Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2011 to 31 December 2011 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2012-02-24
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012056EN.01000101.xml










24.2.2012   


EN


Official Journal of the European Union


C 56/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2011 to 31 December 2011

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

2012/C 56/01
—   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




3.11.2011


Plenadren


hydrocortisone







DuoCort Pharma AB




Kullagatan 8-10,




S-252 20 Helsingborg,




Sveridge






EU/1/11/715/001-002


Modified-release tablet


H02AB09


14.11.2011




16.11.2011


IOA


nomegestrol / estradiol







N.V. Organon




Kloosterstraat 6,




5349 AB Oss,




Nederland






EU/1/11/689/001-002


Film-coated tablet


G03AA14


18.11.2011




16.11.2011


Vyndaqel


tafamidis







Pfizer Specialty UK Limited




Ramsgate Road,




Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/1/11/717/001


Capsule, soft


N07XX08


18.11.2011




22.11.2011


Rasitrio


aliskiren / amlodipine / hydrochlorothiazide







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex,




RH12 5AB,




United Kingdom






EU/1/11/730/001-060


Film-coated tablet


C09XA54


24.11.2011




24.11.2011


Desloratadine Teva


desloratadine







Teva Pharma B.V




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/11/732/001-013


Film-coated tablet


R06AX27


29.11.2011




24.11.2011


Komboglyze


saxagliptin / metformin







Bristol Myers Squibb/AstraZeneca EEIG




Bristol Myers Squibb House,




Uxbridge Business Park,




Sanderson Road,




Uxbridge,




Middlesex




UB8 1DH,




United Kingdom






EU/1/11/731/001-012


Film-coated tablet


A10BD


28.11.2011




24.11.2011


Onduarp


telmisartan / amlodipine







Boehringer Ingelheim International GmbH




Binger Str. 173,




D-55216 Ingelheim am Rhein,




Deutschland






EU/1/11/729/001-006


Tablet


C09DB04


28.11.2011




28.11.2011


Dasselta


desloratadine







KRKA, d.d., Novo mesto




Šmarješka cesta 6,




8501 Novo mesto,




Slovenija






EU/1/11/739/001-008


Film-coated tablet


R06AX27


30.11.2011




28.11.2011


EDURANT


rilpivirine







Janssen Cilag International NV




Turnhoutseweg 30,




B 2340 Beerse,




België






EU/1/11/736/001


Film-coated tablet


J05AG05


30.11.2011




28.11.2011


Eviplera


emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)







Gilead Sciences International Limited




Cambridge,




CB21 6GT,




United Kingdom






EU/1/11/737/001-002


Film-coated tablet


J05AR08


28.11.2011




5.12.2011


Dificlir


fidaxomicin







FGK Representative Service GmbH




Heimeranstrasse 35,




80339 München,




Deutschland






EU/1/11/733/001-004


Film-coated tablet


Pending


7.12.2011




5.12.2011


Levetiracetam Actavis Group


levetiracetam







Actavis Group PTC ehf.




