Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2011 to 28 February 2011 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2011-04-29
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, pharmaceutical industry, pharmaceutical legislation








C_2011128EN.01000101.xml










29.4.2011   


EN


Official Journal of the European Union


C 128/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2011 to 28 February 2011

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

2011/C 128/01
—   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




6.1.2011


Potactasol


topotecan







Actavis Group PTC ehf.




Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland






EU/1/10/660/001-002


powder for concentrate for solution for infusion


L01XX17


10.1.2011




21.1.2011


Docetaxel Teva Pharma


Docetaxel







Teva Pharma B.V.




Computerweg 10, DR Utrecht 3542, Nederland






EU/1/10/662/001-002


Concentrate and solvent for solution for infusion


L01CD02


26.1.2011




21.1.2011


Iasibon


Ibandronic acid







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/10/659/001-010


Concentrate for solution for infusion
Film-coated tablet


M05BA06


25.1.2011




27.1.2011


Fluenz


influenza vaccine (live attenuated, nasal)







MedImmune, LLC




Lagelandseweg 78, 6545 CG Nijmegen, Nederland






EU/1/10/661/001-002


Nasal spray, suspension


J07BB03


1.2.2011




18.2.2011


Entacapone Teva


entacapone







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/10/665/001-004


Film-coated tablet


N04BX02


22.2.2011




28.2.2011


Daliresp


roflumilast







Nycomed GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






EU/1/11/668/001-003


Film-coated tablet


R03DX07


2.3.2011




28.2.2011


Esbriet


Pirfenidone







InterMune Europe Ltd




Wellesley House, Duke of Wellington Avenue, Royal Arsenal, London SE18 6SS, United Kingdom






EU/1/11/667/001-003


Capsule, hard


L04AX05


2.3.2011




28.2.2011


Lamivudine / Zidovudine Teva


Lamivudine/Zidovudine







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/10/663/001-002


Film-coated tablet


J05AR01


2.3.2011




28.2.2011


Libertek


roflumilast







Nycomed GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






EU/1/11/666/001-003


Film-coated tablet


R03DX07


2.3.2011




28.2.2011


Xiapex


collagenase clostridium histolyticum







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom






EU/1/11/671/001


Powder and solvent for solution for injection


M09AB02


2.3.2011







—   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




6.1.2011


Invirase







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/96/026/001-002


10.1.2011




6.1.2011


Irbesartan HCT Winthrop







SANOFI PHARMA BRISTOL MYERS SQUIBB SNC




174 avenue de France, F- 75013 Paris, France






EU/1/06/377/001-028


11.1.2011




6.1.2011


Irbesartan Winthrop







SANOFI PHARMA BRISTOL MYERS SQUIBB SNC




174 avenue de France, F- 75013 Paris, France






EU/1/06/376/001-033


11.1.2011




6.1.2011


Lucentis







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/06/374/001


11.1.2011




6.1.2011


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
EU/1/01/171/013-014


11.1.2011




6.1.2011


Resolor







Movetis NV




Veedijk 58, B-2300 Turnhout, België






EU/1/09/581/001-008


11.1.2011




6.1.2011


Tepadina







ADIENNE S.r.l.




