# C_2012371EN.01000201.xml

| 30.11.2012 | EN | Official Journal of the European Union | C 371/2 |
| --- | --- | --- | --- |

30.11.2012

EN

Official Journal of the European Union

C 371/2

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2012 to 31 August 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 371/02

—   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 |
| --- | --- | --- | --- | --- |
| 23.8.2012 | Zinnat and associated names | See Annex | See Annex | 27.8.2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

23.8.2012

Zinnat and associated names

See Annex

See Annex

27.8.2012

---

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

1

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

2

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ANNEX

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

| Member State
  EU/EEA | Marketing authorisation holder | (Invented) Name | Strength | Pharmaceutical form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | GlaxoSmithKline Pharma GmbH |
| Albert-Schweitzer-Gasse 6 |
| 1140 Wien |
| Austria |

Member State

EU/EEA

Marketing authorisation holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Austria

GlaxoSmithKline Pharma GmbH

Albert-Schweitzer-Gasse 6

1140 Wien

Austria

Flolan 0,5 mg - Trockensubstanz zur Infusionsbereitung mit Lösungsmittel

0,5 mg

Powder and solvent for solution for infusion

Intravenous use

0,5 mg/50 ml

Austria

| GlaxoSmithKline Pharma GmbH |
| --- |
| Albert-Schweitzer-Gasse 6 |
| 1140 Wien |
| Austria |

GlaxoSmithKline Pharma GmbH

Albert-Schweitzer-Gasse 6

1140 Wien

Austria

Flolan 1,5 mg - Trockensubstanz zur Infusionsbereitung mit Lösungsmittel

1,5 mg

Powder and solvent for solution for infusion

Intravenous use

1,5 mg/100 ml

Belgium

| GlaxoSmithKline s.a./n.v. |
| --- |
| Rue du Tilleul 13 |
| 1332 Genval |
| Belgium |

GlaxoSmithKline s.a./n.v.

Rue du Tilleul 13

1332 Genval

Belgium

Flolan 0,5 mg powder and solvent for solution for infusion

0,5 mg

Powder and solvent for solution for infusion

Intravenous use

0,5 mg/50 ml

Belgium

| GlaxoSmithKline s.a./n.v. |
| --- |
| Rue du Tilleul 13 |
| 1332 Genval |
| Belgium |

GlaxoSmithKline s.a./n.v.

Rue du Tilleul 13

1332 Genval

Belgium

Flolan 1,5 mg powder and solvent for solution for infusion

1,5 mg

Powder and solvent for solution for infusion

Intravenous use

1,5 mg/100 ml

Belgium

| GlaxoSmithKline s.a./n.v. |
| --- |
| Rue du Tilleul 13 |
| 1332 Genval |
| Belgium |

GlaxoSmithKline s.a./n.v.

Rue du Tilleul 13

1332 Genval

Belgium

Flolan 1,5 mg powder for solution for infusion

1,5 mg

Powder for solution for infusion

Intravenous use

1,5 mg/50 ml

Czech Republic

| The Wellcome Foundation Ltd., |
| --- |
| Berkeley Avenue 21, |
| Greenford, Middlesex, |
| UB6 0NN |
| United Kingdom |

The Wellcome Foundation Ltd.,

Berkeley Avenue 21,

Greenford, Middlesex,

UB6 0NN

United Kingdom

Flolan 0,5 mg, powder and solvent for solution for infusion

0,5 mg

Powder and solvent for solution for infusion

Intravenous use

0,5 mg/50 ml

Czech Republic

| The Wellcome Foundation Ltd., |
| --- |
| Berkeley Avenue 21, |
| Greenford, Middlesex, |
| UB6 0NN |
| United Kingdom |

The Wellcome Foundation Ltd.,

Berkeley Avenue 21,

Greenford, Middlesex,

UB6 0NN

United Kingdom

Flolan 1,5 mg, powder and solvent for solution for infusion

1,5 mg

Powder and solvent for solution for infusion

Intravenous use

1,5 mg/50 ml

Denmark

| GlaxoSmithKline |
| --- |
| Pharma A/S |
| Nykaer 68, |
| 2605 Broendby |
| Denmark |