ReykjavÍkurvegur 76-78,




Hafnarfjörður 220,




Iceland






EU/1/11/738/001-003


Oral solution


N03AX14


7.12.2011




7.12.2011


Edarbi


azilsartan medoxomil







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych,




London




WC2B 4AE,




United Kingdom






EU/1/11/734/001-011


Tablet


C09CA09


9.12.2011




7.12.2011


Ipreziv


azilsartan medoxomil







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych,




London




WC2B 4AE,




United Kingdom






EU/1/11/735/001-011


Tablet


C09CA09


9.12.2011




14.12.2011


Ameluz


5-Aminolaevulinic acid







Biofrontera Bioscience GmbH




Hemmelrather Weg 201,




51377 Leverkusen,




Deutschland






EU/1/11/740/001


Gel


L01XD04


19.12.2011




14.12.2011


Levetiracetam SUN


levetiracetam







Sun Pharmaceutical Industries Europe BV




Polarisavenue 87,




2132 JH Hoofddorp,




Nederland






EU/1/11/741/001


Concentrate for solution for infusion


N03AX14


19.12.2011




22.12.2011


Repaglinide Accord


Repaglinide







Accord Healthcare Limited




Sage house,




319 Pinner road,




Harrow,




HA1 4HF




United Kingdom






EU/1/11/743/001-015


Tablet


A10BX02


28.12.2011




22.12.2011


Topotecan Eagle


topotecan







Eagle Laboratories Limited




The Clock House,




Station Approach,




Marlow,




Bucks




SL7 1NT,




UNITED KINGDOM






EU/1/11/744/001-002


Concentrate for solution for infusion


L01XX17


29.12.2011







—   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




3.11.2011


Clopidogrel Krka







KRKA, d. d., Novo mesto




Šmarješka cesta 6,




8501 Novo mesto,




Slovenija






EU/1/09/556/001-011


7.11.2011




3.11.2011


Clopidogrel TAD







TAD Pharma GmbH




Heinz-Lohmann-Straße 5,




27472 Cuxhaven,




Deutschland






EU/1/09/555/001-009


7.11.2011




3.11.2011


Ozurdex







Allergan Pharmaceuticals (Ireland) Ltd,




Castlebar Road, Westport,




Co. Mayo,




Ireland






EU/1/10/638/001


7.11.2011




3.11.2011


Pandemrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




B-1330 Rixensart,




Belgique






EU/1/08/452/001


7.11.2011




3.11.2011


Protaphane







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/02/234/010-012


7.11.2011




3.11.2011


Tamiflu







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/02/222/001-004


7.11.2011




10.11.2011


Actraphane







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/02/229/030-032


15.11.2011




10.11.2011


Actrapid







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/02/230/010-012


15.11.2011




10.11.2011


Arava







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/99/118/001-010


15.11.2011




10.11.2011


Avamys







Glaxo Group Ltd




Greenford,




Middlesex




UB6 0NN,




United Kingdom






EU/1/07/434/001-003


15.11.2011




10.11.2011


Clopidogrel Mylan







Mylan S.A.S




117 allée des Parcs,




69 800 Saint Priest,




France






EU/1/09/559/001-016


15.11.2011




10.11.2011


Clopidogrel Teva







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/09/540/001-016


15.11.2011




10.11.2011


Clopidogrel Zentiva







Sanofi-Aventis




174, avenue de France,




F-75013 Paris,




France






EU/1/08/465/001-020


15.11.2011




10.11.2011


Conbriza







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/1/09/511/001-005


15.11.2011




10.11.2011


Cyanokit







Merck Santé s.a.s.




37, rue Saint-Romain,




69379 Lyon Cedex 08,




France






EU/1/07/420/001-002


15.11.2011




10.11.2011


ellaOne







Laboratoire HRA Pharma




15, rue Béranger,




75003 Paris,




France






EU/1/09/522/001


15.11.2011




10.11.2011


Helixate NexGen







Bayer Schering Pharma AG




13342 Berlin,




Deutschland






EU/1/00/144/001-005


15.11.2011




10.11.2011


Javlor







Pierre Fabre Médicament




45, place Abel Gance,




F-92100 Boulogne,




France






EU/1/09/550/001-012


15.11.2011




10.11.2011


Kogenate Bayer







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/00/143/004-013


15.11.2011




10.11.2011


Levitra







Bayer Pharma AG




Berlin 13342,




Deutschland






EU/1/03/248/001-023


15.11.2011




10.11.2011


Silgard







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/06/358/001-008
EU/1/06/358/018-021


15.11.2011




10.11.2011


Vectibix







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/07/423/001-003


15.11.2011




10.11.2011


Vfend







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent




CT 13 9NJ,




United Kingdom






EU/1/02/212/025


15.11.2011




10.11.2011


Victoza







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/09/529/001-005


15.11.2011




10.11.2011


Zebinix







BIAL - Portela & Ca, SA




A Av. da Siderurgia Nacional 4745-457 S.




