Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2010 to 30 June 2010 [Published pursuant to Article 13 or Article 38 of Regulation (CE) No 726/2004 of the European Parliament and of the Council]
Date: 2010-09-24
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation








C_2010258EN.01000101.xml










24.9.2010   


EN


Official Journal of the European Union


C 258/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2010 to 30 June 2010
[Published pursuant to Article 13 or Article 38 of Regulation (CE) No 726/2004 of the European Parliament and of the Council (1)]
(2010/C 258/01)
—   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




11.3.2010


Revolade


Eltrombopag


GlaxoSmithKline Trading Services Limited
6900 CorkAirport Business Park, Kinsale Road, Cork, Ireland


EU/1/10/612/001-006


Film-coated tablet


B02BX05


15.3.2010




15.3.2010


DuoCover


clopidogrel / acetylsalicylic acid


Bristol-MyersSquibbPharma EEIG
Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/10/623/001-014


Film-coated tablet


B01AC30


17.3.2010




15.3.2010


DuoPlavin


clopidogrel / acetylsalicylic acid


Sanofi Pharma Bristol-Myers Squibb SNC
174 Avenue de France, F-75013 Paris, France


EU/1/10/619/001-014


Film-coated tablet


B01AC30


17.3.2010




15.3.2010


ImmunoGam


Human Hepatitis B Immunoglobulin


Cangene Europe Limited
Parkshot House, 5 Kew Road, Richmond, SurreyTW9 2PR, United Kingdom


EU/1/10/613/001-002


Solution for injection


J06BB04


17.3.2010




15.3.2010


Menveo


Meningococcal Group A, C, W135 and Y Conjugate Vaccine


Novartis Vaccines and Diagnostics S.r.l.
Via Fiorentina, 1 - Siena, Italia


EU/1/10/614/001


Powder and solution for injection


Pending


17.3.2010




15.3.2010


Ristaben


sitagliptin


Merck Sharp & Dohme Ltd.
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/10/621/001-018


Film-coated tablet


A10BH01


17.3.2010




15.3.2010


Ristfor


sitagliptin / metformin hydrochloride


Merck Sharp & Dohme Ltd.
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/10/620/001-016


Film-coated tablet


A10BD07


17.3.2010




15.3.2010


Temozolomide HEXAL


temozolomide


HEXAL AG
Industriestrasse 25, D-83607 Holzkirchen, Deutschland


EU/1/10/616/001-024


Capsule, hard


L01AX03


17.3.2010




15.3.2010


Temozolomide Hospira


temozolomide


Hospira UK Ltd.
Queensway, Royal Leamington Spa, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom


EU/1/10/615/001-024


Capsule, hard


L01AX03


17.3.2010




15.3.2010


Temozolomide Sandoz


temozolomide


Sandoz Pharmaceuticals GmbH
Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland


EU/1/10/617/001-024


Capsule, hard


L01AX03


17.3.2010




15.3.2010


Tepadina


Thiotepa


ADIENNE S.r.l.
via Broseta, 64/B, 24128 Bergamo, Italia


EU/1/10/622/001-002


powder for concentrate for solution for infusion


L01AC01


17.3.2010




23.3.2010


Arepanrix


Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (X-179A)


GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89, 1330 Rixensart, Belgique


EU/1/10/624/001


Suspension and emulsion for emulsion for injection


J07BB02


25.3.2010




6.4.2010


Ribavirin BioPartners


Ribavirin


BioPartners GmbH
Kaiserpassage 11 - D-72764 Reutlingen, Deutschland


EU/1/10/626/001-004


Film-coated tablet


J05AB04


9.4.2010




19.4.2010


Arzerra


Ofatumumab


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


EU/1/10/625/001-002


Concentrate for solution for infusion


L01XC10


21.4.2010




29.4.2010


Raloxifene Teva


Raloxifene hydrochloride


Teva Pharma B.V.
Computerweg 10, 3542 DR Utrecht, Nederland


EU/1/10/627/001-003


Film-coated tablet


G03XC01


3.5.2010




10.5.2010


Docefrez


Docetaxel


Sun Pharmaceuticals Industries Europe B.V.
Polarisavenue 87, 2132 JH Hoofddorp, Nederland


EU/1/10/630/001-002


Powder and solvent for concentrate for solution for infusion


L01CD02


12.5.2010




26.5.2010


Prolia


denosumab


Amgen Europe B.V.
Minervum 7061, NL-4817 ZK Breda, Nederland


EU/1/10/618/001-004


Solution for injection


M05BX04


28.5.2010




4.6.2010


Tolura


telmisartan


KRKA, d.d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/10/632/001-021


Tablet


C09CA07


8.6.2010




8.6.2010


Humenza


Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (X-179A)


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


EU/1/10/629/001


Suspension and emulsion for emulsion for injection


J07BB02


10.6.2010




8.6.2010


Nivestim


Filgrastim


Hospira UK Limited
Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom


EU/1/10/631/001-009


Solution for injection or infusion


L03AA02


10.6.2010




10.6.2010


Olanzapine Apotex


Olanzapine


Apotex Europe B.V.
Darwingweg 20, 2333 CR Leiden, Nederland


EU/1/10/635/001-014


Film-coated tablet
Orodispersible tablet


N05AH03


14.6.2010




10.6.2010


Ribavirin Three Rivers


Ribavirin


Three Rivers Global Pharma Limited
20-22 Bedford Row, London WC1R4JS, United Kingdom


EU/1/10/634/001-004


Capsule, hard


J05AB04


14.6.2010




10.6.2010


Topotecan Hospira


Topotecan


Hospira UK Limited
Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom


EU/1/10/633/001-002


Concentrate for solution for infusion


L01XX17


14.6.2010




14.6.2010


Votrient


Pazopanib hydrochloride


Glaxo Group Limited
Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom


EU/1/10/628/001-004


Film-coated tablet


L01XE11


16.6.2010




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









Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




8.4.2010


Impulsor


Pierre Fabre Médicament
45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France


 


12.4.2010




8.4.2010


Milnacipran Pierre Fabre Medicament


Pierre Fabre Médicament
45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France


 