via Broseta, 64/B, 24128 Bergamo, Italia






EU/1/10/622/001-002


11.1.2011




6.1.2011


Yttriga







Eckert & Ziegler Nuclitec GmbH




Gieselweg 1, Braunschweig 38110, Deutschland






EU/1/05/322/001


10.1.2011




11.1.2011


IntronA







Schering Plough Europe




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






EU/1/99/127/011-039
EU/1/99/127/041-044


18.1.2011




11.1.2011


Pantoloc Control







Nycomed GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






EU/1/09/519/001-004


13.1.2011




11.1.2011


Rapiscan







Gilead Sciences International Limited




Cambridge CB21 6GT United Kingdom






EU/1/10/643/001


13.1.2010




13.1.2011


Clopidogrel Winthrop







Sanofi-Aventis




174, avenue de France, F-75013 Paris, France






EU/1/08/465/001-020


17.1.2011




13.1.2011


Copalia







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/06/372/037-039


17.1.2010




13.1.2011


INOmax







INO Therapeutics AB




SE-181 81 Lidingö, Sverige






EU/1/01/194/001-002


18.1.2011




13.1.2011


Iscover







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom






EU/1/98/070/001a-001b
EU/1/98/070/002a-002b
EU/1/98/070/003a-003b
EU/1/98/070/004a-004b
EU/1/98/070/005a-005b
EU/1/98/070/006a-006b
EU/1/98/070/007a-007b
EU/1/98/070/008-010
EU/1/98/070/011a-011b
EU/1/98/070/012


17.1.2011




13.1.2011


Nimvastid







KRKA, d.d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/525/001-050


17.1.2011




13.1.2011


Plavix







Sanofi Pharma Bristol-Myers Squibb SNC




174 avenue de France - 75013 Paris, France






EU/1/98/069/001a-001b
EU/1/98/069/002a-002b
EU/1/98/069/003a-003b
EU/1/98/069/004a-004b
EU/1/98/069/005a-005b
EU/1/98/069/006a-006b
EU/1/98/069/007a-007b
EU/1/98/069/008-010
EU/1/98/069/011a-011b
EU/1/98/069/012


17.1.2011




17.1.2011


Cancidas







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/01/196/001
EU/1/01/196/003


19.1.2011




17.1.2011


Kuvan







Merck KGaA




Frankfurter Straße 250, 64293 Darmstadt, Deutschland






EU/1/08/481/001-003


19.1.2011




17.1.2011


Nevanac







Alcon Laboratories (UK) Ltd.




Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom






EU/1/07/433/001


19.1.2011




21.1.2011


Abilify







Otsuka Pharmaceutical Europe Ltd




Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom






EU/1/04/276/001-020
EU/1/04/276/024-036


25.1.2011




21.1.2011


Adenuric







Menarini International Operations Luxembourg S.A.




1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg






EU/1/08/447/001-004


25.1.2011




21.1.2011


Arzerra







Glaxo Group Ltd




Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/10/625/001-002


26.1.2011




21.1.2011


Cubicin







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/05/328/001-004


25.1.2011




21.1.2011


Enbrel







Wyeth Europa Limited




Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom






EU/1/99/126/001-021


25.1.2011




21.1.2011


Humira







Abbott Laboratories




Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom






EU/1/03/256/001-010


25.1.2011




21.1.2011


INOmax







INO Therapeutics AB




SE-181 81 Lidingö, Sverige






EU/1/01/194/001-002


25.1.2011




21.1.2011


Karvea







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom






EU/1/97/049/001-039


26.1.2011




21.1.2011


Kuvan







Merck KGaA




Frankfurter Straße 250, 64293 Darmstadt, Deutschland






EU/1/08/481/001-003


25.1.2011




21.1.2011


Mixtard







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/02/231/001-023
EU/1/02/231/036-037


25.1.2011




21.1.2011


Multaq







Sanofi-Aventis




174, avenue de France, F-75013 Paris, France






EU/1/09/591/001-004


25.1.2011




21.1.2011


Olazax Disperzi







Glenmark Pharmaceuticals s.r.o.




City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika






EU/1/09/592/001-005


25.1.2011




21.1.2011


Pandemrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, Rixensart, B-1330 Belgique






