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Document 52011XC1028(03)

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2011 to 31 August 2011 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

OJ C 316, 28.10.2011, p. 1–17 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

28.10.2011   

EN

Official Journal of the European Union

C 316/1


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

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council  (1) )

2011/C 316/01

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

13.7.2011

Benlysta

belimumab

Glaxo Group Limited

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

EU/1/11/700/001-002

powder for concentrate for solution for infusion

L04AA26

15.7.2011

13.7.2011

Temozolomide Sun

temozolomide

Sun Pharmaceuticals Industries Europe B.V.

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/11/697/001-012

Capsule, hard

L01AX03

18.7.2011

13.7.2011

Xgeva

denosumab

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/11/703/001-002

Solution for injection

M05BX04

15.7.2011

13.7.2011

Yervoy

ipilimumab

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/698/001-002

Concentrate for solution for infusion

L01XC11

15.7.2011

18.7.2011

Victrelis

boceprevir

Merck Sharp & Dohme Limited

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

EU/1/11/704/001

Capsule, hard

J05AE

20.7.2011

20.7.2011

Fampyra

fampridine

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/11/699/001-002

Prolonged-release tablet

N07XX07

25.7.2011

20.7.2011

TOBI Podhaler

Tobramycin

Novartis Europharm Limited

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

EU/1/10/652/001-003

Inhalation powder, hard capsule

J01GB01

25.7.2011

26.7.2011

Ibandronic acid Sandoz

Ibandronic acid

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland

EU/1/11/685/001-005

Film-coated tablet

M05BA06

28.7.2011

27.7.2011

Zoely

nomegestrol/estradiol

Merck Serono Europe Limited

56 Marsh Wall, London E14 9TP, United Kingdom

EU/1/11/690/001-002

Film-coated tablet

G03AA14

1.8.2011

18.8.2011

Entacapone Orion

entacapone

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/708/001-004

Film-coated tablet

N04BX02

22.8.2011

24.8.2011

Levodopa/Carbidopa/Entacapone Orion

Levodopa, carbidopa, entacapone

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/706/001-033

Film-coated tablet

N04BA03

29.8.2011

24.8.2011

Trajenta

linagliptin

Boehringer Ingelheim International GmbH

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

EU/1/11/707/001-011

Film-coated tablet

A10BH05

30.8.2011

26.8.2011

Levetiracetam ratiopharm

levetiracetam

ratiopharm GmbH

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

EU/1/11/702/001-031

Film-coated tablet

Oral solution

N03AX14

31.8.2011

26.8.2011

Levetiracetam Teva

levetiracetam

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/11/701/001-028

Film-coated tablet

N03AX14

31.8.2011


—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

5.7.2011

Irbesartan Winthrop

Sanofi-Aventis

174, avenue de France, F-75013 Paris, France

EU/1/06/376/001-033

7.7.2011

5.7.2011

Relistor

Wyeth Europa Limited

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/08/463/001-011

7.7.2011

7.7.2011

Adrovance

Merck Sharp & Dohme Ltd

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

EU/1/06/364/005

EU/1/06/364/009

11.7.2011

7.7.2011

Ammonaps

Swedish Orphan Biovitrum International AB

SE-112 76 Stockholm, Sverige

EU/1/99/120/001-004

12.7.2011

7.7.2011

Hirobriz Breezhaler

Novartis Europharm Limited

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

EU/1/09/594/001-010

11.7.2011

7.7.2011

Modigraf

Astellas Pharma Europe B.V.

