Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2010 to 31 August 2010 ( Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2010-10-29
Institutions: European Commission
Subjects: European Medicines Agency, drug surveillance, market approval, marketing, medicinal product, pharmaceutical industry, veterinary drug








C_2010295EN.01000101.xml










29.10.2010   


EN


Official Journal of the European Union


C 295/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2010 to 31 August 2010
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
 (1))
2010/C 295/01
—   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




5.7.2010


Daxas


roflumilast


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


EU/1/10/636/001-003


Film-coated tablet


R03DX07


8.7.2010




27.7.2010


Leflunomide medac


leflunomide


medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg - Deutschland


EU/1/10/637/001-009


Film-coated tablet


L04AA13


30.7.2010




27.7.2010


Ozurdex


dexamethasone


Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland


EU/1/10/638/001


Intravitreal implant in applicator


S01BA01


1.8.2010




26.8.2010


VPRIV


Velaglucerase alfa


Shire Pharmaceuticals Ireland Limited 5 Riverside Walk, Citywest Business Campus, Dublin 24, Ireland


EU/1/10/646/001-002


Powder for solution for infusion


A16AB10


30.8.2010




31.8.2010


PecFent


Fentanyl


Archimedes Development Ltd Nottingham, NGT7 2TN, United Kingdom


EU/1/10/644/001-004


Nasal spray, solution


N02AB03


6.9.2010







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










Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




1.7.2010


Enbrel


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


EU/1/99/126/001-021


6.7.2010




1.7.2010


Humira


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


EU/1/03/256/001-010


5.7.2010




1.7.2010


Invega


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


EU/1/07/395/001-095


6.7.2010




1.7.2010


Kiovig


Baxter AG Industriestraße 67, A - 1221 Wien, Österreich


EU/1/05/329/001-006


5.7.2010




1.7.2010


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


5.7.2010




1.7.2010


Orencia


Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/07/389/001-003


5.7.2010




1.7.2010


Pradaxa


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


EU/1/08/442/001-008


5.7.2010




1.7.2010


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


5.7.2010




1.7.2010


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


5.7.2010




1.7.2010


Sutent


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


EU/1/06/347/001-008


5.7.2010




1.7.2010


TachoSil


Nycomed Austria GmbH St.-Peter-Strasse 25, A-4020 Linz, Österreich


EU/1/04/277/001-004


5.7.2010




1.7.2010


Tarceva


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


EU/1/05/311/001-003


5.7.2010




1.7.2010


Taxotere


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


EU/1/95/002/001-005


5.7.2010




1.7.2010


Tygacil


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


EU/1/06/336/001


6.7.2010




1.7.2010


Viagra


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


EU/1/98/077/002-004
EU/1/98/077/006-008
EU/1/98/077/010-019


5.7.2010




2.7.2010


ellaOne


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


EU/1/09/522/001


6.7.2010




2.7.2010


Eucreas


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


EU/1/07/425/001-018


7.7.2010




2.7.2010


Galvus


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


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


7.7.2010




2.7.2010


Intelence


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


EU/1/08/468/001


7.7.2010




2.7.2010


Jalra


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


EU/1/08/485/001-011


7.7.2010




2.7.2010


Myocet


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


EU/1/00/141/001


7.7.2010




2.7.2010


NovoMix


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


EU/1/00/142/004-005
EU/1/00/142/009-022


7.7.2010




2.7.2010


Onglyza


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


EU/1/09/545/001-010


7.7.2010




2.7.2010


Pegasys


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


EU/1/02/221/001-010


7.7.2010




2.7.2010


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


8.7.2010




2.7.2010


Tamiflu


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


EU/1/02/222/001-004


7.7.2010




2.7.2010


Tarceva


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


EU/1/05/311/001-003


7.7.2010




2.7.2010


Torisel


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


EU/1/07/424/001


7.7.2010




2.7.2010


Velcade


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


EU/1/04/274/001-002


6.7.2010




2.7.2010


Xiliarx


