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Document 52010XC0924(03)
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]
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]
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]
OJ C 258, 24.9.2010, p. 1–31
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
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.