Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2010 to 31 October 2010 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2010-12-31
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, pharmaceutical industry, pharmaceutical legislation








C_2010359EN.01000101.xml










31.12.2010   


EN


Official Journal of the European Union


C 359/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2010 to 31 October 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 359/01
—   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




1.9.2010


Brinavess


vernakalant hydrochloride







Merck Sharp & Dohme Limited




Hertford Road,




Hodderson,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/10/645/001-002


Concentrate for solution for infusion


C01BG11


6.9.2010




1.9.2010


Sycrest


Asenapine







N.V. Organon




Kloosterstraat 6,




5349 AB Oss,




Nederland






EU/1/10/640/001-006


Sublingual tablet


N05AH05


6.9.2010




6.9.2010


Rapiscan


regadenoson







Gilead Sciences International Limited




Cambridge




CB21 6GT




United Kingdom






EU/1/10/643/001


Solution for injection


C01EB21


8.9.2010




17.9.2010


Ibandronic Acid Teva


Ibandronic acid







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/10/642/001-004


Film-coated tablet


M05BA06


21.9.2010




30.9.2010


Telmisartan Actavis


telmisartan







Actavis Group PTC ehf.




Reykjavíkurvegi 76-78,




220 Hafnarfjörður,




Iceland






EU/1/10/639/001-030


Tablet


C09CA07


5.10.2010




7.10.2010


Myclausen


mycophenolate mofetil







Herbert J. Passauer GmbH & Co. KG




Stubenrauchstrasse 33,




14167 Berlin,




Deutschland






EU/1/10/647/001-002


Film-coated tablet


L04AA06


11.10.2010




7.10.2010


Twynsta


telmisartan/amlodipine







Boehringer Ingelheim International GmbH




Binger Strasse 173 -




D - 55216 Ingelheim am Rhein,




Deutschland






EU/1/10/648/001-028


Tablet


C09DB04


11.10.2010




28.10.2010


Clopidogrel HCS


Clopidogrel







HCS bvba




H. Kennisstraat 53,




B 2650 Edegem,




Belgïe






EU/1/10/651/001-015


Film-coated tablet


B01AC04


2.11.2010




28.10.2010


Clopidogrel Teva Generics B.V.


Clopidogrel







Teva Generics B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/10/650/001-015


Film-coated tablet


B01AC04


4.11.2010




28.10.2010


Ruconest


Conestat alfa







Pharming Group N.V.




Darwinweg 24,




NL-2333 CR Leiden,




Nederland






EU/1/10/641/001


Powder for solution for injection


Pending


4.11.2010







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




16.9.2010


Zeftera







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






 


20.9.2010







—   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




1.9.2010


Altargo







Glaxo Group Limited




Glaxo Wellcome House,




Berkeley Avenue,




Greenford,




Middlesex UB6 0NN,




United Kingdom






EU/1/07/390/001-004


8.9.2010




1.9.2010


Ecalta







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/1/07/416/001-002


6.9.2010




1.9.2010


Keppra







UCB Pharma SA.




Allée de la Recherche 60,




1070 Bruxelles,




Belgique/Researchdreef, 60,




Brussel 1070,




België






EU/1/00/146/001-032


6.9.2010




1.9.2010


Levitra







Bayer Schering Pharma AG




13342 Berlin,




Deutschland






EU/1/03/248/001-015


6.9.2010




1.9.2010


Prevenar 13







Wyeth Lederle Vaccines S.A.




Rue du Bosquet, 15




B-1348 Louvain-la-Neuve,




Belgique






EU/1/09/590/001-006


6.9.2010




1.9.2010


Regranex







Janssen-Cilag International NV




Turnhoutseweg, 30 - 2340 Beerse - België






EU/1/99/101/001


6.9.2010




1.9.2010


Relistor







Wyeth Europa Limited




Huntercombe Lane South, Taplow,




Maidenhead,




Berkshire, SL6 0PH,




United Kingdom






EU/1/08/463/001-003


6.9.2010




1.9.2010


Vfend







Pfizer Ltd




Ramsgate Road, Sandwich,




Kent CT 13 9NJ,




United Kingdom






EU/1/02/212/001-026


6.9.2010




1.9.2010


Zypadhera







Eli Lilly Nederland B.V.