Elisabethhof 19, 2353 EW Leiderdorp, Nederland

EU/1/09/523/001-002

11.7.2011

7.7.2011

Removab

Fresenius Biotech GmbH

Am Haag 6-7, D-82166 Graefelfing, Deutschland

EU/1/09/512/001-002

11.7.2011

11.7.2011

NovoRapid

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/99/119/001

EU/1/99/119/003

EU/1/99/119/005-015

EU/1/99/119/017-023

13.7.2011

11.7.2011

Onbrez Breezhaler

Novartis Europharm Ltd

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

EU/1/09/593/001-010

13.7.2011

11.7.2011

Optaflu

Novartis Vaccines and Diagnostics GmbH

Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland

EU/1/07/394/001-009

13.7.2011

13.7.2011

Sildenafil ratiopharm

ratiopharm GmbH

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

EU/1/09/603/001-015

18.7.2011

13.7.2011

Stocrin

Merck Sharp & Dohme Ltd

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

EU/1/99/111/001-005

EU/1/99/111/008-011

18.7.2011

13.7.2011

Sustiva

Bristol-Myers Squibb Pharma EEIG

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

EU/1/99/110/001-005

EU/1/99/110/008-010

18.7.2011

13.7.2011

ViraferonPeg

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/00/132/001-050

18.7.2011

13.7.2011

Viread

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/01/200/001-002

18.7.2011

18.7.2011

Crixivan

Merck Sharp & Dohme Ltd

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

EU/1/96/024/001-005

EU/1/96/024/010

20.7.2011

18.7.2011

Intrinsa

Warner Chilcott UK Ltd

Old Belfast Road, Millbrook, Larne, County Antrim BT40 2SH, United Kingdom

EU/1/06/352/001-003

20.7.2011

18.7.2011

Livensa

Warner Chilcott Deutschland Gmbh

Dr.-Otto-Röhm-Strasse 2-4, Weiterstadt 64331, Deutschland

EU/1/06/351/001-003

20.7.2011

18.7.2011

Multaq

Sanofi-Aventis

174, avenue de France, F-75013 Paris, France

EU/1/09/591/001-004

20.7.2011

18.7.2011

ReFacto AF

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/99/103/001-008

20.7.2011

18.7.2011

Savene

SpePharm Holding BV

Kingsfordweg 151, GR Amsterdam 1043, Nederland

EU/1/06/350/001

20.7.2011

20.7.2011

Atriance

Glaxo Group Limited

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

EU/1/07/403/001

25.7.2011

20.7.2011

Betaferon

Bayer Schering Pharma AG

Müllerstrasse 170-178, D - 13342 Berlin, Deutschland

EU/1/95/003/003-012

25.7.2011

20.7.2011

Esbriet

InterMune UK Ltd

4th Floor, One Victoria Street, Bristol, BS1 6AA, United Kingdom

EU/1/11/667/001-003

26.7.2011

20.7.2011

Intelence

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/468/001

25.7.2011

20.7.2011

Ratiograstim

ratiopharm GmbH

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

EU/1/08/444/001-012

25.7.2011

20.7.2011

Rivastigmine 1 A Pharma

1 A Pharma GmbH

Keltenring 1+3, Oberhaching 82041, Deutschland

EU/1/09/585/001-018

25.7.2011

20.7.2011

Rivastigmine Sandoz

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland

EU/1/09/599/001-018

25.7.2011

20.7.2011

Silgard

Merck Sharp & Dohme Ltd

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

EU/1/06/358/001-008

EU/1/06/358/018-021

25.7.2011

20.7.2011

Zalasta

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/07/415/001-056

25.7.2011

26.7.2011

Avaglim

SmithKline Beecham Ltd.

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

EU/1/06/349/001-010

28.7.2011

26.7.2011

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

28.7.2011

26.7.2011

Busilvex

Pierre Fabre Médicament

45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France

EU/1/03/254/002

28.7.2011

26.7.2011

Cymbalta

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/296/001-009

28.7.2011

26.7.2011

Forsteo

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/03/247/001-002

28.7.2011

26.7.2011

Infanrix hexa

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, Rixensart, B-1330 Belgique

