Abano Terme (PD)

ACIDO ALENDRONICO FIDIA

70 mg

tablets

Oral use

IT - Italy

GERMED PHARMA SpA

Via Cesare Cantù, 11 - 20092

Cinisello Balsamo (MI)

ALENDRONATO GERMED

10 mg

tablets

Oral use

IT - Italy

GERMED PHARMA SpA

Via Cesare Cantù, 11 - 20092

Cinisello Balsamo (MI)

ALENDRONATO GERMED

70 mg

tablets

Oral use

IT - Italy

HEXAL SpA

Via Paracelso, 16 - 20041

Agrate Brianza (MI)

ALENDRONATO HEXAL

70 mg

tablets

Oral use

IT - Italy

ISTITUTO CHIMICO INTERNAZIONALE DR. GIUSEPPE RENDE Srl

Via Salaria, 1240 - 00138

Roma

REALEN

70 mg

tablets

Oral use

IT - Italy

ISTITUTO GENTILI SpA

Via San Giuseppe Cottolengo, 15 - 20143

Milano

GENALEN

10 mg

tablets

Oral use

IT - Italy

ISTITUTO GENTILI SpA

Via San Giuseppe Cottolengo, 15 - 20143

Milano

GENALEN

70 mg

tablets

Oral use

IT - Italy

LABORATORI ALTER Srl

Via Lomellina, 39 - 20124

Milano

ALENDRONATO ALTER

70 mg

tablets

Oral use

IT - Italy

MERCK SHARP & DOHME

Ltd

Hertford Road, Hoddesdon

Hertfordshire EN119BU

FOSAMAX

10 mg

tablets

Oral use

IT - Italy

MERCK SHARP & DOHME

Ltd

Hertford Road, Hoddesdon

Hertfordshire EN119BU

FOSAMAX

70 mg

tablets

Oral use

IT - Italy

MYLAN SpA

Via Vittor Pisani, 20 - 20124

Milano

ALENDRONATO MYLAN GENERICS

70 mg

tablets

Oral use

IT - Italy

NEOPHARMED Srl

Via San Giuseppe Cottolengo, 15 - 20143

Milano

ADRONAT

10 mg

tablets

Oral use

IT - Italy

NEOPHARMED Srl

Via San Giuseppe Cottolengo, 15 - 20143

Milano

ADRONAT

70 mg

tablets

Oral use

IT - Italy

PENSA PHARMA SpA

Via Rossellini Ippolito, 12

20124 – Milano

ALENDRONATO PENSA

70 mg

tablets

Oral use

IT - Italy

PHARMEG Srl

Via dei Giardini, 24 - 85033

Episcopia (PZ)

PORODRON

70 mg

tablets

Oral use

IT - Italy

RANBAXY ITALIA SpA

p.zza Filippo Meda, 3 - 20121 Milano

ALENDRONATO RANBAXY ITALIA

70 mg

tablets

Oral use

IT - Italy

RATIOPHARM GMBH

Graf Arco-strasse, 3

Ulm D-89070

ALENDRONATO RATIOPHARM

70 mg

tablets

Oral use

IT - Italy

S.F.GROUP Srl

Via Beniamino Segre, 59

00134 Roma Italy

NOFRATTIL

70 mg

film coated tablets

Oral use

IT - Italy

SANDOZ SpA

L.go U. Boccioni, 1 - 21040

Origgio (VA)

ALENDRONATO SANDOZ

70 mg

tablets

Oral use

IT - Italy

SEGIX ITALIA Srl

Via Del Mare, 36 - 00040

Pomezia (RM)

DRALENOS

10 mg

tablets

Oral use

IT - Italy

SEGIX ITALIA Srl

Via Del Mare, 36 - 00040

Pomezia (RM)

DRALENOS

70 mg

tablets

Oral use

IT - Italy

SIGMATAU GENERICS SpA

Via Pontina Km30, 400

00040 Pomezia (RM)

ACIDO ALENDRONICO SIGMA TAU GENERICS

70 mg

tablets

Oral use

IT - Italy

SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SpA

Viale Shakespeare, 47

00144 Roma

DRONAL

10 mg

tablets

Oral use

IT - Italy

SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SpA

Viale Shakespeare, 47

00144 Roma

DRONAL

70 mg

tablets

Oral use

IT - Italy

SO.SE.PHARM Srl

Via dei Castelli Romani, 22

00040 Pomezia (RM)

LOSS

70 mg

film coated tablets

Oral use

IT - Italy

TEVA ITALIA Srl

Via Messina, 38 - 20154

Milano – Italy

ALENDRONATO TEVA

70 mg

tablets

Oral use

IT - Italy

ACCORD HEALTHCARE LIMITED

Sage House,319

Pinner Road

North Harrow Middlesex

ALENDRONATO AHCL

70 mg

tablets

Oral use

LT - Lithuania

KRKA d.d., Šmarješka Cesta 6 8501 Novo mesto, Slovenia

Lindron

10 mg

Tablet

Oral use

LT - Lithuania

Sandoz d.d., Verovškova 57 SI-1000 Ljubljana Slovenia

Alendon

70 mg

Tablet

Oral use

LT - Lithuania

Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Lendrate

70 mg

Tablet

Oral use

LT - Lithuania

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Alendronic acid Accord

70 mg

Tablet

Oral use

LT - Lithuania

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Alendronic acid Accord

10 mg

Tablet

Oral use

LT - Lithuania

Teva Pharma B.V., Computerweg 10 3542 DR Utrecht, The Netherlands

Alenotop

70 mg

Tablet

Oral use

LT - Lithuania

Teva Pharma B.V., Computerweg 10 3542 DR Utrecht, The Netherlands

Tevanate

70 mg

Tablet

Oral use

LT - Lithuania

Mepha Lda., Lagoas Park, Edificio 5-A, Piso 2, 2740-298 Porto Salvo, Portugal

Densidron

70 mg

Tablet

Oral use

LT - Lithuania

Ranbaxy UK Ltd., 20 Balderton Street London W1K 6TL, United Kingdom

Ralenost

70 mg

Tablet

Oral use

LT - Lithuania

Gedeon Richter Plc., 1103 Budapest Gyömrői út 19-21, Hungary

Sedron

70 mg

Film-coated tablet

Oral use

LT - Lithuania

Pharmaceutical Works POLPHARMA SA, 19 Pelplińska Street 83-200 Starogard Gdański, Poland

Ostemax

70 mg

Tablet

Oral use

LT - Lithuania

UAB „Merck Sharp & Dohme“, Kęstučio 59/27, LT-08124 Vilnius, Lithuania

Fosamax

70 mg

Tablet

Oral use

LT - Lithuania

Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland

Alendorion

70 mg

Tablet

Oral use

LU - Luxembourg

Merck Sharp & Dohme

5, Clos du Linx

B-1200 Bruxelles

Fosamax-70 Hebdomadaire

70 mg

tablets

Oral Use

LV - Latvia

Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, united Kingdom

Alendronate sodium Accord

10 mg

tablets

Oral use

LV - Latvia

Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, united Kingdom

Alendronate sodium Accord

70 mg

tablets

Oral use

LV - Latvia

Orion Corporation, Orionintie 1, FI-02200 Espoo Finland

Alendorion

70 mg

tablets

Oral use

LV - Latvia

Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Netherlands

Alenotop

70 mg

tablets

Oral Use

LV - Latvia

Mepha Lda., Lagoas Park, 2740-298 Porto Salvo, Portugal

Densidron

70 mg

film-coated tablets

Oral Use

LV - Latvia

Gedeon Richter Plc., 1103 Budapest, Gyomroi ut 19-21, Hungary

Sedron

70 mg

film-coated tablets

Oral Use

LV - Latvia

Pharmaceutical Works Polpharma SA., 19 Pelplinska Str., 83-200 Starogard Gdanski, Poland

Ostemax

70 mg

tablets

Oral Use

LV - Latvia

Actavis Group PTC ehf., Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Lendrate

70 mg

tablets

Oral Use

LV - Latvia

SIA "Merck Sharp & Dohme Latvija", Skanstes iela 13, Riga LV-1013, Latvia

Fosamax

70 mg

tablets

Oral Use

MT - Malta

Mepha - Investigação, Desenvolvimento e Fabricação Farmaceutica, Lda.

Densidron

70 mg

film-coated tablets

Oral Use

MT - Malta

Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK

Fosamax

70 mg

tablets

Oral Use

MT - Malta

Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United kingdom.

Alendronic Acid 10 mg tablets

10 mg

Tablet

Oral Use

MT - Malta

Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United kingdom.

Alendronic Acid 70 mg tablets

70 mg

Tablet

Oral Use

MT - Malta

Aurobindo Pharma (Malta) Ltd, 46/2 South Street, Valletta VLT11, Malta

Alendronic Acid 70 mg tablet

70 mg

Tablet

Oral Use

MT - Malta

Accord Healthcare Limited Sage House

319, Pinner Road

North Harrow

Middlesex HA1 4 HF

United Kingdom

Alendronate Sodium Accord 10 mg Tablets

10 mg

Tablets

Oral Use

MT - Malta

Accord Healthcare Limited Sage House

319, Pinner Road

North Harrow

Middlesex HA1 4 HF

United Kingdom

Alendronate Sodium Accord 70 mg Tablets

70 mg

Tablets

Oral Use

MT - Malta

Actavis Group PTC ehf; Reykjavikurvegi 76-78,

220 Hafnarfjordur

Iceland

Lendrate

70 mg

tablets

Oral Use

NL - Netherlands

acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grünwald, Germany

Osteonorm 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

ratiopharm Nederland bv

Florapark 4

2012 HK Haarlem Netherlands

Alendroninezuur ratiopharm 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

Sandoz B.V., Veluwezoom 22 1327 AH Almere Netherlands

Alendroninezuur Sandoz 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

Iono Limited

65 Delamere Road, Hayes

Middlesex UB4 ONN United Kingdom

Alendroninezuur Iono 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

Iono Limited

65 Delamere Road, Hayes

Middlesex UB4 ONN United Kingdom

Alendroninezuur Iono 10 mg

10 mg

Tablet

Oral Use

NL - Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem Netherlands

Alendroninezuur 10 PCH

10 mg

Tablet

Oral Use

NL - Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem Netherlands

Alendroninezuur 70 PCH

70 mg

Tablet

Oral Use

NL - Netherlands

Centrafarm Services B.V.

Nieuwe Donk 9

47879 AC Etten-Leur Netherlands

Alendroninezuur CF 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

Genericon Pharma Gesellschaft m.b.H.

Hafnerstraße 211

8054 Graz Austria

Alendronorm 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

Bentley Pharmaceuticals Limited,

25/28 North Wall Quay

Dublin 1

Ireland

Alendroninezuur Bentley 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

Biomedica Foscama Industria Chimico-Farmaceutica S.p.A.

Via Morolense, 87 – 03010 Ferentino

Dronatex 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ United Kingdom

Alendroninezuur Arrow 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

Apotex Europe BV

Darwinweg 20

2333 CR Leiden Netherlands

Alendroninezuur Apotex 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

Ranbaxy Belgium NV

Leuvensestraat 28b

1800 Vilvoorde Belgium

Alendratol 10 mg

10 mg

Tablet

Oral Use

NL - Netherlands

Ranbaxy Belgium NV

Leuvensestraat 28b

1800 Vilvoorde Belgium

Alendratol 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

Ranbaxy Belgium NV

Leuvensestraat 28b

1800 Vilvoorde Belgium

Randronate 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

Sandoz B.V., Veluwezoom 22 1327 AH Almere Netherlands

Alendroninezuur Sandoz 10 mg

10 mg

Tablet

Oral Use

NL - Netherlands

Sandoz B.V., Veluwezoom 22 1327 AH Almere Netherlands

Alendroninezuur Sandoz 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

Mylan BV

Dieselweg 25

3752 LB Bunschoten Netherlands

Alendroninezuur Mylan 10 mg

10 mg

Tablet

Oral Use

NL - Netherlands

Mylan BV

Dieselweg 25

3752 LB Bunschoten Netherlands

Alendroninezuur Mylan 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

Apothecon B.V.

Nijverheidsweg 3, 3771 ME Barneveld Netherlands

Alendroninezuur 70A

70 mg

Tablet

Oral Use

NL - Netherlands

mibe GmbH Arzneimittel

Münchener Str. 15

06796 Brehna Germany

Ostadil 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

Actavis Group PTC ehf

Reykjavikurvegur 76-78,220 Hafnarfjordur

Alendroninezuur Actavis 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

Centrafarm Services B.V.

Nieuwe Donk 9

47879 AC Etten-Leur Netherlands

Alendroninezuur CF 10 mg

10 mg

Tablet

Oral Use

NL - Netherlands

Bluefish Pharmaceuticals AB, Torsgatan 11 111 23 Stockholm Sweden

Akendroninezuur Bluefish 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

WILL-PHARMA

Wilgenlaan 5

1161 JK Zwanenburg

Netherlands

Bonendro

70 mg / 1 000 mg / 880 IU

Tablet + granulate combination package

Oral Use

NL - Netherlands

Merck Sharp & Dohme BV

Waarderweg 39

2031 BN Haarlem Netherlands

Fosamax 10 mg

10 mg

Tablet

Oral Use

NL - Netherlands

Merck Sharp & Dohme BV

Waarderweg 39

2031 BN Haarlem Netherlands

Fosamax 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

WILL-PHARMA

Wilgenlaan 5

1161 JK Zwanenburg

Netherlands

Alendronax 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF United Kingdom

Alendroninezuur Accord 10 mg

10 mg

Tablet

Oral Use

NL - Netherlands

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF United Kingdom

Alendroninezuur Accord 70 mg

70 mg

Tablet

Oral Use

NL - Netherlands

Ranbaxy Belgium NV

Leuvensestraat 28b

1800 Vilvoorde Belgium

Alendroninezuur 70 Ranbaxy

70 mg

Tablet

Oral Use

NO - Norway

Arrow Generics Ltd, 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, united Kingdom

Alendronat Arrrow

10 mg

Tablet

Oral Use

NO - Norway

Arrow Generics Ltd, 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, united Kingdom

Alendronat Arrrow

70 mg

Tablet

Oral Use

NO - Norway

ratiopharm GmbH, Graf-Arco-Strasse 3, D-89070 Ulm Germany

Alendronate ratiopharm

70 mg

Tablet

Oral Use

NO - Norway

Merck Sharp and Dohme B.V., Postbus 581, Waarderweg 39, Haarlem, NL-2003 PC, Netherlands

Fosamax

10 mg

Tablet

Oral Use

NO - Norway

Merck Sharp and Dohme B.V., Postbus 581, Waarderweg 39, Haarlem, NL-2003 PC, Netherlands

Fosamax

70 mg

Tablet

Oral Use

NO - Norway

Bluefish Pharmaceuticals AB Torsgatan 11, SE-11123 Stockholm, Sweden

Alendronat Bluefish

70 mg

tablet

Oral Use

NO - Norway

Mylan AB, Box 23033, 10435 Stockholm, Sweden

Alendronat Mylan

70 mg

Tablet

Oral Use

NO - Norway

Mylan AB, Box 23033, 10435 Stockholm, Sweden

Alendronat Mylan

70 mg

Tablet

Oral Use

NO - Norway

Sandoz A/S, Edvard Thomsens Vej 14, DK-2300 København S, Danmark

Alendronat Sandoz

70 mg

Tablet

Oral Use

NO - Norway

Teva Sweden AB, Box 1070, 25110 Helsingborg, Sweden

Alendronat Teva

10 mg

Tablet

Oral Use

NO - Norway

Teva Sweden AB, Box 1070, 25110 Helsingborg, Sweden

Alendronat Teva

70 mg

Tablet

Oral Use

PL - Poland

Polfarmex S.A.

Józefów st. 9

99-300 Kutno, Poland

Akost

70 mg + 91,37 mg

tablets

Oral Use

PL - Poland

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Austria

Aldron 70

70 mg

film coated tablets

Oral Use

PL - Poland

ICN Polfa Rezszów S.A.

Przemysłowa 2

35-959 Rzeszów, Poland

Alenato

10 mg

tablets

Oral Use

PL - Poland

Ranbaxy (Poland) Sp. z o.o.

Kubickiego st. 11,

02-954 Warsaw, Poland

Alendran 70

70 mg

tablets

Oral Use

PL - Poland

Orion Corporation

Orionintie 1A, FI-02200 Espoo, Finland

Alendrion

70 mg

tablets

Oral Use

PL - Poland

Generics [UK] Ltd.

Station Close, Potters Bar, Hertfordshire,

EN61TL, United Kingdom

Alendrogen

70 mg

tablets

Oral Use

PL - Poland

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Austria

AlendroLek 70

70 mg

tablets

Oral Use

PL - Poland

Arrow Generics Ltd

2 Eastman Way, Stevenage,

Hertfordshire, SG1 4SZ, United Kingdom

Alendromax 10 mg tabletki

10 mg

tablets

Oral Use

PL - Poland

Arrow Generics Ltd

2 Eastman Way, Stevenage,

Hertfordshire, SG1 4SZ, United Kingdom

Alendromax 70 mg tabletki

70 mg

tablets

Oral Use

PL - Poland

Bluefish Pharmaceuticals AB

Torsgatan 11

SE-111 23 Stockholm

Sweden

Alendronat Bluefish

70 mg/ tabl.

tablets

Oral Use

PL - Poland

PHARMABILL

Jægersborg Alle 213 2 th

DK-2820 Gentofte

Denmark

Alendronat Pharmabill

70 mg

tablets

Oral Use

PL - Poland

ratiopharm GmbH

Graf-Arco-Strasse 3, Ulm, 89073, Germany

Alendronat-ratiopharm 70

70 mg

tablets

Oral Use

PL - Poland

Arrow Poland S.A.

Al. Jana Pawła II 23

00-854 Warsaw, Poalnd

Alendronate Arrow

10 mg

tablets

Oral Use

PL - Poland

Arrow Poland S.A.

Al. Jana Pawła II 23

00-854 Warsaw, Poalnd

Alendronate Arrow

70 mg

tablets

Oral Use

PL - Poland

Medana Pharma S.A.

10 Władysława Łokietka st., 98-200 Sieradz, Poland

Alendronate Medana

70 mg

tablets

Oral Use

PL - Poland

ACCORD HEALTHCARE LTD.

Reg. Off.: Suite No. 10 & 11 Sage House

319 Pinner Road,

North Harrow, Middlesex HA14HF, UK

Alendronate Sodium Accord

10 mg

tablets

Oral Use

PL - Poland

ACCORD HEALTHCARE LTD.

Reg. Off.: Suite No. 10 & 11 Sage House

319 Pinner Road,

North Harrow, Middlesex HA14HF, UK

Alendronate Sodium Accord

70 mg

tablets

Oral Use

PL - Poland

Teva Pharmaceuticals Polska Sp. z o.o.

53 Emilii Plater St.,

00-113, Warsaw, Poland

Alendronate Teva

70 mg

tablets

Oral Use

PL - Poland

Farmacom Sp. z o.o.

Mogilska 80 st.

31-546, Cracow, Poland

Alendronatum Farmacom

70 mg

tablets

Oral Use

PL - Poland

PLIVA Kraków Zakłady Farmaceutyczne S.A.

ul. Mogilska 80

31-546 Cracow, Poland

Alenotop

10 mg

tablets

Oral Use

PL - Poland

Mepha Lda.

Lagoas Park

Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Densidron

70 mg

film coated tablets

Oral Use

PL - Poland

MSD Polska Sp. z o.o.

Chlodna st., 51

00-867, Warsaw, Poland

Fosamax 70

70 mg

tablets

Oral Use

PL - Poland

Phargem Sp. z o.o.

Foksal St. 18/210/02

00-372 Warsaw, Poland

Kwas alendronowy 70 mg Tabletka

70 mg

tablets

Oral Use

PL - Poland

Actavis Group PTC ehf.

Reykjavikurvegi 76-78

220 Hafnarfirdi, Iceland

Lendrate

70 mg

tablets

Oral Use

PL - Poland

Zakłady Farmaceutyczne

Polpharma SA

Pelplińska st. 19

83-200 Starogard Gdański, Poland

Ostemax 70 comfort

70 mg

tablets

Oral Use

PL - Poland

Teva Pharmaceuticals Polska Sp. z o.o.

53 Emilii Plater St.,

00-113, Warsaw, Poland

Ostenil

10 mg

tablets

Oral Use

PL - Poland

Teva Pharmaceuticals Polska Sp. z o.o.

53 Emilii Plater St.,

00-113, Warsaw, Poland

Ostenil 70

70 mg

tablets

Oral Use

PL - Poland

Apotex Europe Ltd.

Rowan House, 41 London Street, Reading

Berkshire, RG1 4PS, United Kingdom

Ostodronic

70 mg

tablets

Oral Use

PL - Poland

Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.

Al. Jana Pawła II 80

00-175 Warsaw, Poland

Ostolek

10 mg

film coated tablets

Oral Use

PL - Poland

Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.

Al. Jana Pawła II 80

00-175 Warsaw, Poland

Ostolek

70 mg

film coated tablets

Oral Use

PL - Poland

Biofarm Sp. z o.o.

Wałbrzyska 13, 60-198,

Poznan, Poalnd

Rekostin 70 mg

70 mg

tablets

Oral Use

PL - Poland

Grodziskie Zakłady Farmaceutyczne "Polfa" Sp. z o.o

Ks. J. Poniatowskiego st. 5

05-825 Grodzisk Mazowiecki, Poland

Sedron 70 mg tabletki powlekane

70 mg

film coated tablets

Oral Use

PT - Portugal

ISUS - Produtos Farmacêuticos e Cosméticos, S.A. Rua António Quadros, 9G - Escritório 3 1600-875 Lisboa Portugal

Ácido Alendrónico Lendral

70 mg

Tablet

Oral Use

PT - Portugal

Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo 1499-016 Algés, Portugal

Ácido Alendrónico Mylan

70 mg

Tablet

Oral Use

PT - Portugal

Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo 1499-016 Algés, Portugal

Ácido Alendrónico Mylan

10 mg

Tablet

Oral Use

PT - Portugal

Premium Pharma - Sociedade Técnico Medicinal, Lda. Rua da Tapada Grande, n.o 2, Abrunheira, São Pedro de Penaferrim 2714-530 Sintra, Portugal

Ácido Alendrónico Flamisul

70 mg

Film-coated Tablet

Oral Use

PT - Portugal

Teva Pharma - Produtos Farmacêuticos, Lda. Edifício Cyprium, Av. 25 de Abril, 15, 2o F 2795-195 Linda-a-Velha Portugal

Ácido Alendrónico Teva

70 mg

Tablet

Oral use

PT - Portugal

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78 IS-220 Hafnarfjörour, Islândia

Ácido Alendrónico Actavis

70 mg

Tablet

Oral use

PT - Portugal

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78 IS-220 Hafnarfjörour, Islândia

Caldronate

70 mg

Tablet

Oral use

PT - Portugal

Almus, Lda. Rua Engenheiro Ferreira Dias, 772 4149-014 Porto

Ácido Alendrónico Almus

70 mg

Film-coated Tablet

Oral use

PT - Portugal

Alter, S.A. Estrada Marco do Grilo - Zemouto 2830 Coina, Portugal

Ácido Alendrónico Alter

70 mg

Tablet

Oral use

PT - Portugal

Alter, S.A. Estrada Marco do Grilo - Zemouto 2830 Coina, Portugal

Ácido Alendrónico Alter

10 mg

Tablet

Oral use

PT - Portugal

Alter, S.A. Estrada Marco do Grilo - Zemouto 2830 Coina, Portugal

Ácido Alendrónico Bifosal 10 mg Comprimidos

10 mg

Tablet

Oral use

PT - Portugal

Alter, S.A. Estrada Marco do Grilo - Zemouto 2830 Coina, Portugal

Ácido Alendrónico Bifosal 70 mg Comprimidos

70 mg

Tablet

Oral use

PT - Portugal

APceuticals - Farmacêutica, Lda.

Ácido Alendrónico Apceuticals

70 mg

Film-coated Tablet

Oral use

PT - Portugal

Apotex Europe, B.V. Darwinweg 20 2333 CR Leiden Netherland

Ácido Alendrónico Apotex

70 mg

Tablet

Oral use

PT - Portugal

Arrowblue Produtos Farmacêuticos S.A. Av. D. João II, 10 Esqo - Torre Fernão de Magalhães 1998-025 Lisboa, Portugal

Ácido Alendrónico Arrowblue 10 mg Comprimidos

10 mg

Tablet

Oral use

PT - Portugal

Arrowblue Produtos Farmacêuticos S.A. Av. D. João II, 10 Esqo - Torre Fernão de Magalhães 1998-025 Lisboa, Portugal

Ácido Alendrónico Arrowblue 70 mg Comprimidos

70 mg

Tablet

Oral use

PT - Portugal

Arrowblue Produtos Farmacêuticos S.A. Av. D. João II, 10 Esqo - Torre Fernão de Magalhães 1998-025 Lisboa, Portugal

Ácido Alendrónico Winthrop 70 mg Comprimidos

70 mg

Tablet

Oral use

PT - Portugal

Atlantic Pharma - Produções Farmacêuticas, S.A. Zona Industrial da Abrunheira, Rua da Tapada Grande, 2 2710-089 Sintra Portugal

Ácido Alendrónico Blocan

70 mg

Film-coated Tablet

Oral use

PT - Portugal

Aurobindo Pharma (Portugal), Unipessoal Lda. Av. do Forte, no 3 - Parque Suécia, Edifício. IV, 2o 2794-038 Carnaxide, Portugal

Ácido Alendrónico Glob

70 mg

Tablet

Oral use

PT - Portugal

Aurobindo Pharma (Portugal), Unipessoal Lda. Av. do Forte, no 3 - Parque Suécia, Edifício. IV, 2o 2794-038 Carnaxide, Portugal

Ácido Alendrónico Glob

10 mg

Tablet

Oral use

PT - Portugal

Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa, Portugal

Ácido Alendrónico Nozat

70 mg

Film-coated Tablet

Oral use

PT - Portugal

Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa, Portugal

Ácido Alendrónico Baldacci

70 mg

Tablet

Oral use

PT - Portugal

Biara - Produtos Farmacêuticos, Lda. Av. José Malhoa - Edifício Malhoa Plaza no 2, piso-escritório 2.2 1070-325 Lisboa, Portugal

Ácido Alendrónico Prella

70 mg

Tablet

Oral use

PT - Portugal

Bluepharma - Indústria Farmacêutica, S.A. São Martinho do Bispo Apartado 7003 3045-016 Coimbra, Portugal

Ácido Alendrónico Bluepharma

70 mg

Tablet

Oral use

PT - Portugal

Ciclum Farma Unipessoal, Lda. Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B 2770-229 Paço de Arcos, Portugal

Ácido Alendrónico Ciclum 10 mg Comprimidos

10 mg

Tablet

Oral use

PT - Portugal

Ciclum Farma Unipessoal, Lda. Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B 2770-229 Paço de Arcos, Portugal

Ácido Alendrónico Ciclum 70 mg Comprimidos

70 mg

Tablet

Oral use

PT - Portugal

Cinfa Portugal, Lda. Av. Tomás Ribeiro, 43 - Bloco 1, 4o B - Edifício Neopark 2790-221 Carnaxide, Portugal

Ácido alendrónico Cinfa

70 mg

Tablet

Oral use

PT - Portugal

Daquimed - Comércio de Produtos Farmacêuticos, S.A. Av. Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da Portelinha 4510-688 Fânzeres, Portugal

Ácido Alendrónico Daquimed

70 mg

Tablet

Oral use

PT - Portugal

Dr. Reddy's Laboratories (UK) Ltd. 6 Riverview Road, Beverley HU17 OLD East Yorkshire, UK

Ácido Alendrónico Dr. Reddy's

70 mg

Tablet

Oral use

PT - Portugal

Faribérica - Produtos Farmacêuticos, S.A. Estrada de Luz, 90 - 9o D/E 1600-160 Lisboa, Portugal

Ácido Alendrónico Faribérica

70 mg

Tablet

Oral use

PT - Portugal

Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra, Portugal

Ácido Alendrónico Rinicas

70 mg

Tablet

Oral use

PT - Portugal

Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra, Portugal

Ácido Alendrónico Farmoz

70 mg

Film-coated Tablet

Oral use

PT - Portugal

Frosst Portuguesa - Produtos Farmacêuticos, Lda. Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo Apartado 214 2780-730 Paço D' Arcos, Portugal

Ácido Alendrónico Frosst 70 mg

70 mg

Tablet

Oral use

PT - Portugal

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escritório 8 2710-444 Sintra, Portugal

Ácido Alendrónico Generis 70 mg Comprimidos

70 mg

Tablet

Oral use

PT - Portugal

Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide, Portugal

Ácido Alendrónico Germed

70 mg

Tablet

Oral use

PT - Portugal

Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide, Portugal

Ácido Alendrónico Normon

70 mg

Tablet

Oral use

PT - Portugal

Helm Portugal, Lda. Estrada Nacional n.o 10, Km 140, 260 2695-066 Bobadela - Loures Portugal

Alehelm

70 mg

Tablet

Oral use

PT - Portugal

Helm Portugal, Lda. Estrada Nacional n.o 10, Km 140, 260 2695-066 Bobadela - Loures Portugal

Aleostito

70 mg

Tablet

Oral use

PT - Portugal

ITF Farma - Produtos Farmacêuticos, Lda. Rua Consiglieri Pedroso, 123 - Queluz de Baixo 2730-056 Barcarena, Portugal

Ácido Alendrónico ITF

70 mg

Tablet

Oral use

PT - Portugal

Jaba Recordati, S. A. Lagoas Park, Edificio 5, Torre C, Piso 3 2740-298 Porto Salvo, Portugal

Ácido Alendrónico Jaba 70 mg Comprimidos

70 mg

Tablet

Oral use

PT - Portugal

Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo 3465-157 Santiago de Besteiros, Portugal

Ácido Alendrónico Labesfal

10 mg

Tablet

Oral use

PT - Portugal

Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo 3465-157 Santiago de Besteiros, Portugal

Ácido Alendrónico Labesfal

70 mg

Tablet

Oral use

PT - Portugal

Laboratórios Anova - Produtos Farmacêuticos, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo 1499-016 Algés, Portugal

