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Document 52008XC0725(03)

    Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2008 to 30 June 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )

    OJ C 188, 25.7.2008, p. 6–15 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    25.7.2008   

    EN

    Official Journal of the European Union

    C 188/6

    Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2008 to 30 June 2008

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

    (2008/C 188/04)

    —   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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

    10.6.2008

    Tyverb

    Lapatinib

    Glaxo Group Limited

    Berkeley Avenue

    Greenford

    Middlesex UB6 0NN

    United Kingdom

    EU/1/07/440/001-002

    Film-coated tablet

    L01XE07

    12.6.2008

    —   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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

    2.6.2008

    Xyrem

    UCB Pharma Ltd

    208 Bath Road

    Slough

    Berkshire SL1 3WE

    United Kingdom

    EU/1/05/312/001

    4.6.2008

    2.6.2008

    Dafiro

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/06/371/001-033

    4.6.2008

    2.6.2008

    Copalia

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/06/372/001-033

    4.6.2008

    3.6.2008

    Exforge

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/06/370/001-033

    5.6.2008

    3.6.2008

    Imprida

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/06/373/001-003

    5.6.2008

    4.6.2008

    Evoltra

    Bioenvision Limited

    Bassett House

    5 Southwell Park Road

    Camberley

    Surrey GU15 3PU

    United Kingdom

    EU/1/06/334/001-004

    6.6.2008

    Genzyme Europe BV

    Gooimeer 10

    1411 DD Naarden

    Nederland

    6.6.2008

    Vaniqa

    Shire Pharmaceutical Contracts Ltd

    Hampshire International Business Park

    Chineham

    Basingstoke

    Hampshire RG24 8EP

    United Kingdom

    EU/1/01/173/001-003

    10.6.2008

    Laboratorios Almirall S.A.

    Ronda General Mitre, no 151

    E-08022 Barcelona

    11.6.2008

    10.6.2008

    Olanzapine Neopharma

    Neopharma Limited

    57 High Street

    Odiham

    Hampshire RG29 1LF

    United Kingdom

    EU/1/07/426/001-011

    12.6.2008

    10.6.2008

    Imprida

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/06/373/001-033

    12.6.2008

    10.6.2008

    Irbesartan BMS

    Bristol-Myers Squibb Pharma EEIG

    Uxbridge Business Park

    Sanderson Road

    Uxbridge UB8 1DH

    United Kingdom

    EU/1/06/375/001-033

    12.6.2008

    10.6.2008

    Exforge

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/06/370/001-033

    12.6.2008

    10.6.2008

    Copalia

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/06/372/001-033

    12.6.2008

    10.6.2008

    Aprovel

    Sanofi Pharma Bristol-Myers Squibb SNC

    174, avenue de France

    F-75013 Paris

    EU/1/97/046/001-039

    12.6.2008

    10.6.2008

    Olanzapine Teva

    Teva Pharma B.V.

