29.1.2010   

RO

Jurnalul Oficial al Uniunii Europene

C 22/2

Rezumatul deciziilor comunitare cu privire la autorizațiile de comercializare de la 1 noiembrie 2009 până la 30 noiembrie 2009

[Publicat în conformitate cu articolul 13 sau articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului  (1) ]

2010/C 22/02

—   Emiterea unei autorizații de comercializare [articolul 13 din Regulamentul (CE) nr. 726/2004]: Acceptare

Data deciziei

Denumirea medicamentului

DCI (denumire comunã internaționalã)

Titularul autorizației de comercializare

Numãrul de înregistrare în Registrul comunitar

Forma farmaceuticã

Codul ATC (cod anatomic terapeutic chimic)

Data notificării

4.11.2009

Repaglinide Krka

repaglinidă

KRKA, d. d.

Novo mesto

Šmarješka cesta 6

SI-8501 Novo mesto

SLOVENIJA

EU/1/09/579/001-018

Comprimat

A10B X02

6.11.2009

4.11.2009

Copalia HCT

besilat de amlodipină/valsartan/hidrochlorotiazidă

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/09/575/001-060

Comprimat filmat

C09DX01

6.11.2009

4.11.2009

Dafiro HCT

besilat de amlodipină/valsartan/hidrochlorotiazidă

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/09/574/001-060

Comprimat filmat

C09DX01

6.11.2009

26.11.2009

Multaq

dronedaronă

Sanofi-Aventis

174 avenue de France

75013 Paris

FRANCE

EU/1/09/591/001-004

Comprimate filmate

Nu este cazul

1.12.2009

26.11.2009

Irbesartan/Hydrochlorothiazide Teva

irbesartan/hidroclorotiazidă

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/09/583/001-072

Comprimat filmat

C09D A04

1.12.2009

30.11.2009

Sildenafil Teva

sildenafil

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/09/584/001-018

Comprimat filmat

G04BE03

2.12.2009

30.11.2009

Nevirapine Teva

nevirapină

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/09/598/001-004

Comprimate

J05AG01

2.12.2009

30.11.2009

Hirobriz Breezhaler

maleat de indacaterol

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/09/594/001-010

Capsulă cu pulbere de inhalat

Nu este cazul

2.12.2009

30.11.2009

Onbrez Breezhaler

maleat de indacaterol

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/09/593/001-010

Capsulă cu pulbere de inhalat

Nu este cazul

2.12.2009

30.11.2009

Oslif Breezhaler

maleat de indacaterol

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/09/586/001-010

Capsulă cu pulbere de inhalat

Nu este cazul

2.12.2009

30.11.2009

Zutectra

imunoglobulină umană antihepatită B

Biotest Pharma GmbH

Landsteinerstr. 5

63303 Dreieich

DEUTSCHLAND

EU/1/09/600/001

soluție injectabilă

J06BB04

2.12.2009

—   Modificarea unei autorizații de comercializare [articolul 13 din Regulamentul (CE) nr. 726/2004]: Acceptare

Data deciziei

Denumirea medicamentului

Titularul autorizației de comercializare

Numărul de înregistrare în Registrul comunitar

Data notificării

4.11.2009

Intelence

Janssen-Cilag International NV

Turnhoutseweg 30

2340 Beerse

BELGIË

EU/1/08/468/001

6.11.2009

4.11.2009

Optisulin

Sanofi-Aventis Deutschland GmbH

65926 Frankfurt am Main

DEUTSCHLAND

EU/1/00/133/001-032

6.11.2009

4.11.2009

Lantus

Sanofi-Aventis Deutschland GmbH

65926 Frankfurt am Main

DEUTSCHLAND

EU/1/00/134/001-037

6.11.2009

4.11.2009

Ketek

Aventis Pharma S.A.