EU/1/00/152/001-008

EU/1/00/152/019-020

28.7.2011

26.7.2011

Kuvan

Merck Serono Europe Limited

56 Marsh Wall, London E14 9TP, United Kingdom

EU/1/08/481/001-003

28.7.2011

26.7.2011

Menveo

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/10/614/001-003

28.7.2011

26.7.2011

Remicade

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116/001-005

28.7.2011

26.7.2011

Retacrit

Hospira UK Limited

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

EU/1/07/431/001-025

28.7.2011

26.7.2011

Stelara

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/494/001-004

28.7.2011

26.7.2011

Xeristar

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/297/001-008

28.7.2011

27.7.2011

Avastin

Roche Registration Limited

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

EU/1/04/300/001-002

2.8.2011

27.7.2011

Beromun

Boehringer Ingelheim International GmbH

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

EU/1/99/097/001

1.8.2011

27.7.2011

Bondenza

Roche Registration Limited

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

EU/1/03/266/003-006

29.7.2011

27.7.2011

Bonviva

Roche Registration Limited

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

EU/1/03/265/003-006

29.7.2011

27.7.2011

Copalia

Novartis Europharm Ltd

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

EU/1/06/372/001-039

1.8.2011

27.7.2011

Dafiro

Novartis Europharm Ltd

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

EU/1/06/371/001-039

1.8.2011

27.7.2011

Ecalta

Pfizer Limited

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

EU/1/07/416/001-002

29.7.2011

27.7.2011

Emtriva

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/03/261/001-003

3.8.2011

27.7.2011

Eporatio

ratiopharm GmbH

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

EU/1/09/573/001-028

29.7.2011

27.7.2011

Exforge

Novartis Europharm Ltd

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

EU/1/06/370/001-039

29.7.2011

27.7.2011

Exjade

Novartis Europharm Ltd

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

EU/1/06/356/001-009

1.8.2011

27.7.2011

Faslodex

AstraZeneca UK Limited

Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom

EU/1/03/269/001-002

1.8.2011

27.7.2011

Fosavance

Merck Sharp & Dohme Ltd

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

EU/1/05/310/005

EU/1/05/310/009

29.7.2011

27.7.2011

Gardasil

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, 69007 Lyon, France

EU/1/06/357/001-008

EU/1/06/357/018-021

29.7.2011

27.7.2011

Imprida

Novartis Europharm Ltd

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

EU/1/06/373/001-039

29.7.2011

27.7.2011

Integrilin

Glaxo Group Ltd

Greenford, Middlesex, UB6 ONN, United Kingdom

EU/1/99/109/001-002

1.8.2011

27.7.2011

Kiovig

Baxter AG

Industriestraße 67, A - 1221 Wien, Österreich

EU/1/05/329/001-006

29.7.2011

27.7.2011

Leflunomide Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/09/604/001-010

2.8.2011

27.7.2011

Nevanac

Alcon Laboratories (UK) Ltd.

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

EU/1/07/433/001

29.7.2011

27.7.2011

PhotoBarr

Axcan Pharma International BV

Engelenkampstraat 72, 6131 JJ Sittard, Nederland

EU/1/04/272/001-002

2.8.2011

27.7.2011

PREZISTA

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/06/380/001-005

2.8.2011

27.7.2011

Rapamune

Wyeth Europa Limited

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/01/171/001

EU/1/01/171/007-010

EU/1/01/171/013-014

1.8.2011

27.7.2011

Relistor

TMC Pharma Services Ltd.

Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire, RG27 8AS, United Kingdom

EU/1/08/463/001-011

1.8.2011

27.7.2011

Silgard

Merck Sharp & Dohme Ltd

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

EU/1/06/358/001-021

2.8.2011

27.7.2011

Sycrest

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/10/640/001-006

2.8.2011

27.7.2011

Thymanax

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498/001-008

29.7.2011

27.7.2011

Truvada

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/04/305/001-002

3.8.2011

27.7.2011

Valdoxan

Les Laboratoires Servier

22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/08/499/001-008

1.8.2011

27.7.2011

Vantavo

Merck Sharp & Dohme Ltd.

