# C_2012264EN.01000901.xml

| 31.8.2012 | EN | Official Journal of the European Union | C 264/9 |
| --- | --- | --- | --- |

31.8.2012

EN

Official Journal of the European Union

C 264/9

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 2012

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

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC

1

or Article 38 of Directive 2001/82/EC

2

)

2012/C 264/02

—   Issuing, maintenance or modification of a national marketing authorization

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 |
| --- | --- | --- | --- | --- |
| 31.7.2012 | Tavanic and associated names | See Annex I | See Annex I | 2.8.2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

31.7.2012

Tavanic and associated names

See Annex I

See Annex I

2.8.2012

—   Refusal of modification of a national marketing authorization

Refusal of 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 |
| --- | --- | --- | --- | --- |
| 6.7.2012 | Ethinylestradiol-Drospirenone 24 + 4 and associated names | See Annex II | See Annex II | 10.7.2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

6.7.2012

Ethinylestradiol-Drospirenone 24 + 4 and associated names

See Annex II

See Annex II

10.7.2012

---

(1)  OJ L 311, 28.11.2001, p. 67.

1

(2)  OJ L 311, 28.11.2001, p. 1.

2

---

ANNEX I

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 |
| --- | --- | --- | --- | --- | --- |
| Austria | Sanofi-aventis GmbH |
| Leonard-Bernstein-Straße 10, A-1220 Vienna |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Sanofi-aventis GmbH

Leonard-Bernstein-Straße 10, A-1220 Vienna

Tavanic 250 mg Filmtabletten

250 mg

Film-coated tablets

Oral use

Austria

| Sanofi-aventis GmbH |
| --- |
| Leonard-Bernstein-Straße 10, A-1220 Vienna |

Sanofi-aventis GmbH

Leonard-Bernstein-Straße 10, A-1220 Vienna

Tavanic 500 mg Filmtabletten

500 mg

Film-coated tablets

Oral use

Austria

| Sanofi-aventis GmbH |
| --- |
| Leonard-Bernstein-Straße 10, A-1220 Vienna |

Sanofi-aventis GmbH

Leonard-Bernstein-Straße 10, A-1220 Vienna

Tavanic Infusionsflasche

5 mg/ml

Solution for infusion

Intravenous use

Belgium

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem - Belgium |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem - Belgium

Tavanic 250 mg filmomhulde tabletten

250 mg

Film-coated tablets

Oral use

Belgium

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem - Belgium |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem - Belgium

Tavanic 500 mg filmomhulde tabletten

500 mg

Film-coated tablets

Oral use

Belgium

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem - Belgium |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem - Belgium

Tavanic 5 mg/ml oplossing voor infusie

5 mg/ml

Solution for infusion

Intravenous use

Bulgaria

| Sanofi-Avenstis Bulgaria EOOD, |
| --- |
| Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8 |

Sanofi-Avenstis Bulgaria EOOD,

Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8

Tavanic

250 mg

Film-coated tablets

Oral use

Bulgaria

| Sanofi-Avenstis Bulgaria EOOD, |
| --- |
| Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8 |

Sanofi-Avenstis Bulgaria EOOD,

Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8

Tavanic

500 mg

Film-coated tablets

Oral use

Bulgaria

| Sanofi-Avenstis Bulgaria EOOD, |
| --- |
| Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8 |

Sanofi-Avenstis Bulgaria EOOD,

Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8

Tavanic

5 mg/ml

Solution for infusion

Intravenous use

Cyprus

| Sanofi-aventis Cyprus Ltd, |
| --- |
| 14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus |

Sanofi-aventis Cyprus Ltd,

14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus

Tavanic

250 mg

Film-coated tablets

Oral use

Cyprus

| Sanofi-aventis Cyprus Ltd, |
| --- |
| 14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus |

Sanofi-aventis Cyprus Ltd,

14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus

Tavanic

500 mg

Film-coated tablets

Oral use

Cyprus

| Sanofi-aventis Cyprus Ltd, |
| --- |
| 14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus |

Sanofi-aventis Cyprus Ltd,

14 Charalambou Mouskou street, 2015 – Nicosia, Cyprus

Tavanic

5 mg/ml

Solution for infusion

Intravenous use

Czech Republic

| sanofi-aventis, s.r.o. |
| --- |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Czech Republic |

sanofi-aventis, s.r.o.