20 avenue Raymond Aron

92160 Antony

FRANCE

EU/1/01/191/001-005

6.11.2009

4.11.2009

Osseor

Les Laboratoires Servier

22 rue Garnier

92200 Neuilly-sur-Seine

FRANCE

EU/1/04/287/001-006

6.11.2009

4.11.2009

Protelos

Les Laboratoires Servier

22 rue Garnier

92200 Neuilly-sur-Seine

FRANCE

EU/1/04/288/001-006

6.11.2009

5.11.2009

Abilify

Otsuka Pharmaceutical Europe Ltd

Hunton House

Highbridge Business Park

Oxford Road

Uxbridge

Middlesex

UB8 1HU

UNITED KINGDOM

EU/1/04/276/001-020

EU/1/04/276/024-036

10.11.2009

5.11.2009

Tyverb

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/07/440/001-002

9.11.2009

5.11.2009

Pre-pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89

1330 Rixensart

BELGIQUE

EU/1/08/478/001

9.11.2009

5.11.2009

Celsentri

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/07/418/001-010

9.11.2009

5.11.2009

Invega

Janssen-Cilag International NV

Turnhoutseweg 30

2340 Beerse

BELGIË

EU/1/07/395/001-095

9.11.2009

5.11.2009

Foscan

Biolitec Pharma Ltd

United Drug House

Magna Drive

Dublin 24

IRELAND

EU/1/01/197/003-005

9.11.2009

6.11.2009

Fosavance

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/05/310/001-009

10.11.2009

9.11.2009

Januvia

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/07/383/001-018

11.11.2009

11.11.2009

Celvapan

Baxter AG

Industriestraße 67

1221 Wien

ÖSTERREICH

EU/1/08/506/001

12.11.2009

11.11.2009

Focetria

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina 1

53100 Siena SI

ITALIA

EU/1/07/385/001-002

EU/1/07/385/004

12.11.2009

11.11.2009

Pandemrix

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89

1330 Rixensart

BELGIQUE

EU/1/08/452/001

12.11.2009

11.11.2009

Insuman

Sanofi-Aventis Deutschland GmbH

65926 Frankfurt am Main

DEUTSCHLAND

EU/1/97/030/028-195

13.11.2009

11.11.2009

PegIntron

Schering Plough Europe

Rue de Stalle 73

1180 Bruxelles

BELGIQUE

Stallestraat 73

1180 Brussel

BELGIË

EU/1/00/131/001-050

13.11.2009

11.11.2009

Soliris

Alexion Europe S.A.S.

25 boulevard de l'Amiral Bruix

75016 Paris

FRANCE

EU/1/07/393/001

13.11.2009

11.11.2009

Rebetol

Schering Plough Europe

Rue de Stalle 73

1180 Bruxelles

BELGIQUE

Stallestraat 73

1180 Brussel

BELGIË

EU/1/99/107/001-005

13.11.2009

12.11.2009

Intelence

Janssen-Cilag International NV

Turnhoutseweg 30

2340 Beerse

BELGIË

EU/1/08/468/001

17.11.2009

12.11.2009

IntronA

Schering Plough Europe

Rue de Stalle 73

1180 Bruxelles

BELGIQUE

Stallestraat 73

1180 Brussel

BELGIË

EU/1/99/127/001-044

17.11.2009

12.11.2009

ViraferonPeg

Schering Plough Europe

Rue de Stalle 73

1180 Bruxelles

BELGIQUE

Stallestraat 73

1180 Brussel

BELGIË

EU/1/00/132/001-050

17.11.2009

19.11.2009

IntronA

Schering Plough Europe

Rue de Stalle 73

1180 Bruxelles

BELGIQUE

Stallestraat 73

1180 Brussel

BELGIË

EU/1/99/127/031-039

23.11.2009

19.11.2009

Clopidogrel Teva Pharma

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

HCS bvba, H.

Kennisstraat 53

2650 Edegem

BELGIË

EU/1/09/561/001-009

23.11.2009

20.11.2009

Circadin

RAD Neurim Pharmaceuticals EEC Limited

One Forbury Square

The Forbury, Reading

Berkshire

RG1 3EB

UNITED KINGDOM

EU/1/07/392/001-002

18.12.2009

20.11.2009

Bondronat

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

UNITED KINGDOM

EU/1/96/012/004

EU/1/96/012/009-013

24.11.2009

20.11.2009

Ebixa

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

DANMARK

EU/1/02/219/001-003

EU/1/02/219/005-049

24.11.2009

20.11.2009

Mycamine

Astellas Pharma Europe B.V.