Ácido Alendrónico Anova

70 mg

Tablet

Oral use

PT - Portugal

Laboratórios Anova - Produtos Farmacêuticos, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo 1499-016 Algés, Portugal

Ácido Alendrónico Laquifa

70 mg

Tablet

Oral use

PT - Portugal

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche, Portugal

Ácido Alendrónico Azevedos

70 mg

Tablet

Oral use

PT - Portugal

Laboratórios Basi - Indústria Farmacêutica, S.A. Rua do Padrão, 98 3000-312 Coimbra, Portugal

Ácido Alendrónico Basi

70 mg

Tablet

Oral use

PT - Portugal

Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5 A - Piso 2 2740-298 Porto Salvo, Portugal

Ácido Alendrónico Mepha 70 mg Comprimidos

70 mg

Tablet

Oral use

PT - Portugal

Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5 A - Piso 2 2740-298 Porto Salvo, Portugal

Ácido Alendrónico Stroban

70 mg

Tablet

Oral use

PT - Portugal

Mer Medicamentos, Lda. Office Park da Beloura, Edifício 4 - Piso 1 - Escritório 8, Quinta da Beloura 2710-444 Sintra, Portugal

Ácido Alendrónico Mer

70 mg

Tablet

Oral use

PT - Portugal

Merck Sharp & Dohme, Lda. Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo Apartado 214 2770-192 Paço d' Arcos, Portugal

Fosamax

10 mg

Tablet

Oral use

PT - Portugal

Merck Sharp & Dohme, Lda. Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo Apartado 214 2770-192 Paço d' Arcos, Portugal

Fosamax 70 mg

70 mg

Tablet

Oral use

PT - Portugal

Parke-Davis - Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 10 2740-271 Porto Salvo, Portugal

Ácido Alendrónico Parke-Davis

70 mg

Tablet

Oral use

PT - Portugal

Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31 1495-139 Miraflores - Algés, Portugal

Ácido Alendrónico Pharmakern

70 mg

Tablet

Oral use

PT - Portugal

Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31 1495-139 Miraflores - Algés, Portugal

Ácido Alendrónico GIDE

70 mg

Tablet

Oral use

PT - Portugal

Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico 4150-174 Porto, Portugal

Ácido Alendrónico Ranbaxy

70 mg

Tablet

Oral use

PT - Portugal

Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico 4150-174 Porto, Portugal

Ácido Alendrónico Alendrol

70 mg

Tablet

Oral use

PT - Portugal

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso 2790-143 Carnaxide, Portugal

Ácido Alendrónico ratiopharm 70 mg Comprimidos

70 mg

Tablet

Oral use

PT - Portugal

Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15 2710-693 Sintra Portugal

Ácido Alendrónico Sandoz 70 mg Comprimidos

70 mg

Tablet

Oral use

PT - Portugal

Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15 2710-693 Sintra Portugal

Ácido Alendrónico 1Apharma

70 mg

Tablet

Oral use

PT - Portugal

Sociedade J. Neves, Lda. Parque Industrial do Seixal 2840-068 Paio Pires, Portugal

Ácido Alendrónico J. Neves 70 mg Comprimidos

70 mg

Tablet

Oral use

PT - Portugal

Tecnifar - Indústria Técnica Farmacêutica, S.A. Rua Tierno Galvan - Amoreiras - Torre 3 - 12o 1099-036 Lisboa, Portugal

Adronat

10 mg

Tablet

Oral use

PT - Portugal

Tecnifar - Indústria Técnica Farmacêutica, S.A. Rua Tierno Galvan - Amoreiras - Torre 3 - 12o 1099-036 Lisboa, Portugal

Adronat 70 mg

70 mg

Tablet

Oral use

PT - Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 - Abrunheira 2710-089 Sintra Portugal

Ácido Alendrónico Ecosis 70 mg Comprimidos

70 mg

Film-coated Tablet

Oral use

PT - Portugal

Tetrafarma - Produtos Farmacêuticos, Lda. Rua Helena Aragão, 20 R/C Frente - Massamá 2745-879 Queluz, Portugal

Ácido Alendrónico Tetrafarma

70 mg

Film-coated Tablet

Oral use

PT - Portugal

ToLife - Produtos Farmacêuticos, S.A. Avenida do Forte, 3 - Edificio Suécia III, Piso 1 2794-093 Carnaxide, Portugal

Ácido Alendrónico ToLife 70 mg Comprimidos

70 mg

Film-coated Tablet

Oral use

PT - Portugal

Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda Av. Sidónio Pais, n.o 24, rés-do-chão esq, São Sebastião da Pedreira 1000 Lisboa, Portugal

Ácido Alendrónico Flazium

70 mg

Film-coated Tablet

Oral Use

RO - Romania

MERCK SHARP & DOHME ROMÂNIA S.R.L.Bucharest Business ParkȘos. București-Ploiești, Nr. 1A, Clădirea C1, Etaj 3,Sector 1, București, România

FOSAMAX 5 mg

5 mg

Tablet

Oral Use

RO - Romania

MERCK SHARP & DOHME ROMÂNIA S.R.L.Bucharest Business ParkȘos. București-Ploiești, Nr. 1A, Clădirea C1, Etaj 3,Sector 1, București, România

FOSAMAX 10 mg

10 mg

Tablet

Oral Use

RO - Romania

MERCK SHARP & DOHME ROMÂNIA S.R.L.Bucharest Business ParkȘos. București-Ploiești, Nr. 1A, Clădirea C1, Etaj 3,Sector 1, București, România

FOSAMAX 70 mg

70 mg

Tablet

Oral Use

RO - Romania

S.C. TEVA PHARMACEUTICALS S.R.L.,Str. Domnița Ruxandra nr. 12, Parter, Sectorul 2, București, România

TEVANAT 10 mg

10 mg

Tablet

Oral Use

RO - Romania

S.C. TEVA PHARMACEUTICALS S.R.L.,Str. Domnița Ruxandra nr. 12, Parter, Sectorul 2, București, România

TEVANAT 70 mg

70 mg

Tablet

Oral Use

RO - Romania

SANDOZ S.R.L., Str. Livezeni nr. 7A, Târgu Mureș, România

ALENDRONAT SANDOZ

70 mg

film coatet tablet

Oral Use

RO - Romania

GEDEON RICHTER ROMÂNIA S.A., România

SEDRON

70 mg

film coatet tablet

Oral Use

RO - Romania

ACCORD HEALTHCARE LIMITED, Sage house, 319 Pinner road, North Harrow HA1 4 HF, Middlesex, Marea Britanie

ACID ALENDRONIC ACCORD 10 mg

10 mg

Tablet

Oral Use

RO - Romania

ACCORD HEALTHCARE LIMITED, Sage house, 319 Pinner road, North Harrow HA1 4 HF, Middlesex, Marea Britanie

ACID ALENDRONIC ACCORD 70 mg

70 mg

Tablet

Oral Use

RO - Romania

TERAPIA SA, Str. Fabricii nr. 124, Cluj Napoca, România

RANOS 10 mg

10 mg

Tablet

Oral Use

RO - Romania

TERAPIA SA, Str. Fabricii nr. 124, Cluj Napoca, România

RANOS 70 mg

70 mg

Tablet

Oral Use

RO - Romania

LABORATOARELE PROF. Dr. MORAIT, Str. Sperantei nr.29, Bucuresti sector 2, Romania

ANDRONIK

70 mg

film coatet tablet

Oral Use

RO - Romania

BLUEFISH PHARMACEUTICALS AB, Torsgatan 11, 111 23 Stockholm, Sweden

ACID ALENDRONIC BLUEFISH

70 mg

Tablet

Oral Use

RO - Romania

PHARMACEUTICAL WORKS POLPHARMA SA,19 Pelplińska Street, 83-200 Starogard Gdański, Polonia

OSTEMAX

70 mg

Tablet

Oral Use

RO - Romania

Dr. REDDY'S LABORATORIES, Str. Av. Petre Crețu nr. 74, et. 1, ap. 2, sect. 1, București, România

INSTREL

70 mg

Tablet

Oral Use

RO - Romania

Teva Pharmaceuticals S.R.L,

Str Domnita Ruxandra nr. 12, parter, sector 2, 020562, Bucuresti

Romania

Teva nat, 70 mg comprimate

70 mg

Tablet

Oral Use

SE - Sweden

Merck Sharp & Dohme BV, PO Box 581, NL-2003 PC Harlem, Netherlands (NLD)

Fosamax

10 mg

tablet

Oral Use

SE - Sweden

Merck Sharp & Dohme BV, PO Box 581, NL-2003 PC Harlem, Netherlands (NLD)

Fosamax veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Alendronate Arrow

10 mg

tablet

Oral Use

SE - Sweden

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Alendronate Arrow veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Alenat

10 mg

tablet

Oral Use

SE - Sweden

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Alenat veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Medarin

10 mg

tablet

Oral Use

SE - Sweden

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Medarin veckotablett

70 mg

tablet

Oral Use

SE - Sweden

ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany

Dedarin veckotablett

70 mg

tablet

Oral Use

SE - Sweden

CT Arzneimittel GmbH, Lengeder Strasse 42 a, DE-13407 Berlin, Germany

Gendarin veckotablett

70 mg

tablet

Oral Use

SE - Sweden

PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield Hampshire, GU32 3QB, United Kingdom and Northern Ireland

Kendarin

10 mg

tablet

Oral Use

SE - Sweden

PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield Hampshire, GU32 3QB, United Kingdom and Northern Ireland

Kendarin veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Alendroarrow

10 mg

tablet

Oral Use

SE - Sweden

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Alendroarrow veckotablett

70 mg

tablet

Oral Use

SE - Sweden

ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany

Alendronat ratiopharm veckotablett

70 mg

tablet

Oral Use

SE - Sweden

STADA Arzneimittel AG, Stadastrasse 2-18, DE-61118 Bad Vilbel, Germany (DEU)

Alendrostad

10 mg

tablet

Oral Use

SE - Sweden

STADA Arzneimittel AG, Stadastrasse 2-18, DE-61118 Bad Vilbel, Germany (DEU)

Alendrostad veckotablett

70 mg

tablet

Oral Use

SE - Sweden

STADA Arzneimittel AG, Stadastrasse 2-18, DE-61118 Bad Vilbel, Germany (DEU)

Alendronat STADA

10 mg

tablet

Oral Use

SE - Sweden

STADA Arzneimittel AG, Stadastrasse 2-18, DE-61118 Bad Vilbel, Germany (DEU)

Alendronat STADA veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Interpharm ProduktionsgmbH, Effingerstrasse 21, AT-1160 Wien, Austria (AUT)

Alendronat Interpharm

10 mg

tablet

Oral Use

SE - Sweden

Interpharm ProduktionsgmbH, Effingerstrasse 21, AT-1160 Wien, Austria (AUT)

Alendronat Interpharm veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark

Alendronat Hexal

10 mg

tablet

Oral Use

SE - Sweden

Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark

Alendronat Hexal Veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

AlendroLich

10 mg

tablet

Oral Use

SE - Sweden

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

AlendroLich Veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Alendronat Orifarm Veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Mylan AB Box 23033 104 35 Stockholm Sweden

Alendronat Mylan Veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Pharmaceutical Works Polpharma S.A. 19 Pelplinska Str. PL-83-200 Starogard Gdanski Poland

Alendropol Veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Pharmaceutical Works Polpharma S.A. 19 Pelplinska Str. PL-83-200 Starogard Gdanski Poland

Alendrixen Veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Pharmaceutical Works Polpharma S.A. 19 Pelplinska Str. PL-83-200 Starogard Gdanski Poland

Polerixen Veckotablett

70 mg

tablet

Oral Use

SE - Sweden

HELP S.A. Pharmaceuticals 10, Valaoritou Str. Metamorphosis 144 52 Athen Greece

Terixen Veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Pharmaceutical Works Polpharma S.A. 19 Pelplinska Str. PL-83-200 Starogard Gdanski Poland

Alenpol Veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Pharmaceutical Works Polpharma S.A. 19 Pelplinska Str. PL-83-200 Starogard Gdanski Poland

Alendronat Polpharma Veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Ranbaxy (UK) Ltd 20 Baldertoon Street London W1K 6TL United Kingdom

Alendronat Ranbaxy Veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Mylan AB Box 23033 104 35 Stockholm Sweden

Alendronat Mylan

10 mg

tablet

Oral Use

SE - Sweden

Sandoz A/S C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Denmark

Alendronat Sandoz Veckotablett

70 mg

film-coated tablet

Oral Use

SE - Sweden

Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark

Alendronat Hexal Veckotablett

70 mg

film-coated tablet

Oral Use

SE - Sweden

1A Farma A/S Herstedøstervej 27-29 DK-2620 Albertslund Denmark

Alendronat 1A Farma Veckotablett

70 mg

film-coated tablet

Oral Use

SE - Sweden

Accord Healthcare Limited Sage House 319 Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom

Alendronat Accord

10 mg

tablet

Oral Use

SE - Sweden

Accord Healthcare Limited Sage House 319 Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom

Alendronat Accord Veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Bluefish Pharmaceuticals AB Torsgatan 11 111 23 Stockholm Sweden

Alendronat Bluefish Veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Actavis Group PTC ehf. Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Island

Alendronat Actavis Veckotablett

70 mg

tablet

Oral Use

SE - Sweden

Orion Corporation, Orion Pharma PO Box 65 FI-02101 Espoo Finland

Alendronat Orion Veckotablett

70 mg

tablet

Oral Use

SI - Slovenia

Generics UK Ltd., Station Close, Potters Bar, Hertford Shire EN6 1AG, UK

Alenax 70 mg tablete

70 mg

tablet

Oral Use

SI - Slovenia

Pliva Ljubljana d.o.o., pot k sejmišču 35, SI-1231 Ljubljana- Črnuče, Slovenia

Alendor 70 mg tablete

70 mg

tablet

Oral Use

SI - Slovenia

Arrow Generics Limited, 2 Eastman Way, Stevenage, Hertfordshire, UK

Alendronat Arrow 10 mg

10 mg

tablet

Oral Use

SI - Slovenia

Arrow Generics Limited, 2 Eastman Way, Stevenage, Hertfordshire, UK

Alendronat Arrow 70 mg

70 mg

tablet

Oral Use

SI - Slovenia

Lek farmacevtska družba, d.d., Verovškova 57, SI-1000 Ljubljana, Slovenia

Alendronat Lek 70 mg filmsko obložene tablete

70 mg

film-coated tablet

Oral Use

SI - Slovenia

Kemofarmacija d.d., cesta na Brdo 100, SI-1000 Ljubljana Slovenia

Forosa 70 mg filmsko obložene tablete

70 mg

film-coated tablet

Oral Use

SI - Slovenia

Merck Sharp& Dohme, inovativna zdravila d.o.o., Šmartinska cesta 140, SI-1000 Ljubljana

Fosamax enkrat tedensko 70 mg tablete

70 mg

tablet

Oral Use

SI - Slovenia

Krka, tovarna zdravil, d.d., Šmarješka cesta 6, SI-8501 Novo mesto, Slovenia

Lindron 10 mg tablete

10 mg

tablet

Oral Use

SI - Slovenia

Actavis Group PTC ehf., Reykjavikurvegi 78, 220 Hafnarfjordur, Iceland

Natrijev alendronat Actavis 70 mg tablete

70 mg

tablet

Oral Use

SI - Slovenia

Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, NL

Tevanate 70 mg tablete

70 mg

tablet

Oral Use

SK - Slovakia

Merck Sharp & Dohme B.V. Waarderweg 39 P.O. Box 581, Haarlem, 2031 BN Netherlands

FOSAMAX 70 mg 1 x týždenne

70 mg

Tablet

Oral Use

SK - Slovakia

Bentley Pharmaceuticals Ireland Limited North Wall Quay 25 - 28 Dublin 1 Ireland

Gendron 70 Tablety

70 mg

Tablet

Oral Use

SK - Slovakia

Teva Pharmaceuticals CR, s.r.o. Radlická 3185/1c 150 00 Praha 5 Czech Republic

Tevalen 70 mg

70 mg

Tablet

Oral Use

SK - Slovakia

Gedeon Richter Plc. Gyômrôi út 19-21 1103, Budapest Hungary

Siranin 70 mg filmom obalené tablety

70 mg

Film coated tablet

Oral Use

SK - Slovakia

Generics (UK) Ltd. Station Close, Hertfordshire Potters Bar, EN6 1TL United Kingdom

Alendrogen 70 mg

70 mg

Tablet

Oral Use

SK - Slovakia

Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG14SZ

United Kingdom

Alendromax 70 mg tablety

70 mg

Tablet

Oral Use

SK - Slovakia

ratiopharm GmbH Graf-Arco-Strasse 3 Ulm, 89079 Germany

Alendronat-ratiopharm 70 mg

70 mg

Tablet

Oral Use

SK - Slovakia

Sandoz Pharmaceuticals d.d. Verovškova 57, Ľubľana 1000

Slovenia

Alendronát Sandoz 70 mg 1 x týždenne tablety

70 mg

Tablet

Oral Use

SK - Slovakia

Xeolas Pharmaceuticals Limited 97 Furry Park Road Killester, Dublin 5

Ireland

Bonasol 70 mg perorálny roztok

70 mg

Oral Solution

Oral Use

SK - Slovakia

Actavis Group PTC ehf; Reykjavikurvegi 76-78,

220 Hafnarfjordur

Iceland

Alendronat Actavis

70 mg

tablets

Oral Use

UK - United Kingdom

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Fosamax

10 mg

Tablet

Oral Use

UK - United Kingdom

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Fosamax Once weekly

70 mg

Tablet

Oral Use

UK - United Kingdom

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Adronat Once weekly

70 mg

Tablet

Oral Use

UK - United Kingdom

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Alegen Once weekly

70 mg

Tablet

Oral Use

UK - United Kingdom

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Alendros Once Weekly

70 mg

Tablet

Oral Use

UK - United Kingdom

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Once weekly

70 mg

Tablet

Oral Use

UK - United Kingdom

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Fosatrol Once weekly

70 mg

Tablet

Oral Use

UK - United Kingdom

Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

alendronic acid

10 mg

Tablet

Oral Use

UK - United Kingdom

Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

alendronic acid

70 mg

Tablet

Oral Use

UK - United Kingdom

Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

alendronic acid

70 mg

Tablet

Oral Use

UK - United Kingdom

Sandoz Limited, 37 Woolmer Way, Bordon, Hampshire GU35 9QE

alendronic acid

70 mg

Film-coated tablet

Oral Use

UK - United Kingdom

Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL

alendronic acid

10 mg

Tablet

Oral Use

UK - United Kingdom

Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL

alendronic acid

70 mg

Tablet

Oral Use

UK - United Kingdom

Gideon Richter Plc, Gyomrui Utca 19-21, Budapest H-1103, Hungary

alendronic acid

70 mg

Film-coated tablet

Oral Use

UK - United Kingdom

Gideon Richter Plc, Gyomrui Utca 19-21, Budapest H-1103, Hungary

alendronic acid

70 mg

Film-coated tablet

Oral Use

UK - United Kingdom

Dr Reddy's Laboratories (UK) Limited, 6 Riverview Road, Beverley, East Yorkshire HU17 0LD, United Kingdom

alendronic acid

70 mg

Tablet

Oral Use

UK - United Kingdom

Pliva Pharma Limited, Vision House, Bedford Road, Petersfield, Hampshire GU23 3QB, United Kingdom

alendronic acid

10 mg

Tablet

Oral Use

UK - United Kingdom

Pliva Pharma Limited, Vision House, Bedford Road, Petersfield, Hampshire GU23 3QB, United Kingdom

alendronic acid once-weekly

70 mg

Tablet

Oral Use

UK - United Kingdom

Ranbaxy (UK) Limited, 95 Park Lane, Mayfair. London W1K 7TE, United Kingdom

alendronic acid

70 mg

Tablet

Oral Use

UK - United Kingdom

Strandhaven Limited, 600 High Road, Seven Kings, Ilford, Essex IG3 8BS, United Kingdom

alendronic acid

70 mg

Tablet

Oral Use

UK - United Kingdom

Ratiopharm GmbH, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hampshire, PO6 1UP

alendronic acid

70 mg

Tablet

Oral Use

UK - United Kingdom

Prostrakan Limited, 3 Galabank Business Park, Queen Street, Galashiels, TD1 1QH, United Kingdom

Ostalis

70 mg

Film-coated tablet

Oral Use

UK - United Kingdom

Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom

alendronic acid

10 mg

Tablet

Oral Use

UK - United Kingdom

Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom

alendronic acid

70 mg

Tablet

Oral Use

UK - United Kingdom

Arrow Generics Limited, Unit 2 Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United Kingdom

alendronic acid

10 mg

Tablet

Oral Use

UK - United Kingdom

Arrow Generics Limited, Unit 2 Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United Kingdom

alendronic acid

70 mg

Tablet

Oral Use

UK - United Kingdom

Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom

alendronic acid

10 mg

Tablet

Oral Use

UK - United Kingdom

Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom

alendronic acid once weekly

70 mg

Tablet

Oral Use

UK - United Kingdom

Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom

alendronic acid

70 mg

Tablet

Oral Use

UK - United Kingdom

Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX, United Kingdom

alendronic acid

70 mg

Tablet

Oral Use

UK - United Kingdom

Resource Medical (UK) Limited, 2 Carlton Avenue, Batley, West Yorkshire WF17 7AQ, United Kingdom

alendronic acid

70 mg

Tablet

Oral Use

UK - United Kingdom

Laboratorios Davur S.L., Calle Teide 4. Parque Empresarial La Marina, 28700 San Sebastian De Los Reyes, Madrid E-28700 Spain

alendronic acid

70 mg

Tablet

Oral Use

UK - United Kingdom

Apotex Europe BV, Darwinweg 20, Leiden, NL 2333 CR, Netherlands

alendronic acid

70 mg

Tablet

Oral Use

UK - United Kingdom

Wockhardt UK Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK

alendronic acid

70 mg

Tablet

Oral Use

UK - United Kingdom

Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland

alendronic acid

70 mg

Tablet

Oral Use


Clodronic acid 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 Ges.m.b.H.

Herbststraße 6 – 10

A-1160 Wien, Austria

Bonefos 800 mg - Filmtabletten

800 mg (Clodronate Disodium)

film-coated tablet

Oral use

AT - Austria

Bayer Austria Ges.m.b.H.

Herbststraße 6 – 10

A-1160 Wien, Austria

Bonefos 300 mg - Konzentrat zur Infusionsbereitung

300 mg/5 ml (Clodronate Disodium)

concentrate for solution for infusion

Intravenous

AT - Austria

Roche Austria GmbH, Engelhorngasse 3, A-1211 Wien, Austria

Lodronat 520 mg - Filmtabletten

520 mg (Clodronate Disodium)

film-coated tablet

Oral use

BE - Belgium

Bayer SA.NV.

J.E. Mommaertslaan 14

1831 Diegem-Machelen

Belgium

Bonefos

300 mg/5 ml

Concentrate for solution for infusion

Intravenous

BE - Belgium

Bayer SA.NV.

J.E. Mommaertslaan 14

1831 Diegem-Machelen

Belgium

Bonefos

800 mg

Film-coated tablets

Oral use

BG - Bulgaria

Atavis EAD

1407 Sofia

29 Atanas Dukov Str.

Bulgaria

Sindronat

400 mg

capsules, hard

Oral use

CZ - Czech Republic

Bayer Schering Pharma Oy

PO Box 415, FI-20101 Turku, Finland

Bonefos

60 mg/1 ml

Concentrate for solution for infusion

Infusion

CZ - Czech Republic

Bayer Schering Pharma Oy

PO Box 415, FI-20101 Turku, Finland

Bonefos 400 mg

400 mg

Capsule, hard

Oral use

CZ - Czech Republic

Bayer Schering Pharma Oy

PO Box 415, FI-20101 Turku, Finland

Bonefos 800 mg

800 mg

Film-coated tablet

Oral use

CZ - Czech Republic

Roche s.r.o., Dukelských hrdinů 567/52, 170 00 Praha-Holešovice, Czech Republic

Lodronat 520

520 mg

Film-coated tablet

Oral use

DE - Germany

1 A Pharma GmbH

Keltenring 1 + 3

D-82041 Oberhaching

Clodron 800-1 A Pharma

1 000 mg

Film-coated tablet

Oral use

DE - Germany

1 A Pharma GmbH

Keltenring 1 + 3

D-82041 Oberhaching

Clodron 400-1 A Pharma

500 mg

Film-coated tablet

Oral use

DE - Germany

Bayer Vital GmbH

Kaiser-Wilhelm-Allee

D-51373 Leverkusen

Bonefos pro infusione

75 mg

Concentrate for solution for infusion

Intravenous

DE - Germany

Bayer Vital GmbH

Kaiser-Wilhelm-Allee

D-51373 Leverkusen

Bonefos

500 mg

Capsule, hard

Oral use

DE - Germany

Bayer Vital GmbH

Kaiser-Wilhelm-Allee

D-51373 Leverkusen

BONEFOS FILMTABLETTEN 800 mg

1 000 mg

Film-coated tablet

Oral use

DE - Germany

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Clodron beta 800 mg

1 000 mg

Film-coated tablet

Oral use

DE - Germany

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Clodron HEXAL PI

374,9 mg

Concentrate for solution for infusion

Intravenous

DE - Germany

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Clodron 800 mg HEXAL Filmtabletten

1 000 mg

Film-coated tablet

Oral use

DE - Germany

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Clodron 800 mg HEXAL Filmtabletten

500 mg

Film-coated tablet

Oral use

DE - Germany

Roche Pharma AG

Emil-Barell-Str. 1

D-79639 Grenzach-Wyhlen

Ostac

649,73 mg

Film-coated tablet

Oral use

DE - Germany

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Clodron Sandoz 300 mg Konzentrat zur Herstellung einer Infusionslösung

300 mg

Concentrate for solution for infusion

Intravenous

DK - Denmark

Bayer AB, Postbox 606, Gustav III:s Boulevard 56, SE-16926 Solna

Bonefos

800 mg

film-coated tablets

Oral use

ES - Spain

QUIMICA FARMACEUTICA BAYER, S.L.Av. Baix Llobregat, 3-5 08970 Sant Joan Despi

BONEFOS 400 mg cápsulas

400 mg

capsules

Oral use

ET - Estonia

Bayer Schering Pharma OY Pansiontie 47

20210 Turku FINLAND

BONEFOS

800 mg

Film-coated tablet

Oral use

ET - Estonia

Bayer Schering Pharma OY Pansiontie 47

20210 Turku FINLAND

BONEFOS

400 mg

Capsule, hard

Oral use

ET - Estonia

Bayer Schering Pharma OY Pansiontie 47

20210 Turku FINLAND

BONEFOS

60 mg 1 ml

Concentrate for solution for infusion

Intravenous

FI - Finland

Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland

Bonefos

60 mg/ml

Concentrate for solution for infusion

Intravenous

FI - Finland

Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland

Bonefos

400 mg

capsule, hard

Oral use

FI - Finland

Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland

Bonefos

800 mg

film-coated tablet

Oral use

FI - Finland

Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland

Clodrobon

400 mg

capsule, hard

Oral use

FI - Finland

Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland

Clodrobon

800 mg

film-coated tablet

Oral use

FR - France

BAYER SANTE

220, avenue de la Recherche

59120 Loos

FRANCE

CLASTOBAN 300 mg/5 ml, solution injectable pour perfusion en ampoule

300 mg/5 ml

solution

Intravenous

FR - France

BAYER SANTE

220, avenue de la Recherche

59120 Loos

FRANCE

CLASTOBAN 400 mg, gélule

400 mg

capsule

Oral use

FR - France

BAYER SANTE

220, avenue de la Recherche

59120 Loos

FRANCE

CLASTOBAN 800 mg, gélule

800 mg

tablet

Oral use

FR - France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

CLODRONATE DE SODIUM G GAM 400 mg, comprimé enrobé

400 mg

tablet

Oral use

FR - France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

CLODRONATE DE SODIUM G GAM 800 mg, comprimé pelliculé

800 mg

tablet

Oral use

FR - France

ROCHE

52, boulevard du Parc

92521 Neuilly-sur-Seine Cedex

FRANCE

LYTOS 520 mg, comprimé pelliculé

520 mg

tablet

Oral use

HU - Hungary

Bayer Schering Pharma Oy

Pansiontie 47.

20210 Turku

Finland

BONEFOS 800 mg tabletta

800 mg Disodium clodronate anhydrous

(in the form of 1 000 mg

Disodium clodronate tetrahydrate

tablet

Oral use

HU - Hungary

Bayer Schering Pharma Oy

Pansiontie 47.

20210 Turku

Finland

BONEFOS 400 mg kemény kapszula

400 mg Disodium clodronate anhydrous

(in the form of 500 mg

Disodium clodronate tetrahydrate

hard capsules

Oral use

HU - Hungary

Bayer Schering Pharma Oy

Pansiontie 47.

20210 Turku

Finland

BONEFOS 60 mg/ml koncentrátum oldatos infúzióhoz

60 mg/ml Disodium clodronate anhydrous

(in the form

Disodium clodronate tetrahydrate

concentrate for solution for infusion

Parenteral

IE - Ireland

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Bonefos 800 mg film-coated tablets.