Mamede do Coronado -




Portugal






EU/1/09/514/001-020


15.11.2011




10.11.2011


Zevalin







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/03/264/001


15.11.2011




10.11.2011


Zoely







Merck Serono Europe Limited




56 Marsh Wall,




London




E14 9TP,




United Kingdom






EU/1/11/690/001-002


15.11.2011




10.11.2011


Zomarist







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/08/483/001-018


15.11.2011




10.11.2011


Zylagren







KRKA, d. d., Novo mesto




Šmarješka cesta 6,




8501 Novo mesto,




Slovenija






EU/1/09/558/001-010


16.11.2011




16.11.2011


Exelon







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/98/066/013
EU/1/98/066/018


18.11.2011




16.11.2011


Gardasil







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/06/357/001-008
EU/1/06/357/018-021


18.11.2011




16.11.2011


Vivanza







Bayer Pharma AG




Berlin 13342,




Deutschland






EU/1/03/249/001-015


18.11.2011




21.11.2011


Adrovance







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/06/364/001-004
EU/1/06/364/006-008


23.11.2011




21.11.2011


Aldurazyme







Genzyme Europe B.V.




Gooimeer 10,




NL-1411 DD Naarden,




Nederland






EU/1/03/253/001-003


23.11.2011




21.11.2011


Celsentri







ViiV Healthcare UK Ltd




980 Great West Road,




Brentford,




Middlesex,




TW8 9GS,




United Kingdom






EU/1/07/418/001-010


23.11.2011




21.11.2011


Champix







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent




CT 13 9NJ,




United Kingdom






EU/1/06/360/001-013


23.11.2011




21.11.2011


Copalia







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/06/372/001-039


22.11.2011




21.11.2011


Dafiro







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/06/371/001-039


22.11.2011




21.11.2011


Evoltra







Genzyme Europe BV




Gooimeer 10,




1411 DD Naarden,




Nederland






EU/1/06/334/001-005


23.11.2011




21.11.2011


Firdapse







BioMarin Europe Ltd




164 Shaftesbury Avenue,




London




WC2H 8HL,




United Kingdom






EU/1/09/601/001


23.11.2011




21.11.2011


Inovelon







Eisai Limited




European Knowledge Centre,




Mosquito Way,




Hatfield,




Hertfordshire,




AL10 9SN,




United Kingdom






EU/1/06/378/001-017


23.11.2011




21.11.2011


Insulin Human Winthrop







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/06/368/001-168


23.11.2011




21.11.2011


Isentress







Merck Sharp & Dohme Limited




Hertford Road,




Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/07/436/001-002


23.11.2011




21.11.2011


Rilonacept Regeneron







Regeneron UK Limited




40 Bank Street,




London,




E14 5DS




United Kingdom






EU/1/09/582/001


23.11.2011




21.11.2011


Tygacil







Wyeth Europa Ltd.




Huntercombe Lane South,




Taplow,




Maidenhead,




Berkshire,




SL6 0PH,




United Kingdom






EU/1/06/336/001


23.11.2011




22.11.2011


Advagraf







Astellas Pharma Europe B.V.




Elisabethhof 19,




NL-2353 EW Leiderdorp,




Nederland






EU/1/07/387/001-026


24.11.2011




22.11.2011


Afinitor







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/09/538/001-008


24.11.2011




22.11.2011


Atripla







Bristol-Myers Squibb and Gilead Sciences Limited




IDA Business & Technology Park,




Carrigtohill,




Co. Cork,




Ireland






EU/1/07/430/001-002


24.11.2011




22.11.2011


Dynastat







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent




CT 13 9NJ,




United Kingdom






EU/1/02/209/001-008


24.11.2011




22.11.2011


Effentora







Cephalon Europe




5 Rue Charles Martigny,




Maisons-Alfort 94700,




France






EU/1/08/441/001-010


24.11.2011




22.11.2011


Exforge







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/06/370/001-039


24.11.2011




22.11.2011


Fabrazyme







Genzyme Europe B.V.




Gooimeer 10,




NL-1411 DD Naarden,




Nederland






EU/1/01/188/001-006


25.11.2011




22.11.2011


Grepid







Pharmathen S.A.




6 Dervenakion,




15351 Pallini Attiki,




Ελλάδα






EU/1/09/535/001-016


24.11.2011




22.11.2011


Imprida







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/06/373/001-039


24.11.2011




22.11.2011


Invirase







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/96/026/001-002


24.11.2011




22.11.2011


Levemir







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/04/278/001-016


24.11.2011




22.11.2011


Lyrica







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent




CT 13 9NJ,




United Kingdom






EU/1/04/279/001-044


24.11.2011




22.11.2011


Myozyme







Genzyme Europe B.V.