Grootslag 1-5,




NL-3991 RA, Houten,




Nederland






EU/1/08/479/001-003


6.9.2010




6.9.2010


Abraxane







Abraxis BioScience Limited




Rosanne House, Parkway,




Welwyn Garden City,




Herts, AL8 6HG,




United Kingdom






EU/1/07/428/001


9.9.2010




6.9.2010


Apidra







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/04/285/001-036


9.9.2010




6.9.2010


Cialis







Eli Lilly Nederland B.V.




Grootslag 1-5,




3991 RA Houten,




Nederland






EU/1/02/237/001-009


9.9.2010




6.9.2010


Clopidogrel Winthrop







Sanofi-Aventis




174, avenue de France,




F-75013 Paris,




France






EU/1/08/465/001-020


9.9.2010




6.9.2010


Cymbalta







Eli Lilly Nederland B.V.




Grootslag 1-5,




3991 RA Houten,




Nederland






EU/1/04/296/001-009


8.9.2010




6.9.2010


Dynastat







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent CT 13 9NJ,




United Kingdom






EU/1/02/209/001-008


8.9.2010




6.9.2010


Emadine







Alcon Laboratories (UK) Ltd.




Pentagon Park, Boundary Way,




Hemel Hempstead,




Herts HP2 7UD,




United Kingdom






EU/1/98/095/001-004


9.9.2010




6.9.2010


Insuman







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/97/030/028-195


9.9.2010




6.9.2010


Menveo







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1,




53100 Siena,




Italia






EU/1/10/614/001


9.9.2010




6.9.2010


M-M-RVAXPRO







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/06/337/001-013


9.9.2010




6.9.2010


Onglyza







Bristol Myers Squibb/AstraZeneca EEIG




Bristol Myers Squibb House, Uxbridge Business Park,




Sanderson Road,




Uxbridge,




Middlesex UB8 1DH,




United Kingdom






EU/1/09/545/001-010


9.9.2010




6.9.2010


Oslif Breezhaler







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex, RH12 5AB,




United Kingdom






EU/1/09/586/001-010


9.9.2010




6.9.2010


ProQuad







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/05/323/001-013


9.9.2010




6.9.2010


Relistor







Wyeth Europa Limited




Huntercombe Lane South, Taplow,




Maidenhead,




Berkshire, SL6 0PH,




United Kingdom






EU/1/08/463/001-011


8.9.2010




6.9.2010


Renvela







Genzyme Europe B.V.




Gooimeer 10,




1411 DD Naarden,




Nederland






EU/1/09/521/001-007


9.9.2010




6.9.2010


Thyrogen







Genzyme Europe B.V.




Gooimeer 10,




NL-1411 DD Naarden,




Nederland






EU/1/99/122/001-002


9.9.2010




6.9.2010


Vimpat







UCB Pharma SA.




Allée de la Recherche 60, 1070 Bruxelles,




Belgique/Researchdreef, 60,




Brussel 1070,




België






EU/1/08/470/001-017


8.9.2010




6.9.2010


Viread







Gilead Sciences International Limited




Cambridge CB21 6GT




United Kingdom






EU/1/01/200/001-002


9.9.2010




6.9.2010


Xeristar







Eli Lilly Nederland B.V.




Grootslag 1-5,




3991 RA Houten,




Nederland






EU/1/04/297/001-008


8.9.2010




6.9.2010


Xolair







Novartis Europharm Limited




Wimblehurst Road, Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/05/319/001-010


8.9.2010




6.9.2010


Zerit







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park,




Sanderson Road,




Uxbridge UB8 1DH,




United Kingdom






EU/1/96/009/001-009


9.9.2010




6.9.2010


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


8.9.2010




6.9.2010


Zyprexa Velotab







Eli Lilly Nederland B.V.




Grootslag 1-5,




3991 RA Houten,




Nederland






EU/1/99/125/001-016


8.9.2010




10.9.2010


Pandemrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




Rixensart,




B-1330 Belgique






EU/1/08/452/001


14.9.2010




10.9.2010


Siklos







ADDMEDICA




101, rue Saint Lazare,




Paris 75009,




FRANCE






EU/1/07/397/001


14.9.2010




16.9.2010


Alimta







Eli Lilly Nederland B.V.




Grootslag 1-5,




3991 RA Houten,




Nederland






EU/1/04/290/001


20.9.2010




16.9.2010


Tracleer







Actelion Registration Ltd




BSI Building 13th Floor,




389 Chiswick High Road,




London W4 4AL,




United Kingdom






EU/1/02/220/001-006


20.9.2010




17.9.2010


Xyrem







UCB Pharma Ltd.