Evropská 846/176a

160 00 Praha 6

Czech Republic

Tavanic i.v.

5 mg/ml

Solution for infusion

Intravenous use

Estonia

| sanofi-aventis Estonia OÜ, |
| --- |
| Pärnu mnt 139 E/2, 11317 Tallinn, Estonia |

sanofi-aventis Estonia OÜ,

Pärnu mnt 139 E/2, 11317 Tallinn, Estonia

Tavanic

250 mg

Film-coated tablets

Oral use

Estonia

| sanofi-aventis Estonia OÜ, |
| --- |
| Pärnu mnt 139 E/2, 11317 Tallinn, Estonia |

sanofi-aventis Estonia OÜ,

Pärnu mnt 139 E/2, 11317 Tallinn, Estonia

Tavanic

500 mg

Film-coated tablets

Oral use

Estonia

| sanofi-aventis Estonia OÜ, |
| --- |
| Pärnu mnt 139 E/2, 11317 Tallinn, Estonia |

sanofi-aventis Estonia OÜ,

Pärnu mnt 139 E/2, 11317 Tallinn, Estonia

Tavanic

5 mg/ml

Solution for infusion

Intravenous use

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| 00350 Helsinki, Finland |

sanofi-aventis Oy

Huopalahdentie 24

00350 Helsinki, Finland

Tavanic

250 mg

Film-coated tablets

Oral use

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| 00350 Helsinki, Finland |

sanofi-aventis Oy

Huopalahdentie 24

00350 Helsinki, Finland

Tavanic

500 mg

Film-coated tablets

Oral use

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| 00350 Helsinki, Finland |

sanofi-aventis Oy

Huopalahdentie 24

00350 Helsinki, Finland

Tavanic

5 mg/ml

Solution for infusion

Intravenous use

France

| Sanofi-aventis France |
| --- |
| 1-13 Boulevard Romain Rolland |
| 75014 Paris |
| FRANCE |

Sanofi-aventis France

1-13 Boulevard Romain Rolland

75014 Paris

FRANCE

TAVANIC 250 mg comprimé pelliculé sécable

250 mg

Film-coated tablets

Oral use

France

| Sanofi-aventis France |
| --- |
| 1-13 Boulevard Romain Rolland |
| 75014 Paris |
| FRANCE |

Sanofi-aventis France

1-13 Boulevard Romain Rolland

75014 Paris

FRANCE

TAVANIC 500 mg comprimé pelliculé sécable

500 mg

Film-coated tablets

Oral use

France

| Sanofi-aventis France |
| --- |
| 1-13 Boulevard Romain Rolland |
| 75014 Paris |
| FRANCE |

Sanofi-aventis France

1-13 Boulevard Romain Rolland

75014 Paris

FRANCE

TAVANIC 5 mg/ml solution pour perfusion

5 mg/ml

Solution for infusion

Intravenous use

Germany

| Sanofi-Aventis Deutschland GmbH, |
| --- |
| Industriepark Höchst, |
| Gebäude K703 |
| 65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH,

Industriepark Höchst,

Gebäude K703

65926 Frankfurt am Main, Deutschland

Tavanic 250 mg Filmtabletten

250 mg

Film-coated tablets

Oral use

Germany

| Sanofi-Aventis Deutschland GmbH, |
| --- |
| Industriepark Höchst, |
| Gebäude K703 |
| 65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH,

Industriepark Höchst,

Gebäude K703

65926 Frankfurt am Main, Deutschland

Tavanic 500 mg Filmtabletten

500 mg

Film-coated tablets

Oral use

Germany

| Sanofi-Aventis Deutschland GmbH, |
| --- |
| Industriepark Höchst, |
| Gebäude K703 |
| 65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH,

