|
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.