Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2009 to 31 December 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








C_2010022EN.01001801.xml










29.1.2010   


EN


Official Journal of the European Union


C 22/18





Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2009 to 31 December 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 22/04
—   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




3.12.2009


Olanzapine Glenmark Europe


Olanzapine







Glenmark Generics (Europe) Limited




Laxmi House




2-B Draycott Avenue




Kenton




Harrow




Middlesex




HA3 OBU




UNITED KINGDOM






EU/1/09/588/001-017


Orodispersible tablet


N05AH03


7.12.2009




3.12.2009


Olanzapine Glenmark


Olanzapine







Glenmark Generics (Europe) Limited




Laxmi House




2-B Draycott Avenue




Kenton




Harrow




Middlesex




HA3 OBU




UNITED KINGDOM






EU/1/09/587/001-012


Tablet


N05AH03


7.12.2009




9.12.2009


Prevenar 13


Pneumococcalpolysaccharide conjugate vaccine (13-valent, adsorbed)







Wyeth Lederle Vaccines S.A.




Rue du Bosquet 15




1348 Louvain-la-Neuve




BELGIQUE






EU/1/09/590/001-006


Suspension for injection


J07AL02


11.12.2009




10.12.2009


Lamivudine Teva Pharma B.V


Lamivudine







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/09/596/001-014


Film-coated tablet


J05AF05


14.12.2009




10.12.2009


Olazax Disperzi


Olanzapine







Glenmark Pharmaceuticals s.r.o




City Tower




Hvězdova 1716/2b




140 78 Praha 4




ČESKÁ REPUBLIKA






EU/1/09/592/001-005


Orodispersible tablet


N05AH03


14.12.2009




10.12.2009


Sildenafil Actavis


Sildenafil







Actavis Group PTC ehf.




Reykjavikurvegi 76-78




220 Hafnarfjordur




ICELAND






EU/1/09/595/001-015


Film-coated tablet


G04BE03


14.12.2009




11.12.2009


Olazax


Olanzapine







Glenmark Pharmaceuticals s.r.o.




City Tower




Hvězdova 1716/2b




140 78 Praha 4




ČESKÁ REPUBLIKA






EU/1/09/597/001-005


Tablet


N05AH03


15.12.2009




11.12.2009


Rivastigmine Hexal


Rivastigmine







HEXAL AG




Industriestrasse 25




83607 Holzkirchen




DEUTSCHLAND






EU/1/09/589/001-016
EU/1/09/589/017-018


Capsule, hard
Oral solution


N06DA03


15.12.2009




11.12.2009


Rivastigmine Sandoz


Rivastigmine







Sandoz Pharmaceuticals GmbH




Raiffeisenstraße 11




83607 Holzkirchen




DEUTSCHLAND






EU/1/09/599/001-016
EU/1/09/599/017-018


Capsule, hard
Oral solution


N06DA03


15.12.2009




23.12.2009


Zenas


Amifampridine







EUSA Pharma SAS




3 allée des Séquoias




69760 Limonest




FRANCE






EU/1/09/601/001


Tablet


N07XX05


28.12.2009




23.12.2009


Sildenafil ratiopharm


Sildenafil







Ratiopharm GmbH




Graf-Arco-Straße 3




89079 Ulm




DEUTSCHLAND






EU/1/09/603/001-012


Film-coated tablet


G04BE03


28.12.2009




—   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




3.12.2009


Champix







Pfizer Ltd.




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/06/360/001-013


7.12.2009




3.12.2009


Rasilez







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/405/001-040


7.12.2009




8.12.2009


Xigiris







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/02/225/001-002


10.12.2009




8.12.2009


Renagel







Genzyme Europe B.V.




Gooimeer 10




1411 DD Naarden




NEDERLAND






EU/1/99/123/005-013


10.12.2009




9.12.2009


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


11.12.2009




9.12.2009


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


11.12.2009




9.12.2009


Pandemrix







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




1330 Rixensart




BELGIQUE






EU/1/08/452/001


11.12.2009




10.12.2009


Effentora







Cephalon Europe




5 rue Charles Martigny




94700 Maisons-Alfort




FRANCE






EU/1/08/441/001-010


14.12.2009




10.12.2009


Effentora







Cephalon Europe




5 rue Charles Martigny




94700 Maisons-Alfort




FRANCE






EU/1/08/441/001-010


14.12.2009




10.12.2009


Synflorix







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




1330 Rixensart




BELGIQUE






EU/1/09/508/001-010


14.12.2009




10.12.2009


Truvada







Gilead Sciences International Limited




Cambridge




CB21 6GT




UNITED KINGDOM






EU/1/04/305/001-002


14.12.2009




10.12.2009


Fendrix







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




1330 Rixensart




BELGIQUE






EU/1/04/299/001-003


14.12.2009




10.12.2009


EVOLTRA







Genzyme Europe B.V.




Gooimeer 10




1411 DD Naarden




NEDERLAND






EU/1/06/334/001-005


14.12.2009




10.12.2009


Revatio







Pfizer Limited




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/05/318/002


24.12.2009




11.12.2009


Kivexa







Glaxo Group Ltd.