208 Bath Road, Slough,




Berkshire SL1 3WE,




United Kingdom






EU/1/05/312/001


21.9.2010




23.9.2010


Kepivance







Biovitrum AB (publ)




SE-112 76 Stockholm,




Sverige






EU/1/05/314/001


27.9.2010




23.9.2010


Levemir







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/04/278/001-011


27.9.2010




23.9.2010


Revatio







Pfizer Limited




Sandwich,




Kent, CT13 9NJ,




United Kingdom






EU/1/05/318/001-002


27.9.2010




27.9.2010


Caelyx







Schering Plough Europe




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




België






EU/1/96/011/001-004


29.9.2010




27.9.2010


Panretin







Eisai Limited




European Knowledge Centre, Mosquito Way,




Hatfield,




Hertfordshire,




AL10 9SN, United Kingdom






EU/1/00/149/001


29.9.2010




30.9.2010


Clopidogrel Apotex







Apotex Europe B.V.




Darwingweg 20,




2333 CR Leiden,




Nederland






EU/1/09/568/001-018


5.10.2010




30.9.2010


Mepact







IDM PHARMA SAS




11-15 Quai De Dion Bouton,




92816 Puteaux Cedex,




France






EU/1/08/502/001


6.10.2010




30.9.2010


Noxafil







SP Europe




Rue de Stalle, 73, 1180 Bruxelles,




Belgique - Stallestraat, 73 - 1180 Brussel,




België






EU/1/05/320/001


5.10.2010




30.9.2010


Rotarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




Rixensart,




B-1330 Belgique






EU/1/05/330/001-011


5.10.2010




30.9.2010


Sprycel







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park,




Sanderson Road,




Uxbridge UB8 1DH,




United Kingdom






EU/1/06/363/001-015


5.10.2010




30.9.2010


Thalidomide Celgene







Celgene Europe Limited




Riverside House,




Riverside Walk,




Windsor SL4 1NA,




United Kingdom






EU/1/08/443/001


5.10.2010




5.10.2010


APTIVUS







Boehringer Ingelheim International GmbH




Binger Strasse 173-




D - 55216 Ingelheim am Rhein,




Deutschland






EU/1/05/315/001-002


7.10.2010




5.10.2010


Mircera







Roche Registration Limited




6 Falcon Way, Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/07/400/001-024


7.10.2010




5.10.2010


Revlimid







Celgene Europe Limited




Riverside House, Riverside Walk,




Windsor,




Berkshire SL4 1NA,




United Kingdom






EU/1/07/391/001-004


7.10.2010




7.10.2010


Cyanokit







Merck Santé s.a.s.




37, rue Saint-Romain,




69379 Lyon Cedex 08,




France






EU/1/07/420/001-002


11.10.2010




7.10.2010


DuoTrav







Alcon Laboratories (UK) Ltd.




Pentagon Park, Boundary Way,




Hemel Hempstead,




Herts HP2 7UD,




United Kingdom






EU/1/06/338/001-003


11.10.2010




7.10.2010


Soliris







Alexion Europe S.A.S.




25, Boulevard de l'Amiral Bruix,




75016 Paris,




France






EU/1/07/393/001


11.10.2010




11.10.2010


Retacrit







HOSPIRA Enterprises B.V.




