# Il-Ġurnal Uffiċjali C 371/2012

| | ISSN 1977-0987
  doi:10.3000/19770987.C_2012.371.mlt |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 371 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5530 ta' Novembru 2012 |

ISSN 1977-0987

doi:10.3000/19770987.C_2012.371.mlt

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 371

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5530 ta' Novembru 2012

---

| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2012/C 371/01 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta' Awwissu 2012 sal-31 ta' Awwissu 2012(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 1 |
| 2012/C 371/02 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 Awwissu 2012 sal-31 Awwissu 2012(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE) | 2 |
| 2012/C 371/03 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2012 sal-31 ta’ Ottubru 2012(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
  ) | 7 |
| 2012/C 371/04 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2012 sal-31 ta’ Ottubru 2012(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE
  jew l-Artikolu 38 tad-Direttiva 2001/82/KE
  ) | 26 |

Avviż Nru

Werrej

Paġna

IV   Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

2012/C 371/01

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta' Awwissu 2012 sal-31 ta' Awwissu 2012(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

1

2012/C 371/02

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 Awwissu 2012 sal-31 Awwissu 2012(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE)

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE)

2

2012/C 371/03

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2012 sal-31 ta’ Ottubru 2012(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
  )

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill

)

7

2012/C 371/04

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2012 sal-31 ta’ Ottubru 2012(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE
  jew l-Artikolu 38 tad-Direttiva 2001/82/KE
  )

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE

jew l-Artikolu 38 tad-Direttiva 2001/82/KE

)

26

| MT | |
| --- | --- |

MT

---

IV Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

| 30.11.2012 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 371/1 |
| --- | --- | --- | --- |

30.11.2012

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 371/1

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta' Awwissu 2012 sal-31 ta' Awwissu 2012

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
   (1)
  )

2012/C 371/01

—   Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 30.8.2012 | Erbitux | Merck KGaA |
| Frankfurter Straße 250, 64271 Darmstadt, Deutschland |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

30.8.2012

Erbitux

Merck KGaA

Frankfurter Straße 250, 64271 Darmstadt, Deutschland

EU/1/04/281/001-005

3.9.2012

---

(1)  ĠU L 136, 30.4.2004, p. 1.

---

| 30.11.2012 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 371/2 |
| --- | --- | --- | --- |

30.11.2012

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 371/2

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 Awwissu 2012 sal-31 Awwissu 2012

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE
   (1)
  jew l-Artikolu 38 tad-Direttiva 2001/82/KE
   (2)
  )

2012/C 371/02

—   Ħruġ, manteniment jew modifika ta' awtorizzazzjoni għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 23.8.2012 | Zinnat and associated names | Ara l-Anness | Ara l-Anness | 27.8.2012 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta' notifika

23.8.2012

Zinnat and associated names

Ara l-Anness

Ara l-Anness

27.8.2012

---

(1)  ĠU L 311, 28.11.2001, p. 67.

(2)  ĠU L 311, 28.11.2001, p. 1.

---

ANNESS

LISTA TAL-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru
  EU/EEA | Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq | Isem (Ivvintat) | Qawwa | Għamla Farmaċewtika | Mnjen jingħata | Il-Kontenut
  (Konċentrat) |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | GlaxoSmithKline Pharma GmbH |
| Albert-Schweitzer-Gasse 6 |
| 1140 Wien |
| Austria |

Stat Membru

EU/EEA

Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq

Isem (Ivvintat)

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

Il-Kontenut

(Konċentrat)

L-Awstrija

GlaxoSmithKline Pharma GmbH

Albert-Schweitzer-Gasse 6

1140 Wien

Austria

Flolan 0,5 mg - Trockensubstanz zur Infusionsbereitung mit Lösungsmittel

0,5 mg

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

0,5 mg/50 ml

L-Awstrija

| 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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

1,5 mg/100 ml

Il-Belġju

| 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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

0,5 mg/50 ml

Il-Belġju

| 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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

1,5 mg/100 ml

Il-Belġju

| 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

Trab għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

1,5 mg/kunjett

Ir-Repubblika Ċeka

| 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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

0,5 mg/50 ml

Ir-Repubblika Ċeka

| 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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

1,5 mg/50 ml

Id-Danimarka

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

GlaxoSmithKline

Pharma A/S

Nykaer 68,

2605 Broendby

Denmark

Epoprostenol 500 micrograms

0,5 mg

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

0,5 mg/50 ml

Id-Danimarka

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

GlaxoSmithKline

Pharma A/S

Nykaer 68,

2605 Broendby

Denmark

Epoprostenol 1,5 mg

1,5 mg

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

1,5 mg/50 ml

L-Estonja

| 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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

0,5 mg/50 ml

Franza

| 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

Trab u solvent għal soluzzjoni għall-injezzjoni

Użu għal ġol-vini

0,5 mg/50 ml

Franza

| 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

Trab u solvent għal soluzzjoni għall-injezzjoni

Użu għal ġol-vini

1,5 mg/50 ml

L-Irlanda

| 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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

0,5 mg/50 ml

L-Irlanda

| 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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

1,5 mg/50 ml

L-Italja

| 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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

0,5 mg/50 ml

L-Italja

| 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

Trab għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

0,5 mg/50 ml

L-Italja

| 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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

1,5 mg/50 ml

Il-Lussemburgu

| 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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

0,5 mg/50 ml

Il-Lussemburgu

| 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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

0,5 mg/50 ml

L-Olanda

| 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

Trab għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

0,5 mg/50 ml

L-Olanda

| 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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

0,5 mg/100 ml

L-Olanda

| 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

Trab għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

1,5 mg/kunjett

L-Olanda

| 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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

1,5 mg/100 ml

In-Norveġja

| 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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

0,5 mg/100 ml

In-Norveġja

| 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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

1,5 mg/100 ml

Spanja

| 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

Trab u solvent għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

0,5 mg/50 ml

Ir-Renju Unit

| 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

Trab imnixxef permezz tal-iffriżar

Użu għal ġol-vini

0,5 mg/50 ml

Ir-Renju Unit

| 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

Trab sterili imnixxef permezz tal-iffriżar għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

1,5 mg/50 ml

---

| 30.11.2012 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 371/7 |
| --- | --- | --- | --- |

30.11.2012

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 371/7

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2012 sal-31 ta’ Ottubru 2012

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
   (1)
  )

2012/C 371/03

—   Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Forma farmaċewtika | Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) | Data ta' notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 23.10.2012 | XALKORI | crizotinib | Pfizer Limited |
| Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Forma farmaċewtika

Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

Data ta' notifika

23.10.2012

XALKORI

crizotinib

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom

EU/1/12/793/001-004

Kapsula, iebsa

L01XE16

26.10.2012

25.10.2012

Adcetris

Brentuximab vedotin

| Takeda Global Research and Development Centre (Europe) Ltd. |
| --- |
| 61 Aldwych, London WC2B 4AE, United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd.

61 Aldwych, London WC2B 4AE, United Kingdom

EU/1/12/794/001

Trab għal konċentrat għal soluzzjoni għall-infużjoni

L01XC12

30.10.2012

25.10.2012

Glybera

Alipogene tiparvovec

| uniQure biopharma B.V. |
| --- |
| Meibergdreef 61, 1105 BA Amsterdam, Nederland |

uniQure biopharma B.V.

Meibergdreef 61, 1105 BA Amsterdam, Nederland

EU/1/12/791/001

Soluzzjoni għall-injezzjoni

C10AX10

29.10.2012

—   Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Miċħud

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 25.10.2012 | Elelyso | Pfizer Limited |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

25.10.2012

Elelyso

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

—

29.10.2012

—   Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 1.10.2012 | Cialis | Eli Lilly Nederland B.V. |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

1.10.2012

Cialis

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/02/237/001-009

3.10.2012

1.10.2012

Conbriza

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/09/511/001-005

3.10.2012

1.10.2012

Olanzapine Neopharma

| Neopharma Limited |
| --- |
| 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom |

Neopharma Limited

57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom

EU/1/07/426/001-011

3.10.2012

1.10.2012

Tamiflu

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/02/222/001-005

3.10.2012

4.10.2012

Cimzia

| UCB Pharma SA. |
| --- |
| Allée de la Recherche 60, 1070 Bruxelles, France/Researchdreef, 60, Brussel 1070, België |

UCB Pharma SA.