12.4.2010




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









Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




11.3.2010


Cancidas


Merck Sharp & Dohme Ltd
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


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


15.3.2010




11.3.2010


Dafiro


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/06/371/001-036


15.3.2010




11.3.2010


Diacomit


Biocodex
7 avenue Gallieni, 94250 Gentilly, France


EU/1/06/367/001-012


15.3.2010




11.3.2010


Eporatio


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


EU/1/09/573/001-028


15.3.2010




11.3.2010


Inovelon


Eisai Limited
European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom


EU/1/06/378/001-016


15.3.2010




11.3.2010


Stelara


Janssen-Cilag International NV
Turnhoutseweg, 30 - 2340 Beerse - België


EU/1/08/494/003-004


15.3.2010




11.3.2010


Zopya


Norpharm Regulatory Services Ltd
26 Laurence Street, Drogheda, Co. Louth, Ireland


EU/1/09/562/001-009


15.3.2010




15.3.2010


Abraxane


Abraxis BioScience Limited
Rosanne House, Parkway, WelwynGarden City, Herts, AL8 6HG, United Kingdom


EU/1/07/428/001


17.3.2010




15.3.2010


Aerinaze


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


EU/1/07/399/001-006


17.3.2010




15.3.2010


Afinitor


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/09/538/001-008


17.3.2010




15.3.2010


Aldara


Meda AB
Pipers väg 2A, Solna 170 73, Svërige


EU/1/98/080/002


17.3.2010




15.3.2010


Altargo


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


EU/1/07/390/001-004


17.3.2010




15.3.2010


Arcalyst


Regeneron UK Limited
40 Bank Street, E14 5DS London, United Kingdom


EU/1/09/582/001


17.3.2010




15.3.2010


Atripla


Bristol-Myers Squibb and Gilead Sciences Limited
IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland


EU/1/07/430/001-002


19.3.2010




15.3.2010


Avonex


Biogen Idec Ltd
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom


EU/1/97/033/002-004


17.3.2010




15.3.2010


BeneFIX


Wyeth Europa Ltd.
Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom


EU/1/97/047/001-007


17.3.2010




15.3.2010


Biopoin


CT Arzneimittel GmbH
Lengeder Straße 42a, D-13407 Berlin, Deutschland


EU/1/09/565/001-028


17.3.2010




15.3.2010


Byetta


Eli Lilly Nederland B.V.
Grootslag 1-5, 3991 RA Houten, Nederland


EU/1/06/362/001-004


17.3.2010




15.3.2010


Carbaglu


Orphan Europe
Immeuble Le Wilson, 70 Avenue du General de Gaulle, 92800 Puteaux, France


EU/1/02/246/001-003


17.3.2010




15.3.2010


Cayston


GileadSciencesInternational Limited
Granta Park, Abington, Cambridge CB21 6GT, United Kingdom


EU/1/09/543/001


17.3.2010




15.3.2010


Clopidogrel DURA


Mylan dura GmbH
Wittichstraße 6, D-64295 Darmstadt, Deutschland


EU/1/09/560/001-009


17.3.2010




15.3.2010


Clopidogrel Hexal


Acino Pharma GmbH
Am Windfeld 35, Miesbach 83714, Deutschland


EU/1/09/534/001-007


17.3.2010




15.3.2010


Clopidogrel Teva Pharma


Teva Pharma B.V.
Computerweg 10, 3542 DR Utrecht, Nederland


EU/1/09/561/001-010


17.3.2010




15.3.2010


Copalia


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/06/372/001-036


17.3.2010




15.3.2010


Cubicin


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/05/328/001-002


17.3.2010




15.3.2010


Doribax


Janssen-Cilag International NV
Turnhoutseweg, 30 - 2340 Beerse - België


EU/1/08/467/001-002


17.3.2010




15.3.2010


Duloxetine Boehringer Ingelheim


Boehringer Ingelheim International GmbH
Binger Strasse 173 - D - 55216 Ingelheim am Rhein, Deutschland


EU/1/08/471/001-012


17.3.2010




15.3.2010


Dynastat


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


EU/1/02/209/001-008


17.3.2010




15.3.2010


Effentora


Cephalon Europe
5 Rue Charles Martigny, Maisons-Alfort 94700, France


EU/1/08/441/001-010


22.3.2010




15.3.2010


Elaprase


Shire Human Genetic Therapies AB
Svärdvägen 11D, 182 33 Danderyd, Sverige


EU/1/06/365/001-003


17.3.2010




15.3.2010


Eucreas


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/07/425/001-018


17.3.2010




15.3.2010


Evoltra


Genzyme Europe BV
Gooimeer 10, 1411 DD Naarden, Nederland


EU/1/06/334/001-005


17.3.2010




15.3.2010


Exjade


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/06/356/001-009


17.3.2010




15.3.2010


Faslodex


AstraZenecaUK Limited
Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom


EU/1/03/269/001


17.3.2010




15.3.2010


Firazyr


Jerini AG
Invalidenstr. 130, D-10115 Berlin, Deutschland


EU/1/08/461/001


17.3.2010




15.3.2010


GONAL-f


Merck Serono Europe Ltd.
56, Marsh Wall, London E14 9TP, United Kingdom


EU/1/95/001/001
EU/1/95/001/003-005
EU/1/95/001/009
EU/1/95/001/012
EU/1/95/001/021-022
EU/1/95/001/025-028
EU/1/95/001/031-035


17.3.2010




15.3.2010


Humira


Abbott Laboratories Limited
Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom


EU/1/03/256/001-010


17.3.2010




15.3.2010


Icandra


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/08/484/001-018


23.3.2010




15.3.2010


IntronA


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


EU/1/99/127/011-044


17.3.2010




15.3.2010


Invirase


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/96/026/001-002


17.3.2010




15.3.2010


Iscover


Bristol-MyersSquibbPharma EEIG
Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/98/070/012