Randstad 22-11,




1316 BN, Almere,




Nederland






EU/1/07/431/001-025


13.10.2010




14.10.2010


Alisade







Glaxo Group Ltd




Greenford,




Middlesex, UB6 ONN,




United Kingdom






EU/1/08/474/001-003


19.10.2010




14.10.2010


Avamys







Glaxo Group Ltd




Greenford,




Middlesex UB6 0NN,




United Kingdom






EU/1/07/434/001-003


19.10.2010




14.10.2010


Biograstim







CT Arzneimittel GmbH




Lengeder Straße 42a,




D-13407 Berlin,




Deutschland






EU/1/08/450/001-010


18.10.2010




14.10.2010


Firmagon







Ferring Pharmaceuticals A/S




Kay Fiskers Plads 11,




Copenhagen S 2300,




Danmark






EU/1/08/504/001-003


18.10.2010




14.10.2010


Multaq







Sanofi-Aventis




174, avenue de France,




F-75013 Paris,




France






EU/1/09/591/001-004


18.10.2010




14.10.2010


Ratiograstim







ratiopharm GmbH




Graf-Arco-Straße 3,




D-89079 Ulm,




Deutschland






EU/1/08/444/001-012


18.10.2010




14.10.2010


Vidaza







Celgene Europe Ltd




Riverside House, Riverside Walk,




Windsor, SL4 1NA,




United Kingdom






EU/1/08/488/001


18.10.2010




14.10.2010


Xarelto







Bayer Schering Pharma AG




13342 Berlin,




Deutschland






EU/1/08/472/001-010


18.10.2010




15.10.2010


Riprazo







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/07/409/001-020


19.10.2010




15.10.2010


Silapo







STADA Arzneimittel AG




Stadastrasse 2-18,




61118 Bad Vilbel,




Deutschland






EU/1/07/432/001-022


19.10.2010




15.10.2010


Sprimeo







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/07/407/001-020


19.10.2010




25.10.2010


Axura







Merz Pharmaceuticals GmbH




Eckenheimer Landstr. 100,




D-60318 Frankfurt/Main - Deutschland






EU/1/02/218/001-003
EU/1/02/218/005-030


27.10.2010




25.10.2010


Azilect







Teva Pharma GmbH




Kandelstrasse 10,




Kirchzarten 79199,




Deutschland






EU/1/04/304/001-007


29.10.2010




25.10.2010


Baraclude







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park,




Sanderson Road,




Uxbridge UB8 1DH,




United Kingdom






EU/1/06/343/001-007


27.10.2010




25.10.2010


Cerezyme







Genzyme Europe B.V.




Gooimeer 10,




NL-1411 DD Naarden,




Nederland






EU/1/97/053/001-005


27.10.2010




25.10.2010


Champix







Pfizer Ltd




Ramsgate Road,




Sandwich, Kent CT 13 9NJ,




United Kingdom






EU/1/06/360/001-013


27.10.2010




25.10.2010


Ebixa







H. Lundbeck A/S




Ottiliavej 9,




DK-2500 Valby,




Danmark






EU/1/02/219/001-049


27.10.2010




25.10.2010


Epivir







ViiV Healthcare UK Ltd




980 Great West Road,




Brentford,




Middlesex, TW8 9GS,




United Kingdom






EU/1/96/015/001-005


27.10.2010




25.10.2010


Faslodex







AstraZeneca UK Limited




Alderley Park,




Macclesfield,




Cheshire, SK10 4TG




United Kingdom






EU/1/03/269/001-002


27.10.2010




25.10.2010


Forsteo







Eli Lilly Nederland B.V.




Grootslag 1-5,




3991 RA Houten,




Nederland






EU/1/03/247/001-002


27.10.2010




25.10.2010


Herceptin







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City, AL7 1TW,




United Kingdom






EU/1/00/145/001


27.10.2010




25.10.2010


Irbesartan/Hydrochlorothiazide Teva







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/09/583/001-072


27.10.2010




25.10.2010


Karvea







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park,




Sanderson Road,




Uxbridge UB8 1DH,




United Kingdom






EU/1/97/049/001-039


27.10.2010




25.10.2010


Mabthera







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City, AL7 1TW,




United Kingdom






EU/1/98/067/001-002


27.10.2010




25.10.2010


Mirapexin







Boehringer Ingelheim International GmbH




Binger Strasse 173-




D - 55216 Ingelheim am Rhein,




Deutschland






EU/1/97/051/001-006
EU/1/97/051/009-033


27.10.2010




25.10.2010


M-M-RVAXPRO







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/06/337/001-013


27.10.2010




25.10.2010


Pradaxa







Boehringer Ingelheim International GmbH




Binger Strasse 173,




D-55216 Ingelheim am Rhein,




Deutschland






EU/1/08/442/001-008


27.10.2010




25.10.2010


ProQuad







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/05/323/001-013


27.10.2010




25.10.2010


Puregon







Organon N.V.




Kloosterstraat 6, Postbus 20,




5340 BH Oss,




Nederland






EU/1/96/008/001-041


27.10.2010




25.10.2010


Revlimid







Celgene Europe Limited




Riverside House, Riverside Walk,




Windsor,




Berkshire SL4 1NA,




United Kingdom






EU/1/07/391/001-004


27.10.2010




25.10.2010


Sifrol







Boehringer Ingelheim International GmbH




Binger Strasse 173,




D-55216 Ingelheim am Rhein,




Deutschland






EU/1/97/050/001-006
EU/1/97/050/009-033


27.10.2010




25.10.2010


Simponi







Centocor B.V.