800 mg

Film-coated tablets

Oral use

IS - Iceland

Bayer Ab, Box 606, Solna, Sweden

Bonefos

800 mg

Tablet

Oral use

IT - Italy

ABIOGEN PHARMA SpA

Via Meucci, 36 - 56014

Ospedaletto (PI)

CLASTEON

100 mg/3,3 ml

Solution for injection

Intramuscolar

IT - Italy

FIDIA FARMACEUTICI SpA

Via Ponte Della Fabbrica, 3/A - 35031

Abano Terme (PD)

CLODRON

100 mg/3,3 ml

Solution for injection

Intramuscular

IT - Italy

PROMEDICA Srl

Via Palermo, 26/A - 43100

Parma

CLODY

100 mg/3,3 ml

Solution for injection

Intramuscular

IT - Italy

SPA - SOCIETA' PRODOTTI ANTIBIOTICI SpA

Via Biella, 8

20143 Milano

DIFOSFONAL

100 mg/3,3 ml

Solution for injection

Intramuscular

IT - Italy

ISTITUTO BIOCHIMICO NAZIONALE SAVIO SRL

Via E. Bazzano, 14 16019 Ronco Scrivia - Genova (Italy)

NIKLOD

100 mg/3,3 ml

Solution for injection

Intramuscular

IT - Italy

ABC FARMACEUTICI SpA

Corso Vittorio Emanuele II, 72 10121 Torino

CLODRONATO ABC

100 mg/3,3 ml

Solution for injection

Intramuscular, Intravenous

IT - Italy

ABC FARMACEUTICI SpA

Corso Vittorio Emanuele II, 72 10121 Torino

CLODRONATO ABC

300 mg/10 ml

Solution for infusion

Intravenous

IT - Italy

ABIOGEN PHARMA SpA

Via Meucci, 36 - 56014

Ospedaletto (PI)

CLASTEON

300 mg

Concentrate for solution for infusion

Intravenous

IT - Italy

ABIOGEN PHARMA SpA

Via Meucci, 36 - 56014

Ospedaletto (PI)

CLASTEON

400 mg

Capsule, hard

Oral Use

IT - Italy

EG SpA

Via Pavia, 6 - 20136

Milano - Italy

ACIDO CLODRONICO EG

100 mg/3,3 ml

Solution for injection

Intramuscular, Intravenous

IT - Italy

FARMACEUTICI CABER SpA

Viale Città d' Europa, 681

00144 Roma

OSTEONORM

100 mg

Solution for injection

Intramuscular, Intravenous

IT - Italy

FIDIA FARMACEUTICI SpA

Via Ponte Della Fabbrica, 3/A - 35031

Abano Terme (PD)

CLODRON

300 mg/10 ml

Solution for injection

Intravenous

IT - Italy

FIDIA FARMACEUTICI SpA

Via Ponte Della Fabbrica, 3/A - 35031

Abano Terme (PD)

CLODRON

400 mg

Capsule

Oral Use

IT - Italy

ISTITUTO BIOCHIMICO NAZIONALE SAVIO SRL

Via E. Bazzano, 14 16019 Ronco Scrivia - Genova (Italy)

NIKLOD

300 mg/10 ml

Concentrate for solution for infusion

Intravenous

IT - Italy

LABORATORI ALTER Srl

Via Lomellina, 39 - 20124

Milano

DISODIO CLODRONATO ALTER

100 mg/3,3 ml

Solution for injection

Intramuscular, Intravenous

IT - Italy

LABORATORI ALTER Srl

Via Lomellina, 39 - 20124

Milano

DISODIO CLODRONATO ALTER

300 mg/10 ml

Solution for infusion

Intravenous

IT - Italy

LISAPHARMA SpA

Via Licinio, 11

22036 Erba (CO)

MOTICLOD

300 mg/10 ml

Solution for infusion

Intravenous

IT - Italy

LISAPHARMA SpA

Via Licinio, 11

22036 Erba (CO)

MOTICLOD

100 mg/3,3 ml

Solution for injection

Intramuscular, Intravenous

IT - Italy

MASTELLI Srl

Via Bussana Vecchia, 32

18032 San Remo (IM)

CLIMACLOD

300 mg/10 ml

Solution for infusion

Intravenous

IT - Italy

MASTELLI Srl

Via Bussana Vecchia, 32

18032 San Remo (IM)

CLIMACLOD

100 mg/3,3 ml

Solution for injection

Intramuscular

IT - Italy

MYLAN SpA

Via Aquileia, 35 - 20092

Cinisello Balsamo

Milano

ACIDO CLODRONICO MYLAN GENERICS

100 mg/3,3 ml

Solution for injection

Intramuscular, Intravenous

IT - Italy

MYLAN SpA

Via Vittor Pisani, 20 - 20124

Milano

ACIDO CLODRONICO MYLAN GENERICS

300 mg/10 ml

Solution for infusion

Intravenous

IT - Italy

PROMEDICA Srl

Via Palermo, 26/A - 43100

Parma

CLODY

300 mg/10 ml

Concentrate for solution for infusion

Intravenous

IT - Italy

ROTTAPHARM SpA

Via Galleria Unione,5

20122 Milano (MI)

OSTEOTAB

100 mg/3,3 ml

Solution for injection

Intramuscular, Intravenous

IT - Italy

ROTTAPHARM SpA

Via Galleria Unione,5

20122 Milano (MI)

OSTEOTAB

300 mg/10 ml

Solution for infusion

Intravenous

IT - Italy

SANDOZ SpA

L.go U. Boccioni, 1 - 21040

Origgio (VA)

ACIDO CLODRONICO

100 mg/3,3 ml

Solution for injection

Intramuscular, Intravenous

IT - Italy

SANDOZ SpA

L.go U. Boccioni, 1 - 21040

Origgio (VA)

ACIDO CLODRONICO

300 mg/10 ml

Solution for infusion

Intravenous

IT - Italy

SPA - SOCIETA' PRODOTTI ANTIBIOTICI SpA

Via Biella, 8

20143 Milano

DIFOSFONAL

300 mg/10 ml

Concentrate for solution for infusion

Intravenous

IT - Italy

SPA - SOCIETA' PRODOTTI ANTIBIOTICI SpA

Via Biella, 8

20143 Milano

DIFOSFONAL

400 mg

Capsule

Oral Use

IT - Italy

TEVA ITALIA Srl

Via Messina, 38 - 20154

Milano – Italy

CLODRONATO TEVA

100 mg/3,3 ml

Solution for injection

Intramuscular, Intravenous

IT - Italy

TEVA ITALIA Srl

Via Messina, 38 - 20154

Milano

CLODRONATO TEVA

300 mg/10 ml

Solution for infusion

Intravenous

IT - Italy

LABORATORIO PRODOTTI FARMACEUTICI BONISCONTRO & GAZZONE Srl

Via Pavia, 6 - 20136

Milano – Italy

CLODEOSTEN

100 mg/3,3 ml

Soluction for injection

Intravenous

IT - Italy

ATHENA PHARMA ITALIA SRL Viale Citta D'Europa, 681 00144 Roma

TRAXOVICAL

100 mg/3,3 ml

Soluction for injection

Intravenous

IT - Italy

ATHENA PHARMA ITALIA SRL Viale Citta D'Europa, 681 00144 Roma

TRAXOVICAL

300 mg/10 ml

Soluction for infusion

Intravenous

LU - Luxembourg

Bayer s.a.

14, J.E. Mommaertslaan

B-1831 Diegem

Bonefos

300 mg/5 ml

solution for infusion

Intraveinous

LV - Latvia

Bayer Schering Pharma Oy, Pansiontie 47, FIN-20210 Turku, Finland

Bonefos

60 mg/ml

concentrate for solution for infusion

Intravenous

LV - Latvia

Bayer Schering Pharma Oy, Pansiontie 47, FIN-20210 Turku, Finland

Bonefos

400 mg

capsules

Oral use

MT - Malta

Bayer plc

Consumer Care Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

United Kingdom

Bonefos

400 mg

Capsules

Oral use

NL - Netherlands

Roche Nederland B.V.

Beneluxlaan 2a

3446 GR Woerden Netherlands

Ostac, concentration for solution for infusion 30 mg/ml

30 mg/ml

concentration for solution for infusion

Intravenous

NL - Netherlands

Roche Nederland B.V.

Beneluxlaan 2a

3446 GR Woerden Netherlands

Ostac® 520, filmcaoted tablets 520 mg

520 mg

filmcoated tablets

Oral use

NL - Netherlands

Bayer B.V. Energieweg 1 3641 RT Mijdrecht

Bonefos

60 mg/ml

concentration for solution for infusion

Intravenous

NL - Netherlands

Bayer B.V. Energieweg 1 3641 RT Mijdrecht

Bonefos capsules 400 mg

400 mg

hard capsules

Oral use

NL - Netherlands

Bayer B.V. Energieweg 1 3641 RT Mijdrecht

Bonefos tablets 800 mg

800 mg

filmcoated tablets

Oral use

NO - Norway

Bayer AB Box 606 169 26 Solna Sweden

Bonefos

800 mg

film-coated tablet

Oral use

PL - Poland

Bayer Schering Pharma AG

Berlin, D-13342, Germany

Bonefos

400 mg

capsules, hard

Oral use

PL - Poland

Bayer Schering Pharma AG

Berlin, D-13342, Germany

Bonefos

60 mg/ml

concentrate for solution for infusion

Intravenous

PL - Poland

Bayer Schering Pharma AG

Berlin, D-13342, Germany

Bonefos

800 mg

film coated tablets

Oral use

PL - Poland

Actavis Group PTC ehf.

Reykjavikurvegi 76-78

220 Hafnarfirdi, Iceland

Sindronat

400 mg

capsules, hard

Oral use

PT - Portugal

Roche Farmacêutica Química, Lda. Estrada Nacional 249, 1, 2720-413 Amadora Portugal

Ostac

520 mg

Coated tablet

Oral use

PT - Portugal

Lusalfarma - Especialidades Farmacêuticas, Lda. Rua Quinta Pinheiro, 5, Outurela 2794-003 Carnaxide Portugal

Bonefos

800 mg

Film-coated tablet

Oral use

RO - Romania

BAYER SCHERING PHARMA OY, Pansiontie 47, 20210 Turku, Finland

BONEFOS 400 mg, capsules

400 mg

capsules

Oral use

RO - Romania

BAYER SCHERING PHARMA OY, Pansiontie 47, 20210 Turku, Finland

BONEFOS 800 mg, capsules

800 mg

capsules

Oral use

RO - Romania

BAYER SCHERING PHARMA OY, Pansiontie 47, 20210 Turku, Finland

BONEFOS 60 mg/ml concentrate for solution for infusion

60 mg/ml

concentrate for solution for infusion

Parenteral

RO - Romania

ACTAVIS S.R.L. B-dul Ion Mihalache, nr. 11 Sector 1, Cod 011171, București, Romania

SINDRONAT 300 mg/5 ml concentrate for solution for infusion

300 mg/5 ml

concentrate for solution for infusion

Prenteral

SE - Sweden

Bayer AB Box 606 169 26 Solna Sweden

Bonefos

60 mg/ml

concentrate for solution for infusion

For infusion

SE - Sweden

Bayer AB Box 606 169 26 Solna Sweden

Bonefos

800 mg

film-coated tablet

Oral use

SI - Slovenia

Bayer Schering Pharma Oy, Pansiontie 47, 20210 Turku, Finland

Bonefos 60 mg/ml koncentrat za raztopine za infundiranje

60 mg/ml

concentrate for solution for infusion

Intravenous

SI - Slovenia

Bayer Schering Pharma Oy, Pansiontie 47, 20210 Turku, Finland

Bonefos 800 mg filmsko obložene tablete

800 mg

film-coated tablet

Oral use

SK - Slovak Republic

Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland

Bonefos

60 mg/ml

Concentrate for solution for infusion

Intravenous

SK - Slovak Republic

Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland

Bonefos

400 mg

capsule, hard

Oral use

SK - Slovak Republic

Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland

Bonefos

800 mg

film-coated tablet

Oral use

UK - United Kingdom

Bayer Plc, bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA, UK

Bonefos

400 mg

Capsules

Oral use

UK - United Kingdom

Bayer Plc, bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA, UK

Bonefos

800 mg

coated Tablets

Oral use

UK - United Kingdom

Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, UK

Loron 540

 

film coated tablets

Oral use

UK - United Kingdom

Beacon Pharmaceuticals Limited, 85, High strret, Tunbridge Wells, TN1 1YG, UK

Clasteon

400 mg

Capsules

Oral use

UK - United Kingdom

Beacon Pharmaceuticals Limited, 85, High strret, Tunbridge Wells, TN1 1YG, UK

Sodium clodronate

400 mg

Capsules

Oral use

UK - United Kingdom

Caduceus Pharma Limited, 6th floor, 94 Wigmore Street, London W1U 3RF, UK

Disodium Clodronate

60 mg/ml

solution for Injection

Intravenous


Etidronic acid 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

BE - Belgium

Procter & Gamble Pharmaceuticals SA.NV.

Temselaan 100

Didronel

200 mg

Tablets

Oral use

BE - Belgium

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Osteodidronel

400 mg

Tablets

Oral use

DE - Germany

mibe GmbH Arznzemittel

Münchener Str. 15

D-06796 Brehna

Etidronat 200 mg Jenapharm

200 mg

Tablet

Oral use

DE - Germany

C.H.R. Heim Arzneimittel GmbH

Elisabethenstr. 34

D-64283 Darmstadt

Etical

400 mg

1 250 mg

Tablet

Oral use

DE - Germany

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Etidron HEXAL Kombi

400 mg

1 250 mg

Tablet and effervescent tablet

Oral use

DE - Germany

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Didronel-Kit

400 mg

1 250 mg

Tablet

Oral use

DK - Denmark

Procter & Gamble Pharmaceuticals UK Ltd., Rusham Park Technical Centre, Whitehall Lane, GB-TW20 9 NW Egham, Surrey, England

Didronate

200 mg

Tablets

Oral use

DK - Denmark

Procter & Gamble Pharmaceuticals UK Ltd., Rusham Park Technical Centre, Whitehall Lane, GB-TW20 9 NW Egham, Surrey, England

Didronate/Calcium "Procter & Gamble"

400 mg + 500 mg calcium

Tablets

Oral use

EL - Greece

UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES

14KM OF NATIONAL HIGHWAY ATHENS-LAMIA

KIFISSIA 14564

OSTOPOR

200 MG/CAP

HARD CAPSULE

Oral use

EL - Greece

UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES

14KM OF NATIONAL HIGHWAY ATHENS-LAMIA

KIFISSIA 14565

OSTOPOR

300 MG/CAP

HARD CAPSULE

Oral use

EL - Greece

UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES

14KM OF NATIONAL HIGHWAY ATHENS-LAMIA

KIFISSIA 14566

OSTOPOR

400 MG/CAP

HARD CAPSULE

Oral use

EL - Greece

PHARMACEUTICAL INDUSTRY PROEL EPAMEINONDAS G. KORONIS S.A.

ANFOZAN

400 MG/CAP

HARD CAPSULE

Oral use

ES - Spain

LABORATORIOS VIÑAS, S.A. Provenza, 386 08025 Barcelona

OSTEUM

200 mg

tablets

Oral use

FR - France

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense Cedex

France

DIDRONEL 200 mg, comprimé

200 mg

tablet

Oral use

FR - France

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense Cedex

France

DIDRONEL 400 mg, comprimé

400 mg

tablet

Oral use

FR - France

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense Cedex

France

DIPOROS 400 mg, comprimé

400 mg

tablet

Oral use

FR - France

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense Cedex

France

ETIDRONATE DISODIQUE PROCTER & GAMBLE PHARMACEUTICALS 200 mg, comprimé

200 mg

tablet

Oral use

FR - France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

FRANCE

ETIDRONATE MYLAN 200 mg, comprimé

200 mg

tablet

Oral use

FR - France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

FRANCE

ETIDRONATE MYLAN 400 mg, comprimé

400 mg

tablet

Oral use

FR - France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

ETIDRONATE SANDOZ 400 mg, comprimé

400 mg

tablet

Oral use

IT - Italy

ABIOGEN PHARMA SpA

Via Meucci, 36 - 56014

Ospedaletto (PI)

ETIDRON

300 mg

Capsule

Oral use

NL - Netherlands

Procter & Gamble Pharmaceuticals Nederland B.V. Postbus 2507 3000 CM Rotterdam Netherlands

Didronel 400

400 mg

Tablet

Oral use

NL - Netherlands

Warner Chilcott Nederland B.V.

Lichtenauerlaan 102-120

3062 ME Rotterdam Netherlands

Didrokit, combinatieverpakking

400 mg + 1 250 mg

Tablet + Effervescent tablets

Oral use

NO - Norway

Warner Chilcott UK Ltd.; Old Belfast Rd, Larne BT40 2SH, UK

Didronate + Calsium Kombinasjonspakning

400 mg/500 mg

tablet

Oral use

SE - Sweden

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom

Didronate

200 mg

tablet

Oral use

SE - Sweden

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom

Didronate 400 mg + Calcium 500 mg

Didronate 400 mg + Calcium 500 mg

tablet

Oral use

UK - United Kingdom

Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL

ETIDRONATE DISODIUM

200 mg

Tablets

Oral use

UK - United Kingdom

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK

DIDRONEL

200 mg

Tablets

Oral use

UK - United Kingdom

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK

DIDRONEL PMO

400 mg

Tablets

Oral use

UK - United Kingdom

Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St. Neots, Cambridgeshire, PE19 8ET, UK

TILOETCA COMBI

400 mg

Tablets

Oral use

UK - United Kingdom

Arrow Generics Limited, Unit 2 Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United Kingdom

DISODIUM ETIDRONATE

200 mg

Tablets

Oral use

UK - United Kingdom

Arrow Generics Limited, Unit 2 Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United Kingdom

DISODIUM ETIDRONATE

400 mg

Tablets

Oral use


Neridronic acid 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

IT - Italy

ABIOGEN PHARMA SpA

Via Meucci, 36 - 56014

Ospedaletto (PI)

NERIXIA

25 mg

Solution for injection

Intramuscular, Intravenous

IT - Italy

ABIOGEN PHARMA SpA

Via Meucci, 36 - 56014

Ospedaletto (PI)

NERIXIA

100 mg

Concentrate for solution for infusion

Intravenous


Pamidronic acid 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

Novartis Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria

Aredia 15 mg - Trockensubstanz zur Infusionsbereitung mit Lösungsmittel

15 mg/5 ml (Pamidronate Disodium)

Powder and solvent for solution for infusion

Intravenous

AT - Austria

Novartis Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria

Aredia 30 mg - Trockensubstanz zur Infusionsbereitung mit Lösungsmittel

30 mg/10 ml (Pamidronate Disodium)

Powder and solvent for solution for infusion

Intravenous

AT - Austria

Novartis Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria

Aredia 90 mg - Trockensubstanz zur Infusionsbereitung mit Lösungmittel

90 mg/10 ml (Pamidronate Disodium)

Powder and solvent for solution for infusion

Intravenous

AT - Austria

Medac

Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstraße 3

D-20354 Hamburg, Germany

Ebedronat 3 mg/ml Konzentrat zur Herstellung einer Infusionslösung

3 mg/ml (Pamidronate Disodium)

concentrate for solution for infusion

Intravenous

AT - Austria

Hospira Deutschland GmbH

Rablstraße 24

81669 München, Germany

Pamidronat Dinatrium Hospira 3 mg/ml, Konzentrat zur Herstellung einer Infusionslösung

3 mg/ml (Pamidronate Disodium)

concentrate for solution for infusion

Intravenous

AT - Austria

Hospira Deutschland GmbH

Rablstraße 24

81669 München, Germany

Pamidronat Dinatrium Hospira 6 mg/ml, Konzentrat zur Herstellung einer Infusionslösung

6 mg/ml (Pamidronate Disodium)

concentrate for solution for infusion

Intravenous

AT - Austria

Hospira Deutschland GmbH

Rablstraße 24

81669 München, Germany

Pamidronat Dinatrium Hospira 9 mg/ml, Konzentrat zur Herstellung einer Infusionslösung

9 mg/ml (Pamidronate Disodium)

concentrate for solution for infusion

Intravenous

AT - Austria

Stada Arzneimittel GmbH, Muthgasse 36, A-1190 Wien, Austria

Pamidronat STADA 3 mg/ml Konzentrat zur Herstellung einer Infusionslösung

3 mg/ml (Pamidronate Disodium)

concentrate for solution for infusion

Intravenous

AT - Austria

Torrex Chiesi Pharma GmbH

Gonzagagasse 16/16, A- 1010 Wien, Austria

Pamitor 15 mg/ml - Konzentrat zur Herstellung einer Infusionslösung

15 mg/ml (Pamidronate Disodium)

concentrate for solution for infusion

Intravenous

BE - Belgium

Novartis Pharma N.V.

Medialaan 40

1800 Vilvoorde

Belgium

Aredia

15 mg/5 ml

Powder for Solution for infusion

Intravenous

BE - Belgium

Novartis Pharma N.V.

Medialaan 40

1800 Vilvoorde

Belgium

Aredia

90 mg/10 ml

Powder for Solution for infusion

Intravenous

BE - Belgium

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Pamidrin

3 mg/ml

Concentrate for solution for infusion

Intravenous

BE - Belgium

Actavis Group PTC EHF

Reykjavikuregur 76-78

220 Hafnarfjordur

Iceland

Pamidronaat Actavis

3 mg/ml

Concentrate for solution for infusion

Intravenous

BE - Belgium

Actavis Group PTC EHF

Reykjavikuregur 76-78

220 Hafnarfjordur

Iceland

Pamidronaat Actavis

6 mg/ml

Concentrate for solution for infusion

Intravenous

BE - Belgium

Actavis Group PTC EHF

Reykjavikuregur 76-78

220 Hafnarfjordur

Iceland

Pamidronaat Actavis

9 mg/ml

Concentrate for solution for infusion

Intravenous

BE - Belgium

Hospira Benelux BVBA

Stallestraat 63

1180 Brussels

Belgium

Pamidronaatdinatrium Hospira

3 mg/ml

Concentrate for solution for infusion

Intravenous

BE - Belgium

Hospira Benelux BVBA

Stallestraat 63

1180 Brussels

Belgium

Pamidronaatdinatrium Hospira

6 mg/ml

Concentrate for solution for infusion

Intravenous

BE - Belgium

Hospira Benelux BVBA

Stallestraat 63

1180 Brussels

Belgium

Pamidronaatdinatrium Hospira

9 mg/ml

Concentrate for solution for infusion

Intravenous

BE - Belgium

Eurogenerics N.V.

Heizel Esplanade b22

1020 Brussels

Belgium

Pamidronate EG

3 mg/ml

Concentrate for solution for infusion

Intravenous

BE - Belgium

Mylan BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

Pamidronate Mylan

15 mg/ml

Concentrate for solution for infusion

Intravenous

BG - Bulgaria

Tchaikapharma High Quality Medicines, 1, G.M. Dimitorv Blvd, 1172 Sofia, Bulgaria

Pamitor

15 mg/ml

Concentrate for solution for infusion

Intravenous

BG - Bulgaria

Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nuernberg, Germany

Aredia

30 mg

powder and solvent for solution for infusion

Intravenous

BG - Bulgaria

Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220, Hafnarfjordur

Clastodron

3 mg/ml,

concentrate for solution for infusion, 5 ml

Intravenous

BG - Bulgaria

Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220, Hafnarfjordur

Clastodron

6 mg/ml

concentrate for solution for infusion - 10 ml

Intravenous

BG - Bulgaria

Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220, Hafnarfjordur

Clastodron

9 mg/ml

concentrate for solution for infusion - 10 ml

Intravenous

CY - Cyprus

PHARMACEUTICAL TRADING CO LTD, 18 THOUKIDIDOU STR, P O BOX 40628, 6306 LARNACA, CYPRUS

PAMIDRONATE DISODIUM CONCENTRATE FOR SOLUTION FOR INFUSION 9 mg/ml

9 mg/ml, 10 ml

SOLUTION FOR INFUSION

Intravenous

CZ - Czech Republic

Novartis s.r.o., U nákladového nádraží 3265/10, 130 00 Praha-Strašnice

(Nagano III.), Czech Republic

Aredia 15 mg

1,5 mg/ml

Powder and solvent for solution for infusion

Infusion

CZ - Czech Republic

Novartis s.r.o., U nákladového nádraží 3265/10, 130 00 Praha-Strašnice

(Nagano III.), Czech Republic

Aredia 30 mg

3 mg/ml

Powder and solvent for solution for infusion

Infusion

CZ - Czech Republic

Medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstraße 3, D-20354 Hamburg, Germany

Pamidronate Medac 3 mg/ml

3 mg/ml

Concentrate for solution for infusion

Infusion

CZ - Czech Republic

Teva Pharmaceuticals CR, s.r.o., Radlická 3185/1c

150 00 Praha 5

Cezch Republic

Pamidronate-Teva 3 mg/ml

3 mg/ml

Concentrate for solution for infusion

Infusion

CZ - Czech Republic

Torrex Chiesi CZ, s.r.o., Na květnici 878/33, 140 00 Praha-Nusle, Czech Republic

Pamitor 15 mg/ml

15 mg/ml

Concentrate for solution for infusion

Infusion

DE - Germany

axios Pharma GmbH

Hauptstr. 198

D-33647 Bielefeld

axidronat 3 mg/ml Konzentrat zur Herstellung einer Infusionslösung

3 mg

Concentrate for solution for infusion

Intravenous

DE - Germany

Cancernova GmbH onkologische Arzneimittel

Lil-Dagover-Ring 7

D-82031 Grünwald

NOVAPAM 15 mg Pulver zur Herstellung einer Infusionslösung

15 mg

Powder for solution for infusion

Intravenous

DE - Germany

Cancernova GmbH onkologische Arzneimittel

Lil-Dagover-Ring 7

D-82031 Grünwald

NOVAPAM 30 mg Pulver zur Herstellung einer Infusionslösung

30 mg

Powder for solution for infusion

Intravenous

DE - Germany

Cancernova GmbH onkologische Arzneimittel

Lil-Dagover-Ring 7

D-82031 Grünwald

NOVAPAM 60 mg Pulver zur Herstellung einer Infusionslösung

60 mg

Powder for solution for infusion

Intravenous

DE - Germany

Cancernova GmbH onkologische Arzneimittel

Lil-Dagover-Ring 7

D-82031 Grünwald

NOVAPAM 60 mg Pulver zur Herstellung einer Infusionslösung

60 mg

Powder for solution for infusion

Intravenous

DE - Germany

cell Pharm GmbH

Theodor-Heuss-Str. 52

D-61118 Bad Vilbel

PAMIDRO-cell 3 mg/ml Konzentrat zur Herstellung einer Infsionslösung

3 mg

Concentrate for solution for infusion

Intravenous

DE - Germany

TEVA Deutschland GmbH

Wasastr. 50

D-01445 Radebeul

Pamidronat-GRY 3 mg/ml Konzentrat zur Herstellung einer Infsionslösung

3 mg

Concentrate for solution for infusion

Intravenous

DE - Germany

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Pamidron HEXAL 15 mg/ml Konzentrat zur Herstellung einer Infsionslösung

15 mg

Concentrate for solution for infusion

Intravenous

DE - Germany

HIKMA Farmaceutica (Portugal) S.A.

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

P-2705-906 TERRUGem SNT

Ribodronat 3 mg/ ml Konzentrat zur Herstellung einer Infsionslösung

3 mg

Concentrate for solution for infusion

Intravenous

DE - Germany

Hospira Deutschland GmbH

Rablstr. 24

D-81669 München

Pamidronat Hospira 3 mg/ml Konzentrat zur Herstellung einer Infsionslösung

3 mg

Concentrate for solution for infusion

Intravenous

DE - Germany

Hospira Deutschland GmbH

Rablstr. 24

D-81669 München

Pamidronat Hospira 6 mg/ml Konzentrat zur Herstellung einer Infsionslösung

6 mg

Concentrate for solution for infusion

Intravenous

DE - Germany

Hospira Deutschland GmbH

Rablstr. 24

D-81669 München

Pamidronat Hospira 9 mg/ml Konzentrat zur Herstellung einer Infsionslösung

9 mg

Concentrate for solution for infusion

Intravenous

DE - Germany

medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstr. 3

D-20354 Hamburg

Pamifos 3 mg/ml Konzentrat zur Herstellung eriner Infusionslösung

3 mg

Concentrate for solution for infusion

Intravenous

DE - Germany

Novartis Pharma GmbH

Roonstr. 25

D-90429 Nürnberg

Aredia 15 mg

15 mg

Dry substanced and solvent

Intravenous

DE - Germany

Novartis Pharma GmbH

Roonstr. 25

D-90429 Nürnberg

Aredia 30 mg

30 mg

Dry substanced and solvent

Intravenous

DE - Germany

Novartis Pharma GmbH

Roonstr. 25

D-90429 Nürnberg

Aredia 90 mg

90 mg

Dry substanced and solvent

Intravenous

DE - Germany

Novartis Pharma GmbH

Roonstr. 25

D-90429 Nürnberg

Aredia 60 mg

60 mg

Dry substanced and solvent

Intravenous

DE - Germany

Onkovis GmbH

Grube 45

D-82377 Penzberg

Pamidronat Onkovis 3 mg/ml Konzentrat zur Herstellung einer Infusionslösung

3 mg

Concentrate for solution for infusion

Intravenous

DK - Denmark

Helm AG, Nordkanalstrasse 28D, DE-20097 Hamburg, Germany

Epsilonat

15 mg/ml

Concentrat for infusion, solution

Intravenous

DK - Denmark

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany

Pamidrocell

3 mg/ml

Concentrat for infusion, solution

Intravenous

DK - Denmark

Hexal AG, Industriestrasse 25, DE-83607 Holzkirchen, Germany

Pamidronat "Hexal"

15 mg/ml

Concentrat for infusion, solution

Intravenous

DK - Denmark

Meda AS, Solvang 8, DK-3450 Allerød, Denmark

Pamidronat "Meda"

15 mg/ml

Concentrat for infusion, solution

Intravenous

DK - Denmark

BMM Pharma AB, Blasieholmsgatan 2, SE-11148 Stockholm, Sweden

Pamidronatdinatrium "BMM Pharma"

3 mg/ml

Concentrat for infusion, solution

Intravenous

DK - Denmark

BMM Pharma AB, Blasieholmsgatan 2, SE-11148 Stockholm, Sweden

Pamidronatdinatrium "BMM Pharma"

6 mg/ml

Concentrat for infusion, solution

Intravenous

DK - Denmark

BMM Pharma AB, Blasieholmsgatan 2, SE-11148 Stockholm, Sweden

Pamidronatdinatrium "BMM Pharma"

9 mg/ml

Concentrat for infusion, solution

Intravenous

DK - Denmark

Hospira UK Limited, Queensway, Royal Leamington Spa, GB-CV31 3RW Warwickshire, England

Pamidronatdinatrium "Hospira"

3 mg/ml

Concentrat for infusion, solution

Intravenous

DK - Denmark

Hospira UK Limited, Queensway, Royal Leamington Spa, GB-CV31 3RW Warwickshire, England

Pamidronatdinatrium "Hospira"

6 mg/ml

Concentrat for infusion, solution

Intravenous

DK - Denmark

Hospira UK Limited, Queensway, Royal Leamington Spa, GB-CV31 3RW Warwickshire, England

Pamidronatdinatrium "Hospira"

9 mg/ml

Concentrat for infusion, solution

Intravenous

DK - Denmark

Teva Denmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark

Pamidronatdinatrium "Teva"

3 mg/ml

Concentrat for infusion, solution

Intravenous

DK - Denmark

medac, Gesellschaft fur klinisch, Spezialpraeparate mbH, Fehlandstrasse 3, DE-20354 Hamburg, Germany

Pamifos

3 mg/ml

Concentrat for infusion, solution

Intravenous

EL - Greece

HOSPIRA UK LIMITED, U.K.