Elisabethhof 19

2353 EW Leiderdorp

NEDERLAND

EU/1/08/448/001-002

24.11.2009

20.11.2009

NeoRecormon

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

UNITED KINGDOM

EU/1/97/031/019-046

24.11.2009

20.11.2009

MabCampath

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

NEDERLAND

EU/1/01/193/001-002

24.11.2009

20.11.2009

Somavert

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/02/240/001-004

24.11.2009

20.11.2009

Reyataz

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/03/267/001-010

24.11.2009

20.11.2009

Xeristar

Boehringer Ingelheim International GmbH

Binger Straße 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/04/297/001-008

24.11.2009

20.11.2009

Regranex

Janssen-Cilag International NV

Turnhoutseweg 30

2340 Beerse

BELGIË

EU/1/99/101/001

24.11.2009

20.11.2009

Ziagen

Glaxo Group Ltd

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/99/112/001-002

24.11.2009

20.11.2009

Cymbalta

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

NEDERLAND

EU/1/04/296/001-009

24.11.2009

20.11.2009

Angiox

The Medicines Company UK Ltd

115 L Milton Park

Abingdon

Oxfordshire

OX14 4SA

UNITED KINGDOM

EU/1/04/289/001-002

24.11.2009

20.11.2009

Agenerase

Glaxo Group Limited

Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/00/148/001-004

24.11.2009

20.11.2009

RoActemra

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

UNITED KINGDOM

EU/1/08/492/001-006

24.11.2009

23.11.2009

Nexavar

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

EU/1/06/342/001

25.11.2009

23.11.2009

Noxafil

SP Europe

Rue de Stalle 73

1180 Bruxelles

BELGIQUE

Stallestraat 73

1180 Brussel

BELGIË

EU/1/05/320/001

25.11.2009

23.11.2009

Pritor

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

EU/1/98/089/001-022

25.11.2009

23.11.2009

Aptivus

Boehringer Ingelheim International GmbH

Binger Straße 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/05/315/001-002

26.11.2009

23.11.2009

Exjade

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/06/356/001-009

25.11.2009

23.11.2009

Cervarix

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89

1330 Rixensart

BELGIQUE

EU/1/07/419/001-012

25.11.2009

23.11.2009

Trizivir

Glaxo Group Ltd.

Greenford Road

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/00/156/002-003

25.11.2009

23.11.2009

Telzir

Glaxo Group Ltd.

Greenford Road

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/04/282/001-002

25.11.2009

23.11.2009

Azilect

Teva Pharma GmbH

Kandelstrasse 10

79199 Kirchzarten

DEUTSCHLAND

EU/1/04/304/001-007

25.11.2009

23.11.2009

Invega

Janssen-Cilag International NV

Turnhoutseweg 30

2340 Beerse

BELGIË

EU/1/07/395/001-095

25.11.2009

23.11.2009

Puregon

Organon N.V.

Kloosterstraat 6

Postbus 20

5340 BH Oss

NEDERLAND

EU/1/96/008/001-041

25.11.2009

23.11.2009

Kinzalmono

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

EU/1/98/091/001-014

25.11.2009

23.11.2009

Micardis

Boehringer Ingelheim International GmbH

Binger Straße 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/98/090/001-020

