Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2012 to 31 March 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2012-04-27
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012124EN.01000101.xml










27.4.2012   


EN


Official Journal of the European Union


C 124/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2012 to 31 March 2012

(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 124/01
—   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




9.3.2012


Mercaptopurine Nova Laboratories


Mercaptopurine







Nova Laboratories Limited




Martin House, Gloucester Crescent,




Wigston Leicester,




LE18 4YL,




United Kingdom






EU/1/11/727/001


Oral suspension


L01BB02


13.3.2012




9.3.2012


Sepioglin


pioglitazone







Vaia S.A.




1, 28 Octovriou str.,




Ag. Varvara




123 51, Athens,




Ελλάδα






EU/1/12/754/001-021


Tablet


A10BG03


13.3.2012




15.3.2012


Pioglitazone Actavis


pioglitazone







Actavis Group PTC ehf.




Reykjavíkurvegi 76 78,




220 Hafnarfjörður,




Iceland






EU/1/12/755/001-027


Tablet


A10BG03


20.3.2012




15.3.2012


Pioglitazone Actavis Group


pioglitazone







Actavis Group PTC ehf.




Reykjavíkurvegi 76 - 78,




220 Hafnarfjörður,




Iceland






EU/1/12/756/001-027


Tablet


A10BG03


20.3.2012




21.3.2012


Paglitaz


pioglitazone







KRKA, d. d., Novo mesto




Šmarješka cesta 6,




8501 Novo mesto,




Slovenija






EU/1/11/721/001-021


Tablet


A10BG03


26.3.2012




21.3.2012


Pioglitazone Accord


pioglitazone







Accord Healthcare Limited




5th Floor Charles House, 108/110 Finchley road,




London NW3 5JJ,




United Kingdom






EU/1/11/722/001-030


Tablet


A10BG03


27.3.2012




26.3.2012


Pioglitazone Teva


pioglitazone







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/12/757/001-030


Tablet


A10BG03


29.3.2012




26.3.2012


Pioglitazone Teva Pharma


pioglitazone







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/12/758/001-030


Tablet


A10BG03


29.3.2012







—   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




2.3.2012


ATryn







GTC Biotherapeutics UK Limited




10 Norwich Street,




London




EC4A 1BD,




United Kingdom






EU/1/06/355/001-003


6.3.2012




2.3.2012


Daliresp







Nycomed GmbH




Byk-Gulden-Str. 2,




D-78467 Konstanz,




Deutschland






EU/1/11/668/001-003


6.3.2012




2.3.2012


Esbriet







InterMune UK Ltd




Euston Tower, Floor 32, 286 Euston Road,




London,




NW1 3DP,




United Kingdom






EU/1/11/667/001-004


6.3.2012




2.3.2012


Fampyra







Biogen Idec Limited




Innovation House, 70 Norden Road, Maidenhead,




Berkshire




SL6 4AY,




United Kingdom






EU/1/11/699/001-004


6.3.2012




2.3.2012


Invirase







Roche Registration Limited




6 Falcon Way, Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/96/026/001-002


6.3.2012




2.3.2012


Leflunomide Teva







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/11/675/001-010


6.3.2012




2.3.2012


Libertek







Nycomed GmbH




Byk-Gulden-Str. 2,




D-78467 Konstanz,




Deutschland






EU/1/11/666/001-003


6.3.2012




2.3.2012


NutropinAq







Ipsen Pharma




65, quai Georges Gorse,




92100 Boulogne-Billancourt,




France






EU/1/00/164/003-005


6.3.2012




2.3.2012


Ruconest







Pharming Group N.V.




Darwinweg 24,




NL-2333 CR Leiden,




Nederland






EU/1/10/641/001


6.3.2012




2.3.2012


Tandemact







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych,




London




WC2B 4AE,




United Kingdom






EU/1/06/366/005-022


6.3.2012




2.3.2012


Valtropin







BioPartners GmbH




Kaiserpassage 11 –




D-72764 Reutlingen,




Deutschland






EU/1/06/335/001


6.3.2012




6.3.2012


Clopidogrel Acino







Acino Pharma GmbH




Am Windfeld 35,




83714 Miesbach,




Deutschland






EU/1/09/532/001-007


8.3.2012




6.3.2012


Repso







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/11/674/001-010


8.3.2012




6.3.2012


Rivastigmine Teva







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/09/513/001-020


8.3.2012




6.3.2012


Topotecan Actavis







Actavis Group PTC ehf




Reykjavikurvegur 76-78,




220 Hafnarfjordur,




Iceland






EU/1/09/536/001-004


8.3.2012




8.3.2012


Docetaxel Winthrop







Aventis Pharma S.A.