    Computerweg 10

    DR Utrecht 3542

    Nederland

    EU/1/07/427/001-057

    12.6.2008

    10.6.2008

    Karvea

    Bristol-Myers Squibb Pharma EEIG

    Uxbridge Business Park

    Sanderson Road

    Uxbridge UB8 1DH

    United Kingdom

    EU/1/97/049/001-039

    12.6.2008

    10.6.2008

    Karvezide

    Bristol-Myers Squibb Pharma EEIG

    Uxbridge Business Park

    Sanderson Road

    Uxbridge UB8 1DH

    United Kingdom

    EU/1/98/085/001-034

    12.6.2008

    10.6.2008

    CoAprovel

    Sanofi Pharma Bristol-Myers Squibb SNC

    174, avenue de France

    F-75013 Paris

    EU/1/98/086/001-034

    12.6.2008

    10.6.2008

    Irbesartan HCT BMS

    Bristol-Myers Squibb Pharma EEIG

    Uxbridge Business Park

    Sanderson Road

    Uxbridge UB8 1DH

    United Kingdom

    EU/1/06/369/001-028

    12.6.2008

    10.6.2008

    Irbesartan HCT Winthrop

    Sanofi Pharma Bristol-Myers Squibb SNC

    174, avenue de France

    F-75013 Paris

    EU/1/06/377/001-028

    12.6.2008

    10.6.2008

    Dafiro

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/06/371/001-033

    12.6.2008

    11.6.2008

    Irbesartan Winthrop

    Sanofi Pharma Bristol-Myers Squibb SNC

    174, avenue de France

    F-75013 Paris

    EU/1/06/376/001-033

    13.6.2008

    12.6.2008

    Optison

    GE Healthcare AS

    Nycoveien 1-2

    P.O.Box 4220 Nydalen

    N-0401 Oslo

    EU/1/98/065/001-002

    16.6.2008

    17.6.2008

    Xenical

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City AL7 1TW

    United Kingdom

    EU/1/98/071/001-006

    19.6.2008

    18.6.2008

    Insuman -

    Sanofi-Aventis Deutschland GmbH

    D-65926 Frankfurt am Main

    EU/1/97/030/028-139

    20.6.2008

    18.6.2008

    Novomix

    Novo Nordisk A/S

    Novo Allé

    DK-2880 Bagsværd

    EU/1/00/142/004-005

    EU/1/00/142/009-022

    20.6.2008

    18.6.2008

    Insulin Human Winthrop

    Sanofi-Aventis Deutschland GmbH

    D-65926 Frankfurt am Main

    EU/1/06/368/001-057

    20.6.2008

    18.6.2008

    Norvir

    Abbott Laboratories Ltd

    Queenborough

    Kent ME11 5EL

    United Kingdom

    EU/1/96/016/001

    EU/1/96/016/003-004

    20.6.2008

    18.6.2008

    Remicade

    Centocor B.V.

    Einsteinweg 101

    2333 CB Leiden

    Nederland

    EU/1/99/116/001-003

    20.6.2008

    18.6.2008

    Atripla

    Bristol-Myers Squibb and Gilead Sciences Limited

    Unit 13

    Stillorgan Industrial Park

    Blackrock Co.

    Dublin

    Ireland

    EU/1/07/430/001

    23.6.2008

    18.6.2008

    Tamiflu

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City AL7 1TW

    United Kingdom

    EU/1/02/222/001-004

    20.6.2008

    18.6.2008

    Parareg

    Dompé Biotec S.p.A.

    Via San Martino, 12

    I-20122 Milano

    EU/1/04/293/001-012

    20.6.2008

    18.6.2008

    Agenerase

    Glaxo Group Ltd

    Greenford Road

    Greenford

    Middlesex UB6 0NN

    United Kingdom

    EU/1/00/148/001-004

    20.6.2008

    18.6.2008

    Renagel

    Genzyme Europe B.V.

    Gooimeer 10

    1411 DD Naarden

    Nederland

    EU/1/99/123/005-012

    20.6.2008

    19.6.2008

    Twinrix Paediatric

    GlaxoSmithKline Biologicals s.a.

    rue de l'Institut 89

    B-1330 Rixensart

    EU/1/97/029/001-010

    23.6.2008

    19.6.2008

    Rotarix

    GlaxoSmithKline Biologicals s.a.

    rue de l'Institut 89

    B-1330 Rixensart

    EU/1/05/330/001-004

    23.6.2008

    19.6.2008

    Cholestagel

    Genzyme Europe B.V.

    Gooimeer 10

    1411 DD Naarden

    Nederland

    EU/1/03/268/001-004

    23.6.2008

    19.6.2008

    Plavix

    Sanofi Pharma Bristol-Myers Squibb SNC

    174, avenue de France

    F-75013 Paris

    EU/1/98/069/001a-007b, 008-010

    23.6.2008

    19.6.2008

    Iscover

    Bristol-Myers Squibb Pharma EEIG

    Uxbridge Business Park

    Sanderson Road

    Uxbridge UB8 1DH

    United Kingdom

    EU/1/98/070/001a-007b, 008-010

    23.6.2008

    19.6.2008

    InductOs

    Wyeth Europa Ltd

    Huntercombe Lane South

    Taplow

    Maidenhead

    Berkshire SL6 0PH

    United Kingdom

    EU/1/02/226/001

    23.6.2008

    19.6.2008

    Paxene

    Norton Healthcare Limited

    Albert Basin

    Royal Docks

    London E16 2QJ

    United Kingdom

    EU/1/99/113/001-004

    24.6.2008

    19.6.2008

    Mimpara

    Amgen Europe B.V.