EU/1/08/452/001


26.1.2011




21.1.2011


Pradaxa







Boehringer Ingelheim International GmbH




Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland






EU/1/08/442/001-008


25.1.2011




21.1.2011


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
EU/1/01/171/013-014


26.1.2011




21.1.2011


Rasilez







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/07/405/001-040


25.1.2011




21.1.2011


Revatio







Pfizer Limited




Sandwich, Kent, CT13 9NJ, United Kingdom






EU/1/05/318/002


25.1.2011




21.1.2011


Revlimid







Celgene Europe Limited




Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom






EU/1/07/391/001-004


26.1.2011




21.1.2011


RotaTeq







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk, Lyon 69007, France






EU/1/06/348/001-002


26.1.2011




21.1.2011


Sprimeo







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/07/407/001-020


26.1.2011




21.1.2011


Temomedac







medac Gesellschaft für klinische Spezialpräparate mbH




Fehlandtstrasse 3, D-20354 Hamburg - Deutschland






EU/1/09/605/001-012


26.1.2011




21.1.2011


Thymanax







Servier (Ireland) Industries Limited




Gorey Road, Arklow, Co. Wicklow, Ireland






EU/1/08/498/001-008


25.1.2011




21.1.2011


Valdoxan







Les Laboratoires Servier




22, rue Garnier, 92200 Neuilly-sur-Seine, France






EU/1/08/499/001-008


26.1.2011




21.1.2011


Yentreve







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/04/280/001-008


25.1.2011




24.1.2011


Apidra







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/04/285/001-036


27.1.2011




24.1.2011


Ceplene







EpiCept GmbH




Goethestrasse 4, D-80336 München, Deutschland






EU/1/08/477/001


27.1.2011




24.1.2011


Dafiro







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/06/371/001-039


27.1.2011




24.1.2011


Eucreas







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/07/425/001-018


27.1.2011




24.1.2011


Galvus







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






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


27.1.2011




24.1.2011


Isentress







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/07/436/001-002


27.1.2011




24.1.2011


Jalra







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/08/485/001-011


27.1.2011




24.1.2011


Lantus







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/00/134/001-037


27.1.2011




24.1.2011


NutropinAq







Ipsen Pharma




65, quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/00/164/003-005


27.1.2011




24.1.2011


Olanzapine Glenmark







Glenmark Generics (Europe) Limited




Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom






EU/1/09/587/001-017


27.1.2011




24.1.2011


Olanzapine Glenmark Europe







Glenmark Generics (Europe) Limited




Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom






EU/1/09/588/001-012


27.1.2011




24.1.2011


Optisulin







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/00/133/001-032


27.1.2011




24.1.2011


Pelzont







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/08/460/009-011
EU/1/08/460/013-014


26.1.2011




24.1.2011


Rotarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, Rixensart, B-1330 Belgique






EU/1/05/330/001-011


27.1.2011




24.1.2011


SonoVue







Bracco International B.V.




Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland






EU/1/01/177/002


27.1.2011




24.1.2011


Synflorix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/09/508/001-010


27.1.2011




24.1.2011


Torisel







Wyeth Europa Ltd




Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom






EU/1/07/424/001


27.1.2011




24.1.2011


Tredaptive







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/08/459/009-011
EU/1/08/459/013-014


26.1.2011




24.1.2011


Trevaclyn







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/08/458/009-011
EU/1/08/458/013-014


26.1.2011




24.1.2011


Vistide







Gilead Sciences International Limited




Cambridge, CB21 6GT, United Kingdom






EU/1/97/037/001


27.1.2011




24.1.2011


Xarelto







Bayer Schering Pharma AG




13342 Berlin, Deutschland






EU/1/08/472/001-010


27.1.2011




24.1.2011


Xiliarx







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/08/486/001-011


27.1.2011




26.1.2011


Naglazyme







BioMarin Europe Ltd




164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom






EU/1/05/324/001-002


27.1.2011




27.1.2011


Adrovance







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/06/364/001-009


1.2.2011




27.1.2011


Alimta







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/04/290/001-002


1.2.2011




27.1.2011


Cymbalta







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/04/296/001-009


31.1.2011




27.1.2011


Herceptin







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/00/145/001


1.2.2011




27.1.2011


Icandra







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/08/484/001-018


1.2.2011




27.1.2011


Menveo







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1, 53100 Siena, Italia






EU/1/10/614/001


31.1.2011




27.1.2011


Nonafact







Sanquin




Plesmanlaan 125, Amsterdam 1066 CX, Nederland






EU/1/01/186/001-002


1.2.2011




27.1.2011


Orgalutran







N.V. Organon




P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland






EU/1/00/130/001-002


31.1.2011




27.1.2011


Ranexa







Menarini International Operations Luxembourg S.A.




