Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 November 2009 to 30 November 2009 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2010-01-29
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, pharmaceutical product, withdrawal from the market








C_2010022EN.01000201.xml










29.1.2010   


EN


Official Journal of the European Union


C 22/2





Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 November 2009 to 30 November 2009

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

2010/C 22/02
—   Issuing of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




4.11.2009


Repaglinide Krka


Repaglinide







KRKA, d. d.




Novo mesto




Šmarješka cesta 6




SI-8501 Novo mesto




SLOVENIJA






EU/1/09/579/001-018


Tablet


A10B X02


6.11.2009




4.11.2009


Copalia HCT


amlodipine besylate/valsartan/hydrochlorothiazide







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/09/575/001-060


Film-coated tablet


C09DX01


6.11.2009




4.11.2009


Dafiro HCT


amlodipine besylate/valsartan/hydrochlorothiazide







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/09/574/001-060


Film-coated tablet


C09DX01


6.11.2009




26.11.2009


Multaq


dronedarone







Sanofi-Aventis




174 avenue de France




75013 Paris




FRANCE






EU/1/09/591/001-004


Film-coated tablet


Not applicable


1.12.2009




26.11.2009


Irbesartan/Hydrochlorothiazide Teva


hydrochlorothiazide







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/09/583/001-072


Film-coated tablet


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


Film-coated tablet


G04BE03


2.12.2009




30.11.2009


Nevirapine Teva


nevirapine







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/09/598/001-004


Tablet


J05AG01


2.12.2009




30.11.2009


Hirobriz Breezhaler


Indacaterol







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/09/594/001-010


Inhalation powder


Not applicable


2.12.2009




30.11.2009


Onbrez Breezhaler


Indacaterol







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/09/593/001-010


Inhalation powder


Not applicable


2.12.2009




30.11.2009


Oslif Breezhaler


Indacaterol







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/09/586/001-010


Inhalation powder


Not applicable


2.12.2009




30.11.2009


Zutectra


Human Hepatitis B Immunoglobulin







Biotest Pharma GmbH




Landsteinerstr. 5




63303 Dreieich




DEUTSCHLAND






EU/1/09/600/001


Solution for injection


J06BB04


2.12.2009




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










Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




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




—   Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004)










Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




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




—   Issuing of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




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




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










Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




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




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.