20 avenue Raymond Aron,




F-92165 Antony Cedex,




France






EU/1/07/384/003-005


12.3.2012




8.3.2012


Firazyr







Shire Orphan Therapies GmbH




Friedrichstrasse 149,




D-10117 Berlin,




Deutschland






EU/1/08/461/001-002


12.3.2012




8.3.2012


Pritor







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/98/089/001-022


12.3.2012




8.3.2012


PritorPlus







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/02/215/001-021


12.3.2012




9.3.2012


Samsca







Otsuka Pharmaceutical Europe Ltd




Hunton House, Highbridge Business Park, Oxford Road,




Uxbridge, Middlesex




UB8 1HU,




United Kingdom






EU/1/09/539/001-004


13.3.2012




15.3.2012


Avamys







Glaxo Group Ltd




Greenford, Middlesex




UB6 0NN,




United Kingdom






EU/1/07/434/001-003


19.3.2012




15.3.2012


Carbaglu







Orphan Europe




Immeuble Le Wilson,




70 Avenue du General de Gaulle,




92800 Puteaux,




France






EU/1/02/246/001-003


19.3.2012




15.3.2012


Orencia







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road,




Uxbridge




UB8 1DH,




United Kingdom






EU/1/07/389/001-003


19.3.2012




15.3.2012


Prolia







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/10/618/001-004


19.3.2012




15.3.2012


Toviaz







Pfizer Limited




Ramsgate Road, Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/1/07/386/001-018


19.3.2012




15.3.2012


Ventavis







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/03/255/001-008


19.3.2012




15.3.2012


Vizarsin







KRKA, d.d., Novo mesto




Šmarješka cesta 6,




8501 Novo mesto,




Slovenija






EU/1/09/551/001-012


19.3.2012




19.3.2012


Afinitor







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/09/538/001-008


21.3.2012




19.3.2012


Arava







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/99/118/001-010


21.3.2012




19.3.2012


Avastin







Roche Registration Limited




6 Falcon Way, Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/04/300/001-002


22.3.2012




19.3.2012


Benlysta







Glaxo Group Limited




Glaxo Wellcome House, Berkely Avenue, Greenford,




Middlesex




UB6 0NN,




United Kingdom






EU/1/11/700/001-002


21.3.2012




19.3.2012


Byetta







Eli Lilly Nederland B.V.




Grootslag 1-5,




3991 RA Houten,




Nederland






EU/1/06/362/001-004


22.3.2012




19.3.2012


Fasturtec







Sanofi-Aventis




174, avenue de France,




F-75013 Paris,




France






EU/1/00/170/001-002


21.3.2012




19.3.2012


Helixate NexGen







Bayer Schering Pharma AG




13342 Berlin,




Deutschland






EU/1/00/144/001-005


22.3.2012




19.3.2012


IDflu







Sanofi Pasteur SA




2, avenue Pont Pasteur,




F-69007 Lyon,




France






EU/1/08/507/001-006


22.3.2012




19.3.2012


Incivo







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/11/720/001-002


21.3.2012




19.3.2012


Intanza







Sanofi Pasteur MSD SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/08/505/001-006


21.3.2012




19.3.2012


Intelence







Janssen-Cilag International NV




Turnhoutseweg, 30 –




2340 Beerse –




België






EU/1/08/468/001-002


21.3.2012




19.3.2012


Isentress







Merck Sharp & Dohme Limited




Hertford Road,




Hoddesdon, Hertfordshire




EN11 9BU,




United Kingdom






EU/1/07/436/001-002


21.3.2012




19.3.2012


Kogenate Bayer







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/00/143/004-013


22.3.2012




19.3.2012


Leflunomide Winthrop







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/09/604/001-010


21.3.2012




19.3.2012


Levitra







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/03/248/001-023


21.3.2012




19.3.2012


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


21.3.2012




19.3.2012


PegIntron







Schering Plough Europe




Clos du Lynx 5,




1200 Bruxelles,




Belgique –









Lynx Binnenhof 5,




1200 Brussel,




België






EU/1/00/131/001-050


21.3.2012




19.3.2012


Prevenar 13







Wyeth-Lederle Vaccines S.A.




