Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2010 to 28 February 2010 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2010-04-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing, medicinal product, pharmaceutical industry, veterinary drug








C_2010111EN.01000201.xml










30.4.2010   


EN


Official Journal of the European Union


C 111/2





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2010 to 28 February 2010

(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 111/02
—   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




8.1.2010


Leflunomide Winthrop


leflunomide







Sanofi-Aventis Deutschland GmbH




65926 Frankfurt am Main




DEUTSCHLAND






EU/1/09/604/001-010


Film-coated tablet


L04AA13


12.1.2010




11.1.2010


Scintimun


besilesomab







CIS bio international




32 Boite Postale




91192 Gif-sur-Yvette




FRANCE






EU/1/09/602/001-002


Kit for radiopharmaceutical preparation


V09HA03


15.1.2010




25.1.2010


Elonva


corifollitropin alfa







N.V. Organon




Kloosterstraat 6




5349 AB Oss




NEDERLAND






EU/1/09/609/001-002


Solution for injection


GO3GA09


27.1.2010




25.1.2010


Temomedac


temozolomide







ALFRED E. TIEFENBACHER




(GmbH & Co. KG)




Van-der-Smissen-Straße 1




22767 Hamburg




DEUTSCHLAND






EU/1/09/605/001-012


Capsule, hard


L01AX03


27.1.2010




26.1.2010


Docetaxel Teva


Docetaxel







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/09/611/001-002


Concentrate and solvent for solution for infusion


L01CD02


28.1.2010




26.1.2010


Telmisartan Teva


telmisartan







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/09/610/001-030


Tablet


C09CA07


28.1.2010




28.1.2010


Temozolomide Teva


temozolomide







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/09/606/001-012


Capsule, hard


L01AX03


1.2.2010




29.1.2010


Silodyx


silodosin







Recordati Ireland Ltd




Raheens East




Ringaskiddy Co. Cork




IRELAND






EU/1/09/607/001-014


Capsule, hard


G04CA04


2.2.2010




29.1.2010


Urorec


silodosin







Recordati Ireland Ltd




Raheens East




Ringaskiddy Co. Cork




IRELAND






EU/1/09/608/001-014


Capsule, hard


G04CA04


2.2.2010







—   Issuing 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




29.1.2010


Gemesis







BioMimetic Therapeutics Ltd




Arnold & Porter




Tower 42




25 Old Broad Street




London




EC2N 1HQ




UNITED KINGDOM






 


2.2.2010







—   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




7.1.2010


Lumigan







Allergan Pharmaceuticals Ireland




Castlebar Road




Westport




Co. Mayo




IRELAND






EU/1/02/205/001-004


11.1.2010




8.1.2010


Kaletra







Abbott Laboratories Ltd




Abbott House




Vanwall Business Park




Vanwall Road




Maidenhead




Berkshire




SL6 4XE




UNITED KINGDOM






EU/1/01/172/001-007


12.1.2010




8.1.2010


Osseor







Les Laboratoires Servier




22 rue Garnier




92200 Neuilly-sur-Seine




FRANCE






EU/1/04/287/001-006


12.1.2010




8.1.2010


Protelos







Les Laboratoires Servier




22 rue Garnier




92200 Neuilly-sur-Seine




FRANCE






EU/1/04/288/001-006


12.1.2010




8.1.2010


Ratiograstim







ratiopharm GmbH




Graf-Arco-Straße 3




89079 Ulm




DEUTSCHLAND






EU/1/08/444/001-012


13.1.2010




8.1.2010


Revlimid







Celgene Europe Limited




Riverside House




Riverside Walk




Windsor




Berkshire




SL4 1NA




UNITED KINGDOM






EU/1/07/391/001-004


12.1.2010




11.1.2010


CoAprovel







Sanofi Pharma Bristol-Myers Squibb SNC




174 avenue de France




75013 Paris




FRANCE






EU/1/98/086/001-034


13.1.2010




11.1.2010


Nplate







Amgen Europe B.V.