Gooimeer 10,




NL-1411 DD Naarden,




Nederland






EU/1/06/333/001-003


24.11.2011




22.11.2011


Norvir







Abbott Laboratories Ltd




Abbott House,




Vanwall Business Park,




Vanwall Road,




Maidenhead,




Berkshire




SL6 4XE,




United Kingdom






EU/1/96/016/001
EU/1/96/016/003-008


24.11.2011




22.11.2011


Onglyza







Bristol Myers Squibb/AstraZeneca EEIG




Bristol Myers Squibb House,




Uxbridge Business Park,




Sanderson Road,




Uxbridge,




Middlesex




UB8 1DH,




United Kingdom






EU/1/09/545/001-015


24.11.2011




22.11.2011


Optaflu







Novartis Vaccines and Diagnostics GmbH




Emil-von-Behring-Strasse 76,




D-35041 Marburg,




Deutschland






EU/1/07/394/001-009


24.11.2011




22.11.2011


Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




1330 Rixensart,




Belgique






EU/1/09/578/001


24.11.2011




22.11.2011


PecFent







Archimedes Development Ltd




Nottingham,




NGT7 2TN,




United Kingdom






EU/1/10/644/001-006


24.11.2011




22.11.2011


Prepandrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




B-1330 Rixensart,




Belgique






EU/1/08/453/002


24.11.2011




22.11.2011


Rasilez







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/07/405/001-040


24.11.2011




22.11.2011


Reyataz







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park,




Sanderson Road,




Uxbridge




UB8 1DH,




United Kingdom






EU/1/03/267/001-006
EU/1/03/267/008-010


24.11.2011




22.11.2011


Riprazo







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/07/409/001-040


24.11.2011




22.11.2011


Riprazo HCT







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex,




RH12 5AB,




United Kingdom






EU/1/11/680/001-080


24.11.2011




22.11.2011


Sprimeo







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/07/407/001-040


24.11.2011




22.11.2011


Tasigna







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/07/422/001-012


24.11.2011




22.11.2011


Thalidomide Celgene







Celgene Europe Limited




1 Longwalk Road,




Stockley Park,




Uxbridge




UB11 1DB,




United Kingdom






EU/1/08/443/001


24.11.2011




22.11.2011


Trisenox







Cephalon Europe




5 Rue Charles Martigny,




94700 Maisons Alfort, Cedex,




France






EU/1/02/204/001


24.11.2011




22.11.2011


Victoza







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/09/529/001-005


25.11.2011




24.11.2011


Adenuric







Menarini International Operations Luxembourg S.A.




1, Avenue de la Gare,




L-1611 Luxembourg,




Luxembourg






EU/1/08/447/001-012


29.11.2011




24.11.2011


Atriance







Glaxo Group Limited




Berkeley Avenue,




Greenford,




Middlesex




UB6 0NN,




United Kingdom






EU/1/07/403/001


1.12.2011




24.11.2011


Avastin







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/04/300/001-002


30.11.2011




24.11.2011


Clopidogrel HCS







HCS bvba




H. Kennisstraat 53,




B 2650 Edegem,




Belgïe






EU/1/10/651/001-015


29.11.2011




24.11.2011


Clopidogrel Teva Generics B.V.







Teva Generics B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/10/650/001-015


29.11.2011




24.11.2011


Eucreas







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/07/425/001-018


28.11.2011




24.11.2011


Galvus







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/07/414/001-010
EU/1/07/414/018


29.11.2011




24.11.2011


Icandra







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/08/484/001-018


30.11.2011




24.11.2011


Intelence







Janssen-Cilag International NV




Turnhoutseweg, 30 -




2340 Beerse –




België






EU/1/08/468/001-002


29.11.2011




24.11.2011


Jalra







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/08/485/001-011


29.11.2011




24.11.2011


ReFacto AF







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/1/99/103/001-008


29.11.2011




24.11.2011


Soliris







Alexion Europe S.A.S.




25, boulevard de l'Amiral Bruix,




75016 Paris,




France






EU/1/07/393/001


29.11.2011




24.11.2011


Vimpat







UCB Pharma SA.