GlaxoSmithKline

Pharma A/S

Nykaer 68,

2605 Broendby

Denmark

Epoprostenol 500 micrograms

0,5 mg

Powder and solvent for solution for infusion

Intravenous use

0,5 mg/50 ml

Denmark

| GlaxoSmithKline |
| --- |
| Pharma A/S |
| Nykaer 68, |
| 2605 Broendby |
| Denmark |

GlaxoSmithKline

Pharma A/S

Nykaer 68,

2605 Broendby

Denmark

Eepoprostenol 1,5 mg

1,5 mg

Powder and solvent for solution for infusion

Intravenous use

1,5 mg/50 ml

Estonia

| Glaxo Wellcome UK Limited trading as Glaxo Wellcome Operations |
| --- |
| Glaxo Wellcome House |
| Berkeley Avenue, Greenford |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Wellcome UK Limited trading as Glaxo Wellcome Operations

Glaxo Wellcome House

Berkeley Avenue, Greenford

Middlesex UB6 0NN

United Kingdom

Flolan

0,5 mg

Powder and solvent for solution for infusion

Intravenous use

0,5 mg/50 ml

France

| Laboratoire GLAXOSMITHKLINE |
| --- |
| 100, route de Versailles |
| 78163 Marly-le-Roi Cedex |
| France |

Laboratoire GLAXOSMITHKLINE

100, route de Versailles

78163 Marly-le-Roi Cedex

France

Flolan 0,5 mg, powder and solvent for solution for injection

0,5 mg

Powder and solvent for solution for injection

Intravenous use

0,5 mg/50 ml

France

| Laboratoire GLAXOSMITHKLINE |
| --- |
| 100, route de Versailles |
| 78163 Marly-le-Roi Cedex |
| France |

Laboratoire GLAXOSMITHKLINE

100, route de Versailles

78163 Marly-le-Roi Cedex

France

Flolan 1,5 mg, powder and solvent for solution for injection

1,5 mg

Powder and solvent for solution for injection

Intravenous use

1,5 mg/50 ml

Ireland

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way |
| Rathfarnham, Dublin 16 |
| Ireland |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way

Rathfarnham, Dublin 16

Ireland

Flolan 500 micrograms Powder and Solvent for Solution for Infusion

0,5 mg

Powder and solvent for solution for infusion

Intravenous use

0,5 mg/50 ml

Ireland

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way |
| Rathfarnham, Dublin 16 |
| Ireland |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way

Rathfarnham, Dublin 16

Ireland

Flolan 1,5 mg Infusion, powder and solvent for solution for infusion

1,5 mg

Powder and solvent for solution for infusion

Intravenous use

1,5 mg/50 ml

Italy

| The Wellcome Foundation Ltd. |
| --- |
| Glaxo Wellcome house |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 ONN |
| United Kingdom |

The Wellcome Foundation Ltd.

Glaxo Wellcome house

Berkeley Avenue

Greenford

Middlesex UB6 ONN

United Kingdom

Flolan

0,5 mg

Powder and solvent for solution for infusion

Intravenous use

0,5 mg/50 ml

Italy

| The Wellcome Foundation Ltd. |
| --- |
| Glaxo Wellcome house |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 ONN |
| United Kingdom |

The Wellcome Foundation Ltd.

Glaxo Wellcome house

Berkeley Avenue

Greenford

Middlesex UB6 ONN

United Kingdom

Flolan

0,5 mg

Powder for solution for infusion

Intravenous use

0,5 mg/100 ml

Italy

| The Wellcome Foundation Ltd. |
| --- |
| Glaxo Wellcome house |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 ONN |
| United Kingdom |

The Wellcome Foundation Ltd.

Glaxo Wellcome house

Berkeley Avenue

Greenford

Middlesex UB6 ONN

United Kingdom

Flolan

1,5 mg

Powder and solvent for solution for infusion

Intravenous use

1,5 mg/50 ml

Luxembourg

| GlaxoSmithKline Pharmaceuticals SA |
| --- |
| 2-4-6, Avenue Pascal |
| B-1330 Wavre |
| Belgium |

GlaxoSmithKline Pharmaceuticals SA

2-4-6, Avenue Pascal

B-1330 Wavre

Belgium

Flolan 0,5 mg powder and solvent for solution for infusion

0,5 mg

Powder and solvent for solution for infusion

Intravenous use

0,5 mg/50 ml

Luxembourg

| GlaxoSmithKline Pharmaceuticals SA |
| --- |
| 2-4-6, Avenue Pascal |
| B-1330 Wavre |
| Belgium |