    Minervum 7061

    4817 ZK Breda

    Nederland

    EU/1/04/292/001-012

    23.6.2008

    19.6.2008

    Twinrix Adult

    GlaxoSmithKline Biologicals s.a.

    rue de l'Institut 89

    B-1330 Rixensart

    EU/1/96/020/001-009

    23.6.2008

    20.6.2008

    PEGASYS

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City AL7 1TW

    United Kingdom

    EU/1/02/221/001-010

    24.6.2008

    20.6.2008

    Viracept

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City AL7 1TW

    United Kingdom

    EU/1/97/054/001

    EU/1/97/054/004-005

    24.6.2008

    20.6.2008

    Azopt

    Alcon Laboratories (UK) Ltd

    Pentagon Park

    Boundary Way

    Hemel Hempstead

    Herts HP2 7UD

    United Kingdom

    EU/1/00/129/001-003

    24.6.2008

    20.6.2008

    Tysabri

    Elan Pharma International Ltd

    Monksland

    Athlone

    County Westmeath

    Ireland

    EU/1/06/346/001

    26.6.2008

    20.6.2008

    REYATAZ

    Bristol-Myers Squibb Pharma EEIG

    Uxbridge Business Park

    Sanderson Road

    Uxbridge UB8 1DH

    United Kingdom

    EU/1/03/267/001-009

    24.6.2008

    20.6.2008

    Evra

    Janssen-Cilag International NV

    Turnhoutseweg 30

    B-2340 Beerse

    EU/1/02/223/001-003

    24.6.2008

    20.6.2008

    Crixivan

    Merck Sharp & Dohme Ltd

    Hertford Road

    Hoddesdon

    Hertfordshire EN11 9BU

    United Kingdom

    EU/1/96/024/001-005

    EU/1/96/024/007-08

    EU/1/96/024/010

    24.6.2008

    20.6.2008

    Apidra

    Sanofi-Aventis Deutschland GmbH

    Brueningstrasse, 50

    D-65926 Frankfurt am Main

    EU/1/04/285/001-036

    24.6.2008

    20.6.2008

    Prezista

    Janssen-Cilag International NV

    Turnhoutseweg 30

    B-2340 Beerse

    EU/1/06/380/001

    24.6.2008

    20.6.2008

    ProQuad

    Sanofi Pasteur MSD, SNC

    8, rue Jonas Salk

    F-69007 Lyon

    EU/1/05/323/001-013

    24.6.2008

    20.6.2008

    Abilify

    Otsuka Pharmaceutical Europe Ltd

    Hunton House

    Highbridge Business Park

    Oxford Road

    Uxbridge

    Middlesex UB8 1HU

    United Kingdom

    EU/1/04/276/036

    24.6.2008

    20.6.2008

    M-M-RVAXPRO

    Sanofi Pasteur MSD, SNC

    8, rue Jonas Salk

    F-69007 Lyon

    EU/1/06/337/001-013

    24.6.2008

    20.6.2008

    Puregon

    Organon N.V.

    Kloosterstraat 6

    Postbus 20

    5340 BH Oss

    Nederland

    EU/1/96/008/001-041

    24.6.2008

    20.6.2008

    Kaletra

    Abbott Laboratories Ltd

    Queenborough

    Kent ME11 5EL

    United Kingdom

    EU/1/01/172/001-006

    24.6.2008

    20.6.2008

    Vistide

    Pfizer Enterprises SARL

    51, Avenue Kennedy-Rond Point du Kirchberg

    L-1855 Luxembourg

    EU/1/97/037/001-

    24.6.2008

    20.6.2008

    Raptiva

    Serono Europe Limited

    56, Marsh Wall

    London E14 9TP

    United Kingdom

    EU/1/04/291/001-002

    24.6.2008

    20.6.2008

    Prevenar

    Wyeth-Lederle Vaccines S.A.

    Rue du Bosquet 15

    B-1348 Louvain-La-Neuve

    EU/1/00/167/001-008

    24.6.2008

    20.6.2008

    Rapilysin

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City AL7 1TW

    United Kingdom

    EU/1/97/033/002

    24.6.2008

    Actavis Group PTC ehf.