Allée de la Recherche 60,




1070 Bruxelles,




Belgique/Researchdreef, 60,




Brussel 1070,




België






EU/1/08/470/001-017


29.11.2011




24.11.2011


Xiliarx







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/08/486/001-011


29.11.2011




24.11.2011


Zomarist







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/08/483/001-018


29.11.2011




24.11.2011


Zypadhera







Eli Lilly Nederland B.V.




Grootslag 1-5,




NL-3991 RA Houten,




Nederland






EU/1/08/479/001-003


28.11.2011




24.11.2011


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/1/96/022/019-040


28.11.2011




24.11.2011


Zyprexa Velotab







Eli Lilly Nederland B.V.




Grootslag 1-5,




3991 RA Houten,




Nederland






EU/1/99/125/001-020


28.11.2011




28.11.2011


Emend







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/03/262/001-010


30.11.2011




28.11.2011


Pradaxa







Boehringer Ingelheim International GmbH




Binger Strasse 173,




D-55216 Ingelheim am Rhein,




Deutschland






EU/1/08/442/001-014


1.12.2011




28.11.2011


Tamiflu







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/02/222/001-005


30.11.2011




28.11.2011


Zutectra







Biotest Pharma GmbH




Landsteinerstr.5,




63303 Dreieich,




Deutschland






EU/1/09/600/001


30.11.2011




28.11.2011


Zyllt







KRKA, d.d., Novo mesto




Šmarješka cesta 6,




8501 Novo mesto,




Slovenija






EU/1/09/553/001-010


30.11.2011




5.12.2011


Aranesp







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/01/185/001-022
EU/1/01/185/031-111


7.12.2011




5.12.2011


Cervarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




1330 Rixensart,




Belgique






EU/1/07/419/001-012


7.12.2011




5.12.2011


Clopidogrel Acino







Acino Pharma GmbH




Am Windfeld 35,




83714 Miesbach,




Deutschland






EU/1/09/532/001-007


7.12.2011




5.12.2011


Clopidogrel Hexal







Acino Pharma GmbH




Am Windfeld 35,




83714 Miesbach,




Deutschland






EU/1/09/534/001-007


7.12.2011




5.12.2011


Controloc Control







Nycomed GmbH




Byk-Gulden-Str. 2,




D-78467 Konstanz,




Deutschland






EU/1/09/515/001-004


7.12.2011




5.12.2011


Pantozol Control







Nycomed GmbH




Byk-Gulden-Str. 2,




D-78467 Konstanz,




Deutschland






EU/1/09/517/001-004


7.12.2011




5.12.2011


Somac Control







Nycomed GmbH




Byk-Gulden-Str. 2,




D-78467 Konstanz,




Deutschland






EU/1/09/516/001-004


7.12.2011




5.12.2011


Xenical







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/98/071/001-006


7.12.2011




7.12.2011


Clopidogrel Teva Pharma







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/09/561/001-011


9.12.2011




7.12.2011


Pantecta Control







Nycomed GmbH




Byk-Gulden-Str. 2,




D-78467 Konstanz,




Deutschland






EU/1/09/518/001-004


9.12.2011




7.12.2011


Pantoloc Control







Nycomed GmbH




Byk-Gulden-Str. 2,




D-78467 Konstanz,




Deutschland






EU/1/09/519/001-004


9.12.2011




7.12.2011


Prometax







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/98/092/013
EU/1/98/092/018-026


12.12.2011




7.12.2011


Torisel







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/1/07/424/001


9.12.2011




8.12.2011


Ceplene







EpiCept GmbH




Goethestrasse 4,




D-80336 München,




Deutschland






EU/1/08/477/001


12.12.2011




9.12.2011


Rasilamlo







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex,




RH12 5AB,




United Kingdom






EU/1/11/686/001-056


13.12.2011




9.12.2011


Xarelto







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/08/472/001-021


20.12.2011




9.12.2011


Zeffix







Glaxo Group Ltd.