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

EU/1/09/572/005

EU/1/09/572/009

1.8.2011

27.7.2011

Yentreve

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/280/001-008

29.7.2011

1.8.2011

alli

Glaxo Group Limited

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

EU/1/07/401/007-016

3.8.2011

1.8.2011

Doribax

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/467/001-002

3.8.2011

1.8.2011

Gardasil

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, 69007 Lyon, France

EU/1/06/357/001-021

3.8.2011

1.8.2011

Iressa

AstraZeneca AB

Sodertalje S 151 85, Sverige

EU/1/09/526/001-002

3.8.2011

1.8.2011

Nexavar

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/06/342/001

2.8.2011

1.8.2011

Pradaxa

Boehringer Ingelheim International GmbH

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

EU/1/08/442/001-014

3.8.2011

1.8.2011

Rivastigmine Teva

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/513/001-020

3.8.2011

1.8.2011

RoActemra

Roche Registration Limited

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

EU/1/08/492/001-006

3.8.2011

5.8.2011

ATryn

GTC Biotherapeutics UK Limited

10 Norwich Street, London EC4A 1BD, United Kingdom

EU/1/06/355/001-003

10.8.2011

5.8.2011

Biograstim

CT Arzneimittel GmbH

Lengeder Straße 42a, D-13407 Berlin, Deutschland

EU/1/08/450/001-010

10.8.2011

5.8.2011

Biopoin

CT Arzneimittel GmbH

Lengeder Straße 42a, D-13407 Berlin, Deutschland

EU/1/09/565/001-028

10.8.2011

5.8.2011

Enbrel

Wyeth Europa Limited

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/99/126/001-022

10.8.2011

5.8.2011

Focetria

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/07/385/001-002

EU/1/07/385/004

10.8.2011

5.8.2011

Hepsera

Gilead Sciences International Limited

Cambridge, CB21 6GT, United Kingdom

EU/1/03/251/001-002

10.8.2011

5.8.2011

Hycamtin

SmithKline Beecham Ltd.

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

EU/1/96/027/001

EU/1/96/027/003-007

10.8.2011

5.8.2011

InductOs

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/02/226/001

10.8.2011

5.8.2011

Silapo

STADA Arzneimittel AG

Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland

EU/1/07/432/001-022

10.8.2011

5.8.2011

Synflorix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/09/508/001-010

10.8.2011

5.8.2011

Viread

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/01/200/001-002

10.8.2011

10.8.2011

Arava

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/99/118/001-010

12.8.2011

10.8.2011

Cholestagel

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/03/268/001-004

12.8.2011

10.8.2011

Filgrastim Hexal

HEXAL AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/08/496/001-016

12.8.2011

10.8.2011

Lantus

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/134/001-037

12.8.2011

10.8.2011

Optisulin

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/133/001-032

12.8.2011

10.8.2011

Oslif Breezhaler

Novartis Europharm Limited

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

EU/1/09/586/001-010

12.8.2011

10.8.2011

Vidaza

Celgene Europe Ltd

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

EU/1/08/488/001

12.8.2011

10.8.2011

Zarzio

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/08/495/001-016

12.8.2011

18.8.2011

Ariclaim

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/283/008-012

22.8.2011

18.8.2011

Karvezide

Bristol-Myers Squibb Pharma EEIG

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

EU/1/98/085/001-034

22.8.2011

18.8.2011

Osseor

Les Laboratoires Servier

22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/04/287/001-006

22.8.2011

18.8.2011

Pandemrix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, Rixensart, B-1330 Belgique

EU/1/08/452/001

22.8.2011

18.8.2011

Protelos

Les Laboratoires Servier

22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/04/288/001-006

22.8.2011

18.8.2011

Sutent

Pfizer Ltd

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

EU/1/06/347/001-008

22.8.2011

18.8.2011

Volibris

Glaxo Group Ltd

Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/08/451/001-004

22.8.2011

19.8.2011

Atripla

Bristol-Myers Squibb and Gilead Sciences Limited

IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland

EU/1/07/430/001-002

23.8.2011

24.8.2011

Afinitor

Novartis Europharm Ltd

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

EU/1/09/538/001-008

30.8.2011

24.8.2011

Efficib

Merck Sharp & Dohme Ltd.

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

EU/1/08/457/001-016

30.8.2011

24.8.2011

Enbrel

Pfizer Limited

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

EU/1/99/126/001-022

9.9.2011

24.8.2011

Intelence

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/468/001

30.8.2011

24.8.2011

IntronA

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/99/127/011-039

EU/1/99/127/041-044

30.8.2011

24.8.2011

Janumet

Merck Sharp & Dohme Ltd.

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

EU/1/08/455/001-016

30.8.2011

24.8.2011

Januvia

Merck Sharp & Dohme Ltd

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

EU/1/07/383/001-018

30.8.2011

24.8.2011

Kentera

Nicobrand Limited

189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP

EU/1/03/270/001-005

30.8.2011

24.8.2011

Lantus

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/134/001-037

30.8.2011

24.8.2011

Mepact

IDM PHARMA SAS

11-15 quai De Dion Bouton, 92816 Puteaux Cedex, France

EU/1/08/502/001

30.8.2011

24.8.2011

Micardis

Boehringer Ingelheim International GmbH

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

EU/1/98/090/017-022

29.8.2011

24.8.2011

Modigraf

Astellas Pharma Europe B.V.