Industriepark Höchst,

Gebäude K703

65926 Frankfurt am Main, Deutschland

Tavanic 5 mg/ml Infusionslösung

5 mg/ml

Solution for infusion

Intravenous use

Greece

| sanofi-aventis AEBE |
| --- |
| 348 Syngrou avenue-Building A |
| 176 74 Kalithea – Athens |
| GR-Greece |

sanofi-aventis AEBE

348 Syngrou avenue-Building A

176 74 Kalithea – Athens

GR-Greece

Tavanic

250 mg

Film-coated tablets

Oral use

Greece

| sanofi-aventis AEBE |
| --- |
| 348 Syngrou avenue-Building A |
| 176 74 Kalithea – Athens |
| GR-Greece |

sanofi-aventis AEBE

348 Syngrou avenue-Building A

176 74 Kalithea – Athens

GR-Greece

Tavanic

500 mg

Film-coated tablets

Oral use

Greece

| sanofi-aventis AEBE |
| --- |
| 348 Syngrou avenue-Building A |
| 176 74 Kalithea – Athens |
| GR-Greece |

sanofi-aventis AEBE

348 Syngrou avenue-Building A

176 74 Kalithea – Athens

GR-Greece

Tavanic

5 mg/1 ml

Solution for infusion

Intravenous use

Hungary

| sanofi-aventis Zrt. |
| --- |
| To u. 1-5. |
| 1045 Budapest, |
| Hungary |

sanofi-aventis Zrt.

To u. 1-5.

1045 Budapest,

Hungary

Tavanic

250 mg

Film-coated tablets

Oral use

Hungary

| sanofi-aventis Zrt. |
| --- |
| To u. 1-5. |
| 1045 Budapest, |
| Hungary |

sanofi-aventis Zrt.

To u. 1-5.

1045 Budapest,

Hungary

Tavanic

500 mg

Film-coated tablets

Oral use

Hungary

| sanofi-aventis Zrt. |
| --- |
| To u. 1-5. |
| 1045 Budapest, |
| Hungary |

sanofi-aventis Zrt.

To u. 1-5.

1045 Budapest,

Hungary

Tavanic

5 mg/ml

Solution for infusion

Intravenous use

Ireland

| sanofi-aventis Ireland Ltd., |
| --- |
| Citywest Business Campus, Dublin 24, Ireland |

sanofi-aventis Ireland Ltd.,

Citywest Business Campus, Dublin 24, Ireland

Tavanic 250 mg film-coated tablets

250 mg

Film-coated tablets

Oral use

Ireland

| sanofi-aventis Ireland Ltd., |
| --- |
| Citywest Business Campus, Dublin 24, Ireland |

sanofi-aventis Ireland Ltd.,

Citywest Business Campus, Dublin 24, Ireland

Tavanic 500 mg film-coated tablets

500 mg

Film-coated tablets

Oral use

Ireland

| sanofi-aventis Ireland Ltd., |
| --- |
| Citywest Business Campus, Dublin 24, Ireland |

sanofi-aventis Ireland Ltd.,

Citywest Business Campus, Dublin 24, Ireland

Tavanic 5 mg/ml solution for infusion

5 mg/ml

Solution for infusion

Intravenous use

Italy

| sanofi-aventis S.p.A. |
| --- |
| Viale Luigi Bodio 37/B |
| 20158 Milan |
| Italy |

sanofi-aventis S.p.A.

Viale Luigi Bodio 37/B

20158 Milan

Italy

TAVANIC

250 mg

Film-coated tablets

Oral use

Italy

| sanofi-aventis S.p.A. |
| --- |
| Viale Luigi Bodio 37/B |
| 20158 Milan |
| Italy |

sanofi-aventis S.p.A.

Viale Luigi Bodio 37/B

20158 Milan

Italy

TAVANIC

500 mg

Film-coated tablets

Oral use

Italy

| sanofi-aventis S.p.A. |
| --- |
| Viale Luigi Bodio 37/B |
| 20158 Milan |
| Italy |

sanofi-aventis S.p.A.