Allée de la Recherche 60, 1070 Bruxelles, France/Researchdreef, 60, Brussel 1070, België

EU/1/09/544/001-002

8.10.2012

4.10.2012

Orencia

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/07/389/001-009

8.10.2012

4.10.2012

Soliris

| Alexion Europe S.A.S. |
| --- |
| 25, boulevard de l'Amiral Bruix, 75016 Paris, France |

Alexion Europe S.A.S.

25, boulevard de l'Amiral Bruix, 75016 Paris, France

EU/1/07/393/001

8.10.2012

4.10.2012

Topotecan Eagle

| Eagle Laboratories Limited |
| --- |
| The Clock House, Station Approach, Marlow, Bucks SL7 1NT, UNITED KINGDOM |

Eagle Laboratories Limited

The Clock House, Station Approach, Marlow, Bucks SL7 1NT, UNITED KINGDOM

EU/1/11/744/002

8.10.2012

4.10.2012

Vepacel

| Baxter Innovations GmbH |
| --- |
| Industriestrasse 67, A – 1221 Vienna, Österreich |

Baxter Innovations GmbH

Industriestrasse 67, A – 1221 Vienna, Österreich

EU/1/12/752/001-002

8.10.2012

8.10.2012

Biograstim

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3, 89079 Ulm, Deutschland |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3, 89079 Ulm, Deutschland

EU/1/08/450/001-010

11.10.2012

8.10.2012

Comtan

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/081/001-004

10.10.2012

8.10.2012

DuoTrav

| Alcon Laboratories (UK) Ltd. |
| --- |
| Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom |

Alcon Laboratories (UK) Ltd.

Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom

EU/1/06/338/001-003

10.10.2012

8.10.2012

Vidaza

| Celgene Europe Ltd |
| --- |
| 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom |

Celgene Europe Ltd

1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom

EU/1/08/488/001

10.10.2012

8.10.2012

Zavesca

| Actelion Registration Ltd. |
| --- |
| Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom |

Actelion Registration Ltd.

Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom

EU/1/02/238/001

10.10.2012

10.10.2012

Aprovel

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 54, rue La Boétie, 75008 Paris, France |

Sanofi Pharma Bristol-Myers Squibb SNC

54, rue La Boétie, 75008 Paris, France

EU/1/97/046/001-039

12.10.2012

10.10.2012

Biopoin

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3, 89079 Ulm, Deutschland |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3, 89079 Ulm, Deutschland

EU/1/09/565/001-028

12.10.2012

10.10.2012

Dynastat

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/02/209/001-008

12.10.2012

10.10.2012

Emend

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/03/262/001-010

15.10.2012

10.10.2012

Karvea

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/97/049/034-039

12.10.2012

10.10.2012

Pylobactell

| Torbet Laboratories Limited |
| --- |
| Unit 14D, Wendover Road, Rackheath Industrial Estate, Norwich, Norfolk NR13 6LH, United Kingdom |

Torbet Laboratories Limited

Unit 14D, Wendover Road, Rackheath Industrial Estate, Norwich, Norfolk NR13 6LH, United Kingdom

EU/1/98/064/001

12.10.2012

10.10.2012

Rapamune

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/01/171/007-010

12.10.2012

10.10.2012

Synagis

| AbbVie Ltd. |
| --- |
| Maidenhead, SL6 4XE, United Kingdom |

AbbVie Ltd.

Maidenhead, SL6 4XE, United Kingdom

EU/1/99/117/001-002

12.10.2012

15.10.2012

Ceplene

| Meda AB |
| --- |
| Box 906, SE 170 09 Solna, Sverige |

Meda AB

Box 906, SE 170 09 Solna, Sverige

EU/1/08/477/001

17.10.2012

15.10.2012

Clopidogrel Apotex

| Apotex Europe B.V. |
| --- |
| Darwingweg 20, 2333 CR Leiden, Nederland |

Apotex Europe B.V.

Darwingweg 20, 2333 CR Leiden, Nederland

EU/1/09/568/001-018

17.10.2012

15.10.2012

Olazax

| Glenmark Pharmaceuticals s.r.o. |
| --- |
| City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika |

Glenmark Pharmaceuticals s.r.o.

City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika

EU/1/09/597/001-005

16.10.2012

23.10.2012

Alimta

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/290/001-002

26.10.2012

23.10.2012

Glivec

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/198/001-013

26.10.2012

23.10.2012

Helixate NexGen

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin, Deutschland |

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/00/144/001-005

26.10.2012

23.10.2012

Humira

| AbbVie Ltd. |
| --- |
| Maidenhead, SL6 4XE, United Kingdom |

AbbVie Ltd.

Maidenhead, SL6 4XE, United Kingdom

EU/1/03/256/001-010

26.10.2012

23.10.2012

Kogenate Bayer

| Bayer Pharma AG |
| --- |
| 13342 Berlin, Deutschland |

Bayer Pharma AG

13342 Berlin, Deutschland

EU/1/00/143/004-013

26.10.2012

23.10.2012

Nplate

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/08/497/001-008

26.10.2012

23.10.2012

NULOJIX

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/11/694/001-002

26.10.2012

23.10.2012

Osseor

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot, 92284 Suresnes cedex, France |

Les Laboratoires Servier

50, rue Carnot, 92284 Suresnes cedex, France

EU/1/04/287/001-006

26.10.2012

23.10.2012

Prolia

| Amgen Europe B.V. |
| --- |
| Minervum 7061, NL-4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/10/618/001-004

26.10.2012

23.10.2012

Protelos

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot, 92284 Suresnes cedex, France |

Les Laboratoires Servier

50, rue Carnot, 92284 Suresnes cedex, France

EU/1/04/288/001-006

26.10.2012

23.10.2012

Telzir

| ViiV Healthcare UK Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

ViiV Healthcare UK Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/04/282/001-002

26.10.2012

23.10.2012

Victoza

| Novo Nordisk A/S |
| --- |
| Novo Allé, DK-2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/09/529/001-005

26.10.2012

23.10.2012

Visudyne

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/00/140/001

26.10.2012

24.10.2012

Adenuric

| Menarini International Operations France S.A. |
| --- |
| 1, Avenue de la Gare, L-1611 France, France |

Menarini International Operations France S.A.

1, Avenue de la Gare, L-1611 France, France

EU/1/08/447/001-012

26.10.2012

24.10.2012

Avastin

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/04/300/001-002

26.10.2012

24.10.2012

Baraclude

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/06/343/001-007

26.10.2012

24.10.2012

Benlysta

| Glaxo Group Limited |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Limited

Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/11/700/001-002

26.10.2012

24.10.2012

Brilique

| AstraZeneca AB |
| --- |
| Södertälje S 151 85, Sverige |

AstraZeneca AB

Södertälje S 151 85, Sverige

EU/1/10/655/001-006

26.10.2012

24.10.2012

ChondroCelect

| TiGenix NV |
| --- |
| Romeinse straat 12/2, B-3001 LEUVEN, België |

TiGenix NV

Romeinse straat 12/2, B-3001 LEUVEN, België

EU/1/09/563/001

26.10.2012

24.10.2012

Cialis

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/02/237/007-008

26.10.2012

24.10.2012

Clopidogrel HCS

| HCS bvba |
| --- |
| H. Kennisstraat 53, B 2650 Edegem, Belgïe |

HCS bvba

H. Kennisstraat 53, B 2650 Edegem, Belgïe

EU/1/10/651/001-015

26.10.2012

24.10.2012

Daliresp

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |

Nycomed GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/11/668/001-003

26.10.2012

24.10.2012

Daxas

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |

Nycomed GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/10/636/001-007

26.10.2012

24.10.2012

Dynastat

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/02/209/005-008

26.10.2012

24.10.2012

EDURANT

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/736/001

26.10.2012

24.10.2012

Enbrel

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/99/126/001-022

26.10.2012

24.10.2012

Eviplera

| Gilead Sciences International Limited |
| --- |
| Cambridge, CB21 6GT, United Kingdom |

Gilead Sciences International Limited

Cambridge, CB21 6GT, United Kingdom

EU/1/11/737/001-002

26.10.2012

24.10.2012

Exjade

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/356/001-009

26.10.2012

24.10.2012

Ganfort

| Allergan Pharmaceuticals Ireland |
| --- |
| Castlebar Road, Westport, Co. Mayo, Ireland |

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, Co. Mayo, Ireland

EU/1/06/340/001-002

26.10.2012

24.10.2012

Humira

| AbbVie Ltd. |
| --- |
| Maidenhead, SL6 4XE, United Kingdom |

AbbVie Ltd.