Greenford Road,




Greenford,




Middlesex




UB6 0NN,




United Kingdom






EU/1/99/114/003


13.12.2011




14.12.2011


Clopidogrel ratiopharm







Acino Pharma GmbH




Am Windfeld 35,




83714 Miesbach,




Deutschland






EU/1/09/554/001-008


19.12.2011




14.12.2011


Emselex







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/04/294/001-028


19.12.2011




14.12.2011


GILENYA







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/11/677/001-005


20.12.2011




14.12.2011


Glivec







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/01/198/001-013


19.12.2011




14.12.2011


Insulatard







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/02/233/010-012


21.12.2011




14.12.2011


Lucentis







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/06/374/001


19.12.2011




14.12.2011


Mabthera







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/98/067/001-002


19.12.2011




14.12.2011


Pegasys







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/02/221/001-016


19.12.2011




14.12.2011


Simulect







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/98/084/001-002


19.12.2011




14.12.2011


Vfend







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent




CT 13 9NJ,




United Kingdom






EU/1/02/212/001-026


19.12.2011




14.12.2011


Viread







Gilead Sciences International Limited




Cambridge




CB21 6GT




United Kingdom






EU/1/01/200/001-002


19.12.2011




14.12.2011


Volibris







Glaxo Group Ltd




Greenford,




Middlesex




UB6 0NN,




United Kingdom






EU/1/08/451/001-004


19.12.2011




19.12.2011


Advate







Baxter AG




Industriesstrasse 67,




1221 Vienna,




Österreich






EU/1/03/271/001-010


21.12.2011




19.12.2011


APTIVUS







Boehringer Ingelheim International GmbH




Binger Strasse 173-




D - 55216 Ingelheim am Rhein,




Deutschland






EU/1/05/315/001-002


21.12.2011




19.12.2011


Avastin







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/04/300/001-002


21.12.2011




19.12.2011


Clopidogrel Acino Pharma GmbH







Acino Pharma GmbH




Am Windfeld 35,




83714 Miesbach,




Deutschland






EU/1/09/548/001-007


21.12.2011




19.12.2011


Emend







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/03/262/001-008


21.12.2011




19.12.2011


Exjade







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/06/356/001-009


21.12.2011




19.12.2011


Fendrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




B-1330 Rixensart,




Belgique






EU/1/04/299/001-003


21.12.2011




19.12.2011


Gardasil







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/06/357/001-008
EU/1/06/357/018-021


21.12.2011




19.12.2011


Herceptin







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/00/145/001


21.12.2011




19.12.2011


Humira







Abbott Laboratories Ltd




Abbott House,




Vanwall Business Park,




Vanwall Road,




Maidenhead, Berkshire




SL6 4XE,




United Kingdom






EU/1/03/256/001-010


21.12.2011




19.12.2011


Kentera







Nicobrand Limited




189 Castleroe Road,




Coleraine,




BT51 3 RP




Northern Ireland






EU/1/03/270/001-005


21.12.2011




19.12.2011


Levemir







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/04/278/001-016


21.12.2011




19.12.2011


Noxafil







Merck Sharp & Dohme Ltd.




Hertford Road,




Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/05/320/001


21.12.2011




19.12.2011


Pandemic influenza vaccine H5N1 BAXTER







Baxter AG




Industriestraße 67,




A - 1221 Wien,




Österreich






EU/1/09/571/001


21.12.2011




19.12.2011


Pandemrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




B-1330 Rixensart,




Belgique






EU/1/08/452/001


21.12.2011




19.12.2011


Silgard







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/06/358/001-008
EU/1/06/358/018-021


