Data wydania decyzji |
Nazwa produktu leczniczego |
Posiadacz pozwolenia na dopuszczenie do obrotu |
Numer pozycji w rejestrze Data wspólnotowym notyfikacji |
Data notyfikacji |
1.9.2010 |
Altargo |
Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom
|
EU/1/07/390/001-004 |
8.9.2010 |
1.9.2010 |
Ecalta |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/07/416/001-002 |
6.9.2010 |
1.9.2010 |
Keppra |
UCB Pharma SA. Allée de la Recherche 60,
1070 Bruxelles,
Belgique/Researchdreef, 60,
Brussel 1070,
België
|
EU/1/00/146/001-032 |
6.9.2010 |
1.9.2010 |
Levitra |
Bayer Schering Pharma AG 13342 Berlin, Deutschland |
EU/1/03/248/001-015 |
6.9.2010 |
1.9.2010 |
Prevenar 13 |
Wyeth Lederle Vaccines S.A. Rue du Bosquet, 15
B-1348 Louvain-la-Neuve,
Belgique
|
EU/1/09/590/001-006 |
6.9.2010 |
1.9.2010 |
Regranex |
Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse -België |
EU/1/99/101/001 |
6.9.2010 |
1.9.2010 |
Relistor |
Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
EU/1/08/463/001-003 |
6.9.2010 |
1.9.2010 |
Vfend |
Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom
|
EU/1/02/212/001-026 |
6.9.2010 |
1.9.2010 |
Zypadhera |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA, Houten, Nederland |
EU/1/08/479/001-003 |
6.9.2010 |
6.9.2010 |
Abraxane |
Abraxis BioScience Limited Rosanne House, Parkway, Welwyn Garden City, Herts, AL8 6HG, United Kingdom |
EU/1/07/428/001 |
9.9.2010 |
6.9.2010 |
Apidra |
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland |
EU/1/04/285/001-036 |
9.9.2010 |
6.9.2010 |
Cialis |
Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland |
EU/1/02/237/001-009 |
9.9.2010 |
6.9.2010 |
Clopidogrel Winthrop |
Sanofi-Aventis 174, avenue de France,
F-75013 Paris,
France
|
EU/1/08/465/001-020 |
9.9.2010 |
6.9.2010 |
Cymbalta |
Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland |
EU/1/04/296/001-009 |
8.9.2010 |
6.9.2010 |
Dynastat |
Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
EU/1/02/209/001-008 |
8.9.2010 |
6.9.2010 |
Emadine |
Alcon Laboratories (UK) Ltd. Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom |
EU/1/98/095/001-004 |
9.9.2010 |
6.9.2010 |
Insuman |
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland |
EU/1/97/030/028-195 |
9.9.2010 |
6.9.2010 |
Menveo |
Novartis Vaccines and Diagnostics S.r.l.
Via Fiorentina, 1,
53100 Siena,
Italia
|
EU/1/10/614/001 |
9.9.2010 |
6.9.2010 |
M-M-RVAXPRO |
Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France |
EU/1/06/337/001-013 |
9.9.2010 |
6.9.2010 |
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 |
9.9.2010 |
6.9.2010 |
Oslif Breezhaler |
Novartis Europharm Limited Wimblehurst Road,
Horsham,
West Sussex, RH12 5AB,
United Kingdom
|
EU/1/09/586/001-010 |
9.9.2010 |
6.9.2010 |
ProQuad |
Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France |
EU/1/05/323/001-013 |
9.9.2010 |
6.9.2010 |
Relistor |
Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
EU/1/08/463/001-011 |
8.9.2010 |
6.9.2010 |
Renvela |
Genzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, Nederland |
EU/1/09/521/001-007 |
9.9.2010 |
6.9.2010 |
Thyrogen |
Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland |
EU/1/99/122/001-002 |
9.9.2010 |
6.9.2010 |
Vimpat |
UCB Pharma SA. Allée de la Recherche 60, 1070
Bruxelles,
Belgique/Researchdreef, 60,
Brussel 1070,
België
|
EU/1/08/470/001-017 |
8.9.2010 |
6.9.2010 |
Viread |
Gilead Sciences International Limited
Cambridge CB21 6GT