Maidenhead, SL6 4XE, United Kingdom

EU/1/03/256/001-010

26.10.2012

24.10.2012

Invirase

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/96/026/001-002

26.10.2012

24.10.2012

Kinzalkomb

| Bayer Pharma AG |
| --- |
| Berlin 13342, Deutschland |

Bayer Pharma AG

Berlin 13342, Deutschland

EU/1/02/214/001-015

26.10.2012

24.10.2012

Komboglyze

| Bristol Myers Squibb/AstraZeneca EEIG |
| --- |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |

Bristol Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/11/731/001-014

26.10.2012

24.10.2012

Libertek

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |

Nycomed GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/11/666/001-003

26.10.2012

24.10.2012

MicardisPlus

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173- D – 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Strasse 173- D – 55216 Ingelheim am Rhein, Deutschland

EU/1/02/213/001-023

26.10.2012

24.10.2012

Multaq

| Sanofi |
| --- |
| 54, rue La Boétie, 75008 Paris, France |

Sanofi

54, rue La Boétie, 75008 Paris, France

EU/1/09/591/001-004

26.10.2012

24.10.2012

Norvir

| AbbVie Ltd. |
| --- |
| Maidenhead, SL6 4XE, United Kingdom |

AbbVie Ltd.

Maidenhead, SL6 4XE, United Kingdom

EU/1/96/016/001

EU/1/96/016/003-008

26.10.2012

24.10.2012

NovoSeven

| Novo Nordisk A/S |
| --- |
| Novo Allé, DK-2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/96/006/001-011

26.10.2012

24.10.2012

Onduarp

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/11/729/001-006

26.10.2012

24.10.2012

Pandemrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, Rixensart, B-1330 France |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 France

EU/1/08/452/001

26.10.2012

24.10.2012

Possia

| AstraZeneca AB |
| --- |
| Södertälje S 151 85, Sverige |

AstraZeneca AB

Södertälje S 151 85, Sverige

EU/1/10/656/001-006

26.10.2012

24.10.2012

PREZISTA

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B – 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B – 2340 Beerse, België

EU/1/06/380/001-006

26.10.2012

24.10.2012

PritorPlus

| Bayer Pharma AG |
| --- |
| 13342 Berlin, Deutschland |

Bayer Pharma AG

13342 Berlin, Deutschland

EU/1/02/215/001-021

26.10.2012

24.10.2012

ReFacto AF

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/99/103/001-009

26.10.2012

24.10.2012

RotaTeq

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, Lyon 69007, France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, Lyon 69007, France

EU/1/06/348/001-002

26.10.2012

24.10.2012

SonoVue

| Bracco International B.V. |
| --- |
| Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland |

Bracco International B.V.

Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland

EU/1/01/177/002

26.10.2012

24.10.2012

Thymanax

| Servier (Ireland) Industries Limited |
| --- |
| Gorey Road, Arklow, Co. Wicklow, Ireland |

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498/001-008

26.10.2012

24.10.2012

Trajenta

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173- D – 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Strasse 173- D – 55216 Ingelheim am Rhein, Deutschland

EU/1/11/707/001-011

26.10.2012

24.10.2012

Valdoxan

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot, 92284 Suresnes cedex, France |

Les Laboratoires Servier

50, rue Carnot, 92284 Suresnes cedex, France

EU/1/08/499/001-008

26.10.2012

24.10.2012

Vimpat

| UCB Pharma SA. |
| --- |
| Allée de la Recherche 60, 1070 Bruxelles, France/Researchdreef, 60, Brussel 1070, België |

UCB Pharma SA.

Allée de la Recherche 60, 1070 Bruxelles, France/Researchdreef, 60, Brussel 1070, België

EU/1/08/470/001-013

EU/1/08/470/016-019

29.10.2012

24.10.2012

Votrient

| Glaxo Group Limited |
| --- |
| Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Limited

Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/10/628/001-004

26.10.2012

24.10.2012

Zometa

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/176/001-009

26.10.2012

25.10.2012

Bridion

| N.V. Organon |
| --- |
| Kloosterstraat 6, 5349 AB Oss, Nederland |

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/08/466/001-002

29.10.2012

25.10.2012

Capecitabine Krka

| KRKA, d.d |
| --- |
| Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA, d.d

Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/12/763/001-018

30.10.2012

25.10.2012

Cinryze

| ViroPharma SPRL-BVBA |
| --- |
| rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België |

ViroPharma SPRL-BVBA

rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België

EU/1/11/688/001

29.10.2012

25.10.2012

Clopidogrel Teva Pharma

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/561/001-011

29.10.2012

25.10.2012

Copalia

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/372/001-039

29.10.2012

25.10.2012

Corlentor

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, 92284 Suresnes, Cedex, France |

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes, Cedex, France

EU/1/05/317/001-014

29.10.2012

25.10.2012

Dafiro

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/371/001-039

29.10.2012

25.10.2012

Efavirenz Teva

| Teva Pharma BV |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma BV

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/11/742/001-010

30.10.2012

25.10.2012

Eucreas

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/425/001-018

29.10.2012

25.10.2012

Exforge HCT

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/569/001-060

29.10.2012

25.10.2012

Fasturtec

| Sanofi-aventis groupe |
| --- |
| 54, rue La Boétie, 75008 Paris, France |

Sanofi-aventis groupe

54, rue La Boétie, 75008 Paris, France

EU/1/00/170/001-002

26.10.2012

25.10.2012

Ferriprox

| Apotex Europe B.V. |
| --- |
| Darwingweg 20, 2333 CR Leiden, Nederland |

Apotex Europe B.V.

Darwingweg 20, 2333 CR Leiden, Nederland

EU/1/99/108/001-006

29.10.2012

25.10.2012

Firazyr

| Shire Orphan Therapies GmbH |
| --- |
| Friedrichstrasse 149, D-10117 Berlin, Deutschland |

Shire Orphan Therapies GmbH

Friedrichstrasse 149, D-10117 Berlin, Deutschland

EU/1/08/461/001-002

29.10.2012

25.10.2012

Glidipion

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegi 76 – 78, 220 Hafnarfjörður, Iceland |

Actavis Group PTC ehf.

Reykjavíkurvegi 76 – 78, 220 Hafnarfjörður, Iceland

EU/1/12/756/001-027

29.10.2012

25.10.2012

Helicobacter test INFAI

| INFAI, Institut für biomedizinische Analytik & NMR Imaging GmbH |
| --- |
| Universitätsstrasse 142, D – 44799 Bochum, Deutschland |

INFAI, Institut für biomedizinische Analytik & NMR Imaging GmbH

Universitätsstrasse 142, D – 44799 Bochum, Deutschland

EU/1/97/045/001-005

29.10.2012

25.10.2012

Humalog

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/96/007/002

EU/1/96/007/004-006

EU/1/96/007/008

EU/1/96/007/010

EU/1/96/007/015-021

EU/1/96/007/023-038

30.10.2012

25.10.2012

Incivo

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/720/001-002

29.10.2012

25.10.2012

Instanyl

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1, DK-4000 Roskilde, Danmark |

Nycomed Danmark ApS

Langebjerg 1, DK-4000 Roskilde, Danmark

EU/1/09/531/001-021

29.10.2012

25.10.2012

Irbesartan Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/576/001-042

30.10.2012

25.10.2012

Isentress

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/436/001-002

30.10.2012

25.10.2012

Jentadueto

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/12/780/029-034

30.10.2012

25.10.2012

Kaletra

| AbbVie Ltd. |
| --- |
| Maidenhead, SL6 4XE, United Kingdom |

AbbVie Ltd.