Minervum 7061




4817 ZK Breda




NEDERLAND






EU/1/08/497/001-008


13.1.2010




12.1.2010


Apidra







Sanofi-Aventis Deutschland GmbH




65926 Frankfurt am Main




DEUTSCHLAND






EU/1/04/285/001-004


14.1.2010




12.1.2010


EMEND







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/03/262/001-008


14.1.2010




12.1.2010


Prialt







Eisai Limited




European Knowledge Centre




Mosquito Way




Hatfield




Herts




AL10 9SN




UNITED KINGDOM






EU/1/04/302/001-004


14.1.2010




12.1.2010


Revlimid







Celgene Europe Limited




Riverside House




Riverside Walk




Windsor




Berkshire




SL4 1NA




UNITED KINGDOM






EU/1/07/391/001-004


14.1.2010




15.1.2010


Thyrogen







Genzyme Europe B.V.




Gooimeer 10




1411 DD Naarden




NEDERLAND






EU/1/99/122/001-002


19.1.2010




19.1.2010


Gardasil







Sanofi Pasteur MSD SNC




8 rue Jonas Salk




69007 Lyon




FRANCE






EU/1/06/357/001-021


21.1.2010




19.1.2010


Herceptin







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/00/145/001


21.1.2010




19.1.2010


IRESSA







AstraZeneca AB




SE-151 85 Sodertalje




SVERIGE






EU/1/09/526/001-002


21.1.2010




19.1.2010


M-M-RVAXPRO







Sanofi Pasteur MSD SNC




8 rue Jonas Salk




69007 Lyon




FRANCE






EU/1/06/337/001-013


21.1.2010




19.1.2010


Orfadin







Swedish Orphan International AB




Drottninggatan 98




SE-111 60 Stockholm




SVERIGE






EU/1/04/303/001-003


21.1.2010




19.1.2010


ProQuad







Sanofi Pasteur MSD SNC




8 rue Jonas Salk




69007 Lyon




FRANCE






EU/1/05/323/001-013


21.1.2010




20.1.2010


Abseamed







Medice Arzneimittel Pütter GmbH & Co KG




Kuhloweg 37




58638 Iserlohn




DEUTSCHLAND






EU/1/07/412/001-020


22.1.2010




20.1.2010


Arixtra







Glaxo Group Ltd




Greenford Road




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/02/206/001-035


22.1.2010




20.1.2010


Atriance







Glaxo Group Limited




Berkeley Avenue




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/07/403/001


22.1.2010




20.1.2010


Avaglim







SmithKline Beecham Ltd




980 Great West Road




Brentford




Middlesex




TW8 9GS




UNITED KINGDOM






EU/1/06/349/001-010


22.1.2010




20.1.2010


Avandamet







SmithKline Beecham Ltd




980 Great West Road




Brentford




Middlesex




TW8 9GS




UNITED KINGDOM






EU/1/03/258/001-022


22.1.2010




20.1.2010


AVANDIA







SmithKline Beecham Ltd




980 Great West Road




Brentford




Middlesex




TW8 9GS




UNITED KINGDOM






EU/1/00/137/002-018


22.1.2010




20.1.2010


Binocrit







Sandoz GmbH




Biochemiestrasse 10




6250 Kundl




ÖSTERREICH






EU/1/07/410/001-026


22.1.2010




20.1.2010


Elaprase







Shire Human Genetic Therapies AB




Svärdvägen 11D




SE-182 33 Danderyd




SVERIGE






EU/1/06/365/001-003


25.1.2010




20.1.2010


Epoetin alfa Hexal







Hexal AG.




Industriestraße 25




83607 Holzkirchen




DEUTSCHLAND






EU/1/07/411/001-026


25.1.2010




20.1.2010


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


22.1.2010




20.1.2010


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


22.1.2010




20.1.2010


Integrilin







Glaxo Group Ltd




Greenford




Middlesex




UB6 ONN




UNITED KINGDOM






EU/1/99/109/001-002


22.1.2010




20.1.2010


NeoRecormon







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/97/031/019-046


22.1.2010




20.1.2010


ORENCIA







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/07/389/001-003


22.1.2010




20.1.2010


Orgalutran







N.V. Organon




P.O. Box 20




Kloosterstraat 6




5340 BH Oss




NEDERLAND






EU/1/00/130/001-002


22.1.2010




20.1.2010


RotaTeq







Sanofi Pasteur MSD SNC




8 rue Jonas Salk




69007 Lyon




FRANCE






EU/1/06/348/001-002


22.1.2010




20.1.2010


Tamiflu







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/02/222/001-004


22.1.2010




20.1.2010


Telzir







Glaxo Group Ltd




Greenford Road




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/04/282/001-002


22.1.2010




20.1.2010


Thyrogen







Genzyme Europe B.V.