1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg






EU/1/08/462/001-012


1.2.2011




27.1.2011


Rasilez HCT







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/08/491/001-080


1.2.2011




27.1.2011


Regranex







Janssen-Cilag International NV




Turnhoutseweg, 30 - 2340 Beerse - België






EU/1/99/101/001


31.1.2011




27.1.2011


Remicade







Centocor B.V.




Einsteinweg 101, 2333 CB Leiden, Nederland






EU/1/99/116/001-005


1.2.2011




27.1.2011


Ribavirin Mylan







Three Rivers Global Pharma Limited




20-22 Bedford Row, London WC1R4JS, United Kingdom






EU/1/10/634/001-004


23.2.2011




27.1.2011


RotaTeq







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk, Lyon 69007, France






EU/1/06/348/001-002


1.2.2011




27.1.2011


Sebivo







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/07/388/001-003


1.2.2011




27.1.2011


Simponi







Centocor B.V.




Einsteinweg 101, 2333 CB Leiden, Nederland






EU/1/09/546/001-004


31.1.2011




27.1.2011


Xeristar







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/04/297/001-008


1.2.2011




27.1.2011


Zomarist







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/08/483/001-018


1.2.2011




1.2.2011


Ariclaim







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/04/283/008-012


3.2.2011




1.2.2011


Emend







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/03/262/001-008


3.2.2011




1.2.2011


Exforge







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/06/370/001-039


3.2.2011




1.2.2011


Fosavance







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/05/310/001-009


3.2.2011




1.2.2011


Imprida







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/06/373/001-039


3.2.2011




1.2.2011


INCRELEX







Ipsen Pharma




65, quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/07/402/001


3.2.2011




1.2.2011


Insulin Human Winthrop







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/06/368/001-168


3.2.2011




1.2.2011


Insuman







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/97/030/028-195


3.2.2011




1.2.2011


Irbesartan Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/09/576/001-039


3.2.2011




1.2.2011


Nivestim







Hospira UK Limited




Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom






EU/1/10/631/001-009


3.2.2011




1.2.2011


Orfadin







Swedish Orphan Biovitrum International AB




SE-112 76 Stockholm, Sweden






EU/1/04/303/001-003


3.2.2011




1.2.2011


Riprazo







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/07/409/001-020


3.2.2011




1.2.2011


Votrient







Glaxo Group Limited




Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/10/628/001-004


3.2.2011




2.2.2011


Nplate







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/08/497/001-008


4.2.2011




2.2.2011


Prevenar







Wyeth-Lederle Vaccines S.A.




Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium






EU/1/00/167/001-008


4.2.2011




2.2.2011


Prolia







Amgen Europe B.V.




Minervum 7061, NL-4817 ZK Breda, Nederland






EU/1/10/618/001-004


4.2.2011




2.2.2011


Replagal







Shire Human Genetic Therapies AB




Svärdvägen 11D, 182 33 Danderyd, Sverige






EU/1/01/189/001-006


4.2.2011




2.2.2011


Vantavo







Merck Sharp & Dohme Ltd.




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/09/572/001-009


4.2.2011




8.2.2011


Biopoin







CT Arzneimittel GmbH




Lengeder Straße 42a, D-13407 Berlin, Deutschland






EU/1/09/565/001-028


10.2.2011




8.2.2011


Temodal







Schering Plough Europe




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






EU/1/98/096/001-025


14.2.2011




9.2.2011


Cimzia







UCB Pharma SA.




Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België






EU/1/09/544/001-002


11.2.2011




9.2.2011


Karvezide







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom






EU/1/98/085/001-034


11.2.2011




9.2.2011


Olazax







Glenmark Pharmaceuticals s.r.o.