Pleinlaan 17 Boulevard de la Plaine,




1050 Brussel - Bruxelles,




Belgïe-Belgique






EU/1/09/590/001-006


22.3.2012




19.3.2012


Privigen







CSL Behring GmbH




Emil-von-Behring-Strasse 76,




35041 Marburg,




Deutschland






EU/1/08/446/001-006


21.3.2012




19.3.2012


ProQuad







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/05/323/001-013


21.3.2012




19.3.2012


Ranexa







Menarini International Operations Luxembourg S.A.




1, Avenue de la Gare,




L-1611 Luxembourg,




Luxembourg






EU/1/08/462/001-012


22.3.2012




19.3.2012


Refludan







Celgene Europe Ltd




1 Longwalk Road, Stockley Park,




Uxbridge,




UB11 1DB,




United Kingdom






EU/1/97/035/001-004


21.3.2012




19.3.2012


Remicade







Janssen Biologics B.V.




Einsteinweg 101,




2333 CB Leiden,




Nederland






EU/1/99/116/001-005


22.3.2012




19.3.2012


Resolor







Shire-Movetis NV




Veedjik 58,




B-2300 Turnhout,




België






EU/1/09/581/001-008


21.3.2012




19.3.2012


Tasmar







Meda AB




Pipers väg 2A,




170 09 Solna,




Sverige






EU/1/97/044/001-009


21.3.2012




19.3.2012


Vimpat







UCB Pharma SA.




Allée de la Recherche 60,




1070 Bruxelles,




Belgique/









Researchdreef, 60,




1070 Brussel,




België






EU/1/08/470/001-013
EU/1/08/470/016-017


22.3.2012




19.3.2012


Votrient







Glaxo Group Limited




Berkeley Avenue,




Greenford, Middlesex




UB6 0NN,




United Kingdom






EU/1/10/628/001-004


22.3.2012




21.3.2012


Atriance







Glaxo Group Limited




Berkeley Avenue,




Greenford, Middlesex




UB6 0NN,




United Kingdom






EU/1/07/403/001


26.3.2012




21.3.2012


Champix







Pfizer Ltd




Ramsgate Road, Sandwich,




Kent




CT 13 9NJ,




United Kingdom






EU/1/06/360/001-013


26.3.2012




21.3.2012


Clopidogrel Krka d.d.







KRKA, d.d., Novo mesto




Šmarješka cesta 6,




8501 Novo mesto,




Slovenija






EU/1/09/562/001-009


26.3.2012




21.3.2012


Foclivia







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1,




53100 Siena,




Italia






EU/1/09/577/001-004


26.3.2012




21.3.2012


Integrilin







Glaxo Group Ltd




Greenford, Middlesex,




UB6 ONN,




United Kingdom






EU/1/99/109/001-002


23.3.2012




21.3.2012


Rapiscan







Rapidscan Pharma Solutions EU Ltd.




Regent's Place, 338 Euston Road,




London




NW1 3BT,




UK






EU/1/10/643/001


23.3.2012




21.3.2012


Revatio







Pfizer Limited




Sandwich,




Kent,




CT13 9NJ,




United Kingdom






EU/1/05/318/001-003


26.3.2012




21.3.2012


Thymanax







Servier (Ireland) Industries Limited




Gorey Road, Arklow, Co. Wicklow,




Ireland






EU/1/08/498/001-008


26.3.2012




21.3.2012


VELCADE







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/04/274/001-002


26.3.2012




21.3.2012


Victrelis







Merck Sharp & Dohme Limited




Hertford Road,




Hodderson, Hertfordshire




EN11 9BU,




United Kingdom






EU/1/11/704/001-002


23.3.2012




21.3.2012


Volibris







Glaxo Group Ltd




Greenford,




Middlesex




UB6 0NN,




United Kingdom






EU/1/08/451/001-004


26.3.2012




21.3.2012


Xgeva







Amgen Europe B.V.