Maidenhead, SL6 4XE, United Kingdom

EU/1/01/172/001-008

30.10.2012

25.10.2012

Kepivance

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| SE-112 76, Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

SE-112 76, Stockholm, Sverige

EU/1/05/314/001

29.10.2012

25.10.2012

Kineret

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| SE-112 76, Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

SE-112 76, Stockholm, Sverige

EU/1/02/203/001-004

30.10.2012

25.10.2012

Liprolog

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/01/195/001-027

29.10.2012

25.10.2012

Olanzapine Glenmark

| Glenmark Generics (Europe) Limited |
| --- |
| Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom |

Glenmark Generics (Europe) Limited

Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom

EU/1/09/587/001-017

29.10.2012

25.10.2012

Olanzapine Glenmark Europe

| Glenmark Generics (Europe) Limited |
| --- |
| Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom |

Glenmark Generics (Europe) Limited

Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom

EU/1/09/588/001-012

29.10.2012

25.10.2012

Olanzapine Mylan

| Generics [UK] Limited |
| --- |
| Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/08/475/001-060

29.10.2012

25.10.2012

Olazax Disperzi

| Glenmark Pharmaceuticals s.r.o. |
| --- |
| City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika |

Glenmark Pharmaceuticals s.r.o.

City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika

EU/1/09/592/001-005

29.10.2012

25.10.2012

Procoralan

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot, 92284 Suresnes cedex, France |

Les Laboratoires Servier

50, rue Carnot, 92284 Suresnes cedex, France

EU/1/05/316/001-014

29.10.2012

25.10.2012

Ranexa

| Menarini International Operations France S.A. |
| --- |
| 1, Avenue de la Gare, L-1611 France, France |

Menarini International Operations France S.A.

1, Avenue de la Gare, L-1611 France, France

EU/1/08/462/001-012

30.10.2012

25.10.2012

Synflorix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, 1330 Rixensart, France |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, France

EU/1/09/508/001-011

29.10.2012

25.10.2012

Temomedac

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Fehlandtstrasse 3, D-20354 Hamburg – Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstrasse 3, D-20354 Hamburg – Deutschland

EU/1/09/605/001-012

29.10.2012

25.10.2012

Temozolomide HEXAL

| HEXAL AG |
| --- |
| Industriestrasse 25, D-83607 Holzkirchen, Deutschland |

HEXAL AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/10/616/001-002

EU/1/10/616/005-006

EU/1/10/616/009-010

EU/1/10/616/013-014

EU/1/10/616/017-018

EU/1/10/616/021-022

EU/1/10/616/025-036

30.10.2012

25.10.2012

Temozolomide Sandoz

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland |

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland

EU/1/10/617/001-002

EU/1/10/617/005-006

EU/1/10/617/009-010

EU/1/10/617/013-014

EU/1/10/617/017-018

EU/1/10/617/021-022

EU/1/10/617/025-036

30.10.2012

25.10.2012

Temozolomide SUN

| Sun Pharmaceuticals Industries Europe B.V. |
| --- |
| Polarisavenue 87, 2132 JH Hoofddorp, Nederland |

Sun Pharmaceuticals Industries Europe B.V.

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/11/697/001-024

30.10.2012

25.10.2012

Temozolomide Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, DR Utrecht 3542, Nederland |

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/09/606/001-012

29.10.2012

25.10.2012

Topotecan Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, DR Utrecht 3542, Nederland |

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/09/552/001-004

29.10.2012

25.10.2012

Toviaz

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/07/386/019-020

29.10.2012

25.10.2012

Tracleer

| Actelion Registration Ltd |
| --- |
| Chiswick Tower 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |

Actelion Registration Ltd

Chiswick Tower 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/02/220/001-006

30.10.2012

25.10.2012

Tredaptive

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/459/001-014

29.10.2012

25.10.2012

Trevaclyn

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/458/001-014

29.10.2012

25.10.2012

Twynsta

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 – D – 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Strasse 173 – D – 55216 Ingelheim am Rhein, Deutschland

EU/1/10/648/001-028

29.10.2012

25.10.2012

Vectibix

| Amgen Europe B.V. |
| --- |
| Minervum 7061, NL-4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/07/423/001-003

29.10.2012

29.10.2012

Advagraf

| Astellas Pharma Europe B.V. |
| --- |
| Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland |

Astellas Pharma Europe B.V.

Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland

EU/1/07/387/009-010

EU/1/07/387/016

EU/1/07/387/026

1.11.2012

29.10.2012

Aranesp

| Amgen Europe B.V. |
| --- |
| Minervum 7061, NL-4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/01/185/001-022

EU/1/01/185/031-111

1.11.2012

29.10.2012

Atryn

| GTC Biotherapeutics UK Limited |
| --- |
| 10 Norwich Street, London EC4A 1BD, United Kingdom |

GTC Biotherapeutics UK Limited

10 Norwich Street, London EC4A 1BD, United Kingdom

EU/1/06/355/001-003

6.11.2012

29.10.2012

Biograstim

| CT Arzneimittel GmbH |
| --- |
| Graf-Arco-Strasse 3, 89079 Ulm, Deutschland |

CT Arzneimittel GmbH

Graf-Arco-Strasse 3, 89079 Ulm, Deutschland

EU/1/08/450/001-010

5.11.2012

29.10.2012

Bronchitol

| Pharmaxis Pharmaceuticals Limited |
| --- |
| The Priory, Stomp Road, Burnham, Buckinghamshire, SL1 7LW, United Kingdom |

Pharmaxis Pharmaceuticals Limited

The Priory, Stomp Road, Burnham, Buckinghamshire, SL1 7LW, United Kingdom

EU/1/12/760/001-002

1.11.2012

29.10.2012

Byetta

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/06/362/001-004

1.11.2012

29.10.2012

Caelyx

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/96/011/001-004

5.11.2012

29.10.2012

CANCIDAS

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/01/196/001

EU/1/01/196/003

6.11.2012

29.10.2012

Dificlir

| Astellas Pharma Europe B.V. |
| --- |
| Elisabethhof 19, 2353 EW Leiderdorp, Nederland |

Astellas Pharma Europe B.V.

Elisabethhof 19, 2353 EW Leiderdorp, Nederland

EU/1/11/733/001-004

31.10.2012

29.10.2012

Docetaxel Mylan

| Mylan S.A.S |
| --- |
| 117 allée des Parcs, 69 800 Saint Priest, France |

Mylan S.A.S

117 allée des Parcs, 69 800 Saint Priest, France

EU/1/11/748/001-006

6.11.2012

29.10.2012

Esbriet

| InterMune UK Ltd |
| --- |
| Euston Tower, Floor 32, 286 Euston Road, London, NW1 3DP, United Kingdom |

InterMune UK Ltd

Euston Tower, Floor 32, 286 Euston Road, London, NW1 3DP, United Kingdom

EU/1/11/667/001-004

1.11.2012

29.10.2012

Exforge

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/370/001-039

31.10.2012

29.10.2012

Firdapse

| BioMarin Europe Ltd |
| --- |
| 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom |

BioMarin Europe Ltd

164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom

EU/1/09/601/001

1.11.2012

29.10.2012

Foscan

| Biolitec pharma Ltd |
| --- |
| United Drug House, Magna Drive, Dublin 24, Ireland |

Biolitec pharma Ltd

United Drug House, Magna Drive, Dublin 24, Ireland

EU/1/01/197/001-002

31.10.2012

29.10.2012

Fycompa

| Eisai Europe Limited |
| --- |
| European Knowledge Centre, Mosquito Way, Hatfield, Hertsforshire AL10 9SN, United Kingdom |

Eisai Europe Limited

European Knowledge Centre, Mosquito Way, Hatfield, Hertsforshire AL10 9SN, United Kingdom

EU/1/12/776/001-023

31.10.2012

29.10.2012

Ibandronic Acid Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/10/642/001-004

31.10.2012

29.10.2012

Icandra

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/484/001-018

1.11.2012

29.10.2012

Imprida

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/373/001-039

31.10.2012

29.10.2012

INOmax

| INO Therapeutics AB |
| --- |
| SE-181 81 Lidingö, Sverige |

INO Therapeutics AB

SE-181 81 Lidingö, Sverige

EU/1/01/194/001-004

1.11.2012

29.10.2012

Irbesartan/Hydrochlorothiazide Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/583/001-075

1.11.2012

29.10.2012

Javlor

| Pierre Fabre Médicament |
| --- |
| 45, place Abel Gance, F-92100 Boulogne, France |

Pierre Fabre Médicament

45, place Abel Gance, F-92100 Boulogne, France

EU/1/09/550/001-012

31.10.2012

29.10.2012

Leflunomide Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/11/675/001-010

6.11.2012

29.10.2012

Levetiracetam Actavis Group

| Actavis Group PTC ehf. |
| --- |
| ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland |

Actavis Group PTC ehf.

ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland

EU/1/11/738/001-003

1.11.2012

29.10.2012

Lucentis

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/374/001

1.11.2012

29.10.2012

Myclausen

| Herbert J. Passauer GmbH & Co. KG |
| --- |
| Stubenrauchstrasse 33, 14167 Berlin, Deutschland |

Herbert J. Passauer GmbH & Co. KG

Stubenrauchstrasse 33, 14167 Berlin, Deutschland

EU/1/10/647/001-004

31.10.2012

29.10.2012

Myocet

| Cephalon Europe |
| --- |
| 5 Rue Charles Martigny, Maisons Alfort 94700, France |

Cephalon Europe

5 Rue Charles Martigny, Maisons Alfort 94700, France

EU/1/00/141/001-002

5.11.2012

29.10.2012

Nimvastid

| KRKA, d.d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/525/001-050

5.11.2012

29.10.2012

Pelzont

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/460/001-014

31.10.2012

29.10.2012

Pixuvri

| CTI Life Sciences Ltd |
| --- |
| Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom |

CTI Life Sciences Ltd

Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom

EU/1/12/764/001

6.11.2012

29.10.2012

Plavix

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 54, rue La Boétie, 75008 Paris, France |

Sanofi Pharma Bristol-Myers Squibb SNC

54, rue La Boétie, 75008 Paris, France

EU/1/98/069/001a-001b

EU/1/98/069/002a-002b

EU/1/98/069/003a-003b

EU/1/98/069/004a-004b

EU/1/98/069/005a-005b

EU/1/98/069/006a-006b

EU/1/98/069/007a-007b

EU/1/98/069/008-010

EU/1/98/069/011a-011b

EU/1/98/069/012

2.11.2012

29.10.2012

Plenadren

| ViroPharma SPRL |
| --- |
| Rue Montoyer 47, 1000 Bruxelles/Brussel, France/België |

ViroPharma SPRL

Rue Montoyer 47, 1000 Bruxelles/Brussel, France/België

EU/1/11/715/001-002

6.11.2012

29.10.2012

Pravafenix

| LABORATOIRES SMB SA |
| --- |
| 26-28 rue de la Pastorale, 1080 Bruxelles, France/26-28 Herdersliedstraat, 1080 Brussel, België |

LABORATOIRES SMB SA

26-28 rue de la Pastorale, 1080 Bruxelles, France/26-28 Herdersliedstraat, 1080 Brussel, België

EU/1/11/679/007

6.11.2012

29.10.2012

Pumarix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, Rixensart, B-1330 France |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 France

EU/1/10/664/001

6.11.2012

29.10.2012

Raloxifene Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/10/627/001-003

6.11.2012

29.10.2012

Ranexa

| Menarini International Operations France S.A. |
| --- |
| 1, Avenue de la Gare, L-1611 France, France |

Menarini International Operations France S.A.

1, Avenue de la Gare, L-1611 France, France

EU/1/08/462/001-012

2.11.2012

29.10.2012

Rapiscan

| Rapidscan Pharma Solutions EU Ltd. |
| --- |
| Regent's Place, 338 Euston Road, London NW1 3BT, UK |

Rapidscan Pharma Solutions EU Ltd.

Regent's Place, 338 Euston Road, London NW1 3BT, UK

EU/1/10/643/001

6.11.2012

29.10.2012

Repaglinide Krka

| KRKA, d. d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA, d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/579/001-018

5.11.2012

29.10.2012

Repaglinide Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/530/001-015

6.11.2012

29.10.2012

Repso

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/11/674/001-010

1.11.2012

29.10.2012

Ribavirin Mylan

| Generics [UK] Limited |
| --- |
| Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/10/634/001-011

1.11.2012

29.10.2012

Rienso

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych, London WC2B 4AE, United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych, London WC2B 4AE, United Kingdom

EU/1/12/774/001-004

31.10.2012

29.10.2012

Sabervel

| Pharmathen S.A. |
| --- |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/12/765/001-009

31.10.2012

29.10.2012

Samsca

| Otsuka Pharmaceutical Europe Ltd |
| --- |
| Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom |

Otsuka Pharmaceutical Europe Ltd

Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom

EU/1/09/539/001-004

31.10.2012

29.10.2012

Stelara

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B – 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B – 2340 Beerse, België

EU/1/08/494/001-002

5.11.2012

29.10.2012

Sycrest

| N.V. Organon |
| --- |
| Kloosterstraat 6, 5349 AB Oss, Nederland |

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/10/640/001-006

6.11.2012

29.10.2012

Tasmar

| Meda AB |
| --- |
| Pipers väg 2A, SE-170 73 Solna, Sverige |

Meda AB

Pipers väg 2A, SE-170 73 Solna, Sverige

EU/1/97/044/001-009

1.11.2012

29.10.2012

Telmisartan Actavis

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

Actavis Group PTC ehf.

Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland

EU/1/10/639/001-030

31.10.2012

29.10.2012

Telmisartan Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/610/001-062

31.10.2012

29.10.2012

Telmisartan Teva Pharma

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/11/719/001-062

31.10.2012

29.10.2012

Teysuno

| Nordic Group BV |
| --- |
| Siriusdreef 22, 2132 WT Hoofddorp, Nederland |

Nordic Group BV

Siriusdreef 22, 2132 WT Hoofddorp, Nederland

EU/1/11/669/001-005

6.11.2012

29.10.2012

Topotecan Hospira

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

Hospira UK Limited

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

EU/1/10/633/001-002

31.10.2012

29.10.2012

Vfend

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/02/212/001-027

1.11.2012

29.10.2012

Xarelto

| Bayer Pharma AG |
| --- |
| 13342 Berlin, Deutschland |

Bayer Pharma AG

13342 Berlin, Deutschland

EU/1/08/472/011-021

31.10.2012

29.10.2012

Zalasta

| KRKA, d.d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/07/415/001-056

6.11.2012

29.10.2012

Zomarist

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/483/001-018

1.11.2012

31.10.2012

Adjupanrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l'Institut 89, 1330 Rixensart, France |

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89, 1330 Rixensart, France

EU/1/09/578/001

6.11.2012

31.10.2012

Axura

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstr. 100, D-60318 Frankfurt/Main – Deutschland |

Merz Pharmaceuticals GmbH

Eckenheimer Landstr. 100, D-60318 Frankfurt/Main – Deutschland

EU/1/02/218/001-003

EU/1/02/218/005-030

6.11.2012

31.10.2012

Copalia HCT

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/575/001-060

6.11.2012

31.10.2012

Dafiro HCT

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/574/001-060

6.11.2012

31.10.2012

Docetaxel Winthrop

| Aventis Pharma S.A. |
| --- |
| 20 avenue Raymond Aron, F-92165 Antony Cedex, France |

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92165 Antony Cedex, France

EU/1/07/384/003-005

6.11.2012

31.10.2012

Ebixa

| H. Lundbeck A/S |
| --- |
| Ottiliavej 9, DK-2500 Valby, Danmark |

H. Lundbeck A/S

Ottiliavej 9, DK-2500 Valby, Danmark

EU/1/02/219/001-003

EU/1/02/219/005-049

6.11.2012

31.10.2012

Ifirmasta

| KRKA, d.d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/480/001-024

6.11.2012

31.10.2012

Kaletra

| AbbVie Ltd. |
| --- |
| Maidenhead, SL6 4XE, United Kingdom |

AbbVie Ltd.