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/04/298/001-003


16.12.2009




11.12.2009


Clopidogrel Mylan Pharma







Apotex Europe B.V.




Darwingweg 20




2333 CR Leiden




NEDERLAND









Mylan S.A.S.




117 allée des Parcs




69800 Saint Priest




FRANCE






EU/1/09/568/001-018


16.12.2009




11.12.2009


Rivastigmine 1A Pharma







1A Pharma GmbH




Keltenring 1+3




82041 Oberhaching




DEUTSCHLAND






EU/1/09/585/001-018


16.12.2009




11.12.2009


EVICEL







OMRIX biopharmaceuticals S.A./N.V.




Chaussée de Waterloo/Waterloosesteenweg 200




1640 Rhode-St-Genèse/Sint-Genesius-Rode




BELGIQUE/BELGIË






EU/1/08/473/001-003


15.12.2009




11.12.2009


Abseamed







Medice Arzneimittel Pütter GmbH & Co KG




Kuhloweg 37




58638 Iserlohn




DEUTSCHLAND






EU/1/07/412/001-020


15.12.2009




14.12.2009


Efient







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/08/503/001-016


16.12.2009




14.12.2009


Exalief







BIAL-Portela & Ca, SA




A Av. da Siderurgia Nacional




4745-457 S. Mamede do Coronado




PORTUGAL






EU/1/09/520/001-020


17.12.2009




14.12.2009


Zebinix







BIAL-Portela & Ca, SA




A Av. da Siderurgia Nacional




4745-457 S. Mamede do Coronado




PORTUGAL






EU/1/09/514/001-020


17.12.2009




16.12.2009


REVLIMID







Celgene Europe Limited




Riverside House




Riverside Walk




Windsor




Berkshire




SL4 1NA




UNITED KINGDOM






EU/1/07/391/001-004


18.12.2009




18.12.2009


Docetaxel Winthrop







Aventis Pharma S.A.




20 avenue Raymond Aron




92165 Antony Cedex




FRANCE






EU/1/07/384/001-004


22.12.2009




18.12.2009


Emtriva







Gilead Sciences International Limited




Cambridge




CB21 6GT




UNITED KINGDOM






EU/1/03/261/003


22.12.2009




18.12.2009


Adenuric







Ipsen Pharma




65 quai Georges Gorse




92100 Boulogne-Billancourt




FRANCE









Menarini International Operations Luxembourg S.A.




1, avenue de la Gare




1611 Luxembourg




LUXEMBOURG






EU/1/08/447/001-004


22.12.2009




18.12.2009


Aloxi







Helsinn Birex Pharmaceuticals Ltd.




Damastown




Mulhuddart




Dublin 15




IRELAND






EU/1/04/306/001


22.12.2009




16.12.2009


Binocrit







Sandoz GmbH




Biochemiestraße 10




6250 Kundl




ÖSTERREICH






EU/1/07/410/001-026


18.12.2009




16.12.2009


Epoetin alfa hexal







Hexal AG.




Industriestraße 25




83607 Holzkirchen




DEUTSCHLAND






EU/1/07/411/001-026


21.12.2009




16.12.2009


Silapo







STADA Arzneimittel AG




Stadastraße 2—18




61118 Bad Vilbel




DEUTSCHLAND






EU/1/07/432/001-022


18.12.2009




18.12.2009


Litak







Lipomed GmbH




Hegenheimer Straße 2




79576 Weil/Rhein




DEUTSCHLAND






EU/1/04/275/001-002


22.12.2009




21.12.2009


AZARGA







Alcon Laboratories (UK) Ltd.




Pentagon Park




Boundary Way




Hemel Hempstead




Herts




HP2 7UD




UNITED KINGDOM






EU/1/08/482/001-002


23.12.2009




21.12.2009


Altargo







Glaxo Group Limited




Glaxo Wellcome House




Berkeley Avenue




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/07/390/001-004


24.12.2009




21.12.2009


Zyprexa Velotab







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/99/125/001-016


23.12.2009




21.12.2009


Avastin







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/04/300/001-002


23.12.2009




21.12.2009


LYRICA







Pfizer Ltd.




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/04/279/001-043


24.12.2009




21.12.2009


Taxotere







Aventis Pharma S.A.




20 avenue Raymond Aron




92165 Antony Cedex




FRANCE






EU/1/95/002/001-004


23.12.2009




21.12.2009


Zyprexa







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/96/022/002
EU/1/96/022/004
EU/1/96/022/006
EU/1/96/022/009-012
EU/1/96/022/014
EU/1/96/022/016-017
EU/1/96/022/019-034


23.12.2009




21.12.2009


Revasc







Canyon Pharmaceuticals Ltd.




20-22 Bedford Row




London




WC1R 4JS




UNITED KINGDOM






EU/1/97/043/001-003


11.1.2010




21.12.2009


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


23.12.2009




21.12.2009


SOLIRIS







Alexion Europe S.A.S.




25 Boulevard de l'Amiral Bruix




75016 Paris




FRANCE






EU/1/07/393/001


23.12.2009




21.12.2009


Vimpat







UCB Pharma SA.