Gooimeer 10




1411 DD Naarden




NEDERLAND






EU/1/99/122/001-002


22.1.2010




20.1.2010


Tracleer







Actelion Registration Ltd




BSI Building 13th Floor




389 Chiswick High




London




W4 4AL




UNITED KINGDOM






EU/1/02/220/001-006


22.1.2010




20.1.2010


Truvada







Gilead Sciences International Limited




Cambridge




CB21 6GT




UNITED KINGDOM






EU/1/04/305/001-002


22.1.2010




20.1.2010


Tyverb







Glaxo Group Limited




Berkeley Avenue




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/07/440/001-002


22.1.2010




20.1.2010


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


22.1.2010




20.1.2010


Volibris







Glaxo Group Ltd




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/08/451/001-004


22.1.2010




20.1.2010


Ziagen







Glaxo Group Ltd




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/99/112/001-002


22.1.2010




20.1.2010


Zostavax







Sanofi Pasteur MSD SNC




8 rue Jonas Salk




69007 Lyon




FRANCE






EU/1/06/341/001-013


22.1.2010




25.1.2010


Alisade







Glaxo Group Ltd




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/08/474/001-003


28.1.2010




25.1.2010


Altargo







Glaxo Group Limited




Glaxo Wellcome House




Berkeley Avenue




Greenford, Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/07/390/001-004


28.1.2010




25.1.2010


Avamys







Glaxo Group Ltd




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/07/434/001-003


28.1.2010




25.1.2010


Betaferon







Bayer Schering Pharma AG




Müllerstraße 170—178




13342 Berlin




DEUTSCHLAND






EU/1/95/003/003-010


27.1.2010




25.1.2010


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


27.1.2010




25.1.2010


Combivir







Glaxo Group Ltd




Greenford Road




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/98/058/001-002


28.1.2010




25.1.2010


Fabrazyme







Genzyme Europe B.V.




Gooimeer 10




1411 DD Naarden




NEDERLAND






EU/1/01/188/001-006


27.1.2010




25.1.2010


Kiovig







Baxter AG




Industriesstrasse 67




1220 Wien




ÖSTERREICH






EU/1/05/329/001-005


27.1.2010




25.1.2010


Norvir







Abbott Laboratories Ltd




Abbott House




Vanwall Business Park




Vanwall Road




Maidenhead




Berkshire




SL6 4XE




UNITED KINGDOM






EU/1/96/016/001 EU/1/96/016/003-006


27.1.2010




25.1.2010


Pelzont







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/460/001-014


27.1.2010




25.1.2010


Qutenza







Astellas Pharma Europe B.V.