Queensway, Royal Leamington Spa

Warwickshire

CV31 3RW

United Kingdom

PAMIDRONATE DISODIUM / HOSPIRA

6 MG/1 ML

CONCENTRATE FOR SOLUTION FOR INFUSION

Intravenous

EL - Greece

MEDICUS S.A.

VALAORITOU 10

METAMORFOSI ATTIKIS 14452

PAMIDRONE

60 MG/VIAL

POWDER AND SOLUTION FOR INFUSION

Intravenous

EL - Greece

MEDICUS S.A.

VALAORITOU 10

METAMORFOSI ATTIKIS 14453

PAMIDRONE

90 MG/VIAL

POWDER AND SOLUTION FOR INFUSION

Intravenous

EL - Greece

HOSPIRA UK LIMITED, U.K.

Queensway, Royal Leamington Spa

Warwickshire

CV31 3RW

United Kingdom

PAMIDRONATE DISODIUM / HOSPIRA

3 MG/1 ML

CONCENTRATE FOR SOLUTION FOR INFUSION

Intravenous

EL - Greece

HOSPIRA UK LIMITED, U.K.

Queensway, Royal Leamington Spa

Warwickshire

CV31 3RW

United Kingdom

PAMIDRONATE DISODIUM / HOSPIRA

6 MG/1 ML

CONCENTRATE FOR SOLUTION FOR INFUSION

Intravenous

EL - Greece

HOSPIRA UK LIMITED, U.K.

Queensway, Royal Leamington Spa

Warwickshire

CV31 3RW

United Kingdom

PAMIDRONATE DISODIUM / HOSPIRA

9 MG/1 ML

CONCENTRATE FOR SOLUTION FOR INFUSION

Intravenous

EL - Greece

ALAPIS ABEE

AUTOKRATOROS NIKOLAOU 2

ATHENS 17671

PAMERIT

15 MG/1 ML

CONCENTRATE FOR SOLUTION FOR INFUSION

Intravenous

ES - Spain

HOSPIRA UK LIMITED Queensway. Royal Leadmington Spa Warwickshire CV31 3RW Reino Unido

PAMIDRONATO HOSPIRA 3 mg/ml concentrado para solución para perfusión

3 mg/ml

Concentrate for solution for infusion

Intravenous

ES - Spain

HOSPIRA UK LIMITED Queensway. Royal Leadmington Spa Warwickshire CV31 3RW Reino Unido

PAMIDRONATO HOSPIRA 6 mg/ml concentrado para solución para perfusión

6 mg/ml

Concentrate for solution for infusion

Intravenous

ES - Spain

HOSPIRA UK LIMITED Queensway. Royal Leadmington Spa Warwickshire CV31 3RW Reino Unido

PAMIDRONATO HOSPIRA 9 mg/ml concentrado para solución para perfusión

9 mg/ml

Concentrate for solution for infusion

Intravenous

ES - Spain

NOVARTIS FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 08013 Barcelona

AREDIA 15 mg polvo y disolvente para solución para perfusión

15 mg polvo

solution for infusion

Intravenous

ES - Spain

NOVARTIS FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 08013 Barcelona

AREDIA 30 mg polvo y disolvente para solución para perfusión

30 mg

solution for infusion

Intravenous

ES - Spain

NOVARTIS FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 08013 Barcelona

AREDIA 90 mg polvo y disolvente para solución para perfusión

90 mg

solution for infusion

Intravenous

ES - Spain

GENERIS FARMACÉUTICA, S.A.MOIÁ, 1, 2o 08006 BARCELONA

PAMIDRONATO GENERIS 15 mg/ml concentrado para solución para perfusión

15 mg/ml

Concentrate for solution for infusion

Intravenous

ES - Spain

LABORATORIO STADA, S.L. Frederic Mompou, 5 08960 Sant Just Desvern

PAMIDRONATO STADA 3 mg/ml concentrado para solución para perfusión

3 mg /ml

Concentrate for solution for infusion

Intravenous

ES - Spain

MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH Fehlandtstrasse 3 Hamburgo D-20354

PAMIFOS 3 mg/ml concentrado para solución para perfusión

3 mg /ml

Concentrate for solution for infusion

Intravenous

ES - Spain

LABORATORIO STADA, S.L. Frederic Mompou, 5 08960 Sant Just Desvern

PAMIDRONATO TEVA 3 mg/ml, concentrado para solución para perfusión

3 mg /ml

Concentrate for solution for infusion

Intravenous

ES - Spain

COMBINO PHARM, S.L.Fructuos Gelabert, 6-8 08970 Sant Joan Despi

PAMIDRONATO DISODICO COMBINO PHARM 15 mg polvo para solución para perfusión

15 mg

solution for infusion

Intravenous

ES - Spain

COMBINO PHARM, S.L.Fructuos Gelabert, 6-8 08970 Sant Joan Despi

PAMIDRONATO DISODICO COMBINO PHARM 30 mg polvo para solución para perfusión

30 mg

solution for infusion

Intravenous

ES - Spain

COMBINO PHARM, S.L.Fructuos Gelabert, 6-8 08970 Sant Joan Despi

PAMIDRONATO DISODICO COMBINO PHARM 60 mg polvo para solución para perfusión

60 mg

solution for infusion

Intravenous

ES - Spain

COMBINO PHARM, S.L.Fructuos Gelabert, 6-8 08970 Sant Joan Despi

PAMIDRONATO DISODICO COMBINO PHARM 90 mg polvo para solución para perfusión

90 mg

solution for infusion

Intravenous

ET - Estonia

Novartis Finland OY Metsänneidonkuja 10

FIN-02130 Espoo FINLAND

AREDIA

15 mg

Powder and solvent for solution for infusion

Intravenous

ET - Estonia

Torrex Chiesi Pharma GmbH Gonzagagasse 16/16, 1010 Vienna AUSTRIA

PAMITOR 15 MG/ML

15 mg 1 ml

Concentrate for solution for infusion

Intravenous

FI - Finland

medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstrasse 3, 20354 Hamburg, Germany

Pamifos

3 mg/ml

Concentrate for solution for infusion

Intravenous

FI - Finland

Stada Arzneimittel AG, Stadastrasse 2 - 18, 61118 BAD VILBEL, Germany

Paminject

3 mg/ml

Concentrate for solution for infusion

Intravenous

FI - Finland

Meda Oy, Vaisalantie 4, 02130 Espoo, Finland

Pamidronat Meda

15 mg/ml

Concentrate for solution for infusion

Intravenous

FI - Finland

Hospira UK Limited, Queensway, Royal Leamington Spa, WARWICKSHIRE CV313RW, United Kingdom

Pamidronatdinatrium Hospira

3 mg/ml

Concentrate for solution for infusion

Intravenous

FI - Finland

Hospira UK Limited, Queensway, Royal Leamington Spa, WARWICKSHIRE CV313RW, United Kingdom

Pamidronatdinatrium Hospira

6 mg/ml

Concentrate for solution for infusion

Intravenous

FI - Finland

Hospira UK Limited, Queensway, Royal Leamington Spa, WARWICKSHIRE CV313RW, United Kingdom

Pamidronatdinatrium Hospira

9 mg/ml

Concentrate for solution for infusion

Intravenous

FI - Finland

BMM Pharma AB, Blasieholmsgatan 2, 11148 Stockholm, Sweden

Pamidronate BMM Pharma

3 mg/ml

Concentrate for solution for infusion

Intravenous

FI - Finland

BMM Pharma AB, Blasieholmsgatan 2, 11148 Stockholm, Sweden

Pamidronate BMM Pharma

6 mg/ml

Concentrate for solution for infusion

Intravenous

FI - Finland

BMM Pharma AB, Blasieholmsgatan 2, 11148 Stockholm, Sweden

Pamidronate BMM Pharma

9 mg/ml

Concentrate for solution for infusion

Intravenous

FR - France

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

AREDIA 15 mg/5 ml, poudre et solvant pour solution pour perfusion

15 mg/5 ml

powder and solvent

Intravenous

FR - France

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

AREDIA 60 mg/10 ml, poudre et solvant pour solution pour perfusion

60 mg/10 ml

powder and solvent

Intravenous

FR - France

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

AREDIA 90 mg/10 ml, poudre et solvant pour solution pour perfusion

90 mg/10 ml

powder and solvent

Intravenous

FR - France

NORDIC PHARMA

216, boulevard Saint Germain

75007 Paris

FRANCE

OSTEPAM 15 mg/ml, solution à diluer pour perfusion

15 mg/ml

solution

Intravenous

FR - France

AGUETTANT

1, rue Alexander Fleming

69007 Lyon

FRANCE

PAMIDRONATE DE SODIUM AGUETTANT 15 mg/5 ml, poudre et solvant pour solution pour perfusion

15 mg/5 ml

powder and solvent

Intravenous

FR - France

AGUETTANT

1, rue Alexander Fleming

69007 Lyon

FRANCE

PAMIDRONATE DE SODIUM AGUETTANT 60 mg/10 ml, poudre et solvant pour solution pour perfusion

60 mg/10 ml

powder and solvent

Intravenous

FR - France

AGUETTANT

1, rue Alexander Fleming

69007 Lyon

FRANCE

PAMIDRONATE DE SODIUM AGUETTANT 90 mg/10 ml, poudre et solvant pour solution pour perfusion

90 mg/10 ml

powder and solvent

Intravenous

FR - France

HOSPIRA FRANCE

17-19, rue Jeanne Braconnier

Immeuble Volta

92360 Meudon La Forêt

FRANCE

PAMIDRONATE DE SODIUM HOSPIRA 3 mg/ml, solution à diluer pour perfusion

3 mg/ml

solution

Intravenous

FR - France

HOSPIRA FRANCE

17-19, rue Jeanne Braconnier

Immeuble Volta

92360 Meudon La Forêt

FRANCE

PAMIDRONATE DE SODIUM HOSPIRA 6 mg/ml, solution à diluer pour perfusion

6 mg/ml,

solution

Intravenous

FR - France

HOSPIRA FRANCE

17-19, rue Jeanne Braconnier

Immeuble Volta

92360 Meudon La Forêt

FRANCE

PAMIDRONATE DE SODIUM HOSPIRA 9 mg/ml, solution à diluer pour perfusion

9 mg/ml

solution

Intravenous

FR - France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

FRANCE

PAMIDRONATE DE SODIUM MYLAN 3 mg/ml, solution à diluer pour perfusion

3 mg/ml

solution

Intravenous

FR - France

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

PAMIDRONATE DE SODIUM NOVARTIS PHARMA 15 mg/5 ml, poudre et solvant pour solution pour perfusion

15 mg/5 ml

powder and solvent

Intravenous

FR - France

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

PAMIDRONATE DE SODIUM NOVARTIS PHARMA 60 mg/10 ml, poudre et solvant pour solution pour perfusion

60 mg/10 ml

powder and solvent

Intravenous

FR - France

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

PAMIDRONATE DE SODIUM NOVARTIS PHARMA 90 mg/10 ml, poudre et solvant pour solution pour perfusion

90 mg/10 ml

powder and solvent

Intravenous

FR - France

RATIOPHARM (ALLEMAGNE)

Graf Arco Strasse 3

89079 Ulm

ALLEMAGNE

PAMIDRONATE DE SODIUM RATIOPHARM 3 mg/ml, solution à diluer pour perfusion

3 mg/ml

solution

Intravenous

FR - France

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

FRANCE

PAMIDRONATE DE SODIUM TEVA 3 mg/ml, solution à diluer pour perfusion

3 mg/ml

solution

Intravenous

FR - France

PHARMAKI GENERICS (ROYAUME-UNI)

5 Bourlet Close

W1W 7BL London

ROYAUME-UNI

PAMIDRONATE PHARMAKI GENERICS 3 mg/ml, solution à diluer pour perfusion

3 mg/ml

solution

Intravenous

FR - France

PHARMAKI GENERICS (ROYAUME-UNI)

5 Bourlet Close

W1W 7BL London

ROYAUME-UNI

PAMIDRONATE PHARMAKI GENERICS 6 mg/ml, solution à diluer pour perfusion

6 mg/ml

solution

Intravenous

FR - France

PHARMAKI GENERICS (ROYAUME-UNI)

5 Bourlet Close

W1W 7BL London

ROYAUME-UNI

PAMIDRONATE PHARMAKI GENERICS 9 mg/ml, solution à diluer pour perfusion

9 mg/ml

solution

Intravenous

FR - France

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

FRANCE

PAMINJECT 3 mg/ml, solution à diluer pour perfusion

3 mg/ml

solution

Intravenous

HU - Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47. Bartók-Ház, V. em.

1114 Budapest

Hungary

AREDIA 30 mg por és oldószer oldatos infúzióhoz

30,0 mg Disodium pamidronate, anhydrous [from Disodium pamidronate pentahydrate

powder and solvent for solution for infusion

Parenteral

HU - Hungary

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, UK

PAMIDRONATE HOSPIRA 3 mg/ml koncentrátum oldatos infúzióhoz, 5 ml

3 mg/ml Pamidronic acid (equal to pamidronate disodium)

concentrate for solution for infusion

Parenteral

HU - Hungary

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, UK

PAMIDRONATE HOSPIRA 3 mg/ml koncentrátum oldatos infúzióhoz, 10 ml

3 mg/ml Pamidronic acid (equal to pamidronate disodium)

concentrate for solution for infusion

Parenteral

HU - Hungary

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, UK

PAMIDRONATE HOSPIRA 6 mg/ml koncentrátum oldatos infúzióhoz

6 mg/ml Pamidronic acid (equal to pamidronate disodium)

concentrate for solution for infusion

Parenteral

HU - Hungary

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, UK

PAMIDRONATE HOSPIRA 9 mg/ml koncentrátum oldatos infúzióhoz

9 mg/ml Pamidronic acid (equal to pamidronate disodium)

concentrate for solution for infusion

Parenteral

HU - Hungary

Medac GmbH

Fehlandstrasse 3.

20354 Hamburg

Germany

PAMIFOS 3 mg/ml koncentrátum oldatos infúzióhoz

3 mg/ml Disodium pamidronate (equal to Pamidronic acid)

concentrate for solution for infusion

Parenteral

HU - Hungary

Torrex Chiesi Pharma GmbH

Gonzagagasse 16/16.

1010 Vienna

Austria

PAMITOR 15 mg/ml koncentrátum oldatos infúzióhoz

15 mg/ ml Disodium pamidronate (equal to 12,6 mg pamidronic acid)

concentrate for solution for infusion

Parenteral

IE - Ireland

Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

Aredia

30 mg

Powder and solvent for concentrate for solution for infusion

Slow intravenous infusion

IE - Ireland

Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

Aredia

90 mg

Powder and solvent for concentrate for solution for infusion

Slow intravenous infusion

IS - Iceland

Hospira UK Limited, Queensway Royale Leamington Spa, Warwickshire CV31 3RW United Kingdom

Pamidronatdinatrium Hospira 3 mg/ml

3 mg/ml

Concentrate for solution for infusion

Intravenous

IS - Iceland

Hospira UK Limited, Queensway Royale Leamington Spa, Warwickshire CV31 3RW United Kingdom

Pamidronatdinatrium Hospira 6 mg/ml

6 mg/ml

Concentrate for solution for infusion

Intravenous

IS - Iceland

Hospira UK Limited, Queensway Royale Leamington Spa, Warwickshire CV31 3RW United Kingdom

Pamidronatdinatrium Hospira 9 mg/ml

9 mg/ml

Concentrate for solution for infusion

Intravenous

IT - Italy

BIOINDUSTRIA L.I.M. SpA

Via de Ambrosiis, 2

15067 Novi Ligure (AL)

PAMIDRONATO BIOINDUSTRIA LIM

15 mg/5 ml

Powder and solvent for concentrate for solution for infusion

Intravenous

IT - Italy

BIOINDUSTRIA L.I.M. SpA

Via de Ambrosiis, 2

15067 Novi Ligure (AL)

PAMIDRONATO BIOINDUSTRIA LIM

30 mg/10 ml

Powder and solvent for concentrate for solution for infusion

Intravenous

IT - Italy

BIOINDUSTRIA L.I.M. SpA

Via de Ambrosiis, 2

15067 Novi Ligure (AL)

PAMIDRONATO BIOINDUSTRIA LIM

60 mg/10 ml

Powder and solvent for concentrate for solution for infusion

Intravenous

IT - Italy

BIOINDUSTRIA L.I.M. SpA

Via de Ambrosiis, 2

15067 Novi Ligure (AL)

PAMIDRONATO BIOINDUSTRIA LIM

90 mg/10 ml

Powder and solvent for concentrate for solution for infusion

Intravenous

IT - Italy

HIKMA ITALIA SpA

Viale Certosa, 10

27100 Pavia

PAMIDRONATO DISODICO HIKMA

15 mg/5 ml

Solution for infusion

Intravenous

IT - Italy

HIKMA ITALIA SpA

Viale Certosa, 10

27100 Pavia

PAMIDRONATO DISODICO HIKMA

30 mg/10 ml

Solution for infusion

Intravenous

IT - Italy

HIKMA ITALIA SpA

Viale Certosa, 10

27100 Pavia

PAMIDRONATO DISODICO HIKMA

60 mg/10 ml

Solution for infusion

Intravenous

IT - Italy

HIKMA ITALIA SpA

Viale Certosa, 10

27100 Pavia

PAMIDRONATO DISODICO HIKMA

90 mg/10 ml

Solution for infusion

Intravenous

IT - Italy

HOSPIRA ITALIA Srl

Via Orazio, 20/22

80122 Napoli

PAMIDRONATO DISODICO HIKMA Attenzione: E' Hospira

15 mg

Solution for injection

Intravenous

IT - Italy

HOSPIRA ITALIA Srl

Via Orazio, 20/22

80122 Napoli

PAMIDRONATO DISODICO HOSPIRA

3 mg/ml

concentrate for solution for infusion

Intravenous

IT - Italy

HOSPIRA ITALIA Srl

Via Orazio, 20/22

80122 Napoli

PAMIDRONATO DISODICO HOSPIRA

6 mg/ml

concentrate for solution for infusion

Intravenous

IT - Italy

HOSPIRA ITALIA Srl

Via Orazio, 20/22

80122 Napoli

PAMIDRONATO DISODICO HOSPIRA

9 mg/ml

concentrate for solution for infusion

Intravenous

IT - Italy

NOVARTIS FARMA SpA

Largo Umberto Boccioni, 2

21040 Origgio (VA)

AREDIA

15 mg/5 ml

Powder and solvent for solution for infusion

Intravenous

IT - Italy

NOVARTIS FARMA SpA

Largo Umberto Boccioni, 2

21040 Origgio (VA)

AREDIA

30 mg/10 ml

Powder and solvent for solution for infusion

Intravenous

IT - Italy

NOVARTIS FARMA SpA

Largo Umberto Boccioni, 2

21040 Origgio (VA)

AREDIA

60 mg/10 ml

Powder and solvent for solution for infusion

Intravenous

IT - Italy

NOVARTIS FARMA SpA

Largo Umberto Boccioni, 2

21040 Origgio (VA)

AREDIA

90 mg/10 ml

Powder and solvent for solution for infusion

Intravenous

IT - Italy

PHARMATEX ITALIA Srl

Via Appiani, 22

20121 Milano

TEXPAMI

15 mg/5 ml

Solution for infusion

Intravenous

IT - Italy

PHARMATEX ITALIA Srl

Via Appiani, 22

20121 Milano

TEXPAMI

30 mg/10 ml

Solution for infusion

Intravenous

IT - Italy

PHARMATEX ITALIA Srl

Via Appiani, 22

20121 Milano

TEXPAMI

60 mg/10 ml

Solution for infusion

Intravenous

IT - Italy

PHARMATEX ITALIA Srl

Via Appiani, 22

20121 Milano

TEXPAMI

90 mg/10 ml

Solution for infusion

Intravenous

IT - Italy

RATIOPHARM GMBH

Graf Arco-strasse, 3

Ulm D-89070

PAMIDRONATO RATIOPHARM

3 mg/ml

concentrate for solution for infusion

Intravenous

IT - Italy

TEVA ITALIA Srl

Via Messina, 38 - 20154

Milano

PAMIDRONATO TEVA

3 mg/ml

concentrate for solution for infusion

Intravenous

IT - Italy

CRINOS SpA

Via Pavia, 6

20136 Milano

AMIDROX

3 mg/ml

concentrate for solution for infusion

Intravenous

IT - Italy

Actavis Itlay S.p.A.

Via Luigi Pasteur, 10

20014 Nerviano (MI) Italy

PAMIDRONATO ACTAVIS

3 mg/ml

concentrate for solution for infusion

Intravenous

IT - Italy

Actavis Itlay S.p.A.

Via Luigi Pasteur, 10

20014 Nerviano (MI) Italy

PAMIDRONATO ACTAVIS

6 mg/ml

concentrate for solution for infusion

Intravenous

IT - Italy

Actavis Itlay S.p.A.

Via Luigi Pasteur, 10

20014 Nerviano (MI) Italy

PAMIDRONATO ACTAVIS

9 mg/ml

concentrate for solution for infusion

Intravenous

LT - Lithuania

Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria

Pamitor

60 mg/4 ml

Concentrate for solution for infusion

Intravenous

LT - Lithuania

Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria

Pamitor

90 mg/6 ml

Concentrate for solution for infusion

Intravenous

LT - Lithuania

Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria

Pamitor

30 mg/2 ml

Concentrate for solution for infusion

Intravenous

LT - Lithuania

Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria

Pamitor

15 mg/ml

Concentrate for solution for infusion

Intravenous

LT - Lithuania

Hospira UK Limited, Queensway Royal Leamington Spa Warwickshire CV 31 3RW, United Kingdom

Pamidronate disodium Hospira

9 mg/ ml

Concentrate for solution for infusion

Intravenous

LT - Lithuania

Hospira UK Limited, Queensway Royal Leamington Spa Warwickshire CV 31 3RW, United Kingdom

Pamidronate disodium Hospira

6 mg/ ml

Concentrate for solution for infusion

Intravenous

LT - Lithuania

Hospira UK Limited, Queensway Royal Leamington Spa Warwickshire CV 31 3RW, United Kingdom

Pamidronate disodium Hospira

3 mg/ml

Concentrate for solution for infusion

Intravenous

LU - Luxembourg

NOVARTIS PHARMA GMBH

25, ROONSTRASSE

D 90429 NUERNBERG

Aredia

15 mg

powder for infusion

Intravenous

LU - Luxembourg

EUROGENERICS S.A

ESPLANADE HEYSEL, B.22

B 1020 BRUXELLES

Paminject

3 mg/ml

solution for infusion

Intravenous

LU - Luxembourg

HOSPIRA BENELUX SPRL

63, RUE DE STALLE

B 1180 BRUXELLES

Pamidronate Disodique Hospira

3 mg/ml

solution for infusion

Intravenous

LU - Luxembourg

HOSPIRA BENELUX SPRL

63, RUE DE STALLE

B 1180 BRUXELLES

Pamidronate Disodique Hospira

6 mg/ml

solution for infusion

Intravenous

LU - Luxembourg

TEVA PHARMA BELGIUM S.A.

16, LAARSTRAAT

B 2610 WILRIJK

Pamidrin

3 mg/ml

solution for infusion

Intravenous

LV - Latvia

Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria

PAMITOR

15 mg/ml

Concentrate for solution for infusion

Intravenous

LV - Latvia

Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria

PAMITOR

30 mg/2 ml

Concentrate for solution for infusion

Intravenous

LV - Latvia

Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria

PAMITOR

60 mg/4 ml

Concentrate for solution for infusion

Intravenous

LV - Latvia

Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria

PAMITOR

90 mg/6 ml

Concentrate for solution for infusion

Intravenous

MT - Malta

Novartis Pharmaceuticals UK Limited

Frimley Business Park, Frimley,

Camberley, Surrey GU16 7SR

England

Aredia

15 mg

powder and solvent for solution for infusion

Intravenous

MT - Malta

Novartis Pharmaceuticals UK Limited

Frimley Business Park, Frimley,

Camberley, Surrey GU16 7SR

England

Aredia

30 mg

powder and solvent for solution for infusion

Intravenous

MT - Malta

Novartis Pharmaceuticals UK Limited

Frimley Business Park, Frimley,

Camberley, Surrey GU16 7SR

England

Aredia

60 mg

powder and solvent for solution for infusion

Intravenous

MT - Malta

Novartis Pharmaceuticals UK Limited

Frimley Business Park, Frimley,

Camberley, Surrey GU16 7SR

England

Aredia

90 mg

powder and solvent for solution for infusion

Intravenous

NL - Netherlands

Nordic Pharma B.V.

Tolweg 15

3741 LM Baarn Netherlands

Pamidronaat dinatrium 15 mg

15 mg

Powder for solution for infusion

Intravenous

NL - Netherlands

Nordic Pharma B.V.

Tolweg 15

3741 LM Baarn Netherlands

Pamidronaat dinatrium 30 mg

30 mg

Powder for solution for infusion

Intravenous

NL - Netherlands

Nordic Pharma B.V.

Tolweg 15

3741 LM Baarn Netherlands

Pamidronaat dinatrium 60 mg

60 mg

Powder for solution for infusion

Intravenous

NL - Netherlands

Nordic Pharma B.V.

Tolweg 15

3741 LM Baarn Netherlands

Pamidronaat dinatrium 90 mg

90 mg

Powder for solution for infusion

Intravenous

NL - Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem Netherlands

Pamidronaatdinatrium 3 mg/ml PCH

3 mg/ml

Concentrate for solution for infusion

Intravenous

NL - Netherlands

All-gen Pharmaceuticals & Generics B.V. Rouboslaan 32 2252 TR Voorschoten Netherlands

Pamidronaatdinatrium Allgen 3 mg/ml

3 mg/ml

Concentrate for solution for infusion

Intravenous

NL - Netherlands

All-gen Pharmaceuticals & Generics B.V. Rouboslaan 32 2252 TR Voorschoten Netherlands

Pamidronaatdinatrium Allgen 6 mg/ml

6 mg/ml

Concentrate for solution for infusion

Intravenous

NL - Netherlands

All-gen Pharmaceuticals & Generics B.V. Rouboslaan 32 2252 TR Voorschoten Netherlands

Pamidronaatdinatrium Allgen 9 mg/ml

9 mg/ml

Concentrate for solution for infusion

Intravenous

NL - Netherlands

Hospira Benelux BVBA, Stallestraat 63 1180 Brussel Belgium

Pamidronaatdinatrium Hospira 3 mg/ml

3 mg/ml

Concentrate for solution for infusion

Intravenous

NL - Netherlands

Hospira Benelux BVBA, Stallestraat 63 1180 Brussel Belgium

Pamidronaatdinatrium Hospira 6 mg/ml

6 mg/ml

Concentrate for solution for infusion

Intravenous

NL - Netherlands

Hospira Benelux BVBA, Stallestraat 63 1180 Brussel Belgium

Pamidronaatdinatrium Hospira 9 mg/ml

9 mg/ml

Concentrate for solution for infusion

Intravenous

NL - Netherlands

Medac Gesellschaft für klinische Spezialpreparate mbH Fehlandtstr. 3 20354 Hamburg Germany

Pamipro 3 mg/ml

3 mg/ml

Concentrate for solution for infusion

Intravenous

NO - Norway

Meda, postboks 194, 1371 Asker Norawy

Pamidronat Meda

15 mg/ml

Concentrate for solution for infusion

Intravenous

NO - Norway

Hospira UK Limited, Queensway, Royal Leamington Spa, CV31 3RW Warwickshire, Great Britain

Pamidronatdinatrium Hospira

3 mg/ml

Concentrate for solution for infusion

Intravenous

NO - Norway

Hospira UK Limited, Queensway, Royal Leamington Spa, CV31 3RW Warwickshire, Great Britain

Pamidronatdinatrium Hospira

6 mg/ml

Concentrate for solution for infusion

Intravenous

NO - Norway

Hospira UK Limited, Queensway, Royal Leamington Spa, CV31 3RW Warwickshire, Great Britain

Pamidronatdinatrium Hospira

9 mg/ml

Concentrate for solution for infusion

Intravenous

PL - Poland

Hospira UK Limited

Queensway,

CV31 3RW, Royal Leamington Spa, Warwickshire, United Kingdom

Pamisol 3 mg/ml

3 mg/ml

concentrate for solution for infusion

Intravenous

PL - Poland

Hospira UK Limited

Queensway,

CV31 3RW, Royal Leamington Spa, Warwickshire, United Kingdom

Pamisol 6 mg/ml

6 mg/ml

concentrate for solution for infusion

Intravenous

PL - Poland

Farmacom Sp. z o.o.

Mogilska 80 st.

31-546, Cracow, Poland

Pamidia

3 mg

concentrate for solution for infusion

Intravenous

PL - Poland

Farmacom Sp. z o.o.

Mogilska 80 st.

31-546, Cracow, Poland

Pamidia

6 mg

concentrate for solution for infusion

Intravenous

PL - Poland

Farmacom Sp. z o.o.

Mogilska 80 st.