Maidenhead, SL6 4XE, United Kingdom

EU/1/01/172/001-008

6.11.2012

31.10.2012

Kiovig

| Baxter AG |
| --- |
| Industriestraße 67, A – 1221 Wien, Österreich |

Baxter AG

Industriestraße 67, A – 1221 Wien, Österreich

EU/1/05/329/001-006

6.11.2012

31.10.2012

Levetiracetam Accord

| Accord Healthcare Limited |
| --- |
| 5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom |

Accord Healthcare Limited

5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom

EU/1/11/712/001-040

6.11.2012

31.10.2012

Levetiracetam Actavis

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

Actavis Group PTC ehf.

Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland

EU/1/11/713/001-040

6.11.2012

31.10.2012

Ratiograstim

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/08/444/001-012

7.11.2012

31.10.2012

Repaglinide Accord

| Accord Healthcare Limited |
| --- |
| Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom |

Accord Healthcare Limited

Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom

EU/1/11/743/001-015

6.11.2012

31.10.2012

Rivastigmine Sandoz

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland |

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland

EU/1/09/599/001-018

6.11.2012

31.10.2012

Siklos

| ADDMEDICA |
| --- |
| 101, rue Saint Lazare, Paris 75009, France |

ADDMEDICA

101, rue Saint Lazare, Paris 75009, France

EU/1/07/397/001-004

6.11.2012

31.10.2012

Tevagrastim

| Teva GmbH |
| --- |
| Graf-Arco-Straße 3, 89079 Ulm, Deutschland |

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/08/445/001-014

6.11.2012

31.10.2012

Tolura

| KRKA, d.d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/10/632/001-021

6.11.2012

31.10.2012

Votubia

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

EU/1/11/710/001-007

6.11.2012

—   Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Miċħud

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 4.10.2012 | Daliresp | Nycomed GmbH |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

4.10.2012

Daliresp

Nycomed GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

—

8.10.2012

4.10.2012

Daxas

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |

Nycomed GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

—

8.10.2012

—   Irtirar ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 24.10.2012 | Rilonacept Regeneron | Regeneron UK Limited |
| 40 Bank Street, E14 5DS London, United Kingdom |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

24.10.2012

Rilonacept Regeneron

Regeneron UK Limited

40 Bank Street, E14 5DS London, United Kingdom

EU/1/09/582/001

26.10.2012

—   Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 10.10.2012 | Acticam | Ecuphar NV |
| Legeweg 157-I, B-8020 Oostkamp, Belgïe |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

10.10.2012

Acticam

Ecuphar NV

Legeweg 157-I, B-8020 Oostkamp, Belgïe

EU/2/08/088/004

12.10.2012

15.10.2012

Oxyglobin

| OPK Biotech Netherlands BV |
| --- |
| Teleportboulevard 140, 1043EJ Amsterdam, Nederland |

OPK Biotech Netherlands BV

Teleportboulevard 140, 1043EJ Amsterdam, Nederland

EU/2/99/015/001-004

16.10.2012

23.10.2012

ProteqFlu

| Merial |
| --- |
| 29 Avenue Tony Garnier, 69007 Lyon, France |

Merial

29 Avenue Tony Garnier, 69007 Lyon, France

EU/2/03/037/005

26.10.2012

24.10.2012

Pirsue

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/2/00/027/001-003

26.10.2012

25.10.2012

Dexdomitor

| Orion Corporation |
| --- |
| Orionintie 1, FIN-02200 Espoo, Suomi |

Orion Corporation

Orionintie 1, FIN-02200 Espoo, Suomi

EU/2/02/033/001-004

30.10.2012

25.10.2012

Posatex

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/08/081/001-003

29.10.2012

25.10.2012

Stronghold

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/2/99/014/001-012

29.10.2012

29.10.2012

Improvac

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/2/09/095/001-006

1.11.2012

29.10.2012

Loxicom

| Norbrook Laboratories Limited |
| --- |
| Station Works, Newry, Co. Down, BT35 6JP, United Kindgom |

Norbrook Laboratories Limited

Station Works, Newry, Co. Down, BT35 6JP, United Kindgom

EU/2/08/090/001-028

31.10.2012

29.10.2012

Meloxidyl

| CEVA SANTE ANIMALE |
| --- |
| 10 avenue de la Ballastière, 33500 Libourne, France |

CEVA SANTE ANIMALE

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/06/070/009

31.10.2012

29.10.2012

Previcox

| Merial |
| --- |
| 29 Avenue Tony Garnier, 69007 Lyon, France |

Merial

29 Avenue Tony Garnier, 69007 Lyon, France

EU/2/04/045/001-007

6.11.2012

29.10.2012

Procox

| Bayer Animal Health GmbH |
| --- |
| 51368 Leverkusen, Deutschland |

Bayer Animal Health GmbH

51368 Leverkusen, Deutschland

EU/2/11/123/001-002

2.11.2012

29.10.2012

RevitaCAM

| Abbott Laboratories Limited |
| --- |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM |

Abbott Laboratories Limited

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM

EU/2/12/138/001-003

31.10.2012

29.10.2012

Suvaxyn PCV

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom

EU/2/09/099/001-006

1.11.2012

31.10.2012

PRILACTONE

| CEVA SANTE ANIMALE |
| --- |
| 10 avenue de la Ballastière, 33500 Libourne, France |

CEVA SANTE ANIMALE

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/07/074/001-009

6.11.2012

—   Tneħħija tas-sospensjoni ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 45 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 10.10.2012 | Suvaxyn PCV | Pfizer Limited |
| Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

10.10.2012

Suvaxyn PCV

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom

EU/2/09/099/001-006

12.10.2012

Kull min jixtieq jikkonsulta r-rapport ta' evalwazzjoni pubblika dwar il-prodotti mediċinali kkonċernati u d-deċiżjonijiet marbuta magħhom għandu jikkuntattja lil:

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, |
| Canary Wharf |
| UK - LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK - LONDON E14 4H

---

(1)  ĠU L 136, 30.4.2004, p. 1.

---

| 30.11.2012 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 371/26 |
| --- | --- | --- | --- |

30.11.2012

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 371/26

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2012 sal-31 ta’ Ottubru 2012

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE
   (1)
  jew l-Artikolu 38 tad-Direttiva 2001/82/KE
   (2)
  )

2012/C 371/04

—   Ħruġ, manteniment jew modifika ta' awtorizzazzjoni għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 10.10.2012 | Aminocaproic acid containing medicinal products (antifibrynolitics) | Ara l-Anness I | Ara l-Anness I | 12.10.2012 |
| 8.10.2012 | Mometasone Furoate Sandoz and associated names | Ara l-Anness II | Ara l-Anness II | 9.10.2012 |
| 10.10.2012 | Tranexamic acid containing medicinal products (antifibrynolitics) | Ara l-Anness III | Ara l-Anness III | 12.10.2012 |
| 8.10.2012 | Baytril | Ara l-Anness IV | Ara l-Anness IV | 9.10.2012 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta' notifika

10.10.2012

Aminocaproic acid containing medicinal products (antifibrynolitics)

Ara l-Anness I

Ara l-Anness I

12.10.2012

8.10.2012

Mometasone Furoate Sandoz and associated names

Ara l-Anness II

Ara l-Anness II

9.10.2012

10.10.2012

Tranexamic acid containing medicinal products (antifibrynolitics)

Ara l-Anness III

Ara l-Anness III

12.10.2012

8.10.2012

Baytril

Ara l-Anness IV

Ara l-Anness IV

9.10.2012

---

(1)  ĠU L 311, 28.11.2001, p. 67.

(2)  ĠU L 311, 28.11.2001, p. 1.

---

ANNESS I

LISTA TAL-ISMIJIET IVVINTATI, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

Prodotti mediċinali li fihom Aminocaproic acid b'Awtorizzazzjoni għat-Tqegħid fis-Suq fl-Unjoni Ewropea

| Stat Membru
  UE/ŻEE | Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Isem ivvintat | Qawwa | Għamla farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| ES - Spanja | ROTTAPHARM, S.L. |
| Avda. Diagonal 67-69 |
| 08019Barcelona |
| Spanja |

Stat Membru

UE/ŻEE

Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Isem ivvintat

Qawwa

Għamla farmaċewtika

Mnejn jingħata

ES - Spanja

ROTTAPHARM, S.L.