21.12.2011




19.12.2011


Somavert







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent




CT 13 9NJ,




United Kingdom






EU/1/02/240/001-004


21.12.2011




19.12.2011


Synagis







Abbott Laboratories Ltd




Abbott House,




Vanwall Business Park,




Vanwall Road,




Maidenhead,




Berkshire




SL6 4XE,




United Kingdom






EU/1/99/117/001-002


21.12.2011




19.12.2011


Tasigna







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/07/422/001-012


21.12.2011




19.12.2011


Tesavel







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/07/435/001-018


21.12.2011




19.12.2011


Tracleer







Actelion Registration Ltd




BSI Building 13th Floor,




389 Chiswick High Road,




London




W4 4AL,




United Kingdom






EU/1/02/220/001-006


21.12.2011




22.12.2011


Actos







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych,




London




WC2B 4AE,




United Kingdom






EU/1/00/150/001-030


29.12.2011




22.12.2011


Actos







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych,




London




WC2B 4AE,




United Kingdom






EU/1/00/150/001-030


29.12.2011




22.12.2011


Ambirix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




B-1330 Rixensart,




Belgique






EU/1/02/224/001-005


27.12.2011




22.12.2011


Arzerra







Glaxo Group Ltd




Glaxo Wellcome House,




Berkeley Avenue,




Greenford,




Middlesex




UB6 0NN,




United Kingdom






EU/1/10/625/001
EU/1/10/625/003


28.12.2011




22.12.2011


Competact







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych,




London




WC2B 4AE,




United Kingdom






EU/1/06/354/001-012


29.12.2011




22.12.2011


Competact







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych,




London




WC2B 4AE,




United Kingdom






EU/1/06/354/001-012


3.1.2012




22.12.2011


Glubrava







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych,




London




WC2B 4AE,




United Kingdom






EU/1/07/421/001-009


29.12.2011




22.12.2011


Glubrava







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych,




London




WC2B 4AE,




United Kingdom






EU/1/07/421/001-009


29.12.2011




22.12.2011


Glustin







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych,




London




WC2B 4AE,




United Kingdom






EU/1/00/151/001-024


29.12.2011




22.12.2011


Glustin







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych,




London




WC2B 4AE,




United Kingdom






EU/1/00/151/001-024


29.12.2011




22.12.2011


Invanz







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/02/216/001-002


3.1.2012




22.12.2011


Ivemend







Merck Sharp & Dohme Limited




Hertford Road,




Hodderson,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/07/437/001-004


3.1.2012




22.12.2011


Januvia







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/07/383/001-018


5.1.2012




22.12.2011


Multaq







Sanofi-Aventis




174, avenue de France,




F-75013 Paris,




France






EU/1/09/591/001-004


28.12.2011




22.12.2011


Multaq







Sanofi-Aventis




174, avenue de France,




F-75013 Paris,




France






EU/1/09/591/001-004


29.12.2011




22.12.2011


Nevanac







Alcon Laboratories (UK) Ltd.




Boundary Way,




Hemel Hempstead,




Herts




HP2 7UD,




United Kingdom






EU/1/07/433/001


3.1.2012




22.12.2011


Norvir







Abbott Laboratories Ltd




Abbott House,




Vanwall Business Park,




Vanwall Road,




Maidenhead,




Berkshire




SL6 4XE,




United Kingdom






EU/1/96/016/001
EU/1/96/016/003-008


28.12.2011




22.12.2011


Onglyza







Bristol Myers Squibb/AstraZeneca EEIG




Bristol Myers Squibb House,




Uxbridge Business Park,




Sanderson Road,




Uxbridge,




Middlesex




UB8 1DH,




United Kingdom






EU/1/09/545/001-015


3.1.2012




22.12.2011


Ozurdex







Allergan Pharmaceuticals Ireland




Castlebar Road,




Westport,




Co. Mayo,




Ireland






EU/1/10/638/001


4.1.2012




22.12.2011


Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




1330 Rixensart,




Belgique






EU/1/09/578/001


27.12.2011




22.12.2011


Prepandrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




B-1330 Rixensart,




Belgique






EU/1/08/453/002


27.12.2011




22.12.2011


Renagel







Genzyme Europe B.V.




Gooimeer 10,




NL-1411 DD Naarden,




Nederland






EU/1/99/123/005-013


27.12.2011




22.12.2011


Renvela







Genzyme Europe B.V.




Gooimeer 10,




1411 DD Naarden,




Nederland






EU/1/09/521/001-007


27.12.2011




22.12.2011


Ristaben







Merck Sharp & Dohme Ltd.




Hertford Road,




Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/10/621/001-018


3.1.2012




22.12.2011


Tandemact







Takeda Global Research and Development Centre (Europe) Ltd.




61 Aldwych,




London




WC2B 4AE,




United Kingdom






EU/1/06/366/005-022


29.12.2011




22.12.2011


Tandemact







Takeda Global Research and Development Centre (Europe) Ltd.