Einsteinweg 101,




2333 CB Leiden,




Nederland






EU/1/09/546/001-004


27.10.2010




25.10.2010


Sprimeo







Novartis Europharm Limited




Wimblehurst Road, Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/07/407/001-020


27.10.2010




25.10.2010


Sprycel







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road,




Uxbridge UB8 1DH,




United Kingdom






EU/1/06/363/001-015


27.10.2010




25.10.2010


Toviaz







Pfizer Limited




Ramsgate Road, Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/1/07/386/001-018


27.10.2010




25.10.2010


Vantavo







Merck Sharp & Dohme Ltd.




Hertford Road, Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/09/572/001-009


27.10.2010




25.10.2010


Vasovist







TMC Pharma Services Ltd.




Finchampstead,




Berks, RG40 4LJ,




UK






EU/1/05/313/001-009


27.10.2010




25.10.2010


Vimpat







UCB Pharma SA.




Allée de la Recherche 60,




1070 Bruxelles,









Belgique/Researchdreef, 60,




Brussel 1070,




België






EU/1/08/470/001-017


27.10.2010




25.10.2010


Zonegran







Eisai Limited




European Knowledge Centre, Mosquito Way,




Hatfield,




Hertfordshire, AL10 9SN,




United Kingdom






EU/1/04/307/001-013


27.10.2010




25.10.2010


Zostavax







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/06/341/001-013


27.10.2010




28.10.2010


Ambirix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




Rixensart,




B-1330 Belgique






EU/1/02/224/001-005


2.11.2010




28.10.2010


Aprovel







Sanofi Pharma Bristol-Myers Squibb SNC




174 avenue de France -




75013 Paris,




France






EU/1/97/046/001-039


2.11.2010




28.10.2010


Fertavid







SP Europe




Rue de Stalle, 73




B-1180 Bruxelles,




Belgique






EU/1/09/510/001-019


2.11.2010




28.10.2010


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


4.11.2010




28.10.2010


Mimpara







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/04/292/001-012


4.11.2010




28.10.2010


NovoSeven







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/96/006/001-007


4.11.2010




28.10.2010


Olanzapine Neopharma







Neopharma Limited




57 High Street, Odiham,




Hampshire RG29 1LF,




United Kingdom






EU/1/07/426/001-011


1.11.2010




28.10.2010


Olanzapine Teva







Teva Pharma B.V.




Computerweg 10,




DR Utrecht 3542,




Nederland






EU/1/07/427/001-057


1.11.2010




28.10.2010


PegIntron







Schering Plough Europe




Rue de Stalle, 73,




1180 Bruxelles,









Belgique - Stallestraat, 73 -




1180 Brussel,




België






EU/1/00/131/001-050


4.11.2010




28.10.2010


Travatan







Alcon Laboratories (UK) Ltd.




Boundary Way,




Hemel Hempstead,




Herts HP2 7UD,




United Kingdom






EU/1/01/199/001-002


4.11.2010




28.10.2010


ViraferonPeg







Schering Plough Europe




Rue de Stalle, 73,




1180 Bruxelles,









Belgique - Stallestraat, 73 -




1180 Brussel,




België






EU/1/00/132/001-050


4.11.2010




29.10.2010


Mycamine







Astellas Pharma Europe B.V.




Elisabethhof 19,




2353 EW Leiderdorp,




Nederland






EU/1/08/448/001-002


5.11.2010







—   Withdrawal of a marketing authorization (Article 13 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




6.9.2010


ImmunoGam







Cangene Europe Limited




Parkshot House,




5 Kew Road,




Richmond,




Surrey TW9 2PR,




United Kingdom






EU/1/10/613/001-002


9.9.2010




27.9.2010


Enviage







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/07/406/001-020


29.9.2010




28.10.2010


NeoSpect







CIS bio international




Boite Postale 32 -




F-91192 Gif-sur-Yvette – France






EU/1/00/154/001-002


5.11.2010







—   Suspension of a marketing authorization (Article 20 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