Allée de la Recherche 66/Researchdreef 60




1070 Bruxelles/Brussel




BELGIQUE/BELGIË






EU/1/08/470/001-017


28.12.2009




21.12.2009


ZONEGRAN







Eisai Limited




European Knowledge Centre




Mosquito Way




Hatfield




Hertfordshire




AL10 9SN




UNITED KINGDOM






EU/1/04/307/001-013


24.12.2009




21.12.2009


ZYPADHERA







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/08/479/001-003


23.12.2009




21.12.2009


Agenerase







Glaxo Group Limited




Glaxo Wellcome House




Berkeley Avenue




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/00/148/001-004


23.12.2009




21.12.2009


Irbesartan HCT Winthrop







Sanofi Pharma Bristol Myers Squibb SNC




174 avenue de France




75013 Paris




FRANCE






EU/1/06/377/001-028


23.12.2009




21.12.2009


KARVEZIDE







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/98/085/001-034


23.12.2009




21.12.2009


Tevagrastim







Teva Generics GmbH




Wasastraße 50




01445 Radebeul




DEUTSCHLAND






EU/1/08/445/001-014


23.12.2009




21.12.2009


Avamys







Glaxo Group Ltd.




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/07/434/001-003


24.12.2009




21.12.2009


Thelin







Encysive (UK) Limited




Alder Castle House




10 Noble Street




London




EC2V 7QJ




UNITED KINGDOM






EU/1/06/353/001-005


24.12.2009




21.12.2009


Volibris







Glaxo Group Ltd.




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/08/451/001-004


24.12.2009




22.12.2009


CELVAPAN







Baxter AG




Industriestraße 67




1221 Wien




ÖSTERREICH






EU/1/08/506/001


23.12.2009




22.12.2009


Pandemrix







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




1330 Rixensart




BELGIQUE






EU/1/08/452/001


23.12.2009




22.12.2009


Stelara







Janssen-Cilag International NV




Turnhoutseweg 30




2340 Beerse




BELGIË






EU/1/08/494/001-002


24.12.2009




22.12.2009


Tasigna







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/422/001-004


24.12.2009




22.12.2009


Replagal







Shire Human Genetic Therapies AB




Svärdvägen 11D




SE-182 33 Danderyd




SVERIGE






EU/1/01/189/001-006


28.12.2009




22.12.2009


Evra







Janssen-Cilag International NV




Turnhoutseweg 30




2340 Beerse




BELGIË






EU/1/02/223/001-003


24.12.2009




22.12.2009


Crixivan







Merck Sharp & Dohme Ltd.




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/96/024/001-005
EU/1/96/024/008
EU/1/96/024/010


24.12.2009




22.12.2009


Onsior







Novartis Animal Health UK Ltd.




Frimley Business Park




Frimley/Camberley




Surrey




GU16 7SR




UNITED KINGDOM






EU/2/08/089/001-021


24.12.2009




22.12.2009


RELISTOR







Wyeth Europa Limited




Huntercombe Lane South




Taplow




Maidenhead




Berkshire




SL6 0PH




UNITED KINGDOM






EU/1/08/463/001-003


24.12.2009




23.12.2009


Tractocile







Ferring Pharmaceuticals A/S




Kay Fiskers Plads 11




2300 Copenhagen S




DANMARK






EU/1/99/124/001-002


28.12.2009




23.12.2009


Biograstim







CT Arzneimittel GmbH




Lengeder Straße 42a




13407 Berlin




DEUTSCHLAND






EU/1/08/450/001-010


29.12.2009




23.12.2009


Retacrit







HOSPIRA Enterprises B.V.




Taurusavenue 19-21b




2132 LS Hoofddorp




NEDERLAND






EU/1/07/431/001-025


31.12.2009




23.12.2009


TORISEL







Wyeth Europa Ltd




Huntercombe Lane South




Taplow




Maidenhead




Berkshire




SL6 0PH




UNITED KINGDOM






EU/1/07/424/001


4.1.2010




23.12.2009


IVEMEND







Merck Sharp & Dohme Limited




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/07/437/001-002


4.1.2010




23.12.2009


Alisade







Glaxo Group Ltd, Greenford




Middlesex




UB6 ONN




UNITED KINGDOM






EU/1/08/474/001-003


4.1.2010




23.12.2009


Focetria







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina 1




Siena SI




ITALIA






EU/1/07/385/001-002
EU/1/07/385/004


28.12.2009




—   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




14.12.2009


Aivlosin







ECO Animal Health Ltd.




78 Coombe Road




New Malden




Surrey




KT3 4QS




UNITED KINGDOM






EU/2/04/044/011-012-013


16.12.2009




18.12.2009


Equioxx







MERIAL




29 avenue Tony Garnier




69007 Lyon




FRANCE






EU/2/08/083/002-003


22.12.2009




21.12.2009


Flexicam







Dechra Veterinary Products A/S




Mekuvej 9




7171 Uldum




DANMARK









Omnipharm Ltd.




The Spire




Egypt Road




Nottingham




NG7 7GD




UNITED KINGDOM






EU/2/06/058/001-004


23.12.2009




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.