17.3.2010




15.3.2010


Kepivance


BiovitrumAB (publ)
SE-112 76 Stockholm, Sverige


EU/1/05/314/001


17.3.2010




15.3.2010


Luveris


Merck Serono Europe Limited
56, Marsh Wall, London E14 9TP, United Kingdom


EU/1/00/155/001-007


17.3.2010




15.3.2010


Mircera


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/07/400/001-024


17.3.2010




15.3.2010


M-M-RVAXPRO


Sanofi Pasteur MSD, SNC
8, rue Jonas Salk, 69007 Lyon, France


EU/1/06/337/001-013


17.3.2010




15.3.2010


Mozobil


Genzyme Europe B.V.
Gooimeer 10, NL-1411 DD Naarden, Nederland


EU/1/09/537/001


19.3.2010




15.3.2010


Neupro


Schwarz Pharma Ltd
Shannon, Industrial Estate, Co. Clare, Ireland


EU/1/05/331/001-055


18.3.2010




15.3.2010


Nimvastid


KRKA, d.d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/09/525/047-050


17.3.2010




15.3.2010


Norvir


Abbott Laboratories Ltd
Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom


EU/1/96/016/001
EU/1/96/016/003-004


17.3.2010




15.3.2010


Ovitrelle


Merck Serono Europe Limited
56, Marsh Wall, London E14 9TP, United Kingdom


EU/1/00/165/001-007


17.3.2010




15.3.2010


Pergoveris


Merck Serono Europe Limited
56, Marsh Wall, London E14 9TP, United Kingdom


EU/1/07/396/001-003


17.3.2010




15.3.2010


Plavix


Sanofi Pharma Bristol-Myers Squibb SNC
174 avenue de France - 75013 Paris, France


EU/1/98/069/012


17.3.2010




15.3.2010


Prezista


Janssen-Cilag International NV
Turnhoutseweg, 30 - 2340 Beerse - België


EU/1/06/380/001-005


17.3.2010




15.3.2010


Rapamune


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


EU/1/01/171/007-010


17.3.2010




15.3.2010


Remicade


Centocor B.V.
Einsteinweg 101, 2333 CB Leiden, Nederland


EU/1/99/116/001-005


17.3.2010




15.3.2010


Removab


Fresenius Biotech GmbH
Am Haag 6-7, D-82166 Graefelfing, Deutschland


EU/1/09/512/001-002


17.3.2010




15.3.2010


Revlimid


Celgene Europe Limited
Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom


EU/1/07/391/001-004


17.3.2010




15.3.2010


Reyataz


Bristol-MyersSquibbPharma EEIG
Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/03/267/001-010


17.3.2010




15.3.2010


Sebivo


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/07/388/001-003


17.3.2010




15.3.2010


Sebivo


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/07/388/001-003


17.3.2010




15.3.2010


Stelara


Janssen-Cilag International NV
Turnhoutseweg, 30 - 2340 Beerse - België


EU/1/08/494/001-002


17.3.2010




15.3.2010


Sutent


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


EU/1/06/347/001-008


17.3.2010




15.3.2010


Tamiflu


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/02/222/001-004


17.3.2010




15.3.2010


Thalidomide Celgene


Celgene Europe Limited
Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom


EU/1/08/443/001


17.3.2010




15.3.2010


Twinrix Adult


GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89, Rixensart, B-1330 Belgique


EU/1/96/020/001-009


17.3.2010




15.3.2010


Valtropin


BioPartners GmbH
Kaiserpassage 11 - D-72764 Reutlingen, Deutschland


EU/1/06/335/001


17.3.2010




15.3.2010


Vaniqa


Laboratorios Almirall, S.A.
Ronda General Mitre, 151, 08022 Barcelona, España


EU/1/01/173/001-003


17.3.2010




15.3.2010


Vantavo (ex Alendronate sodium and colecalciferol, MSD)


Merck Sharp & Dohme Ltd.
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/09/572/001-009


17.3.2010




15.3.2010


Vectibix


Amgen Europe B.V.
Minervum 7061, NL-4817 ZK Breda, Nederland


EU/1/07/423/001-003


17.3.2010




15.3.2010


Viread


Gilead Sciences International Limited
Cambridge CB21 6GT United Kingdom


EU/1/01/200/001-002


18.3.2010




15.3.2010


Zomarist


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/08/483/001-018


17.3.2010




15.3.2010


Zylagren


KRKA, d. d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/09/558/001-010


17.3.2010




19.3.2010


Clopidogrel ratiopharm GmbH


Acino Pharma GmbH
Am Windfeld 35, 83714 Miesbach, Deutschland


EU/1/09/541/001-008


23.3.2010




19.3.2010


Copalia


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/06/372/001-036


23.3.2010




19.3.2010


Dafiro


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/06/371/001-036


23.3.2010




19.3.2010


Evoltra


Genzyme Europe BV
Gooimeer 10, 1411 DD Naarden, Nederland


EU/1/06/334/001-005


23.3.2010




19.3.2010


Kineret


BiovitrumAB (publ)
SE-112 76, Stockholm, Sverige


EU/1/02/203/001-003


23.3.2010




19.3.2010


Renvela


Genzyme Europe B.V.
Gooimeer 10, 1411 DD Naarden, Nederland


EU/1/09/521/001-007


23.3.2010




19.3.2010


Ventavis


Bayer Schering Pharma AG
Müllerstrasse 170-178, D-13342 Berlin, Deutschland


EU/1/03/255/001-008


23.3.2010




22.3.2010


Fuzeon


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/03/252/001-003


24.3.2010




23.3.2010


Abilify


Otsuka Pharmaceutical Europe Ltd
Hunton House, HighbridgeBusinessPark, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom


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


25.3.2010




23.3.2010


Aerius


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


EU/1/00/160/001-069


25.3.2010




23.3.2010


Aloxi


Helsinn Birex Pharmaceuticals Ltd
Damastown, Mulhuddart, Dublin 15, Republic of Ireland


EU/1/04/306/001


25.3.2010




23.3.2010


Aranesp


Amgen Europe B.V.
Minervum 7061, NL-4817 ZK Breda, Nederland


EU/1/01/185/001-022
EU/1/01/185/031-099


25.3.2010




23.3.2010


Axura


Merz Pharmaceuticals GmbH
Eckenheimer Landstr. 100, D-60318 Frankfurt/Main - Deutschland