Elisabethhof 19, 2353 EW Leiderdorp, Nederland

EU/1/09/523/001-002

29.8.2011

24.8.2011

Multaq

Sanofi-Aventis

174, avenue de France, F-75013 Paris, France

EU/1/09/591/001-004

26.8.2011

24.8.2011

Mycamine

Astellas Pharma Europe B.V.

Elisabethhof 19, 2353 EW Leiderdorp, Nederland

EU/1/08/448/001-002

26.8.2011

24.8.2011

Neupro

Schwarz Pharma Ltd

Shannon, Industrial Estate, Co.Clare, Ireland

EU/1/05/331/001-055

26.8.2011

24.8.2011

Nplate

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/08/497/001-008

30.8.2011

24.8.2011

Optisulin

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/133/001-032

29.8.2011

24.8.2011

Osigraft

Howmedica International S. de R.L.

Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland

EU/1/01/179/001

30.8.2011

24.8.2011

PegIntron

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/00/131/001-050

26.8.2011

24.8.2011

Pelzont

Merck Sharp & Dohme Ltd

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

EU/1/08/460/001-014

26.8.2011

24.8.2011

Rebetol

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/99/107/001-005

29.8.2011

24.8.2011

Reyataz

Bristol-Myers Squibb Pharma EEIG

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

EU/1/03/267/001-010

30.8.2011

24.8.2011

Ristaben

Merck Sharp & Dohme Ltd.

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

EU/1/10/621/001-018

30.8.2011

24.8.2011

Ristfor

Merck Sharp & Dohme Ltd.

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

EU/1/10/620/001-016

30.8.2011

24.8.2011

Stalevo

Orion Corporation

Orionintie 1, FIN-02200 Espoo, Suomi

EU/1/03/260/001-038

30.8.2011

24.8.2011

Starlix

Novartis Europharm Ltd

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

EU/1/01/174/001-021

30.8.2011

24.8.2011

Tarceva

Roche Registration Limited

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

EU/1/05/311/001-003

26.8.2011

24.8.2011

Tesavel

Merck Sharp & Dohme Ltd

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

EU/1/07/435/001-018

30.8.2011

24.8.2011

Thyrogen

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/99/122/001-002

30.8.2011

24.8.2011

Tredaptive

Merck Sharp & Dohme Ltd

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

EU/1/08/459/001-014

30.8.2011

24.8.2011

Trevaclyn

Merck Sharp & Dohme Ltd

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

EU/1/08/458/001-014

30.8.2011

24.8.2011

Tygacil

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/06/336/001

30.8.2011

24.8.2011

VELCADE

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/04/274/001-002

30.8.2011

24.8.2011

Velmetia

Merck Sharp & Dohme Ltd.

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

EU/1/08/456/001-016

30.8.2011

24.8.2011

Vfend

Pfizer Ltd

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

EU/1/02/212/001-026

30.8.2011

24.8.2011

ViraferonPeg

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/00/132/001-050

30.8.2011

24.8.2011

Yttriga

Eckert & Ziegler Nuclitec GmbH

Gieselweg 1, Braunschweig 38110, Deutschland

EU/1/05/322/001-002

29.8.2011

24.8.2011

Zevalin

Bayer Schering Pharma AG

D-13342 Berlin, Deutschland

EU/1/03/264/001

30.8.2011

24.8.2011

Zometa

Novartis Europharm Ltd

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

EU/1/01/176/001-009

30.8.2011

26.8.2011

Alisade

Glaxo Group Ltd

Greenford, Middlesex, UB6 ONN, United Kingdom

EU/1/08/474/001-003

31.8.2011

26.8.2011

Avamys

Glaxo Group Ltd

Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/434/001-003

31.8.2011

26.8.2011

Cervarix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/07/419/001-012

31.8.2011

26.8.2011

Corlentor

Les Laboratoires Servier

22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/05/317/001-014

31.8.2011

26.8.2011

Fertavid

SP Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/09/510/001-019

31.8.2011

26.8.2011

HBVAXPRO

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, 69007 Lyon, France

EU/1/01/183/001

EU/1/01/183/004-005

EU/1/01/183/007-008

EU/1/01/183/011

EU/1/01/183/013

EU/1/01/183/015

EU/1/01/183/018-032

31.8.2011

26.8.2011

Insulin Human Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/06/368/001-168