31-546, Cracow, Poland

Pamidia

9 mg

concentrate for solution for infusion

Intravenous

PL - Poland

medac Gesellschaft fur klinische Specialpraparate mbH

Theaterstrasse 6

22880 Wedel / Germany

Pamidronat medac 3 mg / ml

3 mg/ml

concentrate for solution for infusion

Intravenous

PL - Poland

ratiopharm GmbH

Graf-Arco-Strasse 3, Ulm, 89073, Germany

Pamidronat-ratiopharm

3 mg/ml

concentrate for solution for infusion

Intravenous

PL - Poland

VIPHARM S.A.

Przewoźników st. 11

03-691 Warsaw, Poland

Pamifos-15

15 mg

powder and solvent for solution for infusion

Intravenous

PL - Poland

VIPHARM S.A.

Przewoźników st. 11

03-691 Warsaw, Poland

Pamifos-30

30 mg

powder and solvent for solution for infusion

Intravenous

PL - Poland

VIPHARM S.A.

Przewoźników st. 11

03-691 Warsaw, Poland

Pamifos-60

60 mg

powder and solvent for solution for infusion

Intravenous

PL - Poland

VIPHARM S.A.

Przewoźników st. 11

03-691 Warsaw, Poland

Pamifos-90

90 mg

powder and solvent for solution for infusion

Intravenous

PL - Poland

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel, Germany

Pamistad

3 mg/ml

concentrate for solution for infusion

Intravenous

PL - Poland

Torrex Chiesi Pharma GmbH

Gonzagagasse 16/16,

A-1010 Vienna, Austria

Pamitor

15 mg/ml

concentrate for solution for infusion

Intravenous

PL - Poland

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg, Germany

Aredia

60 mg

powder and solvent for solution for infusion

Intravenous

PL - Poland

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg, Germany

Aredia

90 mg

powder and solvent for solution for infusion

Intravenous

PT - Portugal

Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal

Pamidran

3 mg/ml

Concentrate for solution for infusion

Intravenous

PT - Portugal

Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal

Pamidran

6 mg/ml

Concentrate for solution for infusion

Intravenous

PT - Portugal

Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal

Pamidran

9 mg/ml

Concentrate for solution for infusion

Intravenous

PT - Portugal

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal

Pamidronato APS

15 mg/ml

Concentrate for solution for infusion

Intravenous

PT - Portugal

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal

Pamidronato Azevedos 15 mg Pó para perfusão

15 mg

Powder for solution for infusion

Intravenous

PT - Portugal

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal

Pamidronato Azevedos 30 mg Pó para perfusão

30 mg

Powder for solution for infusion

Intravenous

PT - Portugal

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal

Pamidronato Azevedos 90 mg Pó para perfusão

90 mg

Powder for solution for infusion

Intravenous

PT - Portugal

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal

Pamidronato Azevedos 60 mg Pó para perfusão

60 mg

Powder for solution for infusion

Intravenous

PT - Portugal

Teva Pharma - Produtos Farmacêuticos, Lda. Edifício Cyprium, Av. 25 de Abril, 15, 2o F, 2795-195 Linda-a-Velha Portugal

Pamidronato Teva

3 mg/ml

Concentrate for solution for infusion

Intravenous

PT - Portugal

Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó, 8 - 8 A/B - Fervença, 2705-906 Terrugem (SNT) Portugal

Pamidronato Hikma

3 mg/ml

Concentrate for solution for infusion

Intravenous

PT - Portugal

Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó, 8 - 8 A/B - Fervença, 2705-906 Terrugem (SNT) Portugal

Pamidronato Hikma

6 mg/ml

Concentrate for solution for infusion

Intravenous

PT - Portugal

Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó, 8 - 8 A/B - Fervença, 2705-906 Terrugem (SNT) Portugal

Pamidronato Hikma

9 mg/ml

Concentrate for solution for infusion

Intravenous

PT - Portugal

Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal

Pamidran

3 mg/ml

Concentrate for solution for infusion

Intravenous

PT - Portugal

Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal

Pamidran

6 mg/ml

Concentrate for solution for infusion

Intravenous

PT - Portugal

Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal

Pamidran

9 mg/ml

Concentrate for solution for infusion

Intravenous

PT - Portugal

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal

Pamidronato APS

15 mg/ml

Concentrate for solution for infusion

Intravenous

PT - Portugal

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal

Pamidronato Azevedos 15 mg Pó para perfusão

15 mg

Powder for solution for infusion

Intravenous

PT - Portugal

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal

Pamidronato Azevedos 30 mg Pó para perfusão

30 mg

Powder for solution for infusion

Intravenous

PT - Portugal

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal

Pamidronato Azevedos 90 mg Pó para perfusão

90 mg

Powder for solution for infusion

Intravenous

PT - Portugal

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal

Pamidronato Azevedos 60 mg Pó para perfusão

60 mg

Powder for solution for infusion

Intravenous

PT - Portugal

Teva Pharma - Produtos Farmacêuticos, Lda. Edifício Cyprium, Av. 25 de Abril, 15, 2o F, 2795-195 Linda-a-Velha Portugal

Pamidronato Teva

3 mg/ml

Concentrate for solution for infusion

Intravenous

PT - Portugal

Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó, 8 - 8 A/B - Fervença, 2705-906 Terrugem (SNT) Portugal

Pamidronato Hikma

3 mg/ml

Concentrate for solution for infusion

Intravenous

PT - Portugal

Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó, 8 - 8 A/B - Fervença, 2705-906 Terrugem (SNT) Portugal

Pamidronato Hikma

6 mg/ml

Concentrate for solution for infusion

Intravenous

PT - Portugal

Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó, 8 - 8 A/B - Fervença, 2705-906 Terrugem (SNT) Portugal

Pamidronato Hikma

9 mg/ml

Concentrate for solution for infusion

Intravenous

RO - Romania

NOVARTIS PHARMA GmbH Roonstrasse 25 D-90429 Nürnberg, Germany

AREDIA 15 mg/ml powder and solvent for solution for infusion

15 mg/ml

powder and solvent for solution for infusion

Parenteral

RO - Romania

TORREX CHIESI PHARMA GmbH Gonzagagasse 16/16, A-1010, Viena, Austria

PAMIDRONAT TORREX 15 mg/ml powder for solution for infusion

15 mg/ml

powder for solution for infusion

Parenteral

RO - Romania

DR. REDDY'S LABORATORIES Str. Av. Petre Crețu, nr. 74, Sector 1, București, Romania

PAMIRED 60 powder for solution for infusion

60 mg

powder for solution for infusion

Parenteral

RO - Romania

DR. REDDY'S LABORATORIES Str. Av. Petre Crețu, nr. 74, Sector 1, București, Romania

PAMIRED 30 powder for solution for infusion

30 mg

powder for solution for infusion

Parenteral

SE - Sweden

Hospira UK Limited Queensway Royal Leamington Spa Warwickshire, CV31 3RW United Kingdom

Pamidronatdinatrium Hospira

3 mg/ml

concentrate for solution for infusion

For infusion

SE - Sweden

Hospira UK Limited Queensway Royal Leamington Spa Warwickshire, CV31 3RW United Kingdom

Pamidronatdinatrium Hospira

6 mg/ml

concentrate for solution for infusion

For infusion

SE - Sweden

Hospira UK Limited Queensway Royal Leamington Spa Warwickshire, CV31 3RW United Kingdom

Pamidronatdinatrium Hospira

9 mg/ml

concentrate for solution for infusion

For infusion

SE - Sweden

Meda AB 170 09 Solna Sweden

Pamidronat Meda

15 mg/ml

concentrate for solution for infusion

For infusion

SE - Sweden

Teva Sweden AB Box 1070 251 10 Helsingborg Sweden

Pamidronat Teva

3 mg/ml

concentrate for solution for infusion

For infusion

SE - Sweden

STADA Arzneimittel AG Stadastrasse 2-18 DE-61118 Bad Vilbel Germany

Pamidrocell

3 mg/ml

concentrate for solution for infusion

For infusion

SE - Sweden

BMM Pharma AB Blasieholmsgatan 2 111 48 Stockholm Sweden

Pamidronate BMM Pharma

3 mg/ml

concentrate for solution for infusion

For infusion

SE - Sweden

BMM Pharma AB Blasieholmsgatan 2 111 48 Stockholm Sweden

Pamidronate BMM Pharma

6 mg/ml

concentrate for solution for infusion

For infusion

SE - Sweden

BMM Pharma AB Blasieholmsgatan 2 111 48 Stockholm Sweden

Pamidronate BMM Pharma

9 mg/ml

concentrate for solution for infusion

For infusion

SI - Slovenia

Novartis Pharma GmbH, Roonstrasse 25, Nuernberg D-90429, Germany

Aredia 15 mg prašek in vehikel za koncentrat za raztopino za infundiranje

15 mg

powder and solvent for solution for injection

Intravenous

SI - Slovenia

Novartis Pharma GmbH, Roonstrasse 25, Nuernberg D-90429, Germany

Aredia 30 mg prašek in vehikel za koncentrat za raztopino za infundiranje

30 mg

powder and solvent for solution for injection

Intravenous

SI - Slovenia

Torrex Chiesi Slovenija d.o.o., Trdinova 4, SI-1000 Ljubljana, Slovenia

Pamitor 30 mg koncentrat za raztopino za infundiranje

12,6 mg/ ml

powder and solvent for solution for injection

Intravenous

SI - Slovenia

Torrex Chiesi Slovenija d.o.o., Trdinova 4, SI-1000 Ljubljana, Slovenia

Pamitor 60 mg koncentrat za raztopino za infundiranje

12,6 mg/ ml

powder and solvent for solution for injection

Intravenous

SI - Slovenia

Torrex Chiesi Slovenija d.o.o., Trdinova 4, SI-1000 Ljubljana, Slovenia

Pamitor 90 mg koncentrat za raztopino za infundiranje

12,6 mg/ ml

powder and solvent for solution for injection

Intravenous

SK - Slovakia

Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria

Pamitor 15 mg/ml

15 mg/ml

concentrate for solution for infusion

Intravenous

SK - Slovakia

medac GmbH Theaterstraße 6

D-22880 Wedel Germany

PAMIFOS

3 mg/ml

Concentrate for infusion

Intravenous

UK - United Kingdom

Novartis Pharmaceuticals UK Limited, Frimly Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

AREDIA DRY POWDER

15 mg

Powder for Injection

Intravenous

UK - United Kingdom

Novartis Pharmaceuticals UK Limited, Frimly Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

AREDIA DRY POWDER

30 mg

Powder for Injection

Intravenous

UK - United Kingdom

Novartis Pharmaceuticals UK Limited, Frimly Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

AREDIA DRY POWDER

90 mg

Powder for Injection

Intravenous

UK - United Kingdom

Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland

PAMIDRONATE DISODIUM

3 MG/ML

CONCENTRATE FOR SOLUTION FOR INFUSION

Intravenous

UK - United Kingdom

Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland

PAMIDRONATE DISODIUM

6 MG/ML

CONCENTRATE FOR SOLUTION FOR INFUSION

Intravenous

UK - United Kingdom

Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland

PAMIDRONATE DISODIUM

9 MG/ML

CONCENTRATE FOR SOLUTION FOR INFUSION

Intravenous

UK - United Kingdom

Apsala Limited, bayview House, 49 Northstrand Road, Dublin 3, Ireland

DISODIUM PAMIDRONATE

3 MG/ML

CONCENTRATE FOR SOLUTION FOR INFUSION

Intravenous

UK - United Kingdom

Apsala Limited, bayview House, 49 Northstrand Road, Dublin 3, Ireland

DISODIUM PAMIDRONATE

6 MG/ML

CONCENTRATE FOR SOLUTION FOR INFUSION

Intravenous

UK - United Kingdom

Apsala Limited, bayview House, 49 Northstrand Road, Dublin 3, Ireland

DISODIUM PAMIDRONATE

9 MG/ML

CONCENTRATE FOR SOLUTION FOR INFUSION

Intravenous


Risedronic acid 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

sanofi-aventis GmbH ÖSTERREICH

SATURN Tower, Leonard-Bernstein-Straße 10

A-1220 Wien, Austria

Actonel Combi Filmtabletten

35 mg (risedronate sodium) + 500 mg/400 UI

film-coated tablets

Oral use

AT - Austria

sanofi-aventis GmbH

SATURN Tower, Leonard-Bernstein-Straße 10

A-1220 Wien, Austria

Actonel einmal wöchentlich 35 mg Filmtabletten

35 mg (risedronate sodium)

film-coated tablets

Oral use

AT - Austria

sanofi-aventis GmbH

SATURN Tower, Leonard-Bernstein-Straße 10

A-1220 Wien, Austria

Actonel 30 mg Filmtabletten

30 mg (risedronate sodium)

film-coated tablets

Oral use

AT - Austria

sanofi-aventis GmbH

SATURN Tower, Leonard-Bernstein-Straße 10

A-1220 Wien, Austria

Actonel 5 mg Filmtabletten

5 mg (risedronate sodium)

film-coated tablets

Oral use

AT - Austria

sanofi-aventis GmbH

SATURN Tower, Leonard-Bernstein-Straße 10

A-1220 Wien, Austria

Actonel 75 mg Filmtabletten

75 mg (risedronate sodium)

film-coated tablets

Oral use

AT - Austria

Arcana Arzneimittel GmbH,

Hütteldorfer Straße 299,

A-1140 Wien,

Austria

Risedronat Arcana einmal wöchentlich 35 mg - Filmtabletten

35 mg (risedronate sodium)

film-coated tablets

Oral use

AT - Austria

Hexal Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria

Risedronat Hexal einmal wöchentlich 35 mg Filmtabletten

35 mg (risedronate sodium)

film-coated tablets

Oral use

AT - Austria

1A Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria

Risedronat 1A Pharma einmal wöchentlich 35 mg Filmtabletten

35 mg (risedronate sodium)

film-coated tablets

Oral use

AT - Austria

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer Gasse 3

A-1140 Wien

Austria

Risedronat-ratiopharm einmal wöchentlich 35 mg Filmtabletten

35 mg (risedronate sodium)

film-coated tablets

Oral use

AT - Austria

Sandoz GmbH, Biochemiestraße 10 A-6250 Kundl, Austria

Risedronat Sandoz einmal wöchentlich 35 mg Filmtabletten

35 mg (risedronate sodium)

film-coated tablets

Oral use

AT - Austria

Stada Arzneimittel GmbH

Muthgasse 36

A-1190 Wien

Austria

Risedronat STADA einmal wöchentlich 35 mg Filmtabletten

35 mg (risedronate sodium)

film-coated tablets

Oral use

AT - Austria

TEVA Pharma B.V.

Computerweg 10

3542 DR Utrecht

Netherlands

Risedronat Teva 35 mg Filmtabletten

35 mg (risedronate sodium)

film-coated tablets

Oral use

BE - Belgium

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel

5 mg

Film-Coated Tablets

Oral Use

BE - Belgium

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel

30 mg

Film-Coated Tablets

Oral Use

BE - Belgium

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel

35 mg

Film-Coated Tablets

Oral Use

BE - Belgium

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel

75 mg

Film-Coated Tablets

Oral Use

BE - Belgium

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel Combi

35 mg + 1 250 mg calcium

Film-Coated Tablets

Oral Use

BE - Belgium

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel Combi D

35 mg + 1 000 mg / 880 IU

Film-Coated Tablets and effervescent granules

Oral Use

BE - Belgium

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel Plus calcium D

35 mg + 500 mg / 400 UI

Film-Coated Tablets

Oral use

BE - Belgium

TEVA Pharma Belgium N.V,

Laarstraat 16,

B-2610 Wilrijk,

Belgium

Risedronate Teva 35 mg filmomhulde tabletten

35 mg

film-coated tablets

Oral use

BG - Bulgaria

LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

Juverital

5 mg

Film-coated tablets

Oral use

BG - Bulgaria

LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

Juverital

35 mg

Film-coated tablets

Oral use

BG - Bulgaria

Sanofi-Aventis Bulgaria EOOD

103, blvd Al. Stamboliyski

Office Building Sofia Tower

Level 8, 1303 Sofia

Bulgaria

ACTONEL 5 MG FILM-COATED TABLETS

5 mg

Film-Coated Tablets

Oral use

BG - Bulgaria

Sanofi-Aventis Bulgaria EOOD

103, blvd Al. Stamboliyski

Office Building Sofia Tower

Level 8, 1303 Sofia

Bulgaria

ACTONEL 30 MG FILM-COATED TABLETS

30 mg

Film-Coated Tablets

Oral use

BG - Bulgaria

Sanofi-Aventis Bulgaria EOOD

103, blvd Al. Stamboliyski

Office Building Sofia Tower

Level 8, 1303 Sofia

Bulgaria

ACTONEL ONCE A WEEK 35 MG FILM-COATED TABLETS

35 mg

Film-Coated Tablets

Oral use

BG - Bulgaria

Sanofi-Aventis Bulgaria EOOD

103, blvd Al. Stamboliyski

Office Building Sofia Tower

Level 8, 1303 Sofia

Bulgaria

ACTONEL 75 MG FILM-COATED TABLETS

75 mg

Film-Coated Tablets

Oral use

BG - Bulgaria

ZENTIVA, k.s. U kabelovny 130, Dolní Měcholupy 102 37 Praga 10, Czech Republic

RISENDROS 35 mg

35 mg

film-coated tablets

Oral use

BG - Bulgaria

ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany

Risedronat-ratiopharm

35 mg

film - coated tablets

Oral use

BG - Bulgaria

Vale Pharmaceuticals Ltd 1B Gurtnafleur Business Park, Gurtnafleur, clonmel, Co. Tipperary IRELAND

RIGAT

35 mg

film - coated tablets

Oral use

BG - Bulgaria

Stada Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Zilar

5 mg

film - coated tablets

Oral use

BG - Bulgaria

Teva Pharmaceuticals

N.V.Gogol 15

ЕООД

Sofia

Bulgaria

Rizida

35 mg

film - coated tablets

Oral use

BG - Bulgaria

Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054 Graz, Austria

Risedronat Genericon

5 mg

film - coated tablets

Oral use

BG - Bulgaria

Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054 Graz, Austria

Risedronat Genericon

30 mg

film - coated tablets

Oral use

BG - Bulgaria

Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054 Graz, Austria

Risedronat Genericon

35 mg

film - coated tablets

Oral use

BG - Bulgaria

Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarjordur, Iceland

Risadis

5 mg

film - coated tablets

Oral use

BG - Bulgaria

Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarjordur, Iceland

Risadis

35 mg

film - coated tablets

Oral use

CY - Cyprus

SANOFI AVENTIS CYPRUS LTD, CHARALAMBOU MOUSKOU 14, 2015 STROVOLOS, CYPRUS

ACTONEL TABLET 5 MG

5 MG

TABLET

Oral use

CY - Cyprus

SANOFI AVENTIS CYPRUS LTD, CHARALAMBOU MOUSKOU 14, 2015 STROVOLOS, CYPRUS

ACTONEL OAW/"ONCE A WEEK" TABLETS 35 MG

35 MG

TABLET

Oral use

CY - Cyprus

SANOFI AVENTIS CYPRUS LTD, CHARALAMBOU MOUSKOU 14, 2015 STROVOLOS, CYPRUS

ACTONEL (2 CONSEQUENTIAL DAYS PER MONTH)

75 MG

TABLET

Oral use

CY - Cyprus

ACTAVIS GROUP PTC ehf., REYKJAVIKURVEGUR 76-78, 220 HAFNAFJORDUR, ICELAND

BIFODRON TABLETS 5 MG

5 MG

TABLET

Oral use

CY - Cyprus

ACTAVIS GROUP PTC ehf., REYKJAVIKURVEGUR 76-78, 220 HAFNAFJORDUR, ICELAND

BIFODRON TABLETS 30 MG

30 MG

TABLET

Oral use

CY - Cyprus

ACTAVIS GROUP PTC ehf., REYKJAVIKURVEGUR 76-78, 220 HAFNAFJORDUR, ICELAND

BIFODRON TABLETS 35 MG

35 MG

TABLET

Oral use

CY - Cyprus

BEACON PHARMACEUTICAL LIMITED, 85 HIGH STREET, TUNBIDGE WELLS TN1 1YG, UK

RISEDRONATE SODIUM TABLET 5 MG

5 MG

TABLET

Oral use

CY - Cyprus

BEACON PHARMACEUTICAL LIMITED, 85 HIGH STREET, TUNBIDGE WELLS TN1 1YG, UK

RISEDRONATE SODIUM TABLET 30 MG

30 MG

TABLET

Oral use

CY - Cyprus

BEACON PHARMACEUTICAL LIMITED, 85 HIGH STREET, TUNBIDGE WELLS TN1 1YG, UK

RISEDRONATE SODIUM TABLET 35 MG

35 MG

TABLET

Oral use

CY - Cyprus

P T HADJIGEORGIOU CO LTD, 31 YILDIZ, P O BOX 53158, 3301 LEMESOS, CYPRUS

ATRONATE "ONCE A WEEK" TABLETS 35 MG

35 MG

TABLET

Oral use

CY - Cyprus

PHARMATHEN SA, DERVENAKION 6, 15351 PALLINI ATTIKI, GREECE

RISEPALLIN TABLETS 5 MG

5 MG

TABLET

Oral use

CY - Cyprus

PHARMATHEN SA, DERVENAKION 6, 15351 PALLINI ATTIKI, GREECE

RISEPALLIN TABLETS 30 MG

30 MG

TABLET

Oral use

CY - Cyprus

PHARMATHEN SA, DERVENAKION 6, 15351 PALLINI ATTIKI, GREECE

RISEPALLIN TABLETS 35 MG

35 MG

TABLET

Oral use

CY - Cyprus

Arrow Generics Limited, Unit 2 Eastman Way, Hertfordshire, SG1 4SZ, Stevenage, UK

RISEDRONATE ARROW TABLETS 35 MG

35 MG

TABLET

Oral use

CZ - Czech Republic

Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00 Praha-Dejvice, Czech Republic

Actonel 30 mg

30 mg

Film-coated tablet

Oral use

CZ - Czech Republic

Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00 Praha-Dejvice, Czech Republic

Actonel 35 mg

35 mg

Film-coated tablet

Oral use

CZ - Czech Republic

Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00 Praha-Dejvice, Czech Republic

Actonel 5 mg

5 mg

Film-coated tablet

Oral use

CZ - Czech Republic

S.C. LaborMed Pharma S.A., Bd. Theodor Pallady nr. 44B, sector 3, Bucharest, Romania

Juverital 35 mg potahované tablety

35 mg

Film-coated tablet

Oral use

CZ - Czech Republic

S.C. LaborMed Pharma S.A., Bd. Theodor Pallady nr. 44B, sector 3, Bucharest, Romania

Juverital 5 mg potahované tablety

5 mg

Film-coated tablet

Oral use

CZ - Czech Republic

Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00 Praha-Dejvice, Czech Republic

Norsed 35 mg

35 mg

Film-coated tablet

Oral use

CZ - Czech Republic

Galex d.d., Tišinska ul. 29g, 9000 Murska Sobota, Slovenia

Risedronat Galex 35 mg

35 mg

Film-coated tablet

Oral use

CZ - Czech Republic

Galex d.d., Tišinska ul. 29g, 9000 Murska Sobota, Slovenia

Risedronat Galex 5 mg

5 mg

Film-coated tablet

Oral use

CZ - Czech Republic

Generics Ltd., Mylan

Albany Gate, Darkes Lane,

Potters Bar

Hertfordshire

EN6 1AG

United Kingdom

Risedronat Mylan 35 mg

5 mg

Film-coated tablet

Oral use

CZ - Czech Republic

Teva Pharmaceuticals CR, s.r.o., Radlická 3185/1c

150 00 Praha 5

Cezch Republic

Risedronat Teva 35 mg

5 mg

Film-coated tablet

Oral use

CZ - Czech Republic

Ratiopharm GmbH, Graf-Arco-Straße 3

89079 Ulm, Germany

Risedronat-Ratiopharm 35 mg

35 mg

Film-coated tablet

Oral use

CZ - Czech Republic

ZENTIVA, k.s.

U kabelovny 130, Dolní Měcholupy 102 37 Praga 10, Czech Republic

Risendros 35 mg

35 mg

Film-coated tablet

Oral use

CZ - Czech Republic

Ingers Industrial Solutions, s.r.o., Slunná 271/16, 617 00 Brno-Komárov, Czech Republic

Tevanel 35 mg

35 mg

Film-coated tablet

Oral use

CZ - Czech Republic

Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054 Ksawerow, Poland

NORIFAZ 35 MG POTAHOVANÉ TABLETY

35 mg

Film-coated tablet

Oral use

DE - Germany

ALIUD PHARMA GmbH

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Risedronat AL 35 mg Filmtabletten

35 mg

Film-coated tablet

Oral use

DE - Germany

Stadapharm GmbH

Stadastr. 2 - 18

D-61118 Bad Vilbel

Risedronat STADA 35 mg Filmtabletten

35 mg

Film-coated tablet

Oral use

DE - Germany

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Actonel 5 mg Filmtabletten

5 mg

Film-coated tablet

Oral use

DE - Germany

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Actonel 30 mg Filmtabletten

30 mg

Film-coated tablet

Oral use

DE - Germany

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Actonel 75 mg Filmtabletten

75 mg

Film-coated tablet

Oral use

DE - Germany

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Actonel einmal wöchentlich 35 mg Filmtabletten

35 mg

Film-coated tablet

Oral use

DE - Germany

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Norsed einmal wöchentlich 35 mg Filmtabletten

35 mg

Film-coated tablet

Oral use

DE - Germany

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Actonel 35 mg plus Calcium Filmtabletten

35 mg + 1 250 mg calcium

Film-coated tablet

Oral use

DE - Germany

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Actonel plus Calcium D 35 mg + 1 000 mg/880 I.E. Filmtabletten + Brausegranulat

35 mg + 1 000 mg / 800 IU

Film-coated tablet and Effervescent granules

Oral use

DE - Germany

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Norsed plus Calcium D 35 mg + 1 000 mg/880 I.E. Filmtabletten + Brausegranulat

35 mg + 1 000 mg / 800 IU

Film-coated tablet and Effervescent granules

Oral use

DE - Germany

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Actonel plus Calcium D 35 mg + 500 mg/400 I.E. Filmtabletten

35 mg + 500 mg / 400 IU

Film-coated tablet and

Oral use

DE - Germany

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Risedronat Heumann 35 mg Filmtabletten

40,17 mg

Film-coated tablet

Oral use

DK - Denmark

Ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany

Risostad

5 mg

Film-coated tablets

Oral use

DK - Denmark

Ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany

Risostad

35 mg

Film-coated tablets

Oral use

DK - Denmark

Mylan AB, P.O.box 23033, Ynglingagatan 14, SE-104 35 Stockholm; Sweden

Vionate

5 mg

Film-coated tablets

Oral use

DK - Denmark

Mylan AB, P.O.box 23033, Ynglingagatan 14, SE-104 35 Stockholm; Sweden

Vionate

35 mg

Film-coated tablets

Oral use

DK - Denmark

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Dimidronat

5 mg

Film-coated tablets

Oral use

DK - Denmark

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Dimidronat

30 mg

Film-coated tablets

Oral use

DK - Denmark

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Dimidronat

35 mg

Film-coated tablets

Oral use

DK - Denmark

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Ellidronat

35 mg

Film-coated tablets

Oral use

DK - Denmark

LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

Juverital

5 mg

Film-coated tablets

Oral use

DK - Denmark

LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

Juverital

35 mg

Film-coated tablets

Oral use

DK - Denmark

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Karadronat

5 mg

Film-coated tablets

Oral use

DK - Denmark

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Karadronat

30 mg

Film-coated tablets

Oral use

DK - Denmark

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Karadronat

35 mg

Film-coated tablets

Oral use

DK - Denmark

ZaKlad Farmaceutyczny, Adamed Phama S.a, 33 Szkolna Street, PL-95054 Ksawerów; Poland

Norifaz

35 mg

Film-coated tablets

Oral use

DK - Denmark

Sanofi-Aventis Denmark A/S, Slotsmarken 13, DK-3970 Hørsholm, Denmark

Optinate

5 mg

Film-coated tablets

Oral use

DK - Denmark

Sanofi-Aventis Denmark A/S, Slotsmarken 13, DK-3970 Hørsholm, Denmark

Optinate

30 mg

Film-coated tablets

Oral use

DK - Denmark

Sanofi-Aventis Denmark A/S, Slotsmarken 13, DK-3970 Hørsholm, Denmark

Optinate

75 mg

Film-coated tablets

Oral use

DK - Denmark

Sanofi-Aventis Denmark A/S, Slotsmarken 13, DK-3970 Hørsholm, Denmark

Optinate Combi

35 mg + 1 250 mg calcium

Film-coated tablets

Oral use

DK - Denmark

Sanofi-Aventis Denmark A/S, Slotsmarken 13, DK-3970 Hørsholm, Denmark

Optinate Septimum

35 mg

Film-coated tablets

Oral use

DK - Denmark

CT Arzneimittel GmbH, Lengeder Str. 42A, DE-13407 Berlin, Germany

Racidrix

35 mg

Film-coated tablets

Oral use

DK - Denmark

ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany

Ridracid

35 mg

Film-coated tablets

Oral use

DK - Denmark

Ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany

Rinon

35 mg

Film-coated tablets

Oral use

DK - Denmark

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany

Risdronostad

5 mg

Film-coated tablets

Oral use

DK - Denmark

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany

Risdronostad

30 mg

Film-coated tablets

Oral use

DK - Denmark

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany

Risdronostad

35 mg

Film-coated tablets

Oral use

DK - Denmark

Actavis Group PTC ehf., PO Box 425, Reykjavikurvegi 76-78, IS-220 Hafnarfjördur, Iceland

Risedronatnatrium "Actavis"

35 mg

Film-coated tablets

Oral use

DK - Denmark

Orifarm Generics A/S, Energivej 15, DK-5260 Odense S., Denmark

Risedronatnatrium "Orifarm"

5 mg

Film-coated tablets

Oral use

DK - Denmark

Orifarm Generics A/S, Energivej 15, DK-5260 Odense S., Denmark

Risedronatnatrium "Orifarm"

30 mg

Film-coated tablets

Oral use

DK - Denmark

Orifarm Generics A/S, Energivej 15, DK-5260 Odense S., Denmark

Risedronatnatrium "Orifarm"

35 mg

Film-coated tablets

Oral use

DK - Denmark

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany

Risedronatnatrium "Stada"

5 mg

Film-coated tablets

Oral use

DK - Denmark

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany

Risedronatnatrium "Stada"

30 mg

Film-coated tablets

Oral use

DK - Denmark

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany

Risedronatnatrium "Stada"

35 mg

Film-coated tablets

Oral use

DK - Denmark

Teva Denmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark

Risedronatnatrium "Teva"

35 mg

Film-coated tablets

Oral use

DK - Denmark

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Risepallin

5 mg

Film-coated tablets

Oral use

DK - Denmark

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Risepallin

30 mg

Film-coated tablets

Oral use

DK - Denmark

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Risepallin

35 mg

Film-coated tablets

Oral use

DK - Denmark

ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany

Riseratio

35 mg

Film-coated tablets

Oral use

DK - Denmark

ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany

Risonat

35 mg

Film-coated tablets

Oral use

EL - Greece

SANOFI-AVENTIS AEBE

SYNGROU AVENUE 348 BUILDING A

KALITHEA 17674

ACTONEL

5 MG/TAB

FILM COATED TABLET

Oral use

EL - Greece

SANOFI-AVENTIS AEBE

SYNGROU AVENUE 348 BUILDING A

KALITHEA 17675

ACTONEL

30 MG/TAB

FILM COATED TABLET

Oral use

EL - Greece

SANOFI-AVENTIS AEBE

SYNGROU AVENUE 348 BUILDING A

KALITHEA 17676

ACTONEL OAW

35 MG/TAB

FILM COATED TABLET

Oral use

EL - Greece

SANOFI-AVENTIS AEBE

SYNGROU AVENUE 348 BUILDING A

KALITHEA 17677

ACTONEL 2 CONSECUTIVE DAYS PER MONTH

75 MG/TAB

FILM COATED TABLET

Oral use

EL - Greece

SANOFI-AVENTIS AEBE

SYNGROU AVENUE 348 BUILDING A

KALITHEA 17678

RISEDRONATE / WINTHROP

35 MG/TAB

FILM COATED TABLET

Oral use

EL - Greece

ACTAVIS GROUP PTC EHF., ICELAND

Reykjavikurvegur 76-78,

220, Hafnarfjordur

Iceland

RISEDRONATE SODIUM / ACTAVIS

35 MG/TAB

FILM COATED TABLET

Oral use

EL - Greece

PNG GEROLYMATOS MEDICAL S.A.