Avda. Diagonal 67-69

08019Barcelona

Spanja

CAPROAMIN FIDES 4 g SOLUCIÓN INYECTABLE

4 g/10 ml

soluzzjoni għall-injezzjoni

użu għal ġol-vini

HU - Ungerija

| PannonPharma Kft. |
| --- |
| Pannonpharma út 1. |
| 7720 Pécsvárad |
| L-Ungerija |

PannonPharma Kft.

Pannonpharma út 1.

7720 Pécsvárad

L-Ungerija

Acepramin

4 g/10 ml

soluzzjoni għall-infużjoni

użu għal ġol-vini

PT - Il-Portugall

| Bial - Aristegui, |
| --- |
| Produtos Farmacêuticos, S.A. |
| À Av. da Siderurgia Nacional Apartado 100 |
| 4745-457 S. Mamede do Coronado |
| Il-Portugall |

Bial - Aristegui,

Produtos Farmacêuticos, S.A.

À Av. da Siderurgia Nacional Apartado 100

4745-457 S. Mamede do Coronado

Il-Portugall

Epsicaprom 25

2 500 mg/10 ml

Soluzzjoni għall-infużjoni

użu għal ġol-vini

---

ANNESS II

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWA TAL-PRODOTT MEDIĊINALI, MNEJN JINGĦATA, L-APPLIKANT FL-ISTATI MEMBRI

| Stat Membru
  EU/EEA | L- applikant | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata |
| --- | --- | --- | --- | --- | --- |
| Il-Belġiu | Sandoz B.V. |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Stat Membru

EU/EEA

L- applikant

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

Il-Belġiu

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasone Sandoz 50 mcg/dosis neusspray, suspensie

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

Ir-Repubblika Ċeka

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mommox 0,05 mg/dávku

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

Id-Danimarka

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasone Sandoz

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

L-Estonja

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Nasometin

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

Il-Finlandja

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasone furoate Sandoz

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

Franza

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

MOMETASONE Sandoz 50 microgrammes/dose, suspension pour pulvérisation nasale

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

Il-Ġermanja

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasonfuroat Sandoz 50 Mikrogramm/Sprühstoß Nasenspray, Suspension

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

Il-Greċja

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasone Furoate/Sandoz

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

L-Ungerija

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometason Sandoz 50 mikrogramm/adag oldatos orrspray

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

L-Italja

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

MOMETASONE FUROATO SANDOZ 50 microgrammi/erogazione, spray nasale

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

Il-Lussemburgu

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometason Sandoz 50 mcg/dose spray nasale

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

L-Olanda

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasonfuroaat Sandoz 50 microgram/dosis, neusspray, suspensie

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

In-Norveġja

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasone Sandoz

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

Il-Polonja

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Nasometin

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

Il-Portugall

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasona Sandoz

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

Ir-Rumanija

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometazonă furoat Sandoz 50 micrograme/doza, spray nazal, suspensie

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

ls-Slovakkja

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasone Sandoz 50 mikrogramov

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

Is-Slovenja

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

FUMOMO 50 mikrogramov/vpih pršilo za nos, suspenzija

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

Spanja

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasona Sandoz 50 mcg/dosis suspensión para nebulización nasal

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

L-Isvezja

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasone Sandoz

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

Ir-Renju Unit

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasone Furoate 50 micrograms/dose, nasal spray, suspension

50 microgrammi/doża

sprej għall-imnieħer, suspensjoni

sprej għall-imnieħer, suspensjoni

---

ANNESS III

LISTA TAL-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWA TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

Prodotti mediċinali li fihom tranexamic acid b’Awtorizzazzjoni għat-Tqegħid fis-Suq fl-Unjoni Ewropea

| Numru ta’ l-
  EU/EEA | Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-Suq | Isem inventat | Qawwa | Għamla farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| AT - L-Awstrija | Pfizer Corporation Austria GmbH |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |
| L-Awstrija |

Numru ta’ l-

EU/EEA

Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-Suq

Isem inventat

Qawwa

Għamla farmaċewtika

Mnejn jingħata

AT - L-Awstrija

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

A-1210 Wien

L-Awstrija

Cyklokapron - Ampullen

0,5 g/5 ml

Soluzzjoni għall-injezzjoni

użu għal ġol-vini

BE - Il-Belġju

| PFIZER S.A.N.V. |
| --- |
| Bld de la Plaine 17 |
| 1050 Brussels |
| Il-Belġju |

PFIZER S.A.N.V.

Bld de la Plaine 17

1050 Brussels

Il-Belġju

Cyklokapron

100 mg/5 ml

Soluzzjoni għall-injezzjoni

użu għal ġol-vini

BE - Il-Belġju

| Eumedica S.A. |
| --- |
| Winston Churchilllaan 67 |
| 1180 Brussels |
| Il-Belġju |

Eumedica S.A.

Winston Churchilllaan 67

1180 Brussels

Il-Belġju

Exacyl 500

500 mg/5 ml

Soluzzjoni għall-injezzjoni

użu għal ġol-vini

CY - Ċipru

| MEDOCHEMIE LTD, 1-10 CONSTANTINOUPOLEOS STREET, P.O.BOX 51409, |
| --- |
| 3505 LEMESOS, ĊIPRU |

MEDOCHEMIE LTD, 1-10 CONSTANTINOUPOLEOS STREET, P.O.BOX 51409,

3505 LEMESOS, ĊIPRU

AZEPTIL INJECTION 500 MG/5 ML

500 MG/5 ML

INJEZZJONI

użu għal ġol-vini

CY - Ċipru

| MEDOCHEMIE LTD, 1-10 CONSTANTINOUPOLEOS STREET, P.O.BOX 51409, |
| --- |
| 3505 LEMESOS, ĊIPRU |

MEDOCHEMIE LTD, 1-10 CONSTANTINOUPOLEOS STREET, P.O.BOX 51409,

3505 LEMESOS, ĊIPRU

AZEPTIL INJECTION 250 MG/5 ML

250 MG/5 ML

INJEZZJONI

użu għal ġol-vini

CZ – Ir-Repubblika Ċeka

| Sanofi-Aventis, s.r.o., Evropská 846/176a, |
| --- |
| 160 00 Praha 6, Ir-Repubblika Ċeka |

Sanofi-Aventis, s.r.o., Evropská 846/176a,

160 00 Praha 6, Ir-Repubblika Ċeka

Exacyl

100 mg/ml

Soluzzjoni għall-injezzjoni

użu għal ġol-vini

DE – Il-Ġermanja

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Cyklokapron-Injektionslösung

500 mg/5 ml

Soluzzjoni għall-injezzjoni

użu għal ġol-vini

DK – Id-Danimarka

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, Id-Danimarka |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup, Id-Danimarka

Tranexamsyre “Pfizer”

100 mg/ml

Soluzzjoni għall-injezzjoni

użu għal ġol-vini

EL – Il-Greċja

| A. NIKOLAKOPOULOS A.E. |
| --- |
| GALATSIOU AVENUE 115, Athens 11146 |

A. NIKOLAKOPOULOS A.E.

GALATSIOU AVENUE 115, Athens 11146

TRANSAMIN

500 MG/5 ML

Soluzzjoni għall-injezzjoni jew għall-infużjoni

użu għal ġol-vini

ES - Spanja

| ROTTAPHARM S.L. |
| --- |
| Avda. Diagonal 67-69 |
| 08019 Barcelona |
| Spanja |

ROTTAPHARM S.L.