GlaxoSmithKline Pharmaceuticals SA

2-4-6, Avenue Pascal

B-1330 Wavre

Belgium

Flolan 1,5 mg powder and solvent for solution for infusion

1,5 mg

Powder and solvent for solution for infusion

Intravenous use

1,5 mg/100 ml

Malta

| Glaxo Wellcome UK Limited |
| --- |
| Glaxo Wellcome House |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 ONN |
| United Kingdom |

Glaxo Wellcome UK Limited

Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex UB6 ONN

United Kingdom

Flolan 0,5 mg Injection Powder and solvent for solution for Infusion 0,5 mg

0,5 mg

Powder and solvent for solution for infusion

Intravenous use

0,5 mg/50 ml

The Netherlands

| GlaxoSmithKline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ Zeist |
| The Netherlands |

GlaxoSmithKline B.V.

Huis ter Heideweg 62

3705 LZ Zeist

The Netherlands

Flolan 500 microgram, powder for solution for infusion

0,5 mg

Powder for solution for infusion

Intravenous use

0,5 mg/50 ml

The Netherlands

| GlaxoSmithKline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ Zeist |
| The Netherlands |

GlaxoSmithKline B.V.

Huis ter Heideweg 62

3705 LZ Zeist

The Netherlands

Flolan 500 microgram, powder and solvent for solution for infusion

0,5 mg

Powder and solvent for solution for infusion

Intravenous use

0,5 mg/100 ml

The Netherlands

| GlaxoSmithKline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ Zeist |
| The Netherlands |

GlaxoSmithKline B.V.

Huis ter Heideweg 62

3705 LZ Zeist

The Netherlands

Flolan 1500 microgram, powder for solution for infusion

1,5 mg

Powder for solution for infusion

Intravenous use

1,5 mg/50 ml

The Netherlands

| GlaxoSmithKline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ Zeist |
| The Netherlands |

GlaxoSmithKline B.V.

Huis ter Heideweg 62

3705 LZ Zeist

The Netherlands

Flolan 1500 microgram, powder and solvent for solution for infusion

1,5 mg

Powder and solvent for solution for infusion

Intravenous use

1,5 mg/100 ml

Norway

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2 A |
| Postboks 180 Vinderen |
| 0319 Oslo |
| Norway |

GlaxoSmithKline AS

Forskningsveien 2 A

Postboks 180 Vinderen

0319 Oslo

Norway

Flolan

0,5 mg

Powder and solvent for solution for infusion

Intravenous use

0,5 mg/100 ml

Norway

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2 A |
| Postboks 180 Vinderen |
| 0319 OSLO |
| Norway |

GlaxoSmithKline AS

Forskningsveien 2 A

Postboks 180 Vinderen

0319 OSLO

Norway

Flolan

1,5 mg

Powder and solvent for solution for infusion

Intravenous use

1,5 mg/100 ml

Spain

| GlaxoSmithKline, S.A. |
| --- |
| P.T.M. - C/Severo Ochoa, 2 |
| 28760 - Tres Cantos |
| Madrid |
| Spain |

GlaxoSmithKline, S.A.

P.T.M. - C/Severo Ochoa, 2

28760 - Tres Cantos

Madrid

Spain

Flolan

0,5 mg

Powder and solvent for solution for infusion

Intravenous use

0,5 mg/50 ml

United Kingdom

| Glaxo Wellcome UK Ltd |
| --- |
| Stockley Park West |
| Uxbridge |
| Middlesex, UB11 1BT |
| United Kingdom |

Glaxo Wellcome UK Ltd

Stockley Park West

Uxbridge

Middlesex, UB11 1BT

United Kingdom

Flolan 0,5 mg Injection

0,5 mg

Freeze-Dried Powder

Intravenous use

0,5 mg/50 ml

United Kingdom

| Glaxo Wellcome UK Ltd |
| --- |
| Stockley Park West |
| Uxbridge |
| Middlesex, UB11 1BT |
| United Kingdom |

Glaxo Wellcome UK Ltd

Stockley Park West

Uxbridge

Middlesex, UB11 1BT

United Kingdom

Flolan 1,5 mg Injection

1,5 mg

Sterile freeze-dried powder for solution for infusion

Intravenous use

1,5 mg/50 ml

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