61 Aldwych,




London




WC2B 4AE,




United Kingdom






EU/1/06/366/005-022


28.12.2011




22.12.2011


Vidaza







Celgene Europe Ltd




1 Longwalk Road,




Stockley Park,




Uxbridge,




UB11 1DB,




United Kingdom






EU/1/08/488/001


28.12.2011




22.12.2011


Xelevia







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/07/382/001-018


3.1.2012




22.12.2011


Zavesca







Actelion Registration Ltd




BSI Building 13th Floor,




389 Chiswick High Road,




London




W4 4AL,




United Kingdom






EU/1/02/238/001


28.12.2011







—   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




28.11.2011


Xigris







Eli Lilly Nederland B.V.




Grootslag 1-5,




3991 RA Houten,




Nederland






EU/1/02/225/001-002


30.11.2011







—   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




24.11.2011


Busilvex







Pierre Fabre Médicament




45, Place Abel Gance,




92654 Boulogne Billancourt Cedex,




France






EU/1/03/254/002


28.11.2011




24.11.2011


Caelyx







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/96/011/001-004


28.11.2011




24.11.2011


VELCADE







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/04/274/001-002


28.11.2011




24.11.2011


Vidaza







Celgene Europe Ltd




1 Longwalk Road,




Stockley Park,




Uxbridge,




UB11 1DB,




United Kingdom






EU/1/08/488/001


25.11.2011




7.12.2011


Ecalta







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/1/07/416/001-002


9.12.2011




7.12.2011


Luminity







Lantheus MI UK Limited




Festival House –




39 Oxford Street –




Newbury –




Berkshire




RG14 1JG –




United Kingdom






EU/1/06/361/001-002


12.12.2011




12.12.2011


Vistide







Gilead Sciences International Limited




Cambridge,




CB21 6GT,




United Kingdom






EU/1/97/037/001


14.12.2011







—   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 Décision


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




9.12.2011


Inflacam


Meloxicam







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea,




Co. Galway,




IRELAND






EU/2/11/134/001-014


Chewable tablet
Oral suspension
Solution for injection


QM01AC06


13.12.2011




9.12.2011


Panacur AquaSol


Fenbendazole







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/11/135/001-003


Oral suspension


QP52AC13


13.12.2011




14.12.2011


TruScient


Dibotermin alfa







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/2/11/136/001


Kit for implant


QM05BC01


19.12.2011







—   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




10.11.2011


ProMeris







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent




CT13 9NJ




United Kingdom






EU/2/06/064/001-004


15.11.2011




10.11.2011


ProMeris Duo







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/2/06/065/001-010


15.11.2011




10.11.2011


Zulvac 8 Bovis







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/2/09/105/001-002


15.11.2011




10.11.2011


Zulvac 8 Ovis







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/2/09/104/001-002


15.11.2011




16.11.2011


Prac-Tic







Novartis Sanidad Animal S.L.




Calle de la Marina, 206,




E - Barcelona 08013,




ESPANA






EU/2/06/066/001-012


18.11.2011




24.11.2011


Coxevac







CEVA SANTE ANIMALE




10 avenue de la Ballastière,




33500 Libourne,




France






EU/2/10/110/001-002


29.11.2011




24.11.2011


Ingelvac CircoFLEX







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein,




Deutschland






EU/2/07/079/001-008


29.11.2011




28.11.2011


Melosus







CP-Pharma Handelsgesellschaft mbH




Ostlandring 13,




D-31303 Burgdorf,




Deutschland






EU/2/10/116/004-006


30.11.2011




5.12.2011


Porcilis Porcoli







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/96/001/001-010


7.12.2011




9.12.2011


Masivet







AB Science S.A.




3 avenue George V,




75008 Paris,




France






EU/2/08/087/001-002


13.12.2011




9.12.2011


Zulvac 1 Ovis







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/2/11/131/001-006


13.12.2011




14.12.2011


Trocoxil







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent




CT13 9NJ




United Kingdom






EU/2/08/084/001-005


19.12.2011




14.12.2011


Zulvac 1 Bovis







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/2/11/130/001-003


19.12.2011




19.12.2011


Meloxidyl







CEVA SANTE ANIMALE




10 avenue de la Ballastière,




33500 Libourne,




France






EU/2/06/070/001-008


21.12.2011




19.12.2011


Ypozane







VIRBAC S.A.




1ère Avenue 2065 m L.I.D. –




06516 Carros –




France






EU/2/06/068/001-004


21.12.2011




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.