31.8.2011

26.8.2011

Procoralan

Les Laboratoires Servier

22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/05/316/001-014

31.8.2011

26.8.2011

Prolia

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/10/618/001-004

31.8.2011

26.8.2011

Sebivo

Novartis Europharm Ltd

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

EU/1/07/388/001-003

31.8.2011

26.8.2011

Tepadina

ADIENNE S.r.l.

via Broseta, 64/B, 24128 Bergamo, Italia

EU/1/10/622/001-002

31.8.2011

26.8.2011

Topotecan Teva

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/09/552/001-004

31.8.2011


—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council  (2) ): Accepted

Date of the Décision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

5.8.2011

Proteq West Nile

West Nile recombinant canarypox virus (vCP2017 virus)

MERIAL

29 avenue Tony Garnier, 69007 LYON, France

EU/2/11/129/001-004

Suspension for injection

QI05AX

10.8.2011

5.8.2011

Zulvac 1 Bovis

Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP ≥ 1

Pfizer Limited

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

EU/2/11/130/001-003

Suspension for injection

QI02AA08

10.8.2011

5.8.2011

Zulvac 1 Ovis

Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP ≥ 1

Pfizer Limited

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

EU/2/11/131/001-006

Suspension for injection

QI04AA02

10.8.2011

18.8.2011

Emdocam

Meloxicam

Emdoka bvba

J. Lijsenstraat 16, B-2321 Hoogstraten, Belgïe

EU/2/11/128/001-003

Solution for injection

QM01AC06

22.8.2011


—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

7.7.2011

Leucofeligen FeLV/RCP

VIRBAC S.A.

1ère Avenue 2065 m L.I.D. - 06516 Carros Cedex France

EU/2/09/097/001-002

11.7.2011

7.7.2011

Palladia

Pfizer Ltd

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

EU/2/09/100/001-003

12.7.2011

7.7.2011

ProMeris Duo

Pfizer Limited

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

EU/2/06/065/001-010

11.7.2011

11.7.2011

Trocoxil

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom

EU/2/08/084/001-005

13.7.2011

13.7.2011

Loxicom

Norbrook Laboratories Limited

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

EU/2/08/090/001-018

18.7.2011

20.7.2011

Posatex

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/08/081/001-003

25.7.2011

27.7.2011

Poulvac FluFend H5N3 RG

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom

EU/2/06/060/001-002

1.8.2011

27.7.2011

ProMeris

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom

EU/2/06/064/001-004

1.8.2011

27.7.2011

Slentrol

Pfizer Ltd

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

EU/2/07/071/001-003

2.8.2011

5.8.2011

Cerenia

Pfizer Ltd

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

EU/2/06/062/001-005

10.8.2011

5.8.2011

Virbagen Omega

VIRBAC S.A.

1ère Avenue 2065 m L.I.D. - 06516 Carros - France

EU/2/01/030/001-004

10.8.2011

19.8.2011

Nobilis Influenza H5N2

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/06/061/001-004

23.8.2011

19.8.2011

Zolvix

Novartis Healthcare A/S

Lyngbyvej 172, DK-2100 Copenhagen, Danmark

EU/2/09/101/001-010

23.8.2011

24.8.2011

Suvaxyn Aujeszky 783 +O/W

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36, 1381 CP Weesp, Nederland

EU/2/98/009/001-006

30.8.2011


—   Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

10.8.2011

Yarvitan

Janssen Pharmaceutica N.V.

Turnhoutseweg 30, B-2340 Beerse, België

EU/2/06/063/001-003

12.8.2011

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK - LONDON E14 4H


(1)  OJ L 136, 30.4.2004, p. 1.

(2)  OJ L 136, 30.4.2004, p. 1.


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