City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika






EU/1/09/597/001-005


11.2.2011




9.2.2011


Peyona







CHIESI FARMACEUTICI SpA




Via Palermo 26/A, I-43100 Parma, ITALIA






EU/1/09/528/001-002


11.2.2011




9.2.2011


Tesavel







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/07/435/001-018


11.2.2011




9.2.2011


Xelevia







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/07/382/001-018


11.2.2011




11.2.2011


Aprovel







Sanofi Pharma Bristol-Myers Squibb SNC




174 avenue de France - 75013 Paris, France






EU/1/97/046/001-039


15.2.2011




11.2.2011


Azarga







Alcon Laboratories (UK) Ltd.




Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom






EU/1/08/482/001-002


15.2.2011




11.2.2011


Brinavess







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/10/645/001-002


15.2.2011




11.2.2011


Clopidogrel Krka







KRKA, d. d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/556/001-011


15.2.2011




11.2.2011


CoAprovel







Sanofi Pharma Bristol-Myers Squibb SNC




174 avenue de France - 75013 Paris, France






EU/1/98/086/001-034


15.2.2011




11.2.2011


Crixivan







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






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


15.2.2011




11.2.2011


Eporatio







ratiopharm GmbH




Graf-Arco-Straße 3, D-89079 Ulm, Deutschland






EU/1/09/573/001-028


15.2.2011




11.2.2011


Januvia







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/07/383/001-018


15.2.2011




11.2.2011


Rilonacept Regeneron







Regeneron UK Limited




40 Bank Street, E14 5DS London, United Kingdom






EU/1/09/582/001


15.2.2011




11.2.2011


Zutectra







Biotest Pharma GmbH




Landsteinerstr.5, 63303 Dreieich, Deutschland






EU/1/09/600/001


15.2.2011




11.2.2011


Zyllt







KRKA, d.d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/553/001-010


15.2.2011




18.2.2011


Actrapid







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/02/230/001-007
EU/1/02/230/016-017


22.2.2011




18.2.2011


Elaprase







Shire Human Genetic Therapies AB




Svärdvägen 11D, 182 33 Danderyd, Sverige






EU/1/06/365/001-003


22.2.2011




18.2.2011


Keppra







UCB Pharma SA.




Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België






EU/1/00/146/001-032


22.2.2011




18.2.2011


Mimpara







Amgen Europe B.V.




Minervum 7061, NL-4817 ZK Breda, Nederland






EU/1/04/292/001-012


22.2.2011




18.2.2011


Optaflu







Novartis Vaccines and Diagnostics GmbH




Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland






EU/1/07/394/001-009


22.2.2011




18.2.2011


Renagel







Genzyme Europe B.V.




Gooimeer 10, NL-1411 DD Naarden, Nederland






EU/1/99/123/005-013


22.2.2011




21.2.2011


Arzerra







Glaxo Group Ltd




Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/10/625/001-003


25.2.2011




21.2.2011


Baraclude







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom






EU/1/06/343/001-007


28.2.2011




21.2.2011


Cervarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/07/419/001-012


25.2.2011




21.2.2011


Cialis







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/02/237/001-009


23.2.2011




21.2.2011


Clopidogrel Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/09/540/001-016


24.2.2011




21.2.2011


Competact







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych, London WC2B 4AE, United Kingdom






EU/1/06/354/001-011


23.2.2011




21.2.2011


Conbriza







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom






EU/1/09/511/001-005


23.2.2011




21.2.2011


Dukoral







Crucell Sweden AB




SE-105 21 Stockholm, Sweden






EU/1/03/263/001-003


1.3.2011




21.2.2011


Dynastat







Pfizer Ltd




Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom






EU/1/02/209/001-008


23.2.2011




21.2.2011


Efficib







Merck Sharp & Dohme Ltd.