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


EU/1/08/486/001-011


7.7.2010




2.7.2010


Xyrem


UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom


EU/1/05/312/001


6.7.2010




2.7.2010


Zeffix


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


EU/1/99/114/001-003


8.7.2010




2.7.2010


Zyllt


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


EU/1/09/553/001-010


7.7.2010




5.7.2010


Celvapan


Baxter AG Industriestraße 67, A - 1221 Wien, Österreich


EU/1/08/506/001


8.7.2010




5.7.2010


Ferriprox


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


EU/1/99/108/001-003


8.7.2010




5.7.2010


Icandra


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


EU/1/08/484/001-018


8.7.2010




5.7.2010


Rebetol


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


EU/1/99/107/001-005


13.7.2010




5.7.2010


Relistor


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


EU/1/08/463/001-003


8.7.2010




5.7.2010


Reyataz


Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/03/267/001-010


8.7.2010




5.7.2010


Thelin


Encysive (UK) Limited Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom


EU/1/06/353/001-005


8.7.2010




5.7.2010


Zomarist


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


EU/1/08/483/001-018


8.7.2010




6.7.2010


Avastin


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


EU/1/04/300/001-002


8.7.2010




6.7.2010


Docetaxel Winthrop


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


EU/1/07/384/001-005


8.7.2010




6.7.2010


Keppra


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


EU/1/00/146/001-032


9.7.2010




6.7.2010


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


12.7.2010




6.7.2010


Savene


TopoTarget A/S Fruebjergvej 3, Copenhagen 2100, Danmark


EU/1/06/350/001


12.7.2010




7.7.2010


ReFacto AF


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


EU/1/99/103/001-004


12.7.2010




13.7.2010


BeneFIX


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


EU/1/97/047/001-007


15.7.2010




13.7.2010


Kepivance


Biovitrum AB (publ) SE-112 76 Stockholm, Sverige


EU/1/05/314/001


15.7.2010




22.7.2010


Thelin


Encysive (UK) Limited Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom


EU/1/06/353/001-005


26.7.2010




27.7.2010


Baraclude


Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/06/343/001-007


29.7.2010




27.7.2010


Conbriza


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


EU/1/09/511/001-004


29.7.2010




27.7.2010


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


30.7.2010




27.7.2010


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


29.7.2010




27.7.2010


MicardisPlus


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


EU/1/02/213/013-016
EU/1/02/213/020
EU/1/02/213/022


29.7.2010




27.7.2010


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


29.7.2010




27.7.2010


Ribavirin Teva


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


EU/1/09/509/001-004


30.7.2010




27.7.2010


Ribavirin Teva Pharma BV


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


EU/1/09/527/001-016


31.7.2010




27.7.2010


Zonegran


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


EU/1/04/307/001-021


29.7.2010




28.7.2010


Aranesp


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


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


2.8.2010




28.7.2010


DaTSCAN


GE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United Kingdom


EU/1/00/135/001-002


2.8.2010




28.7.2010


DuoCover


Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/10/623/001-015


30.7.2010




28.7.2010


Dynastat


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


EU/1/02/209/001-008


2.8.2010




28.7.2010


Erbitux


Merck KGaA Frankfurter Straße 250, 64271 Darmstadt, Deutschland


EU/1/04/281/001-005


2.8.2010




28.7.2010


Fendrix


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


EU/1/04/299/001-003


2.8.2010




28.7.2010


Ferriprox


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


EU/1/99/108/001-006


30.7.2010




28.7.2010


Helixate NexGen


Bayer Schering Pharma AG 13342 Berlin, Deutschland


EU/1/00/144/001-004


30.7.2010




28.7.2010


Herceptin


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


EU/1/00/145/001


30.7.2010




28.7.2010


Increlex


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


EU/1/07/402/001


2.8.2010




28.7.2010


Invanz


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


EU/1/02/216/001-002


2.8.2010




28.7.2010


Invirase


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


EU/1/96/026/001-002


2.8.2010




28.7.2010


Kaletra


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


EU/1/01/172/001-007


2.8.2010




28.7.2010


Kivexa


ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom


EU/1/04/298/001-003


2.8.2010




28.7.2010


Kogenate Bayer


Bayer Schering Pharma AG 13342 Berlin, Deutschland


EU/1/00/143/001-011


30.7.2010




28.7.2010


Onsenal


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


EU/1/03/259/001-006


30.7.2010




28.7.2010


Prevenar 13


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


EU/1/09/590/001-006


3.8.2010




28.7.2010


Simponi


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


EU/1/09/546/001-004


2.8.2010




28.7.2010


Sprycel


Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/06/363/001-011


2.8.2010




28.7.2010


Tyverb


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


EU/1/07/440/001-003


2.8.2010




6.8.2010


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


12.8.2010




6.8.2010


Arava


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


EU/1/99/118/001-010


10.8.2010




6.8.2010


Byetta


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


EU/1/06/362/001-004


10.8.2010




6.8.2010


Cervarix


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


EU/1/07/419/001-012


10.8.2010




6.8.2010


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


12.8.2010




6.8.2010


DuoPlavin


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


EU/1/10/619/001-015


11.8.2010




6.8.2010


Efficib


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


EU/1/08/457/001-016


11.8.2010




6.8.2010


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


11.8.2010




6.8.2010


Ferriprox


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


EU/1/99/108/001-006


10.8.2010




6.8.2010


Grepid


Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα


EU/1/09/535/001-016


10.8.2010




6.8.2010


Herceptin


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


EU/1/00/145/001


12.8.2010




6.8.2010


Janumet


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


EU/1/08/455/001-016


11.8.2010




6.8.2010


Januvia


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


EU/1/07/383/001-018


12.8.2010




6.8.2010


Karvea


Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/97/049/001-039


10.8.2010




6.8.2010


Karvezide


Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/98/085/001-034


10.8.2010




6.8.2010


Mepact


IDM PHARMA SAS 11-15 Quai De Dion Bouton, 92816 Puteaux Cedex, France


EU/1/08/502/001


13.8.2010




6.8.2010


Mycamine


Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland


EU/1/08/448/001-002


10.8.2010




6.8.2010


Naglazyme


BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom


EU/1/05/324/001-002


10.8.2010




6.8.2010


Olanzapine Mylan


Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom


EU/1/08/475/001-034


10.8.2010




6.8.2010


Rebif


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


EU/1/98/063/001-017


10.8.2010




6.8.2010


Ristaben


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


EU/1/10/621/001-018


11.8.2010




6.8.2010


Ristfor


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


EU/1/10/620/001-016


11.8.2010




6.8.2010


RotaTeq


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


EU/1/06/348/001-002


10.8.2010




6.8.2010


Sildenafil ratiopharm


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


EU/1/09/603/001-015


11.8.2010




6.8.2010


Suboxone


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


EU/1/06/359/001-004


10.8.2010




6.8.2010


Sustiva


Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


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


10.8.2010




6.8.2010


Velmetia


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


EU/1/08/456/001-016


11.8.2010




6.8.2010


Xelevia


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


EU/1/07/382/001-018


10.8.2010




10.8.2010


Trisenox


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


EU/1/02/204/001


12.8.2010




12.8.2010


Celvapan


Baxter AG Industriestraße 67, A - 1221 Wien, Österreich


EU/1/08/506/001


13.8.2010




12.8.2010


Focetria


Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia


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


13.8.2010




12.8.2010


Pandemrix


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


EU/1/08/452/001


13.8.2010




16.8.2010


Fosavance


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


EU/1/05/310/001-009


18.8.2010




18.8.2010


alli


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


EU/1/07/401/007-011


24.8.2010




18.8.2010


Binocrit


Sandoz GmbH Biochemiestrasse 10, Kundl 6250, Österreich


EU/1/07/410/001-026


20.8.2010




18.8.2010


Epoetin alfa Hexal


Hexal AG. Industriestrasse 25, D-83607 Holzkirchen, Deutschland


EU/1/07/411/001-026


20.8.2010




18.8.2010


Gardasil


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