16.9.2010


Clopidogrel 1A Pharma







Acino Pharma GmbH




Am Windfeld 35,




83714 Miesbach,




Deutschland






EU/1/09/542/001-007


20.9.2010




16.9.2010


Clopidogrel Acino







Acino Pharma GmbH




Am Windfeld 35,




83714 Miesbach,




Deutschland






EU/1/09/532/001-007


20.9.2010




16.9.2010


Clopidogrel Acino Pharma







Acino Pharma GmbH




Am Windfeld 35,




83714 Miesbach,




Deutschland






EU/1/09/549/001-007


20.9.2010




16.9.2010


Clopidogrel Acino Pharma GmbH







Acino Pharma GmbH




Am Windfeld 35,




83714 Miesbach,




Deutschland






EU/1/09/548/001-007


20.9.2010




16.9.2010


Clopidogrel Hexal







Acino Pharma GmbH




Am Windfeld 35,




Miesbach 83714,




Deutschland






EU/1/09/534/001-007


20.9.2010




16.9.2010


Clopidogrel ratiopharm







Acino Pharma GmbH




Am Windfeld 35,




83714 Miesbach,




Deutschland






EU/1/09/554/001-008


20.9.2010




16.9.2010


Clopidogrel ratiopharm GmbH







Acino Pharma GmbH




Am Windfeld 35,




83714 Miesbach,




Deutschland






EU/1/09/541/001-008


20.9.2010




16.9.2010


Clopidogrel Sandoz







Acino Pharma GmbH




Am Windfeld 35,




83714 Miesbach,




Deutschland






EU/1/09/547/001-007


20.9.2010







—   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 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




6.9.2010


Bovilis BTV8


Inactivated Bluetongue virus







Intervet International B.V.




Wim de Körverstraat 35,




NL - 5831 Boxmeer,




Nederland






EU/2/10/106/001-014


Suspension for injection


QI02AA08(cattle)
QI04AA02(sheep)


8.9.2010




16.9.2010


Rhiniseng


inactivated vaccine against atrophic rhinitis in pigs







Laboratorios Hipra, S.A.




Avda. La Selva, 135,




17170- Amer (Girona),




España






EU/2/10/109/001-009


Suspension for injection


QI09AB04


21.9.2010




30.9.2010


Coxevac


Inactivated Coxiella burnetii vaccine







CEVA SANTE ANIMALE




10 avenue de la Ballastière,




33500 Libourne,




France






EU/2/10/110/001-002


Suspension for injection


QI03AB
ngi


5.10.2010







—   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




1.9.2010


Acticam







Ecuphar NV




Legeweg 157-I,




B-8020 Oostkamp,




Belgïe






EU/2/08/088/001-004


6.9.2010




17.9.2010


Porcilis AR-T DF







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/00/026/001-004


21.9.2010




23.9.2010


Porcilis AR-T DF







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/00/026/001-006


27.9.2010




30.9.2010


Poulvac FluFend H5N3 RG







Fort Dodge Animal Health Ltd




Flanders Road, Hedge End,




Southampton SO30 4QH,




United Kingdom






EU/2/06/060/001-002


13.10.2010




30.9.2010


Prac-Tic







Novartis Sanidad Animal S.L.




Calle de la Marina, 206,




E - Barcelona 08013,




ESPANA






EU/2/06/066/001-012


5.10.2010




5.10.2010


Nobilis Influenza H5N2







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/06/061/001-004


7.10.2010




11.10.2010


Equioxx







MERIAL




29 avenue Tony Garnier,




69007 LYON,




France






EU/2/08/083/001-005


13.10.2010




14.10.2010


Cerenia







Pfizer Ltd




Ramsgate Road, Sandwich,




Kent CT 13 9NJ,




United Kingdom






EU/2/06/062/005


18.10.2010




14.10.2010


Improvac







Pfizer Limited




Ramsgate Road, Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/2/09/095/001-006


18.10.2010




14.10.2010


Novem







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein,




Deutschland






EU/2/04/042/001-002
EU/2/04/042/007-010


18.10.2010




14.10.2010


Posatex







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/08/081/001-003


18.10.2010




14.10.2010


Quadrisol







Pfizer Limited




Ramsgate Road, Sandwich,




Kent CT13 9NJ,




United Kingdom






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


18.10.2010




28.10.2010


Trocoxil







Pfizer Limited




Ramsgate Road, Sandwich,




Kent CT13 9NJ




United Kingdom






EU/2/08/084/001-005


4.11.2010




28.10.2010


Zactran







MERIAL




29 avenue Tony Garnier,




69007 LYON,




France






EU/2/08/082/001-006


4.11.2010







—   Suspension of a marketing authorization (Article 45 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




27.9.2010


Flexicam







Dechra Veterinary Products A/S




Mekuvej 9,




7171 Uldum,




Danmark






EU/2/06/058/001-003


29.9.2010







—   Lift of suspension of a marketing authorization (Article 45 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




1.9.2010


Porcilis Pesti







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/99/016/001-006


6.9.2010




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




UK - LONDON E14 4H






(1)  OJ L 136, 30.4.2004, p. 1.

(2)  OJ L 136, 30.4.2004, p. 1.