ASKLIPIOU 13

KRYONERI ATTIKIS 14568

MOTIVUS

35 MG/TAB

FILM COATED TABLET

Oral use

EL - Greece

DELEGANT HOLDINGS LTD, CYPRUS

AGIAS ELENIS 36

COMMERCIAL CENTRE GALAXY 401

NICOSIA 1061

CYPRUS

RISELIB

35 MG/TAB

FILM COATED TABLET

Oral use

EL - Greece

S.J.A. PHARM Ltd

ARKOLEON 11

10445 PATISSIA

DIFOSFON-S

35 MG/TAB

FILM COATED TABLET

Oral use

EL - Greece

ELPEN S.A. PHARMACEUTICAL INDUSTRY

MARATHONOS AVENUE 95

PIKERMI 190 09

BONDAPEN

35 MG/TAB

FILM COATED TABLET

Oral use

EL - Greece

AURORA PHARMACEUTICALS A.E.

EVROU 4 & MESSINIAS 2

GERAKAS 15344

BONMATE

35 MG/TAB

FILM COATED TABLET

Oral use

EL - Greece

GENERICS (U.K.) LTD - ENGLAND

STATION CLOSE POTTERS BAR HERTS EN6 1TL

ENGLAND

RISEDRONATE / GENERICS

35 MG/TAB

FILM COATED TABLET

Oral use

EL - Greece

TEVA PHARMA B.V., UTRECHT, THE NETHERLANDS

Computerweg 10,

3542 DR, Utrecht,

The Netherlands

RISEDRONATE / TEVA

35 MG/TAB

FILM COATED TABLET

Oral use

ES - Spain

SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona

ACTONEL 30 mg comprimidos recubiertos

30 mg

film coated tablets

Oral use

ES - Spain

SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona

ACTONEL 5 mg comprimidos recubiertos

5 mg

film coated tablets

Oral use

ES - Spain

Warner Chilcott Iberia, S.L.

WTC Almeda Park, Ed. 1, 2a pl.

Plaça de la Pau s/n

08940 Cornellà de Llobregat (Barcelona)

Spain

ACREL 5 mg comprimidos recubiertos con película

5 mg

film coated tablets

Oral use

ES - Spain

Warner Chilcott Iberia, S.L.

WTC Almeda Park, Ed. 1, 2a pl.

Plaça de la Pau s/n

08940 Cornellà de Llobregat (Barcelona)

Spain

ACREL SEMANAL 35 mg comprimidos recubiertos con película

35 mg

film coated tablets

Oral use

ES - Spain

SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona

ACTONEL SEMANAL 35 mg comprimidos recubiertos con película

35 mg

film coated tablets

Oral use

ES - Spain

SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona

ACTONEL 75 mg comprimidos recubiertos con película

75 mg

film coated tablets

Oral use

ES - Spain

SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona

LOSENTRA SEMANAL 35 mg comprimidos recubiertos con película

35 mg

film coated tablets

Oral use

ES - Spain

Warner Chilcott Iberia, S.L.

WTC Almeda Park, Ed. 1, 2a pl.

Plaça de la Pau s/n

08940 Cornellà de Llobregat (Barcelona)

Spain

ACREL 75 mg comprimidos recubiertos con película

75 mg

film coated tablets

Oral use

ES - Spain

SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona

ACTONEL COMBI 35 mg comprimidos recubiertos con película + 1 000 mg/880 UI granulado efervescente

35 mg + 1 000 mg / 880 IU

film coated tablets

Oral use

ES - Spain

Warner Chilcott Iberia, S.L.

WTC Almeda Park, Ed. 1, 2a pl.

Plaça de la Pau s/n

08940 Cornellà de Llobregat (Barcelona)

Spain

ACRELCOMBI 35 mg comprimidos recubiertos con pelicula + 1 000 mg/880UI granulado efervescente

35 mg + 1 000 mg / 880 IU

film coated tablets and efervescent granules

Oral use

ES - Spain

Warner Chilcott Iberia, S.L.

WTC Almeda Park, Ed. 1, 2a pl.

Plaça de la Pau s/n

08940 Cornellà de Llobregat (Barcelona)

Spain

ACREL COMBI 35 mg + 500 mg/400 UI comprimidos recubiertos con película

35 mg + 500 mg/400 UI

film coated tablets and efervescent granules

Oral use

ES - Spain

SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona

ACTONEL COMBI 35 mg + 500 mg/400 UI comprimidos recubiertos con película

35 mg + 500 mg/400 UI

film coated tablets

Oral use

ES - Spain

QUALIGEN, S.L.Avda. Barcelona, 69 08970 Sant Joan Despi, Spain

RISEDRONATO SEMANAL QUALIGEN 35 mg comprimidos recubiertos con película

 

film coated tablets

Oral use

ES - Spain

RATIOPHARM ESPAÑA, S.A.Avda. de Burgos, 16 D - 5a Planta 28036 Madrid

RISEDRONATO SEMANAL RATIOPHARM 35 mg comprimidos recubiertos con película

 

film coated tablets

Oral use

ES - Spain

MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5o Planta 08038 Barcelona

RISEMYL SEMANAL 35 mg comprimidos recubiertos con película

 

film coated tablets

Oral use

ES - Spain

TEVA GENERICOS ESPAÑOLA, S.L. Guzmán el Bueno 133, Edificio Britania 4oIzq 28003 Madrid

MIOSEN SEMANAL 35 mg comprimidos recubiertos con película

 

film coated tablets

Oral use

ES - Spain

HEXAL PHARMA GMBH Carlberger Gasse, 44 A-1235 Viena

RISEDRONATO SEMANAL HEXAL 35 mg comprimidos recubiertos con película

 

film coated tablets

Oral use

ES - Spain

SANDOZ FARMACEUTICA, S.A. Avda. Osa Mayor, 4 28023 Aravaca (Madrid)

RISEDRONATO SEMANAL SANDOZ 35 mg comprimidos recubiertos con pelicula

 

film coated tablets

Oral use

ES - Spain

1A PHARMA GMBH Eduard Kittenberger Gasse, 56 A-1235 Viena

RISEDRONATO SEMANAL SALUTAS 35 mg comprimidos recubiertos con película

 

film coated tablets

Oral use

ES - Spain

LABORATORIO STADA, S.L. Frederic Mompou, 5 08960 Sant Just Desvern

RISEDRONATO SEMANAL STADA 35 mg comprimidos recubiertos con película

 

film coated tablets

Oral use

ES - Spain

KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. 08228 Tarrasa

RISEDRONATO SEMANAL KERN PHARMA 35 mg comprimidos recubiertos con película

 

film coated tablets

Oral use

ES - Spain

LABORATORIOS RANBAXY, S.L. Passeig de Gracia, 9 08007 Barcelona

RISEDRONATO SEMANAL RANBAXY 35 mg comprimidos recubiertos con película

 

film coated tablets

Oral use

ES - Spain

ZAKLAD FARMACEUTYCZNY ADAMED PHARMA, S.A. ul. Szkolna, 33 95-054 Ksawerow/Lodz

NORIFAZ 35 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA

 

film coated tablets

Oral use

ET - Estonia

Portfarma ehf Kollunarklettsvegur 2, 104 Reykjavik ICELAND

OSSINAT

5 mg

Film-coated tablet

Oral use

ET - Estonia

Portfarma ehf Kollunarklettsvegur 2, 104 Reykjavik ICELAND

OSSINAT

35 mg

Film-coated tablet

Oral use

ET - Estonia

Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2

11317 Tallinn ESTONIA

ACTONEL 35 MG OAW

35 mg

Film-coated tablet

Oral use

ET - Estonia

Zentiva, k.s. UKabelovny 130

Dolni Mecholupy

102 37 Prague 10 CZECH REPUBLIC

RISENDROS 35 MG

35 mg

Film-coated tablet

Oral use

ET - Estonia

Actavis Group PTC ehf Reykjavikurvegi 76-78

220 Hafnarfjördur ICELAND

RISEDRONATE SODIUM ACTAVIS

35 mg

Film-coated tablet

Oral use

ET - Estonia

ratiopharm GmbH Graf-Arco-Strasse 3

D-89079 Ulm GERMANY

RIBIDRON

35 mg

Film-coated tablet

Oral use

ET - Estonia

Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2

11317 Tallinn ESTONIA

ACTONEL

75 mg

Film-coated tablet

Oral use

ET - Estonia

Zaklad Farmaceutyczny Adamed Pharma S.A. 33 Szkolna Street, 95-054 Ksawerow POLAND

NORIFAZ

35 mg

Film-coated tablet

Oral use

ET - Estonia

Teva Pharma B.V. Computerweg 10

3542 DR Utrecht THE NETHERLANDS

RISONATE

35 mg

Film-coated tablet

Oral use

ET - Estonia

Vale Pharmaceuticals Ltd 1B Gurtnafleur Business Park, Gurtnafleur, clonmel, Co. Tipperary IRELAND

RIGAT

35 mg

Film-coated tablet

Oral use

FI - Finland

sanofi-Aventis Oy, Huopalahdentie 24, PL 22, 00350 Helsinki, Finland

Optinate

30 mg

film-coated tablet

Oral use

FI - Finland

sanofi-Aventis Oy, Huopalahdentie 24, PL 22, 00350 Helsinki, Finland

Optinate

5 mg

film-coated tablet

Oral use

FI - Finland

sanofi-Aventis Oy, Huopalahdentie 24, PL 22, 00350 Helsinki, Finland

Optinate Combi D

35 mg + 1 000 mg / 880 IU

film-coated tablet and effervescent granules

Oral use

FI - Finland

sanofi-Aventis Oy, Huopalahdentie 24, PL 22, 00350 Helsinki, Finland

Optinate Septimum

35 mg

film-coated tablet

Oral use

FI - Finland

Ranbaxy (UK) Limited, Building 4, Chiswick Park, 566 Chiswick High Road, LONDON W4 5YE, United Kingdom

Risedronat Ranbaxy

35 mg

film-coated tablet

Oral use

FI - Finland

sanofi-Aventis Oy, Huopalahdentie 24, PL 22, 00350 Helsinki, Finland

Optinate

75 mg

film-coated tablet

Oral use

FI - Finland

Oy Leiras Finland Ab, PL 1406, 00101 Helsinki, Finland

Riseos

35 mg

film-coated tablet

Oral use

FI - Finland

ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany

Riseratio

35 mg

film-coated tablet

Oral use

FI - Finland

Mylan AB, BOX 23033, 10435 STOCKHOLM, Sweden

Vionate

35 mg

film-coated tablet

Oral use

FI - Finland

Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 HAFNARFJORDUR, Iceland

Risedronat Actavis

35 mg

film-coated tablet

Oral use

FI - Finland

Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark

Risedronat Orifarm

30 mg

film-coated tablet

Oral use

FI - Finland

Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark

Risedronat Orifarm

35 mg

film-coated tablet

Oral use

FI - Finland

Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark

Risedronat Orifarm

5 mg

film-coated tablet

Oral use

FI - Finland

Sandoz A/S, C. F. Tietgens Boulevard 40, 5220 ODENSE SØ, Denmark

Risedronat Sandoz

35 mg

film-coated tablet

Oral use

FI - Finland

Stada Arzneimittel AG, Stadastrasse 2 - 18, 61118 BAD VILBEL, Germany

Risedronat Stada

35 mg

film-coated tablet

Oral use

FI - Finland

Stada Arzneimittel AG, Stadastrasse 2 - 18, 61118 BAD VILBEL, Germany

Risedronat Stada

5 mg

film-coated tablet

Oral use

FI - Finland

TEVA Sweden AB, Järnvägsgatan 11, BOX 1070, 25110 HELSINGBORG, Sweden

Risedronat Teva

35 mg

film-coated tablet

Oral use

FR - France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

FRANCE

RISEDRONATE ALMUS 35 mg, comprimé pelliculé

35 mg

tablet

Oral use

FR - France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

FRANCE

RISEDRONATE BGR 35 mg, comprimé pelliculé

35 mg

tablet

Oral use

FR - France

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

FRANCE

RISEDRONATE RANBAXY 35 mg, comprimé pelliculé

35 mg

tablet

Oral use

FR - France

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

RISEDRONATE WINTHROP 35 mg, comprimé pelliculé

35 mg

film-coated tablet

Oral use

FR - France

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

RISEDRONATE WINTHROP 75 mg, comprimé pelliculé

75 mg

film-coated tablet

Oral use

FR - France

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense Cedex

France

ACTONEL 30 mg, comprimé pelliculé

30 mg

film-coated tablet

Oral use

FR - France

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense Cedex

France

ACTONEL 35 mg, comprimé pelliculé

35 mg

film-coated tablet

Oral use

FR - France

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense Cedex

France

ACTONEL 5 mg, comprimé pelliculé

5 mg

film-coated tablet

Oral use

FR - France

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense Cedex

France

ACTONELCOMBI 35 mg + 1 000 mg/880 UI, comprimé pelliculé et granulés effervescents

35 mg + 1 000 mg/800 UI

film-coated tablet and effervescent granules

Oral use

FR - France

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense Cedex

France

ACTONEL 75 mg, comprimé pelliculé

75 mg

tablet

Oral use

FR - France

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense Cedex

France

ACTONELCOMBI 35 mg + 500 mg/400 UI, comprimé pelliculé

35 mg + 500 mg/400 UI

tablet

Oral use

HU - Hungary

Sanofi-aventis zrt.

Tó u. 1-5.

1045 Budapest

Hungary

ACTONEL 5 mg filmtabletta

5,00 mg Risedronate sodium

(equivalent to 4,64 mg Risendronic acid)

film-coated tablet

Oral use

HU - Hungary

Sanofi-aventis zrt.

Tó u. 1-5.

1045 Budapest

Hungary

ACTONEL 35 mg filmtabletta

35,00 mg Risedronate sodium

(equivalent to 32,5 mg Risendronic acid)

film-coated tablet

Oral use

HU - Hungary

Sanofi-aventis zrt.

Tó u. 1-5.

1045 Budapest

Hungary

ACTONEL TRIO 35 mg film- és rágótabletta

35,00 mg Risedronate sodium

(equivalent to 69,6 mg Risendronic acid)

film-coated tablet and chewing tablet

Oral use

HU - Hungary

Sanofi-aventis zrt.

Tó u. 1-5.

1045 Budapest

Hungary

ACTONEL TRIO 75 mg film- és rágótabletta

75,00 mg Risedronate sodium

(as Risendronic acid)

film-coated tablet and chewing tablet

Oral use

HU - Hungary

Vera Pharma Kft.

Rákos köz 22.

1028 Budapest

Hungary

BONEACT 35 mg filmtabletta

35,00 mg Risedronate sodium

(as Risendronic acid)

film-coated tablet

Oral use

HU - Hungary

Vera Pharma Kft.

Rákos köz 22.

1028 Budapest

Hungary

BONEACT 755 mg filmtabletta

75,00 mg Risedronate sodium

(as Risendronic acid)

film-coated tablet

Oral use

HU - Hungary

Aramis Pharma Kft.

Mester u. 28. III/5.

1095 Budapest

Hungary

NORIFAZ Trio 35 mg film- és rágótabletta

35,0 mg Risedronate sodium

(equivalent to 40,17 mg Risedronate

sodium hemipentahydrate

film-coated tablet and chewing tablet

Oral use

HU - Hungary

Zentiva k.s.

Dolny Mecholupy, U kabelovny 130.

10237 Prague 10.

Czech Republic

RISENDROS 35 mg filmtabletta

35,0 mg Risedronate sodium

film-coated tablet

Oral use

HU - Hungary

Vera Pharma Kft.

Rákos köz 22.

1028 Budapest

Hungary

RISETACT 35 mg filmtabletta

35,0 mg Risedronate sodium

film-coated tablet

Oral use

HU - Hungary

Sanofi-aventis zrt.

Tó u. 1-5.

1045 Budapest

Hungary

ACTONEL 75 mg filmtabletta

75,00 mg Risedronate sodium

(equal to Risendronic acid)

film-coated tablet

Oral use

HU - Hungary

Ozone Laboratories BV

2 Martinus Nijhofflaan

2624 ES Delft

Holland

JUVERITAL 5 mg filmtabletta

5,0 mg Risedronate sodium

(equivalent to 5,74 mg Risedronate

sodium hemipentahydrate

film-coated tablet

Oral use

HU - Hungary

Ozone Laboratories BV

2 Martinus Nijhofflaan

2624 ES Delft

Holland

JUVERITAL 35 mg filmtabletta

35,0 mg Risedronate sodium

(equivalent to 40,17 mg Risedronate

sodium hemipentahydrate

film-coated tablet

Oral use

HU - Hungary

Aramis Pharma Kft.

Mester u. 28. III/5.

1095 Budapest

Hungary

NORIFAZ 35 mg filmtabletta

35,0 mg Risedronate sodium

(equivalent to 40,17 mg Risedronate

sodium hemipentahydrate

film-coated tablet

Oral use

HU - Hungary

GALEX d.d.

Tisinška ulica 29g

9000 Murska Sobota

Slovenia

RISEDRONAT GALEX 35 mg filmtabletta

35,0 mg Risedronate sodium

(equivalent to 40,17 mg Risedronate

sodium hemipentahydrate

film-coated tablet

Oral use

HU - Hungary

Actavis Group PTC ehf.

Reykjavikurvegur 76-78.

220 Hafnarfjordur

Iceland

RISEDRONATE ACTAVIS 35 mg filmtabletta

35,0 mg Risedronate sodium

(equivalent to 40,17 mg Risedronate

sodium hemipentahydrate

film-coated tablet

Oral use

HU - Hungary

Generics (UK) Ltd.

Albany Gate, Darkes Lane, Potters bar

EN61AG Hertfordshire

UK

RISEDRONATE GENERICS (UK) 5 mg filmtabletta

5,0 mg Risedronate sodium

(equivalent to 5,74 mg Risedronate

sodium hemipentahydrate

film-coated tablet

Oral use

HU - Hungary

Generics (UK) Ltd.

Albany Gate, Darkes Lane, Potters bar

EN61AG Hertfordshire

UK

RISEDRONATE GENERICS (UK) 35 mg filmtabletta

35,0 mg Risedronate sodium

(equivalent to 40,17 mg Risedronate

sodium hemipentahydrate

film-coated tablet

Oral use

HU - Hungary

LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

Juverital

5 mg

Film-coated tablets

Oral use

HU - Hungary

LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

Juverital

35 mg

Film-coated tablets

Oral use

IE - Ireland

Rowex Ltd

Bantry

Co. Cork

Ridate Once a Week 35 mg film-coated tablets

35 mg

film-coated tablets

Oral use

IE - Ireland

TEVA Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Risonate Once Weekly 35 mg Film-Coated Tablets.

35 mg

film-coated tablets

Oral use

IE - Ireland

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim

BT40 2SH

United Kingdom

Actonel 5 mg film coated tablets

5 mg

film-coated tablets

Oral use

IE - Ireland

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim

BT40 2SH

United Kingdom

Actonel 30 mg film coated tablets

30 mg

film-coated tablets

Oral use

IE - Ireland

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim

BT40 2SH

United Kingdom

Actonel Once A Week 35 mg film-coated tablets

35 mg

film-coated tablets

Oral use

IE - Ireland

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim

BT40 2SH

United Kingdom

Actonel 75 Milligram Film Coated Tablets

75 mg

film-coated tablets

Oral use

IE - Ireland

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim

BT40 2SH

United Kingdom

Actonel Combi 35 mg + 500 mg film-coated tablets

35 mg + 1 250 mg calcium

film-coated tablets

Oral use

IE - Ireland

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim

BT40 2SH

United Kingdom

Actonel Plus Ca & D 35 mg film-coated tablet + 1 000 mg/800 IU Effervescent Granules

35 mg + 1 000 mg/880 IU

film-coated tablets + effervescent granules

Oral use

IE - Ireland

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim

BT40 2SH

United Kingdom

Actonel Plus Ca & D Tablet 35 mg and 500 mg/400 IU Film-Coated Tablets.

35 mg + (risedronate sodium) + 500 mg/400 UI

film-coated tablets

Oral use

IE - Ireland

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim

BT40 2SH

United Kingdom

Optinate Once a Week 35 mg Film-coated Tablets

35 mg

film-coated tablets

Oral use

IE - Ireland

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim

BT40 2SH

United Kingdom

Optinate 75 mg Film-coated Tablets

75 mg

film-coated tablets

Oral use

IE - Ireland

Ranbaxy Ireland Ltd. Spafield, Cork Road, Cashel, Co. Tipperary

Ranbaxy Ireland Ltd

Risedronate Sodium 35 mg Once A Week Film-Coated Tablets

35 mg

film-coated tablets

Oral use

IE - Ireland

Clonmel Healthcare Limited

Waterford Road

Clonmel

Co. Tipperary

Ireland

Risontel Once a week 35 mg film-coated tablets

35 mg

film-coated tablets

Oral use

IE - Ireland

Actavis Group PTC ehf Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland

Actavis Group PTC ehf

Risedronate Sodium Actavis 5 mg film-coated tablets

5 mg

film-coated tablets

Oral use

IE - Ireland

Actavis Group PTC ehf Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland

Actavis Group PTC ehf

Risedronate Sodium Actavis 30 mg film-coated tablets

30 mg

film-coated tablets

Oral use

IE - Ireland

Actavis Group PTC ehf Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland

Actavis Group PTC ehf

Risedronate Sodium Actavis 35 mg film-coated tablets

35 mg

film-coated tablets

Oral use

IS - Iceland

Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway

Optinate

5 mg

Film-coated tablet

Oral use

IS - Iceland

Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway

Optinate

30 mg

Film-coated tablet

Oral use

IS - Iceland

Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway

Optinate

75 mg

Film-coated tablet

Oral use

IS - Iceland

Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway

Optinate Combi

35 mg + 1 250 mg calcium

film-coated tablets

Oral use

IS - Iceland

Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway

Optinate Combi D

35 mg and 1 000 mg/880 IU

film-coated tablet and effervescent granules

Oral use

IS - Iceland

Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway

Optinate Septimum

35 mg

film-coated tablet

Oral use

IS - Iceland

Portfarma ehf., Borgartúni 26, 105 Reykjavík, Iceland

Risedronat Sodium Portfarma

5 mg

Film-coated tablet

Oral use

IS - Iceland

Qualigen S.L., Avda. Barcelona 69 08970, Sant Joan Despi, (Barcelona) Spain

Risedronat Qualigen

35 mg

Film-coated tablet

Oral use

IT - Italy

GRUPPO LEPETIT Srl

VIALE LUIGI BODIO, 37/B

20158 Milano – Italy

OPTINATE

5 mg

film-coated tablets

Oral use

IT - Italy

GRUPPO LEPETIT Srl

VIALE LUIGI BODIO, 37/B

20158 Milano – Italy

OPTINATE

30 mg

film-coated tablets

Oral use

IT - Italy

GRUPPO LEPETIT Srl

VIALE LUIGI BODIO, 37/B

20158 Milano – Italy

OPTINATE

35 mg

film-coated tablets

Oral use

IT - Italy

GRUPPO LEPETIT Srl

VIALE LUIGI BODIO, 37/B

20158 Milano – Italy

OPTINATE

75 mg

film-coated tablets

Oral use

IT - Italy

SANOFI-AVENTIS SpA

Viale L. Bodio, 37/B

20158 Milano

Risedronato Winthrop 5 mg compresse rivestite con film

5 mg

film-coated tablets

Oral use

IT - Italy

SANOFI-AVENTIS SpA

Viale L. Bodio, 37/B

20158 Milano

Risedronato Winthrop 30 mg compresse rivestite con film

30 mg

film-coated tablets

Oral use

IT - Italy

SANOFI-AVENTIS SpA

Viale L. Bodio, 37/B

20158 Milano

Risedronato Winthrop 35 mg compresse rivestite con film

35 mg

film-coated tablets

Oral use

IT - Italy

SANOFI-AVENTIS SpA

Viale L. Bodio, 37/B

20158 Milano

Risedronato Winthrop 75 mg compresse rivestite con film

75 mg

film-coated tablets

Oral use

IT - Italy

WARNER CHILCOTT ITALY Srl

Viale Giorgio Ribotta, 11

00144 Roma

ACTONEL

5 mg

film-coated tablets

Oral use

IT - Italy

WARNER CHILCOTT ITALY Srl

Viale Giorgio Ribotta, 11

00144 Roma

ACTONEL

30 mg

film-coated tablets

Oral use

IT - Italy

WARNER CHILCOTT ITALY Srl

Viale Giorgio Ribotta, 11

00144 Roma

ACTONEL

35 mg

film-coated tablets

Oral use

IT - Italy

WARNER CHILCOTT ITALY Srl

Viale Giorgio Ribotta, 11

00144 Roma

ACTONEL

75 mg

film-coated tablets

Oral use

IT - Italy

WARNER CHILCOTT ITALY Srl

Viale Giorgio Ribotta, 11

00144 Roma

ACTOCALCIO D3

35 mg + 1 000 mg/880 IU

film-coated tablets + effervescent granules

Oral use

IT - Italy

SANOFI-AVENTIS SpA

Viale L. Bodio, 37/B

20158 Milano

OPTICALCIO D3

35 mg + 1 000 mg/880 IU

film-coated tablets + effervescent granules

Oral use

LT - Lithuania

ZENTIVA, k.s., Ukabelovny 130 Dolní Měcholupy 102 37, Praha 10, Czechia

Risendros

35 mg

Film-coated tablet

Oral use

LT - Lithuania

UAB “SANOFI-AVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2 LT-09310 Vilnius, Lithuania

Actonel

35 mg

Film-coated tablet

Oral use

LT - Lithuania

UAB “SANOFI-AVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2 LT-09310 Vilnius, Lithuania

Actonel

5 mg

Film-coated tablet

Oral use

LT - Lithuania

Teva Pharma B.V., Computerweg 10 3542 DR Utrecht, The Netherlands

Risonate

35 mg

Film-coated tablet

Oral use

LT - Lithuania

Zakład Farmaceutyczny Adamed Pharma S.A, Ul. Szkolna 33, 95-054 Ksawerów, Poland

Norifaz

35 mg

Film-coated tablet

Oral use

LT - Lithuania

Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Islandia

Risedronate sodium Actavis

35 mg

Film-coated tablet

Oral use

LT - Lithuania

UAB “SANOFI-AVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2 LT-09310 Vilnius, Lithuania

Actonel

75 mg

Film-coated tablet

Oral use

LT - Lithuania

UAB “SANOFI-AVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2 LT-09310 Vilnius, Lithuania

Actonel

35 mg + 1 000 mg/880 IU

film-coated tablets + effervescent granules

Oral use

LT - Lithuania

ratiopharm GmbH, Graf-Arco-Strasse 3, Ulm D-89079, Germany

Ribidron

35 mg

Film-coated tablet

Oral use

LU - Luxembourg

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel

5 mg

Film-coated tablets

oral use

LU - Luxembourg

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel

30 mg

film-coated tablets

oral use

LU - Luxembourg

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel

75 mg

film-coated tablets

Oral use

LU - Luxembourg

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel Combi D

35 mg + 1 000 mg/880 IU

film-coated tablets + effervescent granules

Oral use

LU - Luxembourg

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel Combi

35 mg + 1 250 mg calcium

film-coated tablets

Oral use

LU - Luxembourg

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel hebdomadaire

35 mg

film-coated tablets

Oral use

LV - Latvia

Portfarma ehf, Köllunarklettsvegi 2, 104 Reykjavík, Iceland

Risedronate sodium Portfarma

5 mg

film-coated tablets

Oral use

LV - Latvia

Portfarma ehf, Köllunarklettsvegi 2, 104 Reykjavík, Iceland

Risedronate sodium Portfarma

35 mg

film-coated tablets

Oral use

LV - Latvia

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Praha 10, Czech Republic

Risendros

35 mg

film-coated tablets

Oral use

LV - Latvia

sanofi-aventis Latvia SIA, Kr. Valdemara iela 33-8, Riga LV 1010, Latvia

Actonel Combi

35 mg + 1 000 mg/880 IU

Film-coated tablets + effervescent granules

Oral use

LV - Latvia

sanofi-aventis Latvia SIA, Kr. Valdemara iela 33-8, Riga LV 1010, Latvia

Actonel OAW

35 mg

film-coated tablets

Oral use

LV - Latvia

Vale Pharmaceuticals Ltd., 1B Gurtnafleur Business Park, Gurtnafleur, Clonmel, Co. Tipperary, Ireland