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/08/457/001-016


24.2.2011




21.2.2011


Enbrel







Wyeth Europa Limited




Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom






EU/1/99/126/001-021


25.2.2011




21.2.2011


Firazyr







Jerini AG




Invalidenstr. 130, D-10115 Berlin, Deutschland






EU/1/08/461/001-002


24.2.2011




21.2.2011


Glivec







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/01/198/001-013


28.2.2011




21.2.2011


Humira







Abbott Laboratories Ltd




Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom






EU/1/03/256/001-010


23.2.2011




21.2.2011


Insulatard







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/02/233/005-007


25.2.2011




21.2.2011


Intanza







Sanofi Pasteur MSD SNC




8, rue Jonas Salk, Lyon 69007, France






EU/1/08/505/001-006


23.2.2011




21.2.2011


Ivemend







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/07/437/001-004


24.2.2011




21.2.2011


Janumet







Merck Sharp & Dohme Ltd.




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/08/455/001-016


24.2.2011




21.2.2011


Kineret







Swedish Orphan Biovitrum AB (publ)




SE-112 76, Stockholm, Sverige






EU/1/02/203/001-004


25.2.2011




21.2.2011


Levemir







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/04/278/001-003


28.2.2011




21.2.2011


Myozyme







Genzyme Europe B.V.




Gooimeer 10, NL-1411 DD Naarden, Nederland






EU/1/06/333/001-003


28.2.2011




21.2.2011


Neupro







Schwarz Pharma Ltd




Shannon, Industrial Estate, Co.Clare, Ireland






EU/1/05/331/001-055


25.2.2011




21.2.2011


Pritor







Bayer Schering Pharma AG




13342 Berlin, Deutschland






EU/1/98/089/001-022


25.2.2011




21.2.2011


PritorPlus







Bayer Schering Pharma AG




13342 Berlin, Deutschland






EU/1/02/215/001-021


28.2.2011




21.2.2011


Protaphane







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/02/234/005-007


25.2.2011




21.2.2011


Protopic







Astellas Pharma Europe B.V.




Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland






EU/1/02/201/001-006


28.2.2011




21.2.2011


Qutenza







Astellas Pharma Europe B.V.




Elisabethhof 19, 2353 EW Leiderdorp, Nederland






EU/1/09/524/001-002


25.2.2011




21.2.2011


Ranexa







Menarini International Operations Luxembourg S.A.




1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg






EU/1/08/462/001-012


25.2.2011




21.2.2011


Rasilez







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/07/405/001-040


25.2.2011




21.2.2011


Rasilez HCT







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/08/491/001-080


25.2.2011




21.2.2011


Remicade







Janssen Biologics B.V.




Einsteinweg 101, 2333 CB Leiden, Nederland






EU/1/99/116/001-005


25.2.2011




21.2.2011


Ribavirin Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/09/509/001-004


24.2.2011




21.2.2011


Ribavirin Teva Pharma BV







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/09/527/001-016


24.2.2011




21.2.2011


Riprazo







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/07/409/001-020


28.2.2011




21.2.2011


Ristaben







Merck Sharp & Dohme Ltd.




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/10/621/001-018


24.2.2011




21.2.2011


Ristfor







Merck Sharp & Dohme Ltd.




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/10/620/001-016


24.2.2011




21.2.2011


Simponi







Janssen Biologics B.V.




Einsteinweg 101, CB Leiden 2333, Nederland






EU/1/09/546/001-004


23.2.2011




21.2.2011


Sprimeo







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/07/407/001-020


28.3.2011




21.2.2011


Stocrin







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/99/111/001-005
EU/1/99/111/008-011


25.2.2011




21.2.2011


Tamiflu







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/02/222/001-004


23.2.2011




21.2.2011


Tysabri







Elan Pharma International Ltd.




Monksland, Athlone, County Westmeath, Ireland






EU/1/06/346/001


23.2.2011




21.2.2011


Velmetia







Merck Sharp & Dohme Ltd.




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/08/456/001-016


24.2.2011




21.2.2011


Ventavis







Bayer Schering Pharma AG




Müllerstrasse 170-178, D - 13342 Berlin, Deutschland






EU/1/03/255/001-008


23.2.2011




21.2.2011


Volibris







Glaxo Group Ltd




Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/08/451/001-004


2.3.2011




21.2.2011


Zylagren







KRKA, d. d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/558/001-010


28.2.2011




21.2.2011


Zyprexa







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/96/022/016-017


23.2.2011




28.2.2011


Altargo







Glaxo Group Limited




Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/07/390/001-004


4.3.2011




28.2.2011


Aranesp







Amgen Europe B.V.