EU/1/06/357/001-021


20.8.2010




18.8.2010


IDflu


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


EU/1/08/507/001-006


20.8.2010




18.8.2010


Insulin Human Winthrop


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


EU/1/06/368/001-168


20.8.2010




18.8.2010


Intanza


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


EU/1/08/505/001-006


20.8.2010




18.8.2010


Leflunomide Winthrop


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


EU/1/09/604/001-010


20.8.2010




18.8.2010


Neupro


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


EU/1/05/331/001-055


20.8.2010




18.8.2010


Tesavel


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


EU/1/07/435/001-018


20.8.2010




23.8.2010


Aprovel


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


EU/1/97/046/001-039


24.8.2010




23.8.2010


CoAprovel


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


EU/1/98/086/001-034


24.8.2010




23.8.2010


Silgard


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


EU/1/06/358/001-021


25.8.2010




26.8.2010


Baraclude


Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/06/343/001-007


31.8.2010




26.8.2010


Cayston


Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom


EU/1/09/543/001-002


31.8.2010




26.8.2010


Cerezyme


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


EU/1/97/053/001-005


30.8.2010




26.8.2010


Cimzia


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


EU/1/09/544/001-002


30.8.2010




26.8.2010


Cubicin


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


EU/1/05/328/001-004


31.8.2010




26.8.2010


Docetaxel Teva


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


EU/1/09/611/001-002


31.8.2010




26.8.2010


Elonva


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


EU/1/09/609/001-002


30.8.2010




26.8.2010


Emtriva


Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom


EU/1/03/261/001-003


31.8.2010




26.8.2010


Hirobriz Breezhaler


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


EU/1/09/594/001-010


31.8.2010




26.8.2010


Kaletra


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


EU/1/01/172/001-008


31.8.2010




26.8.2010


Lyrica


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


EU/1/04/279/001-044


31.8.2010




26.8.2010


Mircera


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


EU/1/07/400/001-024


31.8.2010




26.8.2010


Myozyme


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


EU/1/06/333/001-003


31.8.2010




26.8.2010


Nexavar


Bayer Schering Pharma AG 13342 Berlin, Deutschland


EU/1/06/342/001


30.8.2010




26.8.2010


Onbrez Breezhaler


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


EU/1/09/593/001-010


31.8.2010




26.8.2010


Osseor


Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France


EU/1/04/287/001-006


31.8.2010




26.8.2010


Pradaxa


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


EU/1/08/442/001-008


30.8.2010




26.8.2010


Prepandrix


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


EU/1/08/453/002


31.8.2010




26.8.2010


Privigen


CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland


EU/1/08/446/001-006


31.8.2010




26.8.2010


Protelos


Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France


EU/1/04/288/001-006


31.8.2010




26.8.2010


Revatio


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


EU/1/05/318/002


31.8.2010




26.8.2010


Stalevo


Orion Corporation Orionintie 1, FIN-02200 Espoo, Suomi


EU/1/03/260/001-033


30.8.2010




26.8.2010


Stelara


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


EU/1/08/494/001-004


30.8.2010




26.8.2010


Tasigna


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


EU/1/07/422/001-004


31.8.2010




26.8.2010


Telzir


ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom


EU/1/04/282/001-002


31.8.2010




26.8.2010


Thymanax


Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland


EU/1/08/498/001-008


31.8.2010




26.8.2010


Valdoxan


Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France


EU/1/08/499/001-008


31.8.2010




26.8.2010


Viramune


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


EU/1/97/055/001-004


30.8.2010




26.8.2010


Zostavax


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


EU/1/06/341/001-013


31.8.2010




31.8.2010


Abseamed


Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland


EU/1/07/412/001-026


2.9.2010




31.8.2010


Actos


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


EU/1/00/150/001-030


2.9.2010




31.8.2010


Adenuric


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


EU/1/08/447/001-012


3.9.2010




31.8.2010


Angiox


The Medicines Company UK Ltd 115 L Milton Park, Abingdon, Oxfordshire, OX14 4SA, United Kingdom