Avda. Diagonal 67-69

08019 Barcelona

Spanja

AMCHAFIBRIN

500 mg SOLUCIÓN INYECTABLE

500 mg/5 ml

Soluzzjoni għall-injezzjoni

użu għal ġol-vini

ET – L-Estonja

| Pfizer Enterprises SARL Round-Point du Kirchberg |
| --- |
| 51, Avenue J.F. Kennedy |
| L-1855 Il-Lussemburgu |

Pfizer Enterprises SARL Round-Point du Kirchberg

51, Avenue J.F. Kennedy

L-1855 Il-Lussemburgu

CYKLOKAPRON

100 mg/ml

Soluzzjoni għall-injezzjoni

użu għal ġol-vini

FI – Il-Finlandja

| Oy Leiras Finland Ab |
| --- |
| Paciuksenkatu 21 |
| PL 1406 |
| 00101 Helsinki |
| Il-Finlandja |

Oy Leiras Finland Ab

Paciuksenkatu 21

PL 1406

00101 Helsinki

Il-Finlandja

CAPRILON

100 mg/ml

Soluzzjoni għall-injezzjoni

użu għal ġol-vini

FR - Franza

| Sanofi Aventis France |
| --- |
| 1-13, bd Romain Rolland |
| 75014 Paris |
| Franza |

Sanofi Aventis France

1-13, bd Romain Rolland

75014 Paris

Franza

Exacyl 0,5 g/5 ml I.V., solution injectable

0,5 g/5 ml

Soluzzjoni għall-injezzjoni

użu għal ġol-vini

HU – L-Ungerija

| sanofi-aventis Zrt. |
| --- |
| Tó u. 1-5. |
| 1045 Budapest, L-Ungerija |

sanofi-aventis Zrt.

Tó u. 1-5.

1045 Budapest, L-Ungerija

Exacyl

0,5 g/5 ml

Soluzzjoni għall-injezzjoni

użu għal ġol-vini

IE – L-Irlanda

| Pharmacia Ireland Ltd, |
| --- |
| 9 Riverwalk, National Digital Park, |
| Citywest Business Campus, |
| Dublin 24 |
| L-Irlanda |

Pharmacia Ireland Ltd,

9 Riverwalk, National Digital Park,

Citywest Business Campus,

Dublin 24

L-Irlanda

Cyklokapron 500 mg/5 ml solution for injection or infusion

100 mg/ml

Soluzzjoni għall-injezzjoni

użu għal ġol-vini

IS – L-Islanda

| Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, |
| --- |
| Id-Danimarka |

Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup,

Id-Danimarka

Tranexamsyre “Pfizer”

100 mg/ml

Soluzzjoni għall-injezzjoni

użu għal ġol-vini

IT – L-Italja

| Rottapharm S.p.A. |
| --- |
| Via Valosa di Sopra, 9 |
| 20052 Monza - L-Italja |

Rottapharm S.p.A.

Via Valosa di Sopra, 9

20052 Monza - L-Italja

UGUROL

500 mg/5 ml

Soluzzjoni għall-injezzjoni

użu għal ġol-vini

IT - L-Italja

| Istituto Farmacobiologico Malesci S.p.A. |
| --- |
| Via Lungo l'Ema 7 |
| 50015 Bagno a Ripoli (Firenze) |
| L-Italja |

Istituto Farmacobiologico Malesci S.p.A.

Via Lungo l'Ema 7

50015 Bagno a Ripoli (Firenze)

L-Italja

TRANEX

500 mg/5 ml

Soluzzjoni għall-injezzjoni

użu għal ġol-vini

IT - L-Italja

| Bioindutria Laboratorio Italiano Medicinali spa |
| --- |
| Via De Ambrosiis, 2 |
| 15067 Novi Ligure Alessandria |
| L-Italja |

Bioindutria Laboratorio Italiano Medicinali spa

Via De Ambrosiis, 2

15067 Novi Ligure Alessandria

L-Italja

ACIDO TRANEXAMICO BIOINDUTRIA L.I.M.

500 mg/5 ml

Soluzzjoni għall-injezzjoni

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LU - Il-Lussemburgu

| Eumedica SA |
| --- |
| 67, Avenue Winston Churchill |
| B- 1180 Bruxelles |

Eumedica SA

67, Avenue Winston Churchill

B- 1180 Bruxelles

EXACYL

500 mg/5 ml

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LU - Il-Lussemburgu

| PFIZER S.A.N.V. |
| --- |
| Bld de la Plaine 17 |
| 1050 Brussels |
| Il-Belġju |

PFIZER S.A.N.V.

Bld de la Plaine 17

1050 Brussels

Il-Belġju

Cyklokapron

100 mg/ml

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NL – L-Olanda

| Pfizer B.V., |
| --- |
| Rivium Westlaan 142, |
| 2909 LD, Capelle a/d Ijssel |

Pfizer B.V.,

Rivium Westlaan 142,

2909 LD, Capelle a/d Ijssel

Cyklokapron, oplossing voor injectie 100 mg/ml

100 mg/ml

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NO – In-Norveġja

| Pfizer AS, |
| --- |
| Postboks 3, |
| 1324 Lysaker In-Norveġja |

Pfizer AS,

Postboks 3,

1324 Lysaker In-Norveġja

CYKLOKAPRON

100 mg/ml

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PL – Il-Polonja

| Warszawskie Zakłady Farmaceutyczne POLFA S.A. |
| --- |
| 22/24 karolkowa st. |
| 01-207 Warsaw, Il-Polonja |

Warszawskie Zakłady Farmaceutyczne POLFA S.A.

22/24 karolkowa st.

01-207 Warsaw, Il-Polonja

Exacyl

100 mg/ml

Soluzzjoni għall-injezzjoni

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PL - Il-Polonja

| Sanofi-Aventis France |
| --- |
| boulevard Romain Rolland 1-13, |
| F-75014 Paris, Franza |

Sanofi-Aventis France

boulevard Romain Rolland 1-13,

F-75014 Paris, Franza

Exacyl

100 mg/ml

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SE – L-Isvezja

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| L-Isvezja |

Pfizer AB,

191 90 Sollentuna,

L-Isvezja

Cyklokapron

100 mg/ml

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UK – Ir-Renju Unit

| Pharmacia Limited, |
| --- |
| Walton Oaks, Dorking Road, Tadworth, |
| Surrey KT20 7NS |
| Ir-Renju Unit |

Pharmacia Limited,

Walton Oaks, Dorking Road, Tadworth,

Surrey KT20 7NS

Ir-Renju Unit

CYKLOKAPRON INJECTION 500 MG/ML

500 mg/ml

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ANNESS IV

Kundizzjonijiet tal-awtorizzazzjonijiet għat-tqegħid fis-suq

L-Awtoritajiet Nazzjonali Kompetenti għandhom jiżguraw li d-Detenturi tal-Awtorizzazzjoni għat- Tqegħid fis-Suq jissodisfaw il-kundizzjoni li ġejja:

| — | Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq għandhom jissostanzjaw l-iskeda ta' dożar fil-fniek filwaqt li jikkunsidraw id-distribuzzjoni attwali tal-MIC għall-patoġeni fil-mira, il- varjabbiltà fil-farmakokinetika li tirriżulta mill-għoti ta' enrofloxacin mal-ilma tax-xorb lil gruppi ta' fniek taħt il-kundizzjonijiet fuq il-post u bl-għan li jkun żgurat trattament effettiv sostenibbli. |
| --- | --- |

—

Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq għandhom jissostanzjaw l-iskeda ta' dożar fil-fniek filwaqt li jikkunsidraw id-distribuzzjoni attwali tal-MIC għall-patoġeni fil-mira, il- varjabbiltà fil-farmakokinetika li tirriżulta mill-għoti ta' enrofloxacin mal-ilma tax-xorb lil gruppi ta' fniek taħt il-kundizzjonijiet fuq il-post u bl-għan li jkun żgurat trattament effettiv sostenibbli.

| — | Għandhom jiġu pprovduti studji dwar it-tnaqqis tar-residwi għal kwalunkwe skeda ġdida ta' dożar. Skeda ta' dożar aktar qasira jew baxxa minn dik attwali ta' 10 mg/kg għal 5 ijiem teħtieġ li tkun issostanzjata minn dejta klinika ġdida. |
| --- | --- |

—

Għandhom jiġu pprovduti studji dwar it-tnaqqis tar-residwi għal kwalunkwe skeda ġdida ta' dożar. Skeda ta' dożar aktar qasira jew baxxa minn dik attwali ta' 10 mg/kg għal 5 ijiem teħtieġ li tkun issostanzjata minn dejta klinika ġdida.

Ir-riżultati ta' dawk l-istudji għandhom ikunu pprovduti lill-Awtoritajiet rilevanti għall-valutazzjoni sa mhux aktar tard minn 18-il xahar wara d-Deċiżjoni tal-Kummissjoni dwar din il-proċedura ta' referenza.

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