Viale Luigi Bodio 37/B

20158 Milan

Italy

TAVANIC

5 mg/ml

Solution for infusion

Intravenous use

Lithuania

| UAB ‘SANOFI-AVENTIS LIETUVA’, |
| --- |
| A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania |

UAB ‘SANOFI-AVENTIS LIETUVA’,

A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania

Tavanic

250 mg

Film-coated tablets

Oral use

Lithuania

| UAB ‘SANOFI-AVENTIS LIETUVA’, |
| --- |
| A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania |

UAB ‘SANOFI-AVENTIS LIETUVA’,

A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania

Tavanic

500 mg

Film-coated tablets

Oral use

Lithuania

| UAB ‘SANOFI-AVENTIS LIETUVA’, |
| --- |
| A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania |

UAB ‘SANOFI-AVENTIS LIETUVA’,

A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania

Tavanic

5 mg/ml

Solution for infusion

Intravenous use

Luxembourg

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem - Belgium |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem - Belgium

Tavanic 250 mg comprimés pelliculés

250 mg

Film-coated tablets

Oral use

Luxembourg

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem - Belgium |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem - Belgium

Tavanic 500 mg comprimés pelliculés

500 mg

Film-coated tablets

Oral use

Luxembourg

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem - Belgium |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem - Belgium

Tavanic 5 mg/ml solution pour perfusion

5 mg/ml

Solution for infusion

Intravenous use

Malta

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

Sanofi-Aventis Malta Ltd,

Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta

Tavanic 250 mg film coated tablets

250 mg

Film-coated tablets

Oral use

Malta

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

Sanofi-Aventis Malta Ltd,

Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta

Tavanic 500 mg film coated tablets

500 mg

Film-coated tablets

Oral use

Malta

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

Sanofi-Aventis Malta Ltd,

Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta

Tavanic 5 mg/ml solution for infusion

5 mg/ml

Solution for infusion

Intravenous use

Netherlands

| sanofi-aventis Netherlands B.V., |
| --- |
| Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands |

sanofi-aventis Netherlands B.V.,

Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands

Tavanic 250

250 mg

Film-coated tablets

Oral use

Netherlands

| sanofi-aventis Netherlands B.V., |
| --- |
| Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands |

sanofi-aventis Netherlands B.V.,

Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands

Tavanic 500

500 mg

Film-coated tablet

Oral use

Netherlands

| sanofi-aventis Netherlands B.V., |
| --- |
| Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands |

sanofi-aventis Netherlands B.V.,

Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands

Tavanic IV

5 mg/ml

Solution for infusion

Intravenous use

Poland

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Brüningstrasse 50 |
| D-65926 Frankfurt am Main, Germany |

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50

D-65926 Frankfurt am Main, Germany

Tavanic 250

250 mg

Film-coated tablets

Oral use

Poland

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Brüningstrasse 50 |
| D-65926 Frankfurt am Main, Germany |

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50

D-65926 Frankfurt am Main, Germany

Tavanic 500

500 mg

Film-coated tablets

Oral use

Poland

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Brüningstrasse 50 |
| D-65926 Frankfurt am Main, Germany |

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50

D-65926 Frankfurt am Main, Germany

Tavanic

5 mg/ml

Solution for infusion

Intravenous use

Portugal

| SANOFI-AVENTIS – Produtos Farmacêuticos, Lda. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 – 3o Piso |
| 2740-244 Porto Salvo |

SANOFI-AVENTIS – Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 – 3o Piso

2740-244 Porto Salvo

TAVANIC

250 mg

Film-coated tablets

Oral use

Portugal

| SANOFI-AVENTIS – Produtos Farmacêuticos, Lda. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 – 3o Piso |
| 2740-244 Porto Salvo |

SANOFI-AVENTIS – Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 – 3o Piso

2740-244 Porto Salvo

TAVANIC

500 mg

Film-coated tablets

Oral use

Portugal

| SANOFI-AVENTIS – Produtos Farmacêuticos, Lda. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 – 3o Piso |
| 2740-244 Porto Salvo |