Elisabethhof 19




2353 EW Leiderdorp




NEDERLAND






EU/1/09/524/001-002


27.1.2010




25.1.2010


Sebivo







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/388/001-003


27.1.2010




25.1.2010


Somavert







Pfizer Ltd




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/02/240/001-004


27.1.2010




25.1.2010


TORISEL







Wyeth Europa Ltd




Huntercombe Lane South




Taplow




Maidenhead




Berkshire




SL6 0PH




UNITED KINGDOM






EU/1/07/424/001


27.1.2010




25.1.2010


Tredaptive







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/459/001-014


27.1.2010




25.1.2010


Trevaclyn







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/458/001-014


27.1.2010




25.1.2010


Xolair







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/05/319/001-010


27.1.2010




25.1.2010


Zometa







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/01/176/001-006


27.1.2010




27.1.2010


Arava







Sanofi-Aventis Deutschland GmbH




65926 Frankfurt am Main




DEUTSCHLAND






EU/1/99/118/001-010


29.1.2010




27.1.2010


Privigen







CSL Behring GmbH




Emil-von-Behring-Straße 76




35041 Marburg




DEUTSCHLAND






EU/1/08/446/001-006


29.1.2010




27.1.2010


Rivastigmine Teva







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/09/513/001-020


29.1.2010




27.1.2010


Sonata







Meda AB




Pipers väg 2A




SE-170 09 Solna




SVERIGE






EU/1/99/102/001-006


29.1.2010




27.1.2010


Zerene







Meda AB




Pipers väg 2A




SE-170 09 Solna




SVERIGE






EU/1/99/099/001-006


29.1.2010




28.1.2010


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


1.2.2010




29.1.2010


Azopt







Alcon Laboratories (UK) Ltd




Pentagon Park




Boundary Way




Hemel Hempstead




Herts




HP2 7UD




UNITED KINGDOM






EU/1/00/129/001-003


2.2.2010




29.1.2010


Clopidogrel Winthrop







Sanofi Pharma Bristol-Myers Squibb SNC




174 avenue de France




75013 Paris




FRANCE






EU/1/08/465/001-020


2.2.2010




29.1.2010


INTANZA







Sanofi Pasteur MSD SNC




8 rue Jonas Salk




69007 Lyon




FRANCE






EU/1/08/505/001-006


3.2.2010




2.2.2010


Yttriga







Eckert & Ziegler Nuclitec GmbH




Gieselweg 1




38110 Braunschweig




DEUTSCHLAND






EU/1/05/322/001


4.2.2010




3.2.2010


CoAprovel







Sanofi Pharma Bristol-Myers Squibb SNC




174 avenue de France




75013 Paris




FRANCE






EU/1/98/086/001-034


5.2.2010




3.2.2010


Karvezide







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/98/085/001-034


5.2.2010




3.2.2010


Temodal







Schering Plough Europe




Rue de Stalle 73




1180 Bruxelles




BELGIQUE









Stallestraat 73




1180 Brussel




BELGIË






EU/1/98/096/001-025


5.2.2010




4.2.2010


Irbesartan HCT Winthrop







SANOFI PHARMA BRISTOL MYERS SQUIBB SNC




174 avenue de France




75013 Paris




FRANCE






EU/1/06/377/001-028


8.2.2010




8.2.2010


Bondenza (Ibandronic Acid Roche)







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/03/266/003-004


10.2.2010




8.2.2010


Bonviva







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/03/265/003-004


10.2.2010




8.2.2010


Pandemrix







GlaxoSmithKline Biologicals s.a.




Rue de l'Institut 89




1330 Rixensart




BELGIQUE






EU/1/08/452/001


10.2.2010




8.2.2010


ReFacto AF







Wyeth Europa Ltd




Huntercombe Lane South




Taplow




Maidenhead




Berkshire




SL6 0PH




UNITED KINGDOM






EU/1/99/103/001-004


10.2.2010




8.2.2010


TOVIAZ







Pfizer Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/07/386/017-018


10.2.2010




9.2.2010


Bridion







N.V. Organon




Kloosterstraat 6




5349 AB Oss




NEDERLAND






EU/1/08/466/001-002


11.2.2010




9.2.2010


Cialis







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/02/237/001-008


11.2.2010




9.2.2010


Clopidogrel 1A Pharma







Acino Pharma GmbH




Am Windfeld 35




83714 Miesbach




DEUTSCHLAND






EU/1/09/542/001-007


11.2.2010




9.2.2010


Exforge







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/06/370/001-036


11.2.2010




9.2.2010


Fertavid







SP Europe




Rue de Stalle 73




1180 Bruxelles




BELGIQUE






EU/1/09/510/001-019


11.2.2010




9.2.2010


Imprida







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/06/373/001-036


11.2.2010




9.2.2010


Kaletra







Abbott Laboratories Limited




Abbott House




Vanwall Business Park




Vanwall Road




Maidenhead




Berkshire




SL6 4XE




UNITED KINGDOM






EU/1/01/172/001-007


11.2.2010




9.2.2010


Kineret







Biovitrum AB (publ)