Minervum 7061, NL-4817 ZK Breda, Nederland






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


4.3.2011




28.2.2011


Arixtra







Glaxo Group Ltd.




Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/02/206/001-035


2.3.2011




28.2.2011


Avastin







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/04/300/001-002


4.3.2011




28.2.2011


Baraclude







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom






EU/1/06/343/001-007


3.3.2011




28.2.2011


Clopidogrel Qualimed







Qualimed




117, Allée des Parcs, 69800 Saint Priest, France






EU/1/09/557/001-010


4.3.2011




28.2.2011


Clopidogrel TAD







TAD Pharma GmbH




Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland






EU/1/09/555/001-009


4.3.2011




28.2.2011


Fabrazyme







Genzyme Europe B.V.




Gooimeer 10, NL-1411 DD Naarden, Nederland






EU/1/01/188/001-006


4.3.2011




28.2.2011


Firazyr







Jerini AG




Invalidenstr. 130, D-10115 Berlin, Deutschland






EU/1/08/461/001-002


4.3.2011




28.2.2011


IDflu







Sanofi Pasteur SA




2, avenue Pont Pasteur, F-69007 Lyon, France






EU/1/08/507/001-006


3.3.2011




28.2.2011


Ilaris







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/09/564/001-002


4.3.2011




28.2.2011


Invanz







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/02/216/001-002


3.3.2011




28.2.2011


Kaletra







Abbott Laboratories




Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom






EU/1/01/172/001-008


4.3.2011




28.2.2011


Kinzalkomb







Bayer Schering Pharma AG




D-13342 Berlin, Deutschland






EU/1/02/214/001-015


2.3.2011




28.2.2011


Kinzalmono







Bayer Schering Pharma AG




D-13342 Berlin, Deutschland






EU/1/98/091/001-014


2.3.2011




28.2.2011


Micardis







Boehringer Ingelheim International GmbH




Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland






EU/1/98/090/001-020


2.3.2011




28.2.2011


MicardisPlus







Boehringer Ingelheim International GmbH




Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland






EU/1/02/213/001-023


3.3.2011




28.2.2011


NovoMix







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/00/142/004-005
EU/1/00/142/009-025


3.3.2011




28.2.2011


Omnitrope







Sandoz GmbH




Biochemiestrasse 10, Kundl 6250, Österreich






EU/1/06/332/001-009


2.3.2011




28.2.2011


Onglyza







Bristol Myers Squibb/AstraZeneca EEIG




Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom






EU/1/09/545/011-015


3.3.2011




28.2.2011


Onglyza







Bristol Myers Squibb/AstraZeneca EEIG




Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom






EU/1/09/545/001-010


3.3.2011




28.2.2011


Osigraft







Howmedica International S. de R.L.




Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland






EU/1/01/179/001


4.3.2011




28.2.2011


Osseor







Les Laboratoires Servier




22, rue Garnier, 92200 Neuilly-sur-Seine, France






EU/1/04/287/001-006


4.3.2011




28.2.2011


PegIntron







Schering Plough Europe




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






EU/1/00/131/001-050


3.3.2011




28.2.2011


PREZISTA







Janssen-Cilag International NV




Turnhoutseweg, 30 - 2340 Beerse - België






EU/1/06/380/001-005


4.3.2011




28.2.2011


ProQuad







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk, 69007 Lyon, France






EU/1/05/323/001-013


2.3.2011




28.2.2011


Protelos







Les Laboratoires Servier




22, rue Garnier, 92200 Neuilly-sur-Seine, France






EU/1/04/288/001-006


4.3.2011




28.2.2011


Quadramet







CIS bio international




Boite Postale 32 - F-91192 Gif-sur-Yvette - France






EU/1/97/057/001


4.4.2011




28.2.2011


RotaTeq







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk, Lyon 69007, France






EU/1/06/348/001-002


3.3.2011




28.2.2011


Siklos







ADDMEDICA




101, rue Saint Lazare, Paris 75009, France






EU/1/07/397/001-004


3.3.2011




28.2.2011


Tracleer







Actelion Registration Ltd




BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom






EU/1/02/220/001-006


3.3.2011




28.2.2011


Vedrop







Orphan Europe SARL




Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92800 Puteaux - France






EU/1/09/533/001-003


3.3.2011




28.2.2011


Ytracis







CIS bio international




Boite Postale 32 - F-91192 Gif-sur-Yvette Cedex- France






EU/1/03/250/001


4.3.2011







—   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




6.1.2011


Thelin







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom






EU/1/06/353/001-005


11.1.2011




1.2.2011


Clopidogrel 1A Pharma







Acino Pharma GmbH




Am Windfeld 35, 83714 Miesbach, Deutschland






EU/1/09/542/001-007


3.2.2011







—   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




27.1.2011


Hiprabovis IBR Marker Live


Live gE<sup>-</sup> tk<sup>-</sup> double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL







Laboratorios Hipra, S.A.




Avda. La Selva, 135, 17170- Amer (Girona), España






EU/2/10/114/001-002


Lyophilisate for suspension


QI02AD01


1.2.2011




11.2.2011


Comfortis


Spinosad







Eli Lilly and Company Ltd




Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom






EU/2/10/115/001-010


Chewable tablet


QP53BX03


15.2.2011




18.2.2011


Activyl


Indoxacarb







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/10/118/001-014


Spot-on solution


QP53AX27


22.2.2011




18.2.2011


Cimalgex


Cimicoxib







Vétoquinol SA




Magny-Vernois - 70200 LURE - France






EU/2/10/119/001-012


Tablet


QM01AH93


24.2.2011




18.2.2011


Purevax Rabies


Rabies recombinant canarypox virus (vCP65)







MERIAL




29 avenue Tony Garnier, 69007 LYON, France






EU/2/10/117/001-002


Suspension for injection


QI06AX


22.2.2011




21.2.2011


Melosus


Meloxicam







CP-Pharma Handelsgesellschaft mbH




Ostlandring 13, D-31303 Burgdorf, Deutschland






EU/2/10/116/001-004


Oral suspension


QM01AC06


24.2.2011







—   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




6.1.2011


Econor







Novartis Animal Health Austria GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/2/98/010/004-006
EU/2/98/010/017-018
EU/2/98/010/021-025


11.1.2011




13.1.2011


Duvaxyn WNV







Fort Dodge Animal Health Ltd




Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom






EU/2/08/086/001-003


18.1.2011




13.1.2011


Palladia







Pfizer Ltd




Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom






EU/2/09/100/001-003


17.1.2011




17.1.2011


Zolvix







Novartis Healthcare A/S




Lyngbyvej 172, DK-2100 Copenhagen, Denmark






EU/2/09/101/001-010


19.1.2011




21.1.2011


Dicural







Fort Dodge Animal Health Holland




C.J. van Houtenlaan 36, 1381 CP Weesp, Nederland






EU/2/97/003/001-018


25.1.2011




21.1.2011


Zulvac 8 Ovis







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom






EU/2/09/104/001-002


26.1.2011




24.1.2011


Poulvac FluFend H5N3 RG







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom






EU/2/06/060/001-002


27.1.2011




24.1.2011


Rheumocam







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, IRELAND






EU/2/07/078/001-010


26.1.2011




27.1.2011


Ingelvac CircoFLEX







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/07/079/001-004


1.2.2011




27.1.2011


Meloxidyl







CEVA SANTE ANIMALE




10 avenue de la Ballastière, 33500 Libourne, France






EU/2/06/070/005-007


1.2.2011




11.2.2011


SevoFlo







Abbott Laboratories Limited




Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM






EU/2/02/035/007


15.2.2011







—   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




24.1.2011


Acticam







Ecuphar NV




Legeweg 157-I, B-8020 Oostkamp, Belgïe






EU/2/08/088/001-003


26.1.2011




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.