SANOFI-AVENTIS – Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 – 3o Piso

2740-244 Porto Salvo

TAVANIC

5 mg/ml

Solution for infusion

Intravenous use

Slovak Republic

| sanofi-aventis Slovakia s.r.o., |
| --- |
| Einsteinova 24, 85101 Bratislava, Slovak Republic |

sanofi-aventis Slovakia s.r.o.,

Einsteinova 24, 85101 Bratislava, Slovak Republic

Tavanic 500 mg

500 mg

Film-coated tablets

Oral use

Slovak Republic

| sanofi-aventis Slovakia s.r.o., |
| --- |
| Einsteinova 24, 85101 Bratislava, Slovak Republic |

sanofi-aventis Slovakia s.r.o.,

Einsteinova 24, 85101 Bratislava, Slovak Republic

Tavanic i.v. 500 mg

5 mg/ml

Solution for infusion

Intravenous use

Slovenia

| sanofi-aventis d.o.o, |
| --- |
| Dunajska 151, 1000 Ljubljana, Slovenia |

sanofi-aventis d.o.o,

Dunajska 151, 1000 Ljubljana, Slovenia

Tavanic 250 mg filmsko obložene tablete

250 mg

Film-coated tablets

Oral use

Slovenia

| sanofi-aventis d.o.o, |
| --- |
| Dunajska 151, 1000 Ljubljana, Slovenia |

sanofi-aventis d.o.o,

Dunajska 151, 1000 Ljubljana, Slovenia

Tavanic 500 mg filmsko obložene tablete

500 mg

Film-coated tablets

Oral use

Slovenia

| sanofi-aventis d.o.o, |
| --- |
| Dunajska 151, 1000 Ljubljana, Slovenia |

sanofi-aventis d.o.o,

Dunajska 151, 1000 Ljubljana, Slovenia

Tavanic 5 mg/ml raztopina za infundiranje

5 mg/ml

Solution for infusion

Intravenous use

Spain

| Sanofi-aventis, S.A. |
| --- |
| Josep Pla, 2 |
| 08019 – Barcelona |
| Spain |

Sanofi-aventis, S.A.

Josep Pla, 2

08019 – Barcelona

Spain

Tavanic 500 mg comprimidos recubiertos con película

500 mg

Film-coated tablets

Oral use

Spain

| Sanofi-aventis, S.A. |
| --- |
| Josep Pla, 2 |
| 08019 – Barcelona |
| Spain |

Sanofi-aventis, S.A.

Josep Pla, 2

08019 – Barcelona

Spain

Tavanic 5 mg/ml solución para perfusión

5 mg/ml

Solution for infusion

Intravenous use

Sweden

| sanofi-aventis AB |
| --- |
| Box 141 42 |
| 167 14 Bromma |
| Sweden |

sanofi-aventis AB

Box 141 42

167 14 Bromma

Sweden

Tavanic

250 mg

Film-coated tablets

Oral use

Sweden

| sanofi-aventis AB |
| --- |
| Box 141 42 |
| 167 14 Bromma |
| Sweden |

sanofi-aventis AB

Box 141 42

167 14 Bromma

Sweden

Tavanic

500 mg

Film-coated tablets

Oral use

Sweden

| sanofi-aventis AB |
| --- |
| Box 141 42 |
| 167 14 Bromma |
| Sweden |

sanofi-aventis AB

Box 141 42

167 14 Bromma

Sweden

Tavanic

5 mg/ml

Solution for infusion

Intravenous use

United Kingdom

| Aventis Pharma Limited, |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling |
| Kent |
| ME19 4AH |
| United Kingdom |

Aventis Pharma Limited,

50 Kings Hill Avenue

Kings Hill

West Malling

Kent

ME19 4AH

United Kingdom

(Trading as:

| Sanofi-aventis |
| --- |
| One Onslow Street, Guildford, Surrey, |
| GU1 4YS, United Kingdom) |

Sanofi-aventis

One Onslow Street, Guildford, Surrey,

GU1 4YS, United Kingdom)

Tavanic 250 mg film-coated tablets

250 mg

Film-coated tablets

Oral use

United Kingdom

| Aventis Pharma Limited, |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling |
| Kent |
| ME19 4AH |
| United Kingdom |

Aventis Pharma Limited,

50 Kings Hill Avenue

Kings Hill

West Malling

Kent

ME19 4AH

United Kingdom

(Trading as:

| Sanofi-aventis |
| --- |
| One Onslow Street, Guildford, Surrey, |
| GU1 4YS, United Kingdom) |