EU/1/04/289/002


7.9.2010




31.8.2010


Ariclaim


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


EU/1/04/283/008-012


3.9.2010




31.8.2010


Arixtra


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


EU/1/02/206/001-035


2.9.2010




31.8.2010


Avastin


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


EU/1/04/300/001-002


2.9.2010




31.8.2010


Corlentor


Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France


EU/1/05/317/001-014


2.9.2010




31.8.2010


Glustin


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


EU/1/00/151/001-024


2.9.2010




31.8.2010


HBVAXPRO


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


EU/1/01/183/001
EU/1/01/183/004-005
EU/1/01/183/007-008
EU/1/01/183/011
EU/1/01/183/013
EU/1/01/183/015
EU/1/01/183/018-032


2.9.2010




31.8.2010


Humira


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


EU/1/03/256/001-010


3.9.2010




31.8.2010


InductOs


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


EU/1/02/226/001


3.9.2010




31.8.2010


Infanrix hexa


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


EU/1/00/152/001-020


3.9.2010




31.8.2010


Infanrix penta


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


EU/1/00/153/001-010


3.9.2010




31.8.2010


Isentress


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


EU/1/07/436/001-002


6.9.2010




31.8.2010


Ivemend


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


EU/1/07/437/001-004


2.9.2010




31.8.2010


Procoralan


Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France


EU/1/05/316/001-014


2.9.2010




31.8.2010


Truvada


Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom


EU/1/04/305/001-002


2.9.2010




31.8.2010


Yentreve


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


EU/1/04/280/001-008


2.9.2010







—   Modification 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




27.7.2010


Osigraft


Howmedica International S. de R.L. Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland


EU/1/01/179/001


29.7.2010







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










Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




1.7.2010


Ingelvac CircoFLEX


Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland


EU/2/07/079/001-004


4.7.2010




1.7.2010


Profender


Bayer Animal Health GmbH 51368 Leverkusen, Deutschland


EU/2/05/054/001-031


6.7.2010




1.7.2010


Suprelorin


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


EU/2/07/072/001-004


5.7.2010




2.7.2010


Cortavance


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


EU/2/06/069/001


7.7.2010




2.7.2010


Metacam


Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland


EU/2/97/004/001
EU/2/97/004/003-040


7.7.2010




5.7.2010


Metacam


Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland


EU/2/97/004/001
EU/2/97/004/003-042


7.7.2010




27.7.2010


Equilis Prequenza


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


EU/2/05/056/001-004


29.7.2010




27.7.2010


Equilis Prequenza Te


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


EU/2/05/057/001-004


29.7.2010




27.7.2010


Equilis Te


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


EU/2/05/055/001-002


29.7.2010




6.8.2010


Fevaxyn Pentofel


Fort Dodge Laboratories Ireland Finisklin Industrial Estate - Sligo, Ireland


EU/2/96/002/001-003


12.8.2010




18.8.2010


Zulvac 8 Bovis


Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom


EU/2/09/105/001-002


20.8.2010




18.8.2010


Zulvac 8 Ovis


Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom


EU/2/09/104/001-002


20.8.2010




26.8.2010


Advocate


Bayer Animal Health GmbH 51368 Leverkusen, Deutschland


EU/2/03/039/001-030


30.8.2010




26.8.2010


Meloxidyl


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


EU/2/06/070/001-008


27.8.2010







—   Modification of a marketing authorization (Article 38 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




26.8.2010


Masivet


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


EU/2/08/087/001-002


31.8.2010







—   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




5.7.2010


Nobilis Influenza H5N6


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


EU/2/07/076/001-004


8.7.2010




7.7.2010


Nobilis Influenza H7N1


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


EU/2/07/073/001-004


9.7.2010




22.7.2010


Medicinal Oxygen Air Liquide Santé


Air Liquide Santé International 10 rue Cognacq-Jay, 75341 Paris Cedex 07, France


EU/2/06/067/001-002


26.7.2010




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.