EU/1/02/218/001-003
EU/1/02/218/007-010
EU/1/02/218/012-016
EU/1/02/218/023


25.3.2010




23.3.2010


Azomyr


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


EU/1/00/157/001-067


23.3.2010




23.3.2010


Cetrotide


SERONO EUROPE LIMITED
56, Marsh Wall, London E14 9TP, United Kingdom


EU/1/99/100/001-003


25.3.2010




23.3.2010


Cholestagel


Genzyme Europe B.V.
Gooimeer 10, NL-1411 DD Naarden, Nederland


EU/1/03/268/001-004


25.3.2010




23.3.2010


Clopidogrel Krka


KRKA, d. d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/09/556/001-011


25.3.2010




23.3.2010


Clopidogrel ratiopharm


Acino Pharma GmbH
Am Windfeld 35, 83714 Miesbach, Deutschland


EU/1/09/554/001-008


25.3.2010




23.3.2010


Clopidogrel Sandoz


Acino Pharma GmbH
Am Windfeld 35, 83714 Miesbach, Deutschland


EU/1/09/547/001-007


25.3.2010




23.3.2010


Clopidogrel TAD


TAD Pharma GmbH
Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland


EU/1/09/555/001-009


25.3.2010




23.3.2010


Clopidogrel Teva


Teva Pharma B.V.
Computerweg 10, 3542 DR Utrecht, Nederland


EU/1/09/540/001-016


25.3.2010




23.3.2010


Copalia HCT


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/09/575/001-060


25.3.2010




23.3.2010


Dafiro HCT


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/09/574/001-060


25.3.2010




23.3.2010


Enviage


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/07/406/001-020


25.3.2010




23.3.2010


Exelon


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/98/066/001-026


25.3.2010




23.3.2010


Exforge


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/06/370/001-036


25.3.2010




23.3.2010


Humira


Abbott Laboratories Limited
Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom


EU/1/03/256/001-010


25.3.2010




23.3.2010


IDflu


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


EU/1/08/507/001-006


25.3.2010




23.3.2010


Imprida


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/06/373/001-036


25.3.2010




23.3.2010


Ixiaro


Intercell AG
Campus Vienna Biocenter 3 A-1030 Wien, Österreich


EU/1/08/501/001-002


25.3.2010




23.3.2010


Mabthera


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/98/067/001-002


25.3.2010




23.3.2010


Mycophenolate mofetil Teva


Teva Pharma B.V.
Computerweg 10, DR Utrecht 3542, Nederland


EU/1/07/439/001-004


25.3.2010




23.3.2010


Myfenax


Teva Pharma B.V.
Computerweg 10, DR Utrecht 3542, Nederland


EU/1/07/438/001-004


23.3.2010




23.3.2010


Neoclarityn


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


EU/1/00/161/001-067


23.3.2010




23.3.2010


Norvir


Abbott Laboratories Ltd
Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom


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


25.3.2010




23.3.2010


Oslif Breezhaler


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom


EU/1/09/586/001-010


25.3.2010




23.3.2010


Prometax


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/98/092/001-026


25.3.2010




23.3.2010


Revlimid


Celgene Europe Limited
Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom


EU/1/07/391/001-004


25.3.2010




23.3.2010


Riprazo


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/07/409/001-020


25.3.2010




23.3.2010


Simponi


Centocor B.V.
Einsteinweg 101, 2333 CB Leiden, Nederland


EU/1/09/546/001-004


25.3.2010




23.3.2010


Sprimeo


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/07/407/001-020


25.3.2010




23.3.2010


Stalevo


Orion Corporation
Orionintie 1, FIN-02200 Espoo, Suomi


EU/1/03/260/001-033


25.3.2010




23.3.2010


Sutent


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


EU/1/06/347/001-008


25.3.2010




23.3.2010


Synagis


Abbott Laboratories Ltd
Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom


EU/1/99/117/001-002


23.3.2010




23.3.2010


Tandemact


Takeda Global Research and Development Centre (Europe) Ltd.
61 Aldwich, London WC2B 4AE, United Kingdom


EU/1/06/366/005-022


25.3.2010




23.3.2010


Tasigna


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/07/422/001-004


25.3.2010




23.3.2010


Thalidomide Celgene


Celgene Europe Limited
Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom


EU/1/08/443/001


25.3.2010




23.3.2010


Visudyne


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/00/140/001


25.3.2010




23.3.2010


Volibris


Glaxo Group Ltd
Greenford, Middlesex UB6 0NN, United Kingdom


EU/1/08/451/001-004


25.3.2010




23.3.2010


Xeloda


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/00/163/001-002


25.3.2010




26.3.2010


Adcirca


Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA, Houten, Nederland


EU/1/08/476/005-006


30.3.2010




26.3.2010


Avandamet


SmithKline Beecham Ltd.
980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom


EU/1/03/258/001-022


30.3.2010




26.3.2010


Avandia


SmithKline Beecham Ltd.
980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom


EU/1/00/137/002-018


30.3.2010




26.3.2010


Celsentri


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


EU/1/07/418/001-010


29.3.2010




26.3.2010


Celsentri


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


EU/1/07/418/001-010


29.3.2010




26.3.2010


Clopidogrel Qualimed


Qualimed
117, Allée des Parcs, 69800 Saint Priest, France


EU/1/09/557/001-010


30.3.2010




26.3.2010


Competact


Takeda Global Research and Development Centre (Europe) Ltd
61 Aldwych, London WC2B 4AE, United Kingdom


EU/1/06/354/001-009


30.3.2010




26.3.2010


Cubicin


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/05/328/001-002


30.3.2010




26.3.2010


Ebixa


H. Lundbeck A/S
Ottiliavej 9, DK-2500 Valby, Danmark


EU/1/02/219/001-003
EU/1/02/219/007-012
EU/1/02/219/014-022
EU/1/02/219/036


30.3.2010




26.3.2010


Exforge HCT


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/09/569/001-060


30.3.2010




26.3.2010


Galvus


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


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


30.3.2010




26.3.2010


Glivec


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/01/198/001-013


29.3.2010




26.3.2010


Glivec


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/01/198/001-013


29.3.2010




26.3.2010


Helixate NexGen


Bayer Schering Pharma AG
13342 Berlin, Deutschland


EU/1/00/144/001-004


30.3.2010




26.3.2010


Hirobriz Breezhaler


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom


EU/1/09/594/001-010


30.3.2010




26.3.2010


Ilaris


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/09/564/001-002


30.3.2010




26.3.2010


Imprida HCT


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/09/570/001-060


30.3.2010




26.3.2010


InductOs


Wyeth Europa Ltd.
Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom


EU/1/02/226/001


30.3.2010




26.3.2010


Intanza


Sanofi Pasteur MSD SNC
8, rue Jonas Salk, Lyon69007, France


EU/1/08/505/001-006


30.3.2010




26.3.2010


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


30.3.2010




26.3.2010


Invega


Janssen-Cilag International NV
Turnhoutseweg, 30 - 2340 Beerse - België


EU/1/07/395/001-095


29.3.2010




26.3.2010


Invirase


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/96/026/001-002


30.3.2010




26.3.2010


Isentress


Merck Sharp & Dohme Limited
Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom


EU/1/07/436/001-002


30.3.2010




26.3.2010


Ivemend


Merck Sharp & Dohme Limited
Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom


EU/1/07/437/001


30.3.2010




26.3.2010


Jalra


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/08/485/001-011


30.3.2010




26.3.2010


Kogenate Bayer


Bayer Schering Pharma AG
13342 Berlin, Deutschland


EU/1/00/143/001-011


30.3.2010




26.3.2010


Onbrez Breezhaler


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/09/593/001-010


30.3.2010




26.3.2010


Panretin


Eisai Limited
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom


EU/1/00/149/001


30.3.2010




26.3.2010


Rasilez HCT


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/08/491/001-080


30.3.2010




26.3.2010


Remicade


Centocor B.V.
Einsteinweg 101, 2333 CB Leiden, Nederland


EU/1/99/116/001-005


30.3.2010




26.3.2010


Sustiva


Bristol-MyersSquibbPharma EEIG
Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/99/110/001-005
EU/1/99/110/008-010


30.3.2010




26.3.2010


Temomedac


ALFRED E. TIEFENBACHER, (GmbH & Co. KG)
Van-der-Smissen-Straße 1, Hamburg 22767, Deutschland


EU/1/09/605/001-012


30.3.2010




26.3.2010


Tygacil


Wyeth Europa Ltd.
Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom


EU/1/06/336/001


29.3.2010




26.3.2010


Vistide


Gilead Sciences International Limited
Cambridge, CB21 6GT, United Kingdom


EU/1/97/037/001


30.3.2010




26.3.2010


Xagrid


ShirePharmaceuticalContracts Ltd
Hampshire InternationalBusinessPark, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom


EU/1/04/295/001


29.3.2010




26.3.2010


Xiliarx


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/08/486/001-011


30.3.2010




30.3.2010


Aclasta


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/05/308/001-002


1.4.2010




30.3.2010


Actos


Takeda Global Research and Development Centre (Europe) Ltd
61 Aldwych, London WC2B 4AE, United Kingdom


EU/1/00/150/001-024


1.4.2010




30.3.2010


Afinitor


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/09/538/001-008


1.4.2010




30.3.2010


Celvapan


Baxter AG
Industriestraße 67, A-1221 Wien, Österreich


EU/1/08/506/001


1.4.2010




30.3.2010


Clopidogrel Mylan


Mylan S.A.S
117 allée des Parcs, 69800 Saint Priest, France


EU/1/09/559/001-016


1.4.2010




30.3.2010


Evicel


OMRIX biopharmaceuticals S.A. / N.V.
200 Chaussée de Waterloo / Waterloosesteenweg 200, B-1640 Rhode-St-Genèse / B-1640 Sint-Genesius-Rode, Belgique / België


EU/1/08/473/001-003


1.4.2010




30.3.2010


Extavia


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/08/454/001-002
EU/1/08/454/005-007


1.4.2010




30.3.2010


Glubrava


Takeda Global Research and Development Centre (Europe) Ltd
61 Aldwych, London WC2B 4AE, United Kingdom


EU/1/07/421/001-009


1.4.2010




30.3.2010


Glustin


Takeda Global Research and Development Centre (Europe) Ltd
61 Aldwych, London WC2B 4AE, United Kingdom


EU/1/00/151/001-024


1.4.2010




30.3.2010


INCRELEX


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


EU/1/07/402/001


1.4.2010




30.3.2010


Intelence


Janssen-Cilag International NV
Turnhoutseweg, 30 - 2340 Beerse - België


EU/1/08/468/001


1.4.2010




30.3.2010


Kaletra


Abbott Laboratories Limited
Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom


EU/1/01/172/004-007


31.3.2010




30.3.2010


Levemir


Novo Nordisk A/S
Novo Allé, DK-2880 Bagsvaerd, Danmark


EU/1/04/278/010-011


6.4.2010




30.3.2010


Lucentis


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/06/374/001


1.4.2010




30.3.2010


Rasilez


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/07/405/001-040


31.3.2010




30.3.2010


RoActemra


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/08/492/001-006


1.4.2010




30.3.2010


Rotarix


GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89, Rixensart, B-1330 Belgique


EU/1/05/330/001-011


1.4.2010




30.3.2010


RotaTeq


Sanofi Pasteur MSD, SNC
8, rue Jonas Salk, Lyon 69007, France


EU/1/06/348/001-002


1.4.2010




30.3.2010


Xolair


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/05/319/001-010


31.3.2010




6.4.2010


Retacrit


HOSPIRA Enterprises B.V.
Taurusavenue 19-21, 2132 LS HOOFDDORP, Nederland


EU/1/07/431/001-025


14.4.2010




6.4.2010


Silapo


STADA Arzneimittel AG
Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland


EU/1/07/432/001-022


9.4.2010




9.4.2010


Avaglim


SmithKline Beecham Ltd.
980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom


EU/1/06/349/001-010


13.4.2010




9.4.2010


Ketek


Aventis Pharma S.A.
20 avenue Raymond Aron, F-92160 Antony, France


EU/1/01/191/001-005


13.4.2010




9.4.2010


Viread


Gilead Sciences International Limited
Cambridge CB21 6GT United Kingdom


EU/1/01/200/001-002


13.4.2010




15.4.2010


Firdapse


EUSA Pharma SAS
3 Allée des Séquoias, Limonest 69760, FRANCE


EU/1/09/601/001


20.4.2010




19.4.2010


Ifirmasta


KRKA, d.d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/08/480/001-018


23.4.2010




22.4.2010


Sildenafil Teva


Teva Pharma B.V.
Computerweg 10, 3542 DR Utrecht, Nederland


EU/1/09/584/001-018


26.4.2010




22.4.2010


Tracleer


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


EU/1/02/220/001-006


26.4.2010




27.4.2010


Afinitor


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/09/538/001-008


29.4.2010




27.4.2010


Aldara


Meda AB
Pipers väg 2A, Solna 170 73, Svërige


EU/1/98/080/001-002


29.4.2010




27.4.2010


Aldurazyme


Genzyme Europe B.V.
Gooimeer 10, NL-1411 DD Naarden, Nederland


EU/1/03/253/001-003


29.4.2010




27.4.2010


Altargo


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


EU/1/07/390/001-004


29.4.2010




27.4.2010


Bridion


N.V. Organon
Kloosterstraat 6, 5349 AB Oss, Nederland


EU/1/08/466/001-002


29.4.2010




27.4.2010


Doribax


Janssen-Cilag International NV
Turnhoutseweg, 30 - 2340 Beerse - België


EU/1/08/467/001-002


29.4.2010




27.4.2010


Exelon


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/98/066/001-026


29.4.2010




27.4.2010


Focetria


Novartis Vaccines and Diagnostics S.r.l.
Via Fiorentina, 1 - Siena, Italia


EU/1/07/385/001-002
EU/1/07/385/004


29.4.2010




27.4.2010


Fuzeon


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/03/252/001-003


29.4.2010




27.4.2010


Kinzalkomb


Bayer Schering Pharma AG
D-13342 Berlin, Deutschland


EU/1/02/214/001-015


29.4.2010




27.4.2010


MicardisPlus


Boehringer Ingelheim International GmbH
Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland


EU/1/02/213/001-023


3.5.2010




27.4.2010


Remicade


Centocor B.V.
Einsteinweg 101, 2333 CB Leiden, Nederland


EU/1/99/116/001-005


29.4.2010




27.4.2010


RoActemra


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/08/492/001-006


29.4.2010




27.4.2010


Tamiflu


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/02/222/001-004


29.4.2010




27.4.2010


Tarceva


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/05/311/001-003


29.4.2010




27.4.2010


Taxotere


Aventis Pharma S.A.
20 avenue Raymond Aron, F-92165 Antony Cedex, France


EU/1/95/002/001-005


29.4.2010




27.4.2010


Tyverb


Glaxo Group Limited
Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom


EU/1/07/440/001-002


29.4.2010




27.4.2010


Velcade


Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België


EU/1/04/274/001-002


29.4.2010




27.4.2010


Vimpat


UCB Pharma SA.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België


EU/1/08/470/014-015


29.4.2010




29.4.2010


Aclasta


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/05/308/001-002


3.5.2010




29.4.2010


Arava


Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main, Deutschland


EU/1/99/118/001-010


3.5.2010




29.4.2010


Ceplene


EpiCept GmbH
Goethestrasse 4, D-80336 München, Deutschland


EU/1/08/477/001


3.5.2010




29.4.2010


Clopidogrel Winthrop


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


EU/1/08/465/001-020


3.5.2010




29.4.2010


Epivir


Glaxo Group Ltd.
Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom


EU/1/96/015/001-005


4.5.2010




29.4.2010


Focetria


Novartis Vaccines and Diagnostics S.r.l.
Via Fiorentina, 1 - Siena, Italia


EU/1/07/385/001-002
EU/1/07/385/004


3.5.2010




29.4.2010


Humira


Abbott Laboratories Limited
Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom


EU/1/03/256/001-010


4.5.2010




29.4.2010


Insulatard


Novo Nordisk A/S
Novo Allé, DK-2880 Bagsvaerd, Danmark


EU/1/02/233/001-017


3.5.2010




29.4.2010


Intelence


Janssen-Cilag International NV
Turnhoutseweg, 30 - 2340 Beerse - België


EU/1/08/468/001


3.5.2010




29.4.2010


Iscover


Bristol-MyersSquibbPharma EEIG
Uxbridge BusinessPark, 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


4.5.2010




29.4.2010


Kepivance


BiovitrumAB (publ)
SE-112 76 Stockholm, Sverige


EU/1/05/314/001


3.5.2010




29.4.2010


Lyrica


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


EU/1/04/279/001-043


4.5.2010




29.4.2010


Mircera


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/07/400/001-024


4.5.2010




29.4.2010


NeoRecormon


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/97/031/019-046


4.5.2010




29.4.2010


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


3.5.2010




29.4.2010


PritorPlus


Bayer Schering Pharma AG
13342 Berlin, Deutschland


EU/1/02/215/001-021


3.5.2010




29.4.2010


Prometax


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/98/092/001-026


4.5.2010




29.4.2010


Protaphane


Novo Nordisk A/S
Novo Allé, DK-2880 Bagsvaerd, Danmark


EU/1/02/234/001-017


3.5.2010




29.4.2010


Tygacil


Wyeth Europa Ltd.
Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom


EU/1/06/336/001


3.5.2010




29.4.2010


Tyverb


Glaxo Group Limited
Berkeley Avenue, Greenford, MiddlesexUB6 0NN, United Kingdom


EU/1/07/440/001-002


3.5.2010




29.4.2010


Vectibix


Amgen Europe B.V.
Minervum 7061, NL-4817 ZK Breda, Nederland


EU/1/07/423/001-003


3.5.2010




5.5.2010


Aloxi


Helsinn Birex Pharmaceuticals Ltd
Damastown, Mulhuddart, Dublin 15, Republic of Ireland


EU/1/04/306/001-003


7.5.2010




5.5.2010


BeneFIX


Wyeth Europa Ltd.
Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom


EU/1/97/047/001-007


7.5.2010




5.5.2010


Bondenza


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/03/266/003-006


7.5.2010




5.5.2010


Bonviva


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/03/265/003-006


7.5.2010




5.5.2010


Celsentri


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


EU/1/07/418/001-010


7.5.2010




5.5.2010


Docetaxel Winthrop


Aventis Pharma S.A.
20 avenue Raymond Aron, F-92165 Antony Cedex, France


EU/1/07/384/001-005


7.5.2010




5.5.2010


Enbrel


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


EU/1/99/126/001-021


7.5.2010




5.5.2010


Kiovig


Baxter AG
Industriestraße 67, A - 1221 Wien, Österreich


EU/1/05/329/001-006


7.5.2010




5.5.2010


Lantus


Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main, Deutschland


EU/1/00/134/001-037


7.5.2010




5.5.2010


Optisulin


Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main, Deutschland


EU/1/00/133/001-032


7.5.2010




5.5.2010


PegIntron


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


EU/1/00/131/001-050


7.5.2010




5.5.2010


Silgard


Merck Sharp & Dohme Ltd
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/06/358/001-021


7.5.2010




5.5.2010


Sprycel


Bristol-MyersSquibbPharma EEIG
Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/06/363/001-011


7.5.2010




5.5.2010


Tyverb


Glaxo Group Limited
Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom


EU/1/07/440/001-003


7.5.2010




5.5.2010


ViraferonPeg


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


EU/1/00/132/001-050


7.5.2010




5.5.2010


Visudyne


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/00/140/001


7.5.2010




10.5.2010


Atripla


Bristol-Myers Squibb and Gilead Sciences Limited
IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland


EU/1/07/430/001-002


12.5.2010




10.5.2010


Combivir


Glaxo Group Ltd.
Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom


EU/1/98/058/001-002


12.5.2010




10.5.2010


Infanrix hexa


GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89, Rixensart, B-1330 Belgique


EU/1/00/152/001-020


12.5.2010




10.5.2010


Optimark


Covidien Deutschland GmbH
Gewerbepark 1, Neustadt/Donau 93333, Deutschland


EU/1/07/398/001-014


12.5.2010




10.5.2010


Orgalutran


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


EU/1/00/130/001-002


12.5.2010




10.5.2010


Ranexa


Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg


EU/1/08/462/001-012


12.5.2010




10.5.2010


Tysabri


Elan Pharma International Ltd.
Monksland, Athlone, County Westmeath, Ireland


EU/1/06/346/001


12.5.2010




10.5.2010


Xeristar


Boehringer Ingelheim International GmbH
Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland


EU/1/04/297/001-008


12.5.2010




10.5.2010


Ziagen


Glaxo Group Ltd.
Greenford Road, Greenford, Middlesex UB6 0NN United Kingdom


EU/1/99/112/001-002


12.5.2010




12.5.2010


Aclasta


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/05/308/001-002


18.5.2010




12.5.2010


Gardasil


Sanofi Pasteur MSD, SNC
8, rue Jonas Salk, 69007 Lyon, France


EU/1/06/357/001-021


18.5.2010




12.5.2010


Kuvan


Merck KGaA
Frankfurter Straße 250, 64293 Darmstadt, Deutschland


EU/1/08/481/001-003


18.5.2010




12.5.2010


Olazax


GlenmarkPharmaceuticals s.r.o.
City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika


EU/1/09/597/001-005


18.5.2010




26.5.2010


Avandia


SmithKline Beecham Ltd.
980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom


EU/1/00/137/002-018


28.5.2010




26.5.2010


Cyanokit


Merck Santé s.a.s.
37, rue Saint-Romain, 69379 Lyon Cedex 08, France


EU/1/07/420/001


28.5.2010




26.5.2010


Kivexa


Glaxo Group Ltd
Greenford, Middlesex UB6 0NN, United Kingdom


EU/1/04/298/001-003


28.5.2010




26.5.2010


Myocet


Cephalon Europe
5 Rue Charles Martigny, Maisons Alfort 94700, France


EU/1/00/141/001


28.5.2010




26.5.2010


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


1.6.2010




26.5.2010


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


1.6.2010




26.5.2010


Olazax Disperzi


GlenmarkPharmaceuticals s.r.o.
City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika


EU/1/09/592/001-005


28.5.2010




26.5.2010


Prevenar


Wyeth-Lederle Vaccines S.A.
Rue du Bosquet, 15 - 1348 Louvain-La-Neuve, Belgique


EU/1/00/167/001-008


28.5.2010




26.5.2010


Telzir


Glaxo Group Ltd.
Greenford Road, Greenford, Middlesex UB6 0NN United Kingdom


EU/1/04/282/001-002


28.5.2010




26.5.2010


Trizivir


Glaxo Group Ltd.
Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom


EU/1/00/156/002-004


28.5.2010




26.5.2010


Xagrid


ShirePharmaceuticalContracts Ltd
Hampshire InternationalBusinessPark, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom


EU/1/04/295/001


28.5.2010




2.6.2010


Abraxane


Abraxis BioScience Limited
Rosanne House, Parkway, WelwynGarden City, Herts, AL8 6HG, United Kingdom


EU/1/07/428/001


4.6.2010




2.6.2010


Avastin


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/04/300/001-002


7.6.2010




2.6.2010


Bridion


N.V. Organon
Kloosterstraat 6, 5349 AB Oss, Nederland


EU/1/08/466/001-002


4.6.2010




2.6.2010


Celsentri


Pfizer Limited
Ramsgate Road, Sandwich, KentCT13 9NJ, United Kingdom


EU/1/07/418/001-010


4.6.2010




2.6.2010


Cervarix


GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89, 1330 Rixensart, Belgique


EU/1/07/419/001-012


4.6.2010




2.6.2010


Circadin


RAD Neurim Pharmaceuticals EEC Limited
One Forbury Square, The Forbury, Reading, BerkshireRG1 3EB, United Kingdom


EU/1/07/392/001-002


7.6.2010




2.6.2010


Erbitux


Merck KGaA
Frankfurter Straße 250, 64271 Darmstadt, Deutschland


EU/1/04/281/001-005


7.6.2010




2.6.2010


Fertavid


SP Europe
Rue de Stalle, 73 B-1180 Bruxelles, Belgique


EU/1/09/510/001-019


4.6.2010




2.6.2010


Humira


Abbott Laboratories Limited
Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom


EU/1/03/256/001-010


7.6.2010




2.6.2010


Intrinsa


Warner Chilcott Pharmaceuticals UK Ltd
Whitehall Lane, Egham, SurreyTW20 9NW, United Kingdom


EU/1/06/352/001-003


4.6.2010




2.6.2010


Prezista


Janssen-Cilag International NV
Turnhoutseweg, 30 - 2340 Beerse - België


EU/1/06/380/001-005


4.6.2010




2.6.2010


Rasilez


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/07/405/001-040


4.6.2010




2.6.2010


Rebif


Merck Serono Europe Limited
56, Marsh Wall, London E14 9TP, United Kingdom


EU/1/98/063/001-017


4.6.2010




2.6.2010


Renagel


Genzyme Europe B.V.
Gooimeer 10, NL-1411 DD Naarden, Nederland


EU/1/99/123/005-013


7.6.2010




2.6.2010


Stalevo


Orion Corporation
Orionintie 1, FIN-02200 Espoo, Suomi


EU/1/03/260/001-033


4.6.2010




2.6.2010


Velcade


Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België


EU/1/04/274/001-002


4.6.2010




2.6.2010


Vimpat


UCB Pharma SA.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België


EU/1/08/470/001-017


7.6.2010




2.6.2010


Zavesca


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


EU/1/02/238/001


4.6.2010




4.6.2010


DepoCyte


Pacira Limited
West Forest Gate, Wellington Road, Wokingham, Berkshire, RG40 2AQ, United Kingdom


EU/1/01/187/001


8.6.2010




4.6.2010


Metalyse


Boehringer Ingelheim International GmbH
Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland


EU/1/00/169/004-006


8.6.2010




4.6.2010


Mircera


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/07/400/001-024


8.6.2010




4.6.2010


Nymusa


CHIESI FARMACEUTICI SpA
Via Palermo 26/A, I-43100 Parma, ITALIA


EU/1/09/528/001-002


8.6.2010




4.6.2010


Rasilez HCT


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/08/491/001-080


8.6.2010




4.6.2010


RoActemra


Roche Registration Limited
6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/08/492/001-006


8.6.2010




4.6.2010


Toviaz


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


EU/1/07/386/001-018


8.6.2010




4.6.2010


Zerit


Bristol-MyersSquibbPharma EEIG
Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/96/009/001-009


8.6.2010




8.6.2010


Lyrica


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


EU/1/04/279/001-044


10.6.2010




10.6.2010


Comtan


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/98/081/001-004


14.6.2010




10.6.2010


Comtess


Orion Corporation
Orionintie 1, FIN-02200 Espoo, Suomi


EU/1/98/082/001-003
EU/1/98/082/005


14.6.2010




10.6.2010


ellaOne


Laboratoire HRA Pharma
15, rue Béranger, 75003 Paris, France


EU/1/09/522/001


14.6.2010




10.6.2010


Mirapexin


Boehringer Ingelheim International GmbH
Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland


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


15.6.2010




10.6.2010


Opgenra


Howmedica International S. de R. L.
Raheen Business Park, Limerick, Ireland


EU/1/08/489/001-002


15.6.2010




10.6.2010


Pergoveris


Merck Serono Europe Limited
56, Marsh Wall, London E14 9TP, United Kingdom


EU/1/07/396/001-003


14.6.2010




10.6.2010


Vasovist


TMC Pharma Services Ltd
Eversley, Hampshire, RG27 0NT, United Kingdom


EU/1/05/313/001-009


14.6.2010




14.6.2010


Lyrica


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


EU/1/04/279/001-044


16.6.2010




14.6.2010


Sifrol


Boehringer Ingelheim International GmbH
Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland


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


17.6.2010




17.6.2010


ATryn


GTC Biotherapeutics UK Limited
10 Norwich Street, London EC4A 1BD, United Kingdom


EU/1/06/355/001-003


21.6.2010




17.6.2010


Luveris


Merck Serono Europe Limited
56, Marsh Wall, London E14 9TP, United Kingdom


EU/1/00/155/001-007


21.6.2010




17.6.2010


Mirapexin


Boehringer Ingelheim International GmbH
Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland


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


21.6.2010




17.6.2010


Onsenal


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


EU/1/03/259/001-006


21.6.2010




17.6.2010


Tyverb


Glaxo Group Limited
Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom


EU/1/07/440/001-003


21.6.2010




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









Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




29.4.2010


Agenerase


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


EU/1/00/148/001-004


5.5.2010




26.5.2010


Duloxetine Boehringer Ingelheim


Boehringer Ingelheim International GmbH
Binger Strasse 173 - D-55216 Ingelheim am Rhein, Deutschland


EU/1/08/471/003-005
EU/1/08/471/011-012


28.5.2010




—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted









Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




15.3.2010


Aivlosin


ECO Animal Health Ltd
78 Coombe Road New Malden Surrey KT3 4QS United Kingdom


EU/2/04/044/001-002


17.3.2010




15.3.2010


Draxxin


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


EU/2/03/041/004


17.3.2010




15.3.2010


Incurin


Intervet International B.V.
Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland


EU/2/00/018/001


17.3.2010




15.3.2010


Masivet


AB Science S.A.
3 avenue George V, 75008 Paris, France


EU/2/08/087/001-002


17.3.2010




15.3.2010


Meloxivet


Janssen Pharmaceutica N.V.
Turnhoutseweg 30, B-2340 Beerse, België


EU/2/07/077/001-005


17.3.2010




15.3.2010


SevoFlo


Abbott Laboratories Limited
Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM


EU/2/02/035/007


17.3.2010




16.3.2010


Rabigen SAG2


VIRBAC S.A.
1ère Avenue 2065 m L.I.D. - 06516 Carros - France


EU/2/00/021/001-002


19.3.2010




22.3.2010


Purevax FeLV


Merial
29 Avenue Tony Garnier, 69007 Lyon, France


EU/2/00/019/005-007


24.3.2010




23.3.2010


Ibraxion


Merial
29 Avenue Tony Garnier, 69007 Lyon, France


EU/2/99/017/001-006


23.3.2010




23.3.2010


Loxicom


Norbrook Laboratories Limited
Station Works, Newry, Co. Down, BT35 6JP, United Kindgom


EU/2/08/090/001-009


25.3.2010




26.3.2010


Meloxidyl


CEVA SANTE ANIMALE
10 avenue de la Ballastière, 33500 Libourne, France


EU/2/06/070/001-007


30.3.2010




30.3.2010


Acticam


Omnipharm Ltd
Suite 3, 24 High Street, Ruddington, Nottingham, NG11 6EA, United Kingdom


EU/2/08/088/001-004


1.4.2010




9.4.2010


Slentrol


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


EU/2/07/071/001-003


13.4.2010




27.4.2010


Vaxxitek HVT+ IBD


Merial
29 Avenue Tony Garnier, 69007 Lyon, France


EU/2/02/032/001-002


29.4.2010




29.4.2010


Trocoxil


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


EU/2/08/084/001-005


4.5.2010




26.5.2010


Ibaflin


Intervet International B.V.
Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland


EU/2/00/022/001a-001b
EU/2/00/022/002a-002b
EU/2/00/022/003a-003b
EU/2/00/022/004a-004b
EU/2/00/022/005-017


28.5.2010




26.5.2010


Naxcel


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


EU/2/05/053/001-003


28.5.2010




2.6.2010


Metacam


Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim am Rhein, Deutschland


EU/2/97/004/026
EU/2/97/004/033-034


4.6.2010




10.6.2010


Flexicam


Dechra Veterinary Products A/S
Mekuvej 9, 7171 Uldum, Danmark


EU/2/06/058/001-004


14.6.2010




—   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




14.6.2010


Pruban


Intervet International B.V.
Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland


EU/2/00/024/001


16.6.2010




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
The European Medicines Agency
7, Westferry Circus, Canary Wharf
UK - LONDON E14 4H


(1)  OJ L 136, 30.4.2004, p. 1.