Sanofi-aventis

One Onslow Street, Guildford, Surrey,

GU1 4YS, United Kingdom)

Tavanic 500 mg film-coated tablets

500 mg

Film-coated tablets

Oral use

United Kingdom

| Aventis Pharma Limited, |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling |
| Kent |
| ME19 4AH |
| United Kingdom |

Aventis Pharma Limited,

50 Kings Hill Avenue

Kings Hill

West Malling

Kent

ME19 4AH

United Kingdom

(Trading as:

| Sanofi-aventis |
| --- |
| One Onslow Street, Guildford, Surrey, |
| GU1 4YS, United Kingdom) |

Sanofi-aventis

One Onslow Street, Guildford, Surrey,

GU1 4YS, United Kingdom)

Tavanic 5 mg/ml solution for infusion

5 mg/ml

Solution for infusion

Intravenous use

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ANNEX II

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

| Member State
  EU/EEA | Marketing authorisaton holder | Product name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Bayer Austria GmbH |
| Herbststrasse 6-10 |
| 1160 Wien |
| Austria |

Member State

EU/EEA

Marketing authorisaton holder

Product name

Strength

Pharmaceutical form

Route of administration

Austria

Bayer Austria GmbH

Herbststrasse 6-10

1160 Wien

Austria

Eloine 0,02 mg/3 mg Filmtabletten

0,02 mg/3 mg

Film-coated tablet

Oral use

Bulgaria

| Bayer Pharma AG, |
| --- |
| Mullerstrasse 170-178 |
| Berlin |
| 13342 |
| Germany |

Bayer Pharma AG,

Mullerstrasse 170-178

Berlin

13342

Germany

ELOINE

0,02 mg/3 mg

Film-coated tablet

Oral use

Cyprus

| Bayer Hellas ABEE |
| --- |
| Sorou 18-20 |
| 151 25 Marousi |
| Greece |

Bayer Hellas ABEE

Sorou 18-20

151 25 Marousi

Greece

LINATERA FC TABLETS

0,02 mg/3 mg

Film-coated tablet

Oral use

Czech Republic

| Bayer Pharma AG Müllerstrasse |
| --- |
| 178 D-13342 Berlin |
| Germany |

Bayer Pharma AG Müllerstrasse

178 D-13342 Berlin

Germany

ELOINE 0,02 MG/3 MG POTAHOVANÉ TABLETY

0,02 mg/3 mg

Film-coated tablet

Oral use

Denmark

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

Bayer AB

Gustav III:s Boulevard 56

Postbox 606

SE-16926 Solna

Sweden

Eloine

0,02 mg/3 mg

Film-coated tablet

Oral use

Finland

| Bayer Oy |
| --- |
| Pansiontie 47 |
| PO Box 415 |
| 20101 Turku |
| Finland |

Bayer Oy

Pansiontie 47

PO Box 415

20101 Turku

Finland

Linatera

0,02 mg/3 mg

Film-coated tablet

Oral use

France

| BAYER SANTE |
| --- |
| 220 avenue de la Recherche |
| 59120 Loos |
| France |

BAYER SANTE

220 avenue de la Recherche

59120 Loos

France

RIMENDIA 0,02 mg/3 mg comprimé pelliculé

0,02 mg/3 mg

Film-coated tablet

Oral use

Germany

| Jenapharm GmbH & Co. KG |
| --- |
| Otto-Schott-Str. 15 |
| D-07745 Jena |
| Germany |

Jenapharm GmbH & Co. KG

Otto-Schott-Str. 15

D-07745 Jena

Germany

Eloine 0,02 mg/3 mg Filmtabletten

0,02 mg/3 mg

Film-coated tablet

Oral use

Greece

| BAYER HELLAS ABEE |
| --- |
| Sorou 18-20 |
| Maroussi 15127 |
| Greece |

BAYER HELLAS ABEE

Sorou 18-20

Maroussi 15127

Greece

LINATERA

0,02 mg/3 mg

Film-coated tablet

Oral use

Iceland

| Bayer AB |
| --- |
| Gustav III:s Boulevard 56 |
| 169 26 Solna |
| Sweden |

Bayer AB

Gustav III:s Boulevard 56

169 26 Solna

Sweden

Eloine

0,02 mg/3 mg

Film-coated tablet

Oral use

Italy

| Bayer S.p.A. |
| --- |
| Viale Certosa 130 |
| Milano 20156 |
| Italy |

Bayer S.p.A.