26.11.2009

23.11.2009

Kaletra

Abbott Laboratories Ltd

Queenborough

Kent

ME11 5EL

UNITED KINGDOM

EU/1/01/172/001-007

25.11.2009

24.11.2009

Synagis

Abbott Laboratories Ltd

Queenborough

Kent

ME11 5EL

UNITED KINGDOM

EU/1/99/117/001-002

26.11.2009

24.11.2009

Alli

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/07/401/007-010

26.11.2009

25.11.2009

Kivexa

Glaxo Group Ltd

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/04/298/001-003

27.11.2009

26.11.2009

Enbrel

Wyeth Europa Limited

Huntercombe Lane South

Taplow

Maidenhead

Berkshire

SL6 0PH

UNITED KINGDOM

EU/1/99/126/001-021

1.12.2009

26.11.2009

Enbrel

Wyeth Europa Limited

Huntercombe Lane South

Taplow

Maidenhead

Berkshire

SL6 0PH

UNITED KINGDOM

EU/1/99/126/001-021

1.12.2009

26.11.2009

Diacomit

Biocodex

7 avenue Gallieni

94250 Gentilly

FRANCE

EU/1/06/367/001-012

1.12.2009

26.11.2009

Intelence

Janssen-Cilag International NV

Turnhoutseweg 30

2340 Beerse

BELGIË

EU/1/08/468/001

1.12.2009

26.11.2009

Abseamed

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

58638 Iserlohn

DEUTSCHLAND

EU/1/07/412/021-026

1.12.2009

27.11.2009

Pandemrix

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89

1330 Rixensart

BELGIQUE

EU/1/08/452/001

30.11.2009

27.11.2009

Focetria

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina 1

53100 Siena SI

ITALIA

EU/1/07/385/001-002

EU/1/07/385/004

30.11.2009

30.11.2009

Velcade

Janssen-Cilag International NV

Turnhoutseweg 30

2340 Beerse

BELGIË

EU/1/04/274/001-002

2.12.2009

30.11.2009

Champix

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/1/06/360/001-013

2.12.2009

30.11.2009

Adcirca

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

NEDERLAND

EU/1/08/476/001-006

2.12.2009

30.11.2009

Docetaxel Winthrop

Aventis Pharma S.A.

20 avenue Raymond Aron

92165 Antony Cedex

FRANCE

EU/1/07/384/003-004

2.12.2009

30.11.2009

Taxotere

Aventis Pharma S.A.

20 avenue Raymond Aron

92165 Antony Cedex

FRANCE

EU/1/95/002/003-004

2.12.2009

—   Retragerea unei autorizații de comercializare [articolul 13 din Regulamentul (CE) nr. 726/2004]

Data deciziei

Denumirea medicamentului

Titularul autorizației de comercializare

Numărul de înregistrare în Registrul comunitar

Data notificării

11.11.2009

Irbesartan BMS

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/06/375/001-033

13.11.2009

11.11.2009

Irbesartan HCT BMS

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/06/369/001-028

13.11.2009

12.11.2009

Clopidogrel BMS

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/08/464/001-019

17.11.2009

26.11.2009

Paxene

Norton Healthcare Limited

Albert Basin

Royal Docks

London

E16 2QJ

UNITED KINGDOM

EU/1/99/113/001-004

10.12.2009

—   Emiterea unei autorizații de comercializare [articolul 38 din Regulamentul (CE) nr. 726/2004]: Acceptare

Data deciziei

Denumirea medicamentului

DCI (denumire comună internaționalã)

Titularul autorizației de comercializare

Numãrul de înregistrare în Registrul comunitar

Forma farmaceuticã

Codul ATC (cod anatomic terapeutic chimic)

Data notificării

4.11.2009

Zolvix

monepantel

Novartis Healthcare A/S

Lyngbyvej 172

2100 Copenhagen

DANMARK

EU/2/09/101/001-010

Oral solution

QP52AX09

6.11.2009

—   Modificarea unei autorizații de comercializare [articolul 38 din Regulamentul (CE) nr. 726/2004]: Acceptare

Data deciziei

Denumirea medicamentului

Titularul autorizației de comercializare

Numărul de înregistrare în Registrul comunitar

Data notificării

18.11.2009

Dexdomitor

Orion Corporation

Orionintie 1

FI-02200 Espoo

SUOMI/FINLAND

EU/2/02/033/001-002

20.11.2009

19.11.2009

Improvac

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/2/09/095/001-003

23.11.2009

20.11.2009

Metacam

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/2/97/004/026

EU/2/97/004/033-034

24.11.2009

23.11.2009

Halocur

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLAND

EU/2/99/013/001-002

25.11.2009

Persoanele care doresc să consulte raportul public de evaluare cu privire la medicamentele în cauză și deciziile referitoare la acestea sunt invitate să contacteze:

Agenția Europeană pentru Medicamente

7 Westferry Circus

Canary Wharf

London

E14 4HB

UNITED KINGDOM

(1)  JO L 136, 30.4.2004, p. 1.