SE-112 76 Stockholm




SVERIGE






EU/1/02/203/001-004


11.2.2010




9.2.2010


NovoSeven







Novo Nordisk A/S




Novo Allé




2880 Bagsvaerd




DANMARK






EU/1/96/006/001-006


11.2.2010




9.2.2010


Temodal







Schering Plough Europe




Rue de Stalle 73




1180 Bruxelles




BELGIQUE









Stallestraat 73




1180 Brussel




BELGIË






EU/1/98/096/001-025


11.2.2010







—   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




20.1.2010


Avastin







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/04/300/001-002


22.1.2010




20.1.2010


Erbitux







Merck KGaA




Frankfurter Straße 250




64271 Darmstadt




DEUTSCHLAND






EU/1/04/281/001-005


22.1.2010




9.2.2010


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


15.2.2010







—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004
 (2)
): 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




14.1.2010


Gripovac 3


Inactivated vaccine against swine influenza in pigs







MERIAL




29 avenue Tony Garnier




69007 Lyon




FRANCE






EU/2/09/102/001-006


Suspension for injection


QI09AA03


18.1.2010




14.1.2010


RESPIPORC FLU3


Inactivated vaccine against swine influenza in pigs







IDT Biologika GmbH




Am Pharmapark




06861 Dessau-Rosslau




DEUTSCHLAND






EU/2/09/103/001-006


Suspension for injection


QI09AA03


18.1.2010




15.1.2010


Zulvac 8 Bovis


Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02







Fort Dodge Animal Health Ltd




Flanders Road




Hedge End




Southampton




SO30 4QH




UNITED KINGDOM






EU/2/09/105/001-002


Suspension for injection


QI02AA08(cattle)


19.1.2010




15.1.2010


Zulvac 8 Ovis


Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02







Fort Dodge Animal Health Ltd




Flanders Road




Hedge End




Southampton




SO30 4QH




UNITED KINGDOM






EU/2/09/104/001-002


Suspension for injection


QIO4AA02


19.1.2010







—   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




12.1.2010


BTVPUR Alsap 8







Merial




29 avenue Tony Garnier




69007 Lyon




FRANCE






EU/2/09/094/001-005


14.1.2010




12.1.2010


METACAM







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/2/97/004/035-038


14.1.2010




12.1.2010


Porcilis PCV







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




NEDERLAND






EU/2/08/091/001-010


14.1.2010




12.1.2010


Previcox







Merial




29 avenue Tony Garnier




69007 Lyon




FRANCE






EU/2/04/045/001-006


14.1.2010




14.1.2010


Poulvac FluFend H5N3 RG







Fort Dodge Animal Health Ltd




Flanders Road




Hedge End




Southampton




SO30 4QH




UNITED KINGDOM






EU/2/06/060/001-002


18.1.2010




14.1.2010


Purevax RCPCh







Merial




29 avenue Tony Garnier




69007 Lyon




FRANCE






EU/2/04/050/001-002


15.1.2010




15.1.2010


Convenia







Pfizer Ltd




Ramsgate Road




Sandwich




Kent




CT 13 9NJ




UNITED KINGDOM






EU/2/06/059/001


19.1.2010




15.1.2010


Purevax RC







Merial




29 avenue Tony Garnier




69007 Lyon




FRANCE






EU/2/04/051/001-002


19.1.2010




15.1.2010


Purevax RCCh







Merial




29 avenue Tony Garnier




69007 Lyon




FRANCE






EU/2/04/049/001-002


19.1.2010




15.1.2010


Purevax RCPCh FeLV







Merial




29 avenue Tony Garnier




69007 Lyon




FRANCE






EU/2/04/047/001-002


19.1.2010




15.1.2010


Purevax RCP FeLV







Merial




29 avenue Tony Garnier




69007 Lyon




FRANCE






EU/2/04/048/001-002


19.1.2010




25.1.2010


Purevax RCP







Merial




29 avenue Tony Garnier




69007 Lyon




FRANCE






EU/2/04/052/001-002


27.1.2010




29.1.2010


Quadrisol







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




NEDERLAND






EU/2/97/005/001 EU/2/97/005/005


2.2.2010




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 4H




UNITED KINGDOM






(1)  OJ L 136, 30.4.2004, p. 1.

(2)  See footnote 1.