Viale Certosa 130

Milano 20156

Italy

ELOINE

0,02 mg/3 mg

Film-coated tablet

Oral use

Malta

| Bayer plc |
| --- |
| Bayer House |
| Strawberry Hill, Newbury |
| Berkshire, RG14 1JA |
| United Kingdom |

Bayer plc

Bayer House

Strawberry Hill, Newbury

Berkshire, RG14 1JA

United Kingdom

ELOINE 0.02 mg/3 mg film coated tablets

0,02 mg/3 mg

Film-coated tablet

Oral use

Norway

| Bayer AB |
| --- |
| Gustav III's Boulevard 56 |
| 169 26 Solna |
| Sweden |

Bayer AB

Gustav III's Boulevard 56

169 26 Solna

Sweden

Eloine

0,02 mg/3 mg

Film-coated tablet

Oral use

Poland

| Bayer Pharma AG |
| --- |
| Müllerstr. 178, Berlin |
| D-13342 |
| Germany |

Bayer Pharma AG

Müllerstr. 178, Berlin

D-13342

Germany

Linatera

0,02 mg/3 mg

Film-coated tablet

Oral use

Portugal

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

Berlifarma - Especialidades Farmacêuticas, Lda.

Rua Quinta Pinheiro, 5, Outurela

2794-003 Carnaxide

Portugal

Linatera

0,02 mg/3 mg

Film-coated tablet

Oral use

Slovak Republic

| Bayer spol. s r.o. |
| --- |
| Einsteinova 25 |
| 851 01 Bratislava |
| Slovak Republic |

Bayer spol. s r.o.

Einsteinova 25

851 01 Bratislava

Slovak Republic

Linatera

0,02 mg/3 mg

Film-coated tablet

Oral use

Slovenia

| Bayer d.o.o. |
| --- |
| Bravničarjeva 13 |
| SI-1000 Ljubljana |
| Slovenia |

Bayer d.o.o.

Bravničarjeva 13

SI-1000 Ljubljana

Slovenia

Linatera 0,02 mg/3 mg filmsko obložene tablete

0,02 mg/3 mg

Film-coated tablet

Oral use

Spain

| BAYHEALTH S.L. |
| --- |
| Avda. Baix Llobregat 3 y 5 |
| 08970 Sant Joan Despi |
| Barcelona |
| Spain |

BAYHEALTH S.L.

Avda. Baix Llobregat 3 y 5

08970 Sant Joan Despi

Barcelona

Spain

ELOINE 0,02 mg/3 mg comprimidos recubiertos con película

0,02 mg/3 mg

Film-coated tablet

Oral use

Sweden

| Bayer AB |
| --- |
| Box 606 |
| SE-16929 Solna |
| Sweden |

Bayer AB

Box 606

SE-16929 Solna

Sweden

Eloine

0,02 mg/3 mg

Film-coated tablet

Oral use

The Netherlands

| Berlipharm BV. |
| --- |
| Energieweg 1 |
| 3641 RT Mijdrecht |
| The Netherlands |

Berlipharm BV.

Energieweg 1

3641 RT Mijdrecht

The Netherlands

Ethinylestradiol/Drospirenon 24 + 4 0,02 mg/3 mg Berlipharm, filmomhulde tabletten

0,02 mg/3 mg

Film-coated tablet

Oral use

United Kingdom

| Bayer PLC |
| --- |
| Bayer House |
| Strawberry Hill, Newbury Berkshire RG14 1JA |
| United Kingdom |

Bayer PLC

Bayer House

Strawberry Hill, Newbury Berkshire RG14 1JA

United Kingdom

ELOINE Film-Coated Tablets 0.02 mg/3 mg

0,02 mg/3 mg

Film-coated tablet

Oral use

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