    Reykjavikurvegi 76-78

    IS-220 Hafnarfjordur

    24.6.2008

    20.6.2008

    Avonex

    Biogen Idec Ltd

    5 Roxborough Way

    Foundation Park

    Maidenhead

    Berkshire SL6 3UD

    United Kindgom

    EU/1/97/033/002-004

    24.6.2008

    20.6.2008

    Vfend

    Pfizer Ltd

    Ramsgate Road

    Sandwich

    Kent CT 13 9NJ

    United Kingdom

    EU/1/02/212/001-026

    24.6.2008

    20.6.2008

    Telzir

    Glaxo Group Ltd

    Greenford Road

    Greenford

    Middlesex UB6 0NN

    United Kingdom

    EU/1/04/282/001-002

    24.6.2008

    23.6.2008

    Humira

    Abbott Laboratories Ltd

    Queenborough

    Kent ME11 5EL

    United Kingdom

    EU/1/03/256/001-010

    25.6.2008

    25.6.2008

    Optisulin

    Sanofi-Aventis Deutschland GmbH

    D-65926 Frankfurt am Main

    EU/1/00/133/001-007

    27.6.2008

    25.6.2008

    Baraclude

    Bristol-Myers Squibb Pharma EEIG

    Uxbridge Business Park

    Sanderson Road

    Uxbridge UB8 1DH

    United Kingdom

    EU/1/06/343/001-007

    27.6.2008

    25.6.2008

    Lantus

    Sanofi-Aventis Deutschland GmbH

    D-65926 Frankfurt am Main

    EU/1/00/134/001-037

    27.6.2008

    25.6.2008

    Temodal

    Schering Plough Europe

    Rue de Stalle 73/Stallestraat 73

    B-1180 Bruxelles/B-1180 Brussel

    EU/1/98/096/001-012

    27.6.2008

    25.6.2008

    Elaprase

    Shire Human Genetic Therapies AB

    Rinkebyvägen 11B

    S-182 36 Danderyd

    EU/1/06/365/001-003

    27.6.2008

    27.6.2008

    Abseamed

    Medice Arzneimittel Pütter GmbH & Co KG

    Kuhloweg 37

    D-58638 Iserlohn

    EU/1/07/412/001-020

    1.7.2008

    30.6.2008

    Sprycel

    Bristol-Myers Squibb Pharma EEIG

    Uxbridge Business Park

    Sanderson Road

    Uxbridge UB8 1DH

    United Kingdom

    EU/1/06/363/001-009

    2.7.2008

    —   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Rejected

    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

    25.6.2008

    Tygacil

    Wyeth Europa Ltd

    Huntercombe Lane South

    Taplow

    Maidenhead

    Berkshire SL6 0PH

    United Kingdom

    EU/1/06/336/001

    27.6.2008

    —   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004) (applicable with effect from 1 January 2009)

    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

    10.6.2008

    Zenapax

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City AL7 1TW

    United Kingdom

    EU/1/99/098/001-002

    12.6.2008

    —   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): 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

    23.6.2008

    Posatex

    Orbifloxacin, Mometasone furoate, Posaconazole

    S-P Veterinary

    Shire Park

    Welwyn Garden City

    Hertfordshire AL7 1TW

    United Kingdom

    EU/2/08/081/001-003

    Ear drops, suspension

    QS02CA91

    25.6.2008

    25.6.2008

    EQUIOXX

    Firocoxib

    MERIAL

    29, avenue Tony Garnier

    F-69007 Lyon

    EU/2/08/083/001

    Oral paste

    QM01AH90

    27.6.2008

    —   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): 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

    3.6.2008

    Convenia

    Pfizer Ltd

    Ramsgate Road

    Sandwich

    Kent CT 13 9NJ

    United Kingdom

    EU/2/06/059/001

    5.6.2008

    4.6.2008

    Aivlosin

    ECO Animal Health Ltd

    78 Coombe Road

    New Malden

    Surrey KT3 4QS

    United Kingdom

    EU/2/04/044/007

    6.6.2008

    13.6.2008

    Gonazon

    Intervet International B.V.

    Wim de Körverstraat 35

    5831 AN Boxmeer

    Nederland

    EU/2/03/040/001-002

    17.6.2008

    20.6.2008

    DRAXXIN

    Pfizer Ltd

    Ramsgate Road

    Sandwich

    Kent CT 13 9NJ

    United Kingdom

    EU/2/03/041/001-005

    24.6.2008

    23.6.2008

    Nobilis Influenza H7N1

    Intervet International B.V.

    Wim de Körverstraat 35

    5831 AN Boxmeer

    Nederland

    EU/2/07/073/001-004

    25.6.2008

    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

    London E14 4HB

    United Kingdom

    (1)  OJ L 136, 30.4.2004, p. 1.

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