United Kingdom
|
EU/1/01/200/001-002 |
9.9.2010 |
6.9.2010 |
Xeristar |
Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland |
EU/1/04/297/001-008 |
8.9.2010 |
6.9.2010 |
Xolair |
Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
EU/1/05/319/001-010 |
8.9.2010 |
6.9.2010 |
Zerit |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/96/009/001-009 |
9.9.2010 |
6.9.2010 |
Zyprexa |
Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland |
EU/1/96/022/002 EU/1/96/022/004
EU/1/96/022/006
EU/1/96/022/009-012
EU/1/96/022/014
EU/1/96/022/016-017
EU/1/96/022/019-034
|
8.9.2010 |
6.9.2010 |
Zyprexa Velotab |
Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland |
EU/1/99/125/001-016 |
8.9.2010 |
10.9.2010 |
Pandemrix |
GlaxoSmithKline Biologicals SA. rue de l'Institut 89, Rixensart, B-1330 Belgique |
EU/1/08/452/001 |
14.9.2010 |
10.9.2010 |
Siklos |
ADDMEDICA 101, rue Saint Lazare, Paris 75009, FRANCE |
EU/1/07/397/001 |
14.9.2010 |
16.9.2010 |
Alimta |
Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland |
EU/1/04/290/001 |
20.9.2010 |
16.9.2010 |
Tracleer |
Actelion Registration Ltd BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |
EU/1/02/220/001-006 |
20.9.2010 |
17.9.2010 |
Xyrem |
UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom |
EU/1/05/312/001 |
21.9.2010 |
23.9.2010 |
Kepivance |
Biovitrum AB (publ) SE-112 76 Stockholm, Sverige |
EU/1/05/314/001 |
27.9.2010 |
23.9.2010 |
Levemir |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/04/278/001-011 |
27.9.2010 |
23.9.2010 |
Revatio |
Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom |
EU/1/05/318/001-002 |
27.9.2010 |
27.9.2010 |
Caelyx |
Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles,
Belgique - Stallestraat, 73 - 1180
Brussel,
België
|
EU/1/96/011/001-004 |
29.9.2010 |
27.9.2010 |
Panretin |
Eisai Limited European Knowledge Centre,
Mosquito Way,
Hatfield,
Hertfordshire,
AL10 9SN, United Kingdom
|
EU/1/00/149/001 |
29.9.2010 |
30.9.2010 |
Clopidogrel Apotex |
Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland |
EU/1/09/568/001-018 |
5.10.2010 |
30.9.2010 |
Mepact |
IDM PHARMA SAS 11-15 Quai De Dion Bouton,
92816 Puteaux Cedex,
France
|
EU/1/08/502/001 |
6.10.2010 |
30.9.2010 |
Noxafil |
SP Europe Rue de Stalle, 73, 1180 Bruxelles,
Belgique - Stallestraat, 73 - 1180
Brussel,
België
|
EU/1/05/320/001 |
5.10.2010 |
30.9.2010 |
Rotarix |
GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique |
EU/1/05/330/001-011 |
5.10.2010 |
30.9.2010 |
Sprycel |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/06/363/001-015 |
5.10.2010 |
30.9.2010 |
Thalidomide Celgene |
Celgene Europe Limited Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom |
EU/1/08/443/001 |
5.10.2010 |
5.10.2010 |
APTIVUS |
Boehringer Ingelheim International GmbH Binger Strasse 173-D - 55216 Ingelheim am Rhein, Deutschland
|
EU/1/05/315/001-002 |
7.10.2010 |
5.10.2010 |
Mircera |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/07/400/001-024 |
7.10.2010 |
5.10.2010 |
Revlimid |
Celgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom
|
EU/1/07/391/001-004 |
7.10.2010 |
7.10.2010 |
Cyanokit |
Merck Santé s.a.s. 37, rue Saint-Romain, 69379 Lyon Cedex 08, France |
EU/1/07/420/001-002 |
11.10.2010 |
7.10.2010 |
DuoTrav |
Alcon Laboratories (UK) Ltd. Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom |
EU/1/06/338/001-003 |
11.10.2010 |
7.10.2010 |
Soliris |
Alexion Europe S.A.S. 25, Boulevard de lAmiral Bruix,