Rigat

35 mg

film-coated tablets

Oral use

LV - Latvia

ratiopharm GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany

Ribidron

35 mg

film-coated tablets

Oral use

LV - Latvia

Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Netherlands

Risonate

35 mg

film-coated tablets

Oral use

LV - Latvia

Zakład Farmaceutyczny Adamed Pharma S.A., ul. Szkolna 33, 95-054 Ksawerow, Poland

Norifaz

35 mg

film-coated tablets

Oral use

LV - Latvia

Actavis Group PTC ehf., Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Risedronate Sodium Actavis

35 mg

film-coated tablets

Oral use

LV - Latvia

sanofi-aventis Latvia SIA, Kr. Valdemara iela 33-8, Riga LV 1010, Latvia

Actonel

75 mg

film-coated tablets

Oral use

MT - Malta

Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta

Actonel

5 mg

film-coated tablet

Oral use

MT - Malta

Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta

Actonel

30 mg

film-coated tablet

Oral use

MT - Malta

Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta

Actonel Once a Week

35 mg

film-coated tablet

Oral use

MT - Malta

Beacon Pharmaceuticals Ltd

85 High Street

Tunbridge Wells

TN1 1YG

United Kingdom

Risedronate 5 mg film coated tablets

5 mg

Tablets

Oral use

MT - Malta

Beacon Pharmaceuticals Ltd

85 High Street

Tunbridge Wells

TN1 1YG

United Kingdom

Risedronate 30 mg film coated tablets

30 mg

Tablets

Oral use

MT - Malta

Beacon Pharmaceuticals Ltd

85 High Street

Tunbridge Wells

TN1 1YG

United Kingdom

Risedronate 35 mg film coated tablets

35 mg

Tablets

Oral use

MT - Malta

Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta

Actonel

75 mg

film-coated tablet

Oral use

MT - Malta

Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta

Actonel Plus Ca & D

35 mg + 1 000 mg/880 IU

film-coated tablet/effervescent granules

Oral use

NL - Netherlands

Warner Chilcott Nederland BV

Lichtenauerlaan 102-120

3062 ME Rotterdam Netherlands

Actokit D, combinatieverpakking

35 mg + 1 000 mg/880 IE

filmcoated tablets + effervescent granules

Oral use

NL - Netherlands

Warner Chilcott Nederland BV

Lichtenauerlaan 102-120

3062 ME Rotterdam Netherlands

Actonel® 30 mg, filmomhulde tabletten

30 mg

filmcoated tablets

Oral use

NL - Netherlands

Warner Chilcott Nederland BV

Lichtenauerlaan 102-120

3062 ME Rotterdam Netherlands

Actonel® 5 mg, filmomhulde tabletten

5 mg

filmcoated tablets

Oral use

NL - Netherlands

Warner Chilcott Nederland BV

Lichtenauerlaan 102-120

3062 ME Rotterdam Netherlands

Actonel® Wekelijks 35 mg, filmomhulde tabletten

35 mg

filmcoated tablets

Oral use

NL - Netherlands

Warner Chilcott Nederland BV

Lichtenauerlaan 102-120

3062 ME Rotterdam Netherlands

Actokit

35 mg + 1 250 mg calcium

Film-coated tablets

Oral use

NL - Netherlands

Ranbaxy Belgium NV

Leuvensestraat 28b

1800 Vilvoorde Belgium

Natriumrisedronaat 35 mg Ranbaxy

35 mg

filmcoated tablets

Oral use

NL - Netherlands

Ceft Limited

65 Delamere Road, Hayes

Middlesex UB4 0NN Belgium

Natriumrisedronaat Ceft 30 mg

30 mg

filmcoated tablets

Oral use

NL - Netherlands

Ceft Limited

65 Delamere Road, Hayes

Middlesex UB4 0NN Belgium

Natriumrisedronaat Ceft 35 mg

35 mg

filmcoated tablets

Oral use

NL - Netherlands

Ceft Limited

65 Delamere Road, Hayes

Middlesex UB4 0NN Belgium

Natriumrisedronaat Ceft 5 mg

5 mg

filmcoated tablets

Oral use

NL - Netherlands

Sandoz B.V., Veluwezoom 22 1327 AH Almere Netherlands

Natriumrisedronaat Sandoz® wekelijks 35 mg

35 mg

filmcoated tablets

Oral use

NL - Netherlands

Centrafarm Services B.V.

Nieuwe Donk 9

47879 AC Etten-Leur Netherlands

Risedronaatnatrium CF 30 mg

30 mg

filmcoated tablets

Oral use

NL - Netherlands

Centrafarm Services B.V.

Nieuwe Donk 9

47879 AC Etten-Leur Netherlands

Risedronaatnatrium CF wekelijks 35 mg

35 mg

filmcoated tablets

Oral use

NL - Netherlands

Centrafarm Services B.V.

Nieuwe Donk 9

47879 AC Etten-Leur Netherlands

Risedronaatnatrium CF 5 mg

5 mg

filmcoated tablets

Oral use

NL - Netherlands

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten Netherlands

Risedronaatnatrium Mylan 5 mg

5 mg

filmcoated tablets

Oral use

NL - Netherlands

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten Netherlands

Risedronaatnatrium Mylan Wekelijks 35 mg

35 mg

filmcoated tablets

Oral use

NL - Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem Netherlands

Risedronaatnatrium Wekelijks 35 mg PCH

35 mg

filmcoated tablets

Oral use

NL - Netherlands

Warner Chilcott Nederland BV

Lichtenauerlaan 102-120

3062 ME Rotterdam Netherlands

ActoCalD tabletten 35 mg + 500 mg / 400 IE filmomhulde tabletten, combinatieverpakking

35 mg + 500 mg / 400 IE

filmcoated tablets

Oral use

NL - Netherlands

Warner Chilcott Nederland BV

Lichtenauerlaan 102-120

3062 ME Rotterdam Netherlands

Actonel® 75 mg, filmomhulde tabletten

75 mg

filmcoated tablets

Oral use

NO - Norway

Sanofi-aventis, Strandveien 15, 1366 Lysaker Norway

Optinate

5 mg

Film-coated tablet

Oral use

NO - Norway

Sanofi-aventis, Strandveien 15, 1366 Lysaker Norway

Optinate

30 mg

Film-coated tablet

Oral use

NO - Norway

Sanofi-aventis, Strandveien 15, 1366 Lysaker Norway

Optinate Septimum

35 mg

Film-coated tablet

Oral use

NO - Norway

Orifarm Energivej 15, POB 69, DK-5260 Odense S Danmark

Risedronat Orifarm

5 mg

Film-coated tablet

Oral use

NO - Norway

Orifarm Energivej 15, POB 69, DK-5260 Odense S Danmark

Risedronat Orifarm

30 mg

Film-coated tablet

Oral use

NO - Norway

Orifarm Energivej 15, POB 69, DK-5260 Odense S Danmark

Risedronat Orifarm

35 mg

Film-coated tablet

Oral use

NO - Norway

Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054 Ksawerow, Poland

Norifaz

35 mg

Film-coated tablet

Oral use

NO - Norway

Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Risedronat Actavis

35 mg

Film-coated tablet

Oral use

NO - Norway

Teva Sweden AB, Box 1070, 25110 Helsingborg, Sweden

Risedronat Teva

35 mg

Film-coated tablet

Oral use

NO - Norway

Mylan AB, Box 23033, 10435 Stockholm, Sweden

Vionate

35 mg

Film-coated tablet

Oral use

PL - Poland

Sanofi-Aventis AB

Gustavslundsvägen 139

Box 14142

167 14 BROMMA, Sweden

Actonel

5 mg

film coated tablets

Oral use

PL - Poland

Ranbaxy (Poland) Sp. z o.o.

Kubickiego st. 11,

02-954 Warsaw, Poland

Resorpate

35 mg

film coated tablets

Oral use

PL - Poland

Sanofi-Aventis AB

Gustavslundsvägen 139

Box 14142

167 14 BROMMA, Sweden

Actonel

30 mg

film coated tablets

Oral use

PL - Poland

Sanofi-Aventis AB

Gustavslundsvägen 139

Box 14142

167 14 BROMMA, Sweden

Actonel

35 mg

film coated tablets

Oral use

PL - Poland

ZENTIVA, k.s.

U kabelovny 130, Dolní Měcholupy 102 37 Praga 10, Czech Republic

Risendros 35

35 mg

film coated tablets

Oral use

PL - Poland

Actavis Group PTC ehf.

Reykjavikurvegi 76-78

220 Hafnarfirdi, Iceland

Bifodron

35 mg

film coated tablets

Oral use

PL - Poland

Teva Pharmaceuticals Polska Sp. z o.o.

53 Emilii Plater St.,

00-113, Warsaw, Poland

Nofemix

35 mg

film coated tablets

Oral use

PL - Poland

Zakład Farmaceutyczny Adamed Pharma S.A.

Szkolna st. 33,

95-054 Ksawerów, Poland

Norifaz

35 mg

film coated tablets

Oral use

PL - Poland

Vale Pharmaceuticals Ltd

1G Gurtnafleur Business Park,

Gurtnafleur, Clonmel, Co. Tipperary, Ireland

Rigat

35 mg

film coated tablets

Oral use

PL - Poland

ratiopharm GmbH

Graf-Arco-Strasse 3, Ulm, 89073, Germany

Risedronat-ratiopharm

35 mg

film coated tablets

Oral use

PL - Poland

Labormed Pharma S.A.

Bd. Theodor Pallady nr. 44B, sector 3, Bucharest, Romania

Juverital

5 mg

film coated tablets

Oral use

PL - Poland

Labormed Pharma S.A.

Bd. Theodor Pallady nr. 44B, sector 3, Bucharest, Romania

Juverital

35 mg

film coated tablets

Oral use

PL - Poland

Galex d.d.

Tišinska ul. 29g,

9000 Murska Sobota, Slovenia

Risedrolex 35 mg

35 mg

film coated tablets

Oral use

PT - Portugal

Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, 2740-244 Porto Salvo Portugal

Actonel

5 mg

Film-coated tablet

Oral use

PT - Portugal

Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, 2740-244 Porto Salvo Portugal

Actonel

30 mg

Film-coated tablet

Oral use

PT - Portugal

Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, 2740-244 Porto Salvo Portugal

Actonel 35 mg

35 mg

Film-coated tablet

Oral use

PT - Portugal

Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, 2740-244 Porto Salvo Portugal

Norsed

35 mg

Film-coated tablet

Oral use

PT - Portugal

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal

Risedronato de sódio Generis

5 mg

Film-coated tablet

Oral use

PT - Portugal

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal

Risedronato de sódio Generis

30 mg

Film-coated tablet

Oral use

PT - Portugal

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal

Risedronato de sódio Generis

35 mg

Film-coated tablet

Oral use

PT - Portugal

Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5 A - Piso 2, 2740-298 Porto Salvo Portugal

Risedronato de sódio Mepha

35 mg

Film-coated tablet

Oral use

PT - Portugal

Bluepharma Genéricos - Comércio de Medicamentos, S.A. São Martinho do Bispo, 3045-016 Coimbra Portugal

Risedronato de sódio Bluepharma

35 mg

Film-coated tablet

Oral use

PT - Portugal

Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31, 1495-139 Miraflores - Algés Portugal

Risedronato de sódio Pharmakern

35 mg

Coated tablet

Oral use

PT - Portugal

GP - Genéricos Portugueses, Lda. Rua Henrique Paiva Couceiro, 29 - Venda Nova, 2700-451 Amadora Portugal

Risedronato de sódio GP

35 mg

Film-coated tablet

Oral use

PT - Portugal

Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira, 2710-089 Sintra Portugal

Risedronato de sódio Farmoz

35 mg

Film-coated tablet

Oral use

PT - Portugal

Alter, S.A. Estrada Marco do Grilo - Zemouto, 2830 Coina Portugal

Risedronato de sódio Alter

5 mg

Film-coated tablet

Oral use

PT - Portugal

Alter, S.A. Estrada Marco do Grilo - Zemouto, 2830 Coina Portugal

Risedronato de sódio Alter

30 mg

Film-coated tablet

Oral use

PT - Portugal

Alter, S.A. Estrada Marco do Grilo - Zemouto, 2830 Coina Portugal

Risedronato de sódio Alter

35 mg

Film-coated tablet

Oral use

PT - Portugal

Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico, 4150-174 Porto Portugal

Risedronato de sódio Ranbaxy

35 mg

Film-coated tablet

Oral use

PT - Portugal

Solufarma - Produtos Farmacêuticos Unipessoal, Lda. Av. dos Bombeiros Voluntários, no 146 - 1o, 2765-201 Estoril Portugal

Risedronato de sódio Riseflore

35 mg

Film-coated tablet

Oral use

PT - Portugal

Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B, 1549-005 Lisboa Portugal

Risedronato de sódio Medilusa

35 mg

Film-coated tablet

Oral use

PT - Portugal

ISUS - Produtos Farmacêuticos e Cosméticos, S.A. Rua António Quadros, 9G - Escritório 3, 1600-875 Lisboa Portugal

Risedronato de sódio Rizat

35 mg

Film-coated tablet

Oral use

PT - Portugal

Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo, 3465-157 Santiago de Besteiros Portugal

Risedronato de sódio Labesfal

35 mg

Film-coated tablet

Oral use

PT - Portugal

Cinfa Portugal, Lda. Av. Tomás Ribeiro, 43 - Bloco 1, 4o B - Edifício Neopark, 2790-221 Carnaxide Portugal

Risedronato de sódio Cinfa

35 mg

Film-coated tablet

Oral use

PT - Portugal

Laboratórios Atral, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio Atral

5 mg

Film-coated tablet

Oral use

PT - Portugal

Laboratórios Atral, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio Atral

30 mg

Film-coated tablet

Oral use

PT - Portugal

Laboratórios Atral, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio Atral

35 mg

Film-coated tablet

Oral use

PT - Portugal

Vida - Produtos Farmacêuticos, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio Vida

5 mg

Film-coated tablet

Oral use

PT - Portugal

Vida - Produtos Farmacêuticos, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio Vida

30 mg

Film-coated tablet

Oral use

PT - Portugal

Vida - Produtos Farmacêuticos, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio Vida

35 mg

Film-coated tablet

Oral use

PT - Portugal

Decomed Farmacêutica, S.A. Rua Sebastião e Silva, 56, 2745-838 Massamá Portugal

Zectoel

5 mg

Film-coated tablet

Oral use

PT - Portugal

Decomed Farmacêutica, S.A. Rua Sebastião e Silva, 56, 2745-838 Massamá Portugal

Zectoel

30 mg

Film-coated tablet

Oral use

PT - Portugal

Decomed Farmacêutica, S.A. Rua Sebastião e Silva, 56, 2745-838 Massamá Portugal

Zectoel

35 mg

Film-coated tablet

Oral use

PT - Portugal

Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide Portugal

Risedronato de sódio Germed

5 mg

Film-coated tablet

Oral use

PT - Portugal

Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide Portugal

Risedronato de sódio Germed

30 mg

Film-coated tablet

Oral use

PT - Portugal

Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide Portugal

Risedronato de sódio Germed

35 mg

Film-coated tablet

Oral use

PT - Portugal

Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, 2740-244 Porto Salvo Portugal

Actonel

75 mg

Film-coated tablet

Oral use

PT - Portugal

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia

Risedronato de sódio Actavis

35 mg

Film-coated tablet

Oral use

PT - Portugal

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal

Norifaz

35 mg

Film-coated tablet

Oral use

PT - Portugal

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso, 2790-143 Carnaxide Portugal

Risedronato de sódio Ratiopharm

35 mg

Film-coated tablet

Oral use

PT - Portugal

Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo, 1499-016 Algés Portugal

Risedronato de sódio Mylan

5 mg

Film-coated tablet

Oral use

PT - Portugal

Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo, 1499-016 Algés Portugal

Risedronato de sódio Mylan

35 mg

Film-coated tablet

Oral use

PT - Portugal

Qualigen, S.L. Avenida Barcelona, 69, Sant Joan Despí, 08970 Barcelona Espanha

Risedronato de sódio Qualigen

35 mg

Film-coated tablet

Oral use

PT - Portugal

Teva Pharma - Produtos Farmacêuticos, Lda. Edifício Cyprium, Av. 25 de Abril, 15, 2o F, 2795-195 Linda-a-Velha Portugal

Risedronato de sódio Teva

35 mg

Film-coated tablet

Oral use

PT - Portugal

Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15, 2710-693 Sintra Portugal

Risedronato de sódio Sandoz

35 mg

Film-coated tablet

Oral use

PT - Portugal

Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15, 2710-693 Sintra Portugal

Risedronato de sódio 1APharma

35 mg

Film-coated tablet

Oral use

PT - Portugal

Ciclum Farma Unipessoal, Lda. Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B, 2770-229 Paço de Arcos Portugal

Risedronato de sódio Ciclum

35 mg

Film-coated tablet

Oral use

PT - Portugal

Ciclum Farma Unipessoal, Lda. Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B, 2770-229 Paço de Arcos Portugal

Risedronato de sódio Ciclum

5 mg

Film-coated tablet

Oral use

PT - Portugal

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia

Claronate

5 mg

Film-coated tablet

Oral use

PT - Portugal

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia

Claronate

30 mg

Film-coated tablet

Oral use

PT - Portugal

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia

Claronate

35 mg

Film-coated tablet

Oral use

PT - Portugal

Arrow Generics, Ltd. Unit 2 - Eastman Way, SG1 4SZ Stevenage - Hertfordshire Reino Unido

Risedronato de sódio Arrow

35 mg

Tablet

Oral use

PT - Portugal

Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054 Ksawerow, Poland

Norifaz, 35 mg, comprimidos revestidos por pelicula

35 mg

film coated tablets

Oral use

RO - Romania

AVENTIS PHARMA AB Bryggvagen 16-18, 11768 Stockholm, Sweden

ACTONEL 5 mg film coated tablets

5 mg

film coated tablets

Oral use

RO - Romania

SANOFI-AVENTIS ROMÂNIA S.R.L.

Str. Izvor, nr 80, etajele 6-11, sector 5 Bucharest, Romania

ACTONEL SAPTAMANAL 35 mg film coated tablets

35 mg

film coated tablets

Oral use

RO - Romania

SANOFI-AVENTIS ROMÂNIA S.R.L.

Str. Izvor, nr 80, etajele 6-11, sector 5 Bucharest, Romania

ACTONEL 75 mg film coated tablets

75 mg

film coated tablets

Oral use

RO - Romania

TERAPIA SA Str. Fabricii nr. 124, Cluj-Napoca, Romania

OSODENS 35 mg film coated tablets

35 mg

film coated tablets

Oral use

RO - Romania

ZENTIVA, k.s.

U kabelovny 130, Dolní Měcholupy 102 37 Praga 10, Czech Republic

RISENDROS 35 mg film coated tablets

35 mg

film coated tablets

Oral use

RO - Romania

Actavis Group PTC ehf Reykjavikurvegi 76-78, 220 Hafnarfjordur, Island

OSTEORON 35 mg film coated tablets

35 mg

film coated tablets

Oral use

RO - Romania

Antibiotice S.A. Valea Lupului nr. 1, 707410 Iași, Romania

LORINE 35 mg film coated tablets

35 mg

film coated tablets

Oral use

RO - Romania

TEVA PHARMACEUTICALS S.R.L. Str. Domnița Ruxandra, nr. 12 parter, sector 2București, Romania

RISEDRONAT TEVA 35 mg film coated tablets

35 mg

film coated tablets

Oral use

RO - Romania

STADA Hemofarm SRL Zugrav Nedelcu nr. 3, Timișoara, Romania

RISEDRONAT SODIC HF 35 mg, film coated tablets

35 mg

film coated tablets

Oral use

RO - Romania

LABORMED PHARMA S.A.

Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

JUVERITAL 5 mg film coated tablets

5 mg

film coated tablets

Oral use

RO - Romania

LABORMED PHARMA S.A.

Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

JUVERITAL 35 mg film coated tablets

35 mg

film coated tablets

Oral use

RO - Romania

Sanofi-aventis AB Gustavslundsvägen 139, Box 141 42, 167 14 Bromma, Sweden

ACTONEL COMBI D 35 mg + 500 mg/400 UI film coated tablets

35 mg + 500 mg/400 UI

film coated tablets

Oral use

SE - Sweden

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom

Fortipan

5 mg

film-coated tablet

Oral use

SE - Sweden

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom

Fortipan

30 mg

film-coated tablet

Oral use

SE - Sweden

Sanofi-aventis AB Box 14142 167 14 Bromma Sweden

Optinate

5 mg

film-coated tablet

Oral use

SE - Sweden

Sanofi-aventis AB Box 14142 167 14 Bromma Sweden

Optinate

30 mg

film-coated tablet

Oral use

SE - Sweden

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Avestra

5 mg

film-coated tablet

Oral use

SE - Sweden

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Avestra

30 mg

film-coated tablet

Oral use

SE - Sweden

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Norsed

5 mg

film-coated tablet

Oral use

SE - Sweden

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Norsed

30 mg

film-coated tablet

Oral use

SE - Sweden

Sanofi-aventis AB Box 14142 167 14 Bromma Sweden

Optinate Septimum

35 mg

film-coated tablet

Oral use

SE - Sweden

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom

Fortipan Septimum

35 mg

film-coated tablet

Oral use

SE - Sweden

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Avestra Septimum

35 mg

film-coated tablet

Oral use

SE - Sweden

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Norsed Septimum

35 mg

film-coated tablet

Oral use

SE - Sweden

Sanofi-aventis AB Box 14142 167 14 Bromma Sweden

Optinate Combi

35 mg + 1 250 mg calcium

film-coated tablet

Oral use

SE - Sweden

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Avestra Combi

35 mg + 1 250 mg calcium

film-coated tablet

Oral use

SE - Sweden

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Norsed Combi

35 mg + 1 250 mg calcium

film-coated tablet

Oral use

SE - Sweden

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom

Fortipan Combi

35 mg + 1 250 mg calcium

film-coated tablet

Oral use

SE - Sweden

Sanofi-aventis AB Box 14142 167 14 Bromma Sweden

Optinate Combi D

35 mg + 1 000 mg/880 IE

film-coated tablet and effervescent granules

Oral use

SE - Sweden

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom

Fortipan Combi D

35 mg + 1 000 mg/880 IE

film-coated tablet and effervescent granules

Oral use

SE - Sweden

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Avestra Combi D

35 mg + 1 000 mg/880 IE

film-coated tablet and effervescent granules

Oral use

SE - Sweden

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Norsed Combi D

35 mg + 1 000 mg/880 IE

film-coated tablet and effervescent granules

Oral use

SE - Sweden

Sanofi-aventis AB Box 14142 167 14 Bromma Sweden

Optinate

75 mg

film-coated tablet

Oral use

SE - Sweden

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Norsed

75 mg

film-coated tablet

Oral use

SE - Sweden

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Norsed Combi D

35 mg + 500 mg/400 IE

film-coated tablet

Oral use

SE - Sweden

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Avestra Combi D

35 mg + 500 mg/400 IE

film-coated tablet

Oral use

SE - Sweden

Ranbaxy (UK) Ltd 3rd floor, CP house 97-107, Uxbridge Road Ealing, London W5 5TL United Kngdom

Risedronate Ranbaxy

35 mg

film-coated tablet

Oral use

SE - Sweden

Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Danmark

Risedronat Sandoz

35 mg

film-coated tablet

Oral use

SE - Sweden

Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Risedronat Orifarm

5 mg

film-coated tablet

Oral use

SE - Sweden

Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Risedronat Orifarm

30 mg

film-coated tablet

Oral use

SE - Sweden

Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Risedronat Orifarm

35 mg

film-coated tablet

Oral use

SE - Sweden

Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany

Riseratio

35 mg

film-coated tablet

Oral use

SE - Sweden

Teva Sweden AB Box 1070 251 10 Helsingborg Sweden

Risedronat Teva

35 mg

film-coated tablet

Oral use

SE - Sweden

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom

Fortipan

75 mg

film-coated tablet

Oral use

SE - Sweden

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Avestra

75 mg

film-coated tablet

Oral use

SE - Sweden

sanofi-aventis AB Box 14142 167 14 Bromma Sweden

Optinate Combi D

35 mg + 500 mg/400 IE

film-coated tablet

Oral use

SE - Sweden

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom

Fortipan Combi D

35 mg + 500 mg/400 IE

film-coated tablet

Oral use

SE - Sweden

Zaklad Farmaceutyczny Adamed Pharma S.A., ul. Szkolna 33 95-054 Ksawerow, Polen

Risedronat Adamed Pharma

35 mg

film-coated tablet

Oral use

SI - Slovenia

Sanofi-aventis d.o.o., Dunajska cesta 151, SI-1000 Ljubljana

Actonel 30 mg filmsko obložene tablete

30 mg

film-coated tablet

Oral use

SI - Slovenia

Sanofi-aventis d.o.o., Dunajska cesta 151, SI-1000 Ljubljana

Actonel 5 mg filmsko obložene tablete

5 mg

film-coated tablet

Oral use

SI - Slovenia

Sanofi-aventis d.o.o., Dunajska cesta 151, SI-1000 Ljubljana

Actonel 75 mg filmsko obložene tablete

75 mg

film-coated tablet

Oral use

SI - Slovenia

Sanofi-aventis d.o.o., Dunajska cesta 151, SI-1000 Ljubljana

Actonel enkrat tedensko 35 mg filmsko obložene tablete

35 mg

film-coated tablet

Oral use

SI - Slovenia

Sanofi-aventis d.o.o., Dunajska cesta 151, SI-1000 Ljubljana

Actonel Combi D

35 mg + 1 000 mg/880 IE

film-coated tablet and effervescent granules

Oral use

SI - Slovenia

Galex, d.d., Tišinska ulica 29g, Murska Sobota, Slovenia

Riserdonat Galex 35 mg filmsko obložene tablete

35 mg

film-coated tablet

Oral use

SK - Slovakia

STADA Arzneimittel AG Stadastrasse 2-18 Bad Vilbel, 61118 Germany

Risedronat STADA 35 mg

35 mg

Film coated tablet

Oral use

SK - Slovakia

Actavis Group PTC ehf Dalshraun 1 220 Hafnarfjordur Iceland

Bifodron 35 mg

35 mg

Film coated tablet

Oral use

SK - Slovakia

Zaklad Farmaceutyczny Adamed Pharma SA 33 Szkolna Street Ksawerów, 95-054 Poland

Norifaz 35 mg

35 mg

Film coated tablet

Oral use

SK - Slovakia

Gedeon Richter Plc. Gyômrôi út 19-21 1103, Budapest Hungary

Nurrid 35 mg

35 mg

Film coated tablet

Oral use

SK - Slovakia

ZENTIVA, k.s. U kabelovny 130, Dolní Měcholupy 102 37 Praga 10, Czech Republic

RISENDROS 35 mg - TBL FLM

35 mg

film-coated tablets

Oral use

SK - Slovakia

LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

Juverital

5 mg

Film-coated tablets

Oral use

SK - Slovakia

LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

Juverital

35 mg

Film-coated tablets

Oral use

SK - Slovakia

Sanofi-aventis Slovakia s.r.o.

Einsteinova 24

SK – 851 01 BRATISLAVA

ACTONEL 5 MG

5 mg

Film coated tablet

Oral use

SK - Slovakia

Sanofi-aventis Slovakia s.r.o.

Einsteinova 24

SK – 851 01 BRATISLAVA

ACTONEL 75 MG

75 mg

Film coated tablet

Oral use

SK - Slovakia

Sanofi-aventis Slovakia s.r.o.