Minervum 7061,




4817 ZK Breda,




Nederland






EU/1/11/703/001-003


23.3.2012




21.3.2012


Zostavax







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/06/341/001-013


23.3.2012




26.3.2012


Azilect







Teva Pharma GmbH




Graf-Arco-Str. 3,




89079 Ulm,




Deutschland






EU/1/04/304/001-007


28.3.2012




26.3.2012


Eurartesim







Sigma-Tau Industrie Farmaceutiche Riunite S.p.A




Viale Shakespeare 47,




00144 Rome,




Italia






EU/1/11/716/001-005


28.3.2012




26.3.2012


Neupro







Schwarz Pharma Ltd




Shannon, Industrial Estate,




Co.Clare,




Ireland






EU/1/05/331/001-055


28.3.2012




26.3.2012


Nimvastid







KRKA, d.d., Novo mesto




Šmarješka cesta 6,




8501 Novo mesto,




Slovenija






EU/1/09/525/001-050


28.3.2012




26.3.2012


Pandemic influenza vaccine H5N1 BAXTER







Baxter AG




Industriestraße 67,




A – 1221 Wien,




Österreich






EU/1/09/571/001-002


28.3.2012




26.3.2012


PegIntron







Schering Plough Europe




Clos du Lynx 5,




1200 Bruxelles,




Belgique –









Lynx Binnenhof 5,




1200 Brussel,




België






EU/1/00/131/001-050


28.3.2012




26.3.2012


Plenadren







DuoCort Pharma AB




Kullagatan 8-10,




S-252 20 Helsingborg,




Sverige






EU/1/11/715/001-002


28.3.2012




26.3.2012


Valdoxan







Les Laboratoires Servier




50 rue Carnot,




92284 Suresnes, Cedex,




France






EU/1/08/499/001-008


28.3.2012




26.3.2012


ViraferonPeg







Schering Plough Europe




Clos du Lynx 5,




1200 Bruxelles,




Belgique –









Lynx Binnenhof 5,




1200 Brussel,




België






EU/1/00/132/001-050


28.3.2012




26.3.2012


VPRIV







Shire Pharmaceuticals Ireland Limited




5 Riverside Walk, Citywest Business Campus,




Dublin 24,




Ireland






EU/1/10/646/001-006


28.3.2012







—   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




15.3.2012


Livensa







Warner Chilcott Deutschland Gmbh




Dr.-Otto-Röhm-Strasse 2-4,




64331 Weiterstadt,




Deutschland






EU/1/06/351/001-003


19.3.2012







—   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




2.3.2012


Omnitrope







Sandoz GmbH




Biochemiestrasse 10,




6250 Kundl,




Österreich






EU/1/06/332/001-012


6.3.2012







—   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




8.3.2012


Zulvac 1+8 Bovis


—







Pfizer Limited




Ramsgate Road, Sandwich,




Kent




CT13 9NJ




United Kingdom






EU/2/12/139/001-003


Suspension for injection


QI02AA08


12.3.2012







—   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




2.3.2012


Easotic







VIRBAC S.A




1ère Avenue 2065 m L.I.D. –




06516 Carros –




France






EU/2/08/085/001-006


6.3.2012




2.3.2012


Flexicam







Dechra Veterinary Products A/S




Mekuvej 9,




7171 Uldum,




Danmark






EU/2/06/058/004


6.3.2012




9.3.2012


Purevax Rabies







MERIAL




29 avenue Tony Garnier,




69007 LYON,




France






EU/2/10/117/001-003


13.3.2012




15.3.2012


BTVPUR AlSap 8







MERIAL




29 avenue Tony Garnier,




69007 LYON,




France






EU/2/09/094/001-004


19.3.2012




15.3.2012


Masivet







AB Science S.A.




3 avenue George V,




75008 Paris,




France






EU/2/08/087/001-003


19.3.2012




15.3.2012


Recuvyra







Nexcyon Pharmaceuticals Ltd.




Bank Barn, How Mill,




Brampton, Cumbria




CA8 9JY,




United Kingdom






EU/2/11/127/001


20.3.2012




26.3.2012


Aivlosin







ECO Animal Health Ltd




78 Coombe Road New Malden




Surrey




KT3 4QS




United Kingdom






EU/2/04/044/001-013


28.3.2012







—   Withdrawal of a marketing authorization (Article 38 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




19.3.2012


Gonazon







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/03/040/001-002


22.3.2012




19.3.2012


Zubrin







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/00/028/002-008


22.3.2012




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.