75016 Paris,
France
|
EU/1/07/393/001 |
11.10.2010 |
11.10.2010 |
Retacrit |
HOSPIRA Enterprises B.V. Randstad 22-11, 1316 BN, Almere, Nederland |
EU/1/07/431/001-025 |
13.10.2010 |
14.10.2010 |
Alisade |
Glaxo Group Ltd Greenford, Middlesex, UB6 ONN, United Kingdom
|
EU/1/08/474/001-003 |
19.10.2010 |
14.10.2010 |
Avamys |
Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom
|
EU/1/07/434/001-003 |
19.10.2010 |
14.10.2010 |
Biograstim |
CT Arzneimittel GmbH Lengeder Straße 42a, D-13407 Berlin, Deutschland |
EU/1/08/450/001-010 |
18.10.2010 |
14.10.2010 |
Firmagon |
Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, Copenhagen S 2300, Danmark |
EU/1/08/504/001-003 |
18.10.2010 |
14.10.2010 |
Multaq |
Sanofi-Aventis 174, avenue de France,
F-75013 Paris,
France
|
EU/1/09/591/001-004 |
18.10.2010 |
14.10.2010 |
Ratiograstim |
ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
EU/1/08/444/001-012 |
18.10.2010 |
14.10.2010 |
Vidaza |
Celgene Europe Ltd Riverside House, Riverside Walk,
Windsor, SL4 1NA,
United Kingdom
|
EU/1/08/488/001 |
18.10.2010 |
14.10.2010 |
Xarelto |
Bayer Schering Pharma AG 13342 Berlin, Deutschland |
EU/1/08/472/001-010 |
18.10.2010 |
15.10.2010 |
Riprazo |
Novartis Europharm Limited Wimblehurst Road,
Horsham,
West Sussex RH12 5AB,
United Kingdom
|
EU/1/07/409/001-020 |
19.10.2010 |
15.10.2010 |
Silapo |
STADA Arzneimittel AG Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland |
EU/1/07/432/001-022 |
19.10.2010 |
15.10.2010 |
Sprimeo |
Novartis Europharm Limited Wimblehurst Road,
Horsham,
West Sussex RH12 5AB,
United Kingdom
|
EU/1/07/407/001-020 |
19.10.2010 |
25.10.2010 |
Axura |
Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100, D-60318 Frankfurt/Main -Deutschland |
EU/1/02/218/001-003 EU/1/02/218/005-030 |
27.10.2010 |
25.10.2010 |
Azilect |
Teva Pharma GmbH Kandelstrasse 10, Kirchzarten 79199, Deutschland |
EU/1/04/304/001-007 |
29.10.2010 |
25.10.2010 |
Baraclude |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/06/343/001-007 |
27.10.2010 |
25.10.2010 |
Cerezyme |
Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland |
EU/1/97/053/001-005 |
27.10.2010 |
25.10.2010 |
Champix |
Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
EU/1/06/360/001-013 |
27.10.2010 |
25.10.2010 |
Ebixa |
H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark |
EU/1/02/219/001-049 |
27.10.2010 |
25.10.2010 |
Epivir |
ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
|
EU/1/96/015/001-005 |
27.10.2010 |
25.10.2010 |
Faslodex |
AstraZeneca UK Limited Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom |
EU/1/03/269/001-002 |
27.10.2010 |
25.10.2010 |
Forsteo |
Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland |
EU/1/03/247/001-002 |
27.10.2010 |
25.10.2010 |
Herceptin |
Roche Registration Limited 6 Falcon Way,
Shire Park,
Welwyn Garden City, AL7 1TW,
United Kingdom
|
EU/1/00/145/001 |
27.10.2010 |
25.10.2010 |
Irbesartan / Hydro-chlorothiazide Teva |
Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland |
EU/1/09/583/001-072 |
27.10.2010 |
25.10.2010 |
Karvea |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/97/049/001-039 |
27.10.2010 |
25.10.2010 |
Mabthera |
Roche Registration Limited 6 Falcon Way,
Shire Park,
Welwyn Garden City, AL7 1TW,
United Kingdom
|
EU/1/98/067/001-002 |
27.10.2010 |
25.10.2010 |
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 |
27.10.2010 |
25.10.2010 |
M-M-RVAXPRO |
Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France |
EU/1/06/337/001-013 |
27.10.2010 |
25.10.2010 |
Pradaxa |
Boehringer Ingelheim International GmbH
Binger Strasse 173,
D-55216 Ingelheim am Rhein,
Deutschland
|
EU/1/08/442/001-008 |
27.10.2010 |
25.10.2010 |
ProQuad |
Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France |
EU/1/05/323/001-013 |
27.10.2010 |
25.10.2010 |
Puregon |
Organon N.V. Kloosterstraat 6, Postbus 20, 5340 BH Oss, Nederland
|
EU/1/96/008/001-041 |
27.10.2010 |
25.10.2010 |
Revlimid |
Celgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom
|
EU/1/07/391/001-004 |
27.10.2010 |
25.10.2010 |
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 |
27.10.2010 |
25.10.2010 |
Simponi |
Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland |
EU/1/09/546/001-004 |
27.10.2010 |
25.10.2010 |
Sprimeo |
Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
EU/1/07/407/001-020 |
27.10.2010 |
25.10.2010 |
Sprycel |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson
Road,
Uxbridge UB8 1DH,
United Kingdom
|
EU/1/06/363/001-015 |
27.10.2010 |
25.10.2010 |
Toviaz |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/07/386/001-018 |
27.10.2010 |
25.10.2010 |
Vantavo |
Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/09/572/001-009 |
27.10.2010 |
25.10.2010 |
Vasovist |
TMC Pharma Services Ltd. Finchampstead,
Berks, RG40 4LJ,
UK
|
EU/1/05/313/001-009 |
27.10.2010 |
25.10.2010 |
Vimpat |
UCB Pharma SA. Allée de la Recherche 60,
1070 Bruxelles,
Belgique/Researchdreef, 60,
Brussel 1070,
België
|
EU/1/08/470/001-017 |
27.10.2010 |
25.10.2010 |
Zonegran |
Eisai Limited European Knowledge Centre,
Mosquito Way,
Hatfield,
Hertfordshire, AL10 9SN,
United Kingdom
|
EU/1/04/307/001-013 |
27.10.2010 |
25.10.2010 |
Zostavax |
Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France |
EU/1/06/341/001-013 |
27.10.2010 |
28.10.2010 |
Ambirix |
GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique |
EU/1/02/224/001-005 |
2.11.2010 |
28.10.2010 |
Aprovel |
Sanofi Pharma Bristol-Myers Squibb SNC
174 avenue de France -
75013 Paris,
France
|
EU/1/97/046/001-039 |
2.11.2010 |
28.10.2010 |
Fertavid |
SP Europe Rue de Stalle, 73 B-1180 Bruxelles, Belgique |
EU/1/09/510/001-019 |
2.11.2010 |
28.10.2010 |
Hycamtin |
SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom
|
EU/1/96/027/001 EU/1/96/027/003-007 |
4.11.2010 |
28.10.2010 |
Mimpara |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/04/292/001-012 |
4.11.2010 |
28.10.2010 |
NovoSeven |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/96/006/001-007 |
4.11.2010 |
28.10.2010 |
Olanzapine Neop-harma |
Neopharma Limited 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom |
EU/1/07/426/001-011 |
1.11.2010 |
28.10.2010 |
Olanzapine Teva |
Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland |
EU/1/07/427/001-057 |
1.11.2010 |
28.10.2010 |
PegIntron |
Schering Plough Europe Rue de Stalle, 73,
1180 Bruxelles,
Belgique - Stallestraat, 73 -
1180 Brussel,
België
|
EU/1/00/131/001-050 |
4.11.2010 |
28.10.2010 |
Travatan |
Alcon Laboratories (UK) Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom |
EU/1/01/199/001-002 |
4.11.2010 |
28.10.2010 |
ViraferonPeg |
Schering Plough Europe Rue de Stalle, 73,
1180 Bruxelles,
Belgique - Stallestraat, 73 -
1180 Brussel,
België
|
EU/1/00/132/001-050 |
4.11.2010 |
29.10.2010 |
Mycamine |
Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland |
EU/1/08/448/001-002 |
5.11.2010 |