Einsteinova 24

SK – 851 01 BRATISLAVA

ACTONEL COMBI

35 mg + 500 mg/400 UI

film coated tablets

Oral use

SK - Slovakia

TEVA Pharmaceuticals Slovakia s.r.o.,

Teslova 26,

82102 Bratislava,

Slovak Republic

Risedronat Teva 35 mg filmom obalené tablety

35 mg

Film coated tablet

Oral use

UK - United Kingdom

Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

Risedronate sodium 35 mg tablets

35 mg

film-coated tablet

Oral use

UK - United Kingdom

Sandoz Limited, 37 Woolmer Way, Bordon, Hampshire GU35 9QE

Risedronate sodium 35 mg tablets

35 mg

film-coated tablet

Oral use

UK - United Kingdom

Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL

Risedronate sodium 5 mg tablets

5 mg

film-coated tablet

Oral use

UK - United Kingdom

Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL

Risedronate sodium 35 mg tablets

35 mg

film-coated tablet

Oral use

UK - United Kingdom

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK

Actonel 5 mg Tablets

5 mg

film-coated tablet

Oral use

UK - United Kingdom

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK

Actonel 30 mg Tablets

30 mg

film-coated tablet

Oral use

UK - United Kingdom

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK

Actonel Once a Week 35 mg Tablet

35 mg

film-coated tablet

Oral use

UK - United Kingdom

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK

Actonel Combi 35 mg film-coated tablets + 1 000 mg / 880 IU effervescent granules

35 mg + 1 000 mg/880 IE

film-coated tablet and effervescent granules

Oral use

UK - United Kingdom

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK

Actonel 75 mg tablet

75 mg

film-coated tablet

Oral use

UK - United Kingdom

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK

Actonel Combi 35 mg + 500 mg / 400 IU film-coated tablets

35 mg + 500 mg/400 UI

film-coated tablet

Oral use

UK - United Kingdom

Winthrop Pharmaceuticals UK Ltd, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Norsed Once a Week

35 mg

film-coated tablet

Oral use

UK - United Kingdom

Ranbaxy (UK) Limited, 95 Park Lane, Mayfair. London W1K 7TE, United Kingdom

Risedronate sodium 35 mg tablets

35 mg

film-coated tablet

Oral use

UK - United Kingdom

Ratiopharm GmbH, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hampshire, PO6 1UP

Risedronate sodium 35 mg tablets

35 mg

film-coated tablet

Oral use

UK - United Kingdom

Pharmathen SA, 6 Dervenakion Street, Pallini, Athens, GR-153 51, Greece

Risedronate sodium 5 mg tablets

5 mg

film-coated tablet

Oral use

UK - United Kingdom

Pharmathen SA, 6 Dervenakion Street, Pallini, Athens, GR-153 51, Greece

Risedronate sodium 30 mg tablets

30 mg

film-coated tablet

Oral use

UK - United Kingdom

Pharmathen SA, 6 Dervenakion Street, Pallini, Athens, GR-153 51, Greece

Risedronate sodium 35 mg tablets

35 mg

film-coated tablet

Oral use

UK - United Kingdom

Beacon Pharmaceuticals Ltd, 85 High Street, Tunbridge Wells, Kent TN1 1YG, UK

Risedronate sodium 5 mg tablets

5 mg

film-coated tablet

Oral use

UK - United Kingdom

Beacon Pharmaceuticals Ltd, 85 High Street, Tunbridge Wells, Kent TN1 1YG, UK

Risedronate sodium 30 mg tablets

30 mg

film-coated tablet

Oral use

UK - United Kingdom

Beacon Pharmaceuticals Ltd, 85 High Street, Tunbridge Wells, Kent TN1 1YG, UK

Risedronate sodium 35 mg tablets

35 mg

film-coated tablet

Oral use

UK - United Kingdom

Zaklad Farmaceutyczny Adamed Pharma SA, ul. Szkolna 33, 95-054 Ksawerow, Poland

Norifaz 35 mg tablet

35 mg

film-coated tablet

Oral use

UK - United Kingdom

Apotex Europe BV, Darwinweg 20, 2333 C R Leiden, The Netherlands

Risedronate sodium 35 mg tablets

35 mg

film-coated tablet

Oral use


Tiludronic acid 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

BE - Belgium

Sanofi-Aventis Belgium NV

Culliganlaan 1C

1831 Diegem

Belgium

Skelid

200 mg

Tablets

Oral use

ES - Spain

SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona

SKELID 200 mg comprimidos

200 mg

tablets

Oral use

FR - France

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

ACIDE TILUDRONIQUE SANOFI PHARMA 200 mg, comprimé

200 mg

tablet

Oral use

FR - France

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

SKELID 200 mg, comprimé

200 mg

tablet

Oral use

LU - Luxembourg

Sanofi-Aventis Belgium NV

Culliganlaan 1C

1831 Diegem

Belgium

Skelid

200 mg

Tablets

Oral use

UK - United Kingdom

Sanofi-Synthelabo Limited, One Onslow Street, Guildford, Surry GU1 4YS, UK

Skelid

200 mg

tablet

Oral use


Ibandronic acid 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

DE - Germany

Mylan dura GmbH

Wittichstr. 6

D-64295 Darmstadt

Ibandronsäure dura 150 mg Filmtabletten

169,32 mg

Film-coated tablet

Oral use

DE - Germany

Orifarm Generixs A/S

Energivej 15

DK-7260ODENSE S

Denmark

Ibandronat Orifarm 50 mg Filmtabletten

65,4 mg

Film-coated tablet

Oral use

DK - Denmark

Pharmathen S.A., 6, Dervenakion str., GR-15351 Pallini Attiki, Greece

Baxogar

150 mg

Filmcoated-tablets

Oral use

DK - Denmark

Gedeon Richter Plc., Gyömröí út 19-21, HU-1103 Budapest, Hungary

Etanorden

50 mg

Filmcoated-tablets

Oral use

DK - Denmark

Gedeon Richter Plc., Gyömröí út 19-21, HU-1103 Budapest, Hungary

Etanorden

150 mg

Filmcoated-tablets

Oral use

DK - Denmark

Mylan AB, Postbox 230 33, Ynglingagatan 14, Se-104 35 Stockholm, Sweden

Ibamyl

150 mg

Filmcoated-tablets

Oral use

DK - Denmark

Actavis Group PTC ehf., Postbox 425, Reykjavikurvegi 76-78, IS-220 Hafnarfjördur, Iceland

Ibandronat "Actavis"

50 mg

Filmcoated-tablets

Oral use

DK - Denmark

Actavis Group PTC ehf., Postbox 425, Reykjavikurvegi 76-78, IS-220 Hafnarfjördur, Iceland

Ibandronat "Actavis"

150 mg

Filmcoated-tablets

Oral use

DK - Denmark

Arrow ApS, Hovedgaden 41, 2, DK-2970 Hørsholm, Denmark

Ibandronate "Arrow"

150 mg

Tablets

Oral use

DK - Denmark

Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S, Denmark

Ibandronate "Orifarm"

50 mg

Filmcoated-tablets

Oral use

DK - Denmark

ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany

Ibandronate "ratiopharm"

50 mg

Filmcoated-tablets

Oral use

DK - Denmark

ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany

Ibandronate "ratiopharm"

150 mg

Filmcoated-tablets

Oral use

DK - Denmark

Pharmathen S.A., 6, Dervenakion str., GR-15351 Pallini Attiki, Greece

Quodixor

150 mg

Filmcoated-tablets

Oral use

DK - Denmark

Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S, Denmark

Ibandronate "Orifarm"

50 mg

Filmcoated-tablets

Oral use

FI - Finland

Arrow Pharma ApS, Hovedgaden 41. 2. sal, 2970 HØRSHOLM, Denmark

Ibandronate Arrow

150 mg

tablet

Oral use

FI - Finland

Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark

Ibandronate Orifarm

50 mg

film-coated tablet

Oral use

FI - Finland

Ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany

Ibandronate ratiopharm

150 mg

film-coated tablet

Oral use

FI - Finland

Ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany

Ibandronate ratiopharm

50 mg

film-coated tablet

Oral use

FI - Finland

Gedeon Richter Plc, Gyömrõi út 19-21, 1103 Budabest, Hungary

Etanorden

150 mg

film-coated tablet

Oral use

FI - Finland

Mylan AB, BOX 23033, 10435 STOCKHOLM, Sweden

Ibamyl

150 mg

film-coated tablet

Oral use

FR - France

GEDEON RICHTER

Gyömroi ut 19-21

1103 Budapest X

HONGRIE

KALOSSO 50 mg, comprimé pelliculé

50 mg

tablet

Oral use

FR - France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

FRANCE

ACIDE IBANDRONIQUE MYLAN 150 mg, comprimé pelliculé

150 mg

tablet

Oral use

FR - France

GEDEON RICHTER

Gyömroi ut 19-21

1103 Budapest X

HONGRIE

ETANORDEN 150 mg, comprimé pelliculé

150 mg

tablet

Oral use

FR - France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

FRANCE

IBANDROMYLAN 150 mg, comprimé pelliculé

150 mg

tablet

Oral use

FR - France

GEDEON RICHTER

Gyömroi ut 19-21

1103 Budapest X

HONGRIE

KALOSSO 150 mg, comprimé pelliculé

150 mg

tablet

Oral use

IS - Iceland

Portfarma ehf., Borgartúni 26, 105 Reykjavík, Iceland

Ziveteno

150 mg

Film-coated tablet

Oral use

LT - Lithuania

Gedeon Richter Plc., 1103 Budapest Gyömrői út 19-21, Hungary

Etanorden

150 mg

Film-coated tablet

Oral use

PT - Portugal

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal

Ácido Ibandrónico Generis

150 mg

Film-coated tablets

Oral use

PT - Portugal

Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5 A - Piso 2, 2740-298 Porto Salvo Portugal

Ácido ibandrónico Ombene

150 mg

Film-coated tablets

Oral use

PT - Portugal

Optimal Regulatory Solutions, S.L. Via Augusta, 59, 08006 Barcelona Espanha

Ácido ibandrónico Orsfelt

150 mg

Film-coated tablets

Oral use

PT - Portugal

Ciclum Farma Unipessoal, Lda. Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B, 2770-229 Paço de Arcos Portugal

Ácido ibandrónico Ciclum

150 mg

Film-coated tablets

Oral use

PT - Portugal

Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31, 1495-139 Miraflores - Algés Portugal

Ácido Ibandrónico Pharmakern

150 mg

Film-coated tablets

Oral use

PT - Portugal

Gedeon Richter, Plc. Gyömröi út, 19-21, H-1103 Budapest Hungria

Etanorden

150 mg

Film-coated tablets

Oral use

PT - Portugal

Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo, 1499-016 Álges Portugal

Ácido Ibandrónico Mylan

150 mg

Film-coated tablets

Oral use

PT - Portugal

Arrow ApS Hovedgaden 41, 2, 2970 Horsholm Dinamarca

Ácido Ibandrónico Arrow

150 mg

Tablets

Oral use

PT - Portugal

Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15, 2710-693 Sintra Portugal

Ácido Ibandrónico Sandoz

150 mg

Film-coated tablets

Oral use

PT - Portugal

Pharmathen - Pharmaceutical Industry, S.A. 6, Dervenakion Street, GR-15351 Pallini Attiki Grécia

Quodixor

150 mg

Film-coated tablets

Oral use

SE - Sweden

Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Ibandronate Orifarm

50 mg

film-coated tablet

Oral use

SI - Slovenia

Generics UK Ltd., Station Close, Potters Bar, Hertford Shire EN6 1AG, UK

Ibandronska kislina Mylan 150 mg filmsko obložene tablete

150 mg

film-coated tablet

Oral use


ANNEX VI

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

Member State

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of administration

Austria

Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml - Peritonealdialyselösung

Anhydrous glucose 13,6 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L

Solution for peritoneal dialysis

Intraperitoneal use

Austria

Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml - Peritonealdialyselösung

Anhydrous glucose 22,7 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L

Solution for peritoneal dialysis

Intraperitoneal use

Austria

Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria

Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml - Peritonealdialyselösung

Anhydrous glucose 38,6 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L

Solution for peritoneal dialysis

Intraperitoneal use

Austria

Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria

EXTRANEAL - Peritonealdialyselösung

75 g/L

Solution for peritoneal dialysis

Intraperitoneal use

Belgium

Baxter SA

Bld R Branquart 80

7860 Lessines

Belgium

Dianeal PD4 Glucose 1,36 % (13,6 mg/ml), solution pour dialyse péritonéale.

13,6 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

Belgium

Baxter SA

Bld R Branquart 80

7860 Lessines

Belgium

Dianeal PD4 Glucose 2,27 % (22,7 mg/ml), solution pour dialyse péritonéale.

22,7 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

Belgium

Baxter SA

Bld R Branquart 80

7860 Lessines

Belgium

Dianeal PD4 Glucose 3,86 % (38,6 mg/ml), solution pour dialyse péritonéale.

38,6 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

Belgium

Baxter SA

Bld R Branquart 80

7860 Lessines

Belgium

EXTRANEAL 7,5 %, solution pour dialyse péritonéale

75,00 g/l Icodextrine

Solution for peritoneal dialysis

Intraperitoneal use

Bulgaria

BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia

Dianeal PD4 Glucose

2,27 % w/v/22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Bulgaria

BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia

Dianeal PD4 Glucose

3,86 % w/v/38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Bulgaria

BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml

1,36 % w/v/13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Bulgaria

BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia

Extraneal

7,50 %

Solution for peritoneal dialysis

Intraperitoneal use

Czech Republic

Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml

1,36 % w/v/13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Czech Republic

Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml

2,27 % w/v/22,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Czech Republic

Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland

Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml

3,86 % w/v/38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Czech Republic

Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland

EXTRANEAL

7,5 % 75 g/1 000 ml

Solution for peritoneal dialysis

Intraperitoneal use

Denmark

Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark

Dianeal PD4 med Glucos

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Denmark

Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark

Dianeal PD4 med Glucos

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Denmark

Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark

Dianeal PD4 med Glucos

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Denmark

Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark

Extraneal

75 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Estonia

Baxter OY P.O box 270, Valimotie 15A, Helsinki 00381 Finland

EXTRANEAL

7,50 %

Solution for peritoneal dialysis

Intraperitoneal use

Finland

Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland

Dianeal PD4 Glucose

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Finland

Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland

Dianeal PD4 Glucose

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Finland

Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland

Dianeal PD4 Glucose

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Finland

Baxter Oy Valimotie 15 A 00380 Helsinki Finland

Extraneal

7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

France

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

DIANEAL PD4 GLUCOSE 1,36 %, solution pour dialyse péritonéale en poche

1,36 %

Solution for peritoneal dialysis

Intraperitoneal use

France

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

DIANEAL PD4 GLUCOSE 2,27 %, solution pour dialyse péritonéale en poche

2,27 %

Solution for peritoneal dialysis

Intraperitoneal use

France

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

DIANEAL PD4 GLUCOSE 3,86 %, solution pour dialyse péritonéale en poche

3,86 %

Solution for peritoneal dialysis

Intraperitoneal use

France

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

EXTRANEAL, solution pour dialyse péritonéale

7,50 %

Solution for peritoneal dialysis

Intraperitoneal use

Germany

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD4 Glucose 1,36 % w/v

13,6 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Germany

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD4 Glucose 2,27 % w/v

22,7 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Germany

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD4 Glucose 3,86 % w/v

38,6 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Germany

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG4 1,36 %

13,6 g/l

5,38 g/l

4,48 g/l

0,184 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Germany

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG4 2,27 %

22,7 g/l

5,38 g/l

4,48 g/l

0,184 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Germany

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD4 Glucose 3,86 % w/v

38,6 g/l

5,38 g/l

4,48 g/l

0,184 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Germany

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Extraneal

75 g/l

5,4 g/l

4,5 g/l

0,257 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Greece

DIOPHAR S.A.

Kifissias Avenue 368,

Halandri, 152 33

Greece

DIANEAL PD4

1,36 %

Solution for peritoneal dialysis

Intraperitoneal use

Greece

DIOPHAR S.A.

Kifissias Avenue 368,

Halandri, 152 33

Greece

EXTRANEAL

(7,5 + 0,54 + 0,45 + 0,0257 + 0,0051) % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Hungary

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 1,36 % peritoneális dializáló oldat

1,36 %

Solution for peritoneal dialysis

Intraperitoneal use

Hungary

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 2,27 % peritoneális dializáló oldat

2,27 %

Solution for peritoneal dialysis

Intraperitoneal use

Hungary

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 3,86 % peritoneális dializáló oldat

3,86 %

Solution for peritoneal dialysis

Intraperitoneal use

Hungary

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

EXTRANEAL peritoneális dializáló oldat

7,5 % (icodextrin)

Solution for peritoneal dialysis

Intraperitoneal use

Iceland

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 Glucose

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Iceland

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 Glucose

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Iceland

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 Glucose

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Ireland

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Dianeal PD4 Glucose 1,36 % w/v (13,6 mg/ml) Solution for peritoneal dialysis

1,36 % w/v (13,6 mg/ml)

Solution for peritoneal dialysis

Intraperitoneal use

Ireland

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Dianeal PD4 Glucose 2,27 % w/v (22,7 mg/ml) Solution for peritoneal dialysis

2,27 % w/v (22,7 mg/ml)

Solution for peritoneal dialysis

Intraperitoneal use

Ireland

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Dianeal PD4 Glucose 3,86 % w/v (38,6 mg/ml) Solution for peritoneal dialysis

3,86 % w/v (38,6 mg/ml)

Solution for peritoneal dialysis

Intraperitoneal use

Ireland

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

EXTRANEAL Solution for peritoneal dialysis

 

Solution for peritoneal dialysis

Intraperitoneal use

Italy

Baxter SPA piazzale dell' industria 20 - 00144-Roma

Italy

EXTRANEAL

7,5 %

Solution for dialysis peritoneal

Intraperitoneal use

Italy

Baxter SPA piazzale dell' industria 20 - 00144-Roma

Italy

SOLUZIONI PER DIALISI PERITONEALE BAXTER

4,95 g/l - 49,54 g/l;

Solution for dialysis peritoneal

Intraperitoneal use

Latvia

Baxter Healthcare S.A. Moneen Road

Castlebar

County Mayo

IRELAND

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml solution for peritoneal dialysis

1,36 % w/v 0,538 % w/v 0,448 % w/v 0,0184 % w/v 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Latvia

Baxter Healthcare S.A. Moneen Road

Castlebar

County Mayo

IRELAND

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml solution for peritoneal dialysis

2,27 % w/v

0,538 % w/v 0,448 % w/v

0,0184 % w/v 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Latvia

Baxter Healthcare S.A. Moneen Road

Castlebar

County Mayo

IRELAND

Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml solution for peritoneal dialysis

3,86 % w/v 0,538 % w/v 0,448 % w/v 0,0184 % w/v 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Latvia

Baxter Oy Valimotie 15 A 00380 Helsinki Finland

FINLAND

Extraneal solution for peritoneal dialysis

75 g/L 5,4 g/L 4,5 g/L 0,257 g/L 0,051 g/L

Solution for peritoneal dialysis

Intraperitoneal use

Lithuania

Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland

Dianeal PD4 Glucose

13,6 g + 5,38 g + 4,48 g + 0,184 g + 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Lithuania

Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland

Dianeal PD4 Glucose

22,7 g + 5,38 g + 4,48 g + 0,184 g + 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Lithuania

Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland

Dianeal PD4 Glucose

38,6 g + 5,38 g + 4,48 g + 0,184 g + 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Lithuania

Baxter Oy, P.O. Box 270 Valimotie 15A 00381 Helsinki, Finland

EXTRANEAL

75 g + 5,4 g + 4,5 g + 0,257 g + 0,051 g/1 000 ml

Solution for peritoneal dialysis

Intraperitoneal use

Luxembourg

Baxter SA,

Bd René Branquart 80,

B-7860 Lessines

Belgium

Dianeal PD4 Glucose

1,36 %/2,27 %/3,86 % dextrose anydre

Solution for peritoneal dialysis

Intraperitoneal use

Luxembourg

Baxter SA,

Bd René Branquart 80,

B-7860 Lessines

Belgium

Extraneal

75,00 g/l Icodextrine

Solution for peritoneal dialysis

Intraperitoneal use

Malta

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD4 Glucose 1,36 % w/v 13,6 mg/ml

Anhydrous Glucose Ph.Eur. 1,36 % w/v

or Glucose Monohydrate Ph.Eur. 1,50 % w/v

Sodium Chloride Ph.Eur. 0,538 % w/v

Sodium Lactate Ph.Eur. 0,448 % w/v

Calcium Chloride Ph.Eur. 0,0184 % w/v

Magnesium Chloride Ph.Eur. 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Malta

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD4 Glucose 2,27 % w/v 22,7 mg/ml

Anhydrous Glucose Ph.Eur. 2,27 % w/v

or Glucose Monohydrate Ph.Eur. 2,50 % w/v

Sodium Chloride Ph.Eur. 0,538 % w/v

Sodium Lactate Ph.Eur. 0,448 % w/v

Calcium Chloride Ph.Eur. 0,0184 % w/v

Magnesium Chloride Ph.Eur. 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Malta

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD4 Glucose 3,86 % w/v 38,6 mg/ml

Anhydrous Glucose Ph.Eur. 3,86 % w/v

or Glucose Monohydrate Ph.Eur. 4,25 % w/v

Sodium Chloride Ph.Eur. 0,538 % w/v

Sodium Lactate Ph.Eur. 0,448 % w/v

Calcium Chloride Ph.Eur. 0,0184 % w/v

Magnesium Chloride Ph.Eur. 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Malta

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Extraneal (Icodextrin 7,5 %)

Icodextrin (75 g/l), Sodium chloride (5,4 g/l),

Calcium chloride (0,257 g/l), Magnesium chloride

(0,051 g/l), Sodium lactate solution (4,5 g/l)

Solution for peritoneal dialysis

Intraperitoneal use

Norway

Baxter AS

Gjerdrumsvei 11

0484 Oslo, Norway

Extraneal

75 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Poland

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warsawa, Poland

Dianeal PD4 (glukoza 1,36 %). Zestaw do dializy otrzewnowej

 

Solution for peritoneal dialysis

Intraperitoneal use

Poland

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warsawa, Poland

Dianeal PD4 (glukoza 2,27 %). Zestaw do dializy otrzewnowej

 

Solution for peritoneal dialysis

Intraperitoneal use

Poland

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warsawa, Poland

Dianeal PD4 (glukoza 3,86 %). Zestaw do dializy otrzewnowej

 

Solution for peritoneal dialysis

Intraperitoneal use

Poland

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warsawa, Poland

Extraneal Zestaw do dializy otrzewnowej

 

Solution for peritoneal dialysis

Intraperitoneal use

Poland

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warsawa, Poland

Extraneal Zestaw do dializy otrzewnowej

 

Solution for peritoneal dialysis

Intraperitoneal use

Portugal

Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal

Dianeal Pd4

42,5 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate.

Solution for peritoneal dialysis

Intraperitoneal use

Portugal

Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal

Dianeal Pd4

25 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate.

Solution for peritoneal dialysis

Intraperitoneal use

Portugal

Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal

Dianeal Pd4

15 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate.

Solution for peritoneal dialysis

Intraperitoneal use

Portugal

Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal

Extraneal

75 mg/ml Icodextrin; 5,4 mg/ml Sodium Chloride; 4,5 mg/ml Sodium (S) - lactate solution; 0,051 mg/ml Magnesium Chloride; 0,257 mg/ml Calcium Chloride.

Solution for peritoneal dialysis

Intraperitoneal use

Romania

BAXTER HEALTHCARE S.A.

Moneen Road, Castelbar, County Mayo, Ireland

DIANEAL PD4 GLUCOSE 1,36 % m/v (13,6 mg/ml),

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Romania

BAXTER HEALTHCARE S.A.

Moneen Road, Castelbar, County Mayo, Ireland

DIANEAL PD4 GLUCOSE 2,27 % m/v (22,7 mg/ml)

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Romania

BAXTER HEALTHCARE S.A.

Moneen Road, Castelbar, County Mayo, Ireland

DIANEAL PD4 GLUCOSE 3,86 % m/v (38,6 mg/ml)

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Romania

BAXTER HEALTHCARE Ltd.,

Caxton Way, Thetford, Norfolk, 1P24 3SE, Thetford,

United Kingdom

EXTRANEAL

75 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovak Republic

Baxter Healthcare SA Moneen Rd

Castlebar, Co. Mayo Ireland

DIANEAL PD4 glucose 1,36 % w/v/13,6 mg/ml

13,6 mg/1 ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovak Republic

Baxter Healthcare SA Moneen Rd

Castlebar, Co. Mayo Ireland

DIANEAL PD4 glucose 2,27 % w/v/22,7 mg/ml

22,7 mg/1 ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovak Republic

Baxter Healthcare SA Moneen Rd

Castlebar, Co. Mayo Ireland

DIANEAL PD4 glucose 3,86 % w/v/38,6 mg/ml

38,6 mg/1 ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovak Republic

Baxter Healthcare Ltd.Caxton Way Thetford Norfolk IP24 3SE

United Kingdom

EXTRANEAL

7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia

Dianeal PD4 13,6 mg/ml glukoze raztopina za peritonelano dializo

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia

Dianeal PD4 22,7 mg/ml glukoze raztopina za peritonelano dializo

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia

Dianeal PD4 38,6 mg/ml glukoze raztopina za peritonelano dializo

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia

Extraneal 75 mg/ml ikodekstrina raztopina za peritonealno dializo

75 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Spain

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 1,36 %

15,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 1,36 % con sistema de desconexión integrado

15,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 2,27 %

25,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 2,27 % con sistema de desconexión integrado

25,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 3,86 %

42,50 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 3,86 % con sistema de desconexión integrado

42,50 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

BAXTER S.L.

Pouet de Camilo 2

46394 Ribarroja del Turia (Valencia)

Spain

EXTRANEAL

Solución para diálisis peritoneal

75 g/l; 5,4 g/l; 4,5 g/l; 0,257 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Sweden

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 med glucos 13,6 mg/ml

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Sweden

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 med glucos 22,7 mg/ml

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Sweden

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 med glucos 38,6 mg/ml

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Sweden

Baxter Medical AB Box 6316494 Kista Sverige

Sweden

Extraneal

7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

The Netherlands

Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands

Dianeal PD4 Glucose 1,36 %/13,6 mg/ml, peritoneaaldialysevloeistof

13,6 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

The Netherlands

Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands

Dianeal PD4 Glucose 2,27 %/22,7 mg/ml, peritoneaaldialysevloeistof

22,7 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

The Netherlands

Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands

Dianeal PD4 Glucose 3,86 %/38,6 mg/ml, peritoneaaldialysevloeistof

38,6 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

The Netherlands

Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands

EXTRANEAL 7,5 %, oplossing voor peritoneale dialyse

75 g/l icodextrine

Solution for peritoneal dialysis

Intraperitoneal use

United Kingdom

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml

magnseium chloride 0,005 % w/v; glucose 1,36 % w/v; sodium lactate 0,45 % w/v; calcium chloride 0,018 % w/v; sodium chloride 0,54 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

United Kingdom

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml

magnseium chloride 0,005 % w/v; glucose 2,27 % w/v; sodium lactate 0,45 % w/v; calcium chloride 0,018 % w/v; sodium chloride 0,54 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

United Kingdom

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom

Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml

magnseium chloride 0,005 % w/v; glucose 3,86 % w/v; sodium lactate 0,45 % w/v; calcium chloride 0,018 % w/v; sodium chloride 0,54 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

United Kingdom

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom

Extraneal (Icodextrin 7,5 %) Solution for peritoneal dialysis

icodextrin 75 g/l; sodium chloride 5,4 g/l; calcium chloride 0,257 g/l; magnesium chloride 0,051 g/l; sodium s-lactate 4,5 g/l

Solution for peritoneal dialysis

Intraperitoneal use


ANNEX VII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND APPLICANT IN THE MEMBER STATES

Member State EU/EEA

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Austria

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics 20 mg Pulver und Lösungsmittel für ein Konzentrat zur Herstellung einer Infusionslösung

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Austria

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics 80 mg Pulver und Lösungsmittel für ein Konzentrat zur Herstellung einer Infusionslösung

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Belgium

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Belgium

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Bulgaria

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Доцетаксел Тева Генерикс

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Bulgaria

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Доцетаксел Тева Генерикс

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Cyprus

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Cyprus

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Czech Republic

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Tevadoxel

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Czech Republic

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Tevadoxel

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Denmark

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Denmark

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Estonia

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Estonia

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Finland

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Finland

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

France

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

France

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Germany

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Germany

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Greece

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Greece

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Hungary

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Hungary

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Ireland

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Ireland

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Italy

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Italy

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Latvia

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Latvia

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Lithuania

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for solution for infusion

Intravenous use

20 mg

Lithuania

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for solution for infusion

Intravenous use

80 mg

Luxembourg

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Luxembourg

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Malta

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Malta

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Netherlands

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Netherlands

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Norway

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Norway

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Poland

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Poland

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Romania

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Romania

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Slovak Republic

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Slovak Republic

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Slovenia

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics 20 mg prašek in vehikel za koncentrat za raztopino za infundiranje

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Slovenia

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics 80 mg prašek in vehikel za koncentrat za raztopino za infundiranje

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Spain

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Spain

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

Sweden

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

Sweden

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg

United Kingdom

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

20 mg

United Kingdom

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Powder and solvent for concentrate for solution for infusion

Intravenous use

80 mg


ANNEX VIII

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIODS, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

Member State EU/EEA

Applicant/Marketing Authorisation Holder

Invented Name

Pharmaceutical form

Strengths

Animal species

Recommended dose, frequency and route of administration

Withdrawal period

(meat and milk)

Ireland

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Noroclav Lactating Cow Intramammary Suspension

Intramammary suspension

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Lactating cattle

Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals

Not established

United Kingdom

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combimox Lactating Cow Intramammary Suspension

Intramammary suspension

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Lactating cattle

Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals

Meat: 7 days

Milk: 60 hours


ANNEX IX

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIODS, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

Member State EU/EEA

Applicant/Marketing Authorisation Holder

Invented Name

Pharmaceutical form

Strengths

Animal species

Recommended dose, frequency and route of administration

Withdrawal period

(meat and milk)

Austria

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combisyn Lactating Cow Intramammary Suspension

Intramammary suspension

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Lactating cattle

Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals

Not established

Belgium

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combisyn Lactating Cow Intramammary Suspension

Intramammary suspension

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Lactating cattle

Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals

Not established

Denmark

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combisyn Lactating Cow Intramammary Suspension

Intramammary suspension

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Lactating cattle

Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals

Not established

Finland

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combisyn Lactating Cow Intramammary Suspension

Intramammary suspension

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Lactating cattle

Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals

Not established

France

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combisyn Lactating Cow Intramammary Suspension

Intramammary suspension

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Lactating cattle

Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals

Not established

Portugal

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combisyn Lactating Cow Intramammary Suspension

Intramammary suspension

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Lactating cattle

Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals

Not established

Spain

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combisyn Lactating Cow Intramammary Suspension

Intramammary suspension

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Lactating cattle

Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals

Not established

United Kingdom

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combisyn Lactating Cow Intramammary Suspension

Intramammary suspension

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Lactating cattle

Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals

Meat: 7 days

Milk: 60 hours


ANNEX X

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIODS, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

Member State EU/EEA

Applicant/Marketing Authorisation Holder

Invented Name

Pharmaceutical form

Strengths

Animal species

Recommended dose, frequency and route of administration

Withdrawal period

(meat and milk)

The Netherlands

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down

BT35 6JP

Northern Ireland

Nisamox Lactating Cow Intramammary Suspension

Intramammary suspension

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Lactating cattle

Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals

Not established

United Kingdom

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down

BT35 6JP

Northern Ireland

Nisamox Lactating Cow Intramammary Suspension

Intramammary suspension

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Lactating cattle

Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals

Meat: 7 days

Milk: 60 hours


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