Zestawienie decyzji Unii Europejskiej w sprawie pozwoleń na dopuszczenie do obrotu produktów leczniczych w okresie od dnia 1 stycznia 2011 r. do dnia 28 lutego 2011 r.

Zestawienie decyzji Unii Europejskiej w sprawie pozwoleń na dopuszczenie do obrotu produktów leczniczych w okresie od dnia 1 stycznia 2011 r. do dnia 28 lutego 2011 r.

(Opublikowano zgodnie z art. 13 lub art. 38 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady⁽¹⁾)

(2011/C 128/01)

(Dz.U.UE C z dnia 29 kwietnia 2011 r.)

– Wydanie pozwolenia na dopuszczenie do obrotu (art. 13 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady): Zatwierdzenie

Data wydania decyzji	Nazwa produktu leczniczego	INN (międzynarodowa niezastrzeżona nazwa)	Posiadacz pozwolenia na dopuszczenie do obrotu	Numer pozycji w rejestrze wspólnotowym	Postać farmaceutyczna	Kod ATC (klasyfikacja anatomiczno-terapeutyczno-chemiczna)	Data notyfikacji
6.1.2011	Potactasol	topotekan	Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland	EU/1/10/660/001-002	Proszek do przygotowania koncentratu do sporządzania roztworu do infuzji	L01XX17	10.1.2011
21.1.2011	Docetaxel Teva Pharma	docetaksel	Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland	EU/1/10/662/001-002	Koncentrat i rozpuszczalnik do sporządzania roztworu do infuzji	L01CD02	26.1.2011
21.1.2011	Iasibon	kwas ibandronowy	Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα	EU/1/10/659/001-010	Koncentrat do sporządzania roztworu do infuzji Tabletka powlekana	M05BA06	25.1.2011
27.1.2011	Fluenz	szczepionka przeciw grypie (żywa atenuowana, do nosa)	MedImmune, LLC Lagelandseweg 78, 6545 CG Nijmegen, Nederland	EU/1/10/661/001-002	Aerozol do nosa, zawiesina	J07BB03	1.2.2011
18.2.2011	Entacapone Teva	entakapon	Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland	EU/1/10/665/001-004	Tabletka powlekana	N04BX02	22.2.2011
28.2.2011	Daliresp	roflumilast	Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland	EU/1/11/668/001-003	Tabletka powlekana	R03DX07	2.3.2011
28.2.2011	Esbriet	Pirfenidon	InterMune Europe Ltd Wellesley House, Duke of Wellington Avenue, Royal Arsenal, London SE18 6SS, United Kingdom	EU/1/11/667/001-003	Kapsułki, twarde	L04AX05	2.3.2011
28.2.2011	Lamivudine / Zidovudine Teva	Lamiwudyna/zydowudyna	Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland	EU/1/10/663/001-002	Tabletka powlekana	J05AR01	2.3.2011
28.2.2011	Libertek	roflumilast	Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland	EU/1/11/666/001-003	Tabletka powlekana	R03DX07	2.3.2011
28.2.2011	Xiapex	kolagenaza clostridium histolyticum	Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom	EU/1/11/671/001	Proszek i rozpuszczalnik do sporządzania roztworu do wstrzykiwań	M09AB02	2.3.2011

– Zmiana pozwolenia na dopuszczenie do obrotu (art. 13 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady): Zatwierdzenie

Data wydania decyzji	Nazwa produktu leczniczego	Posiadacz pozwolenia na dopuszczenie do obrotu	Numer pozycji w rejestrze wspólnotowym	Data notyfikacji
6.1.2011	Invirase	Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom	EU/1/96/026/001-002	10.1.2011
6.1.2011	Irbesartan HCT Winthrop	SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174 avenue de France, F- 75013 Paris, France	EU/1/06/377/001-028	11.1.2011
6.1.2011	Irbesartan Winthrop	SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174 avenue de France, F- 75013 Paris, France	EU/1/06/376/001-033	11.1.2011
6.1.2011	Lucentis	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/06/374/001	11.1.2011
6.1.2011	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	11.1.2011
6.1.2011	Resolor	Movetis NV Veedijk 58, B-2300 Turnhout, België	EU/1/09/581/001-008	11.1.2011
6.1.2011	Tepadina	ADIENNE S.r.l. via Broseta, 64/B, 24128 Bergamo, Italia	EU/1/10/622/001-002	11.1.2011
6.1.2011	Yttriga	Eckert & Ziegler Nuclitec GmbH Gieselweg 1, Braunschweig 38110, Deutschland	EU/1/05/322/001	10.1.2011
11.1.2011	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	18.1.2011
11.1.2011	Pantoloc Control	Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland	EU/1/09/519/001-004	13.1.2011
11.1.2011	Rapiscan	Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom	EU/1/10/643/001	13.1.2010
13.1.2011	Clopidogrel Winthrop	Sanofi-Aventis 174, avenue de France, F-75013 Paris, France	EU/1/08/465/001-020	17.1.2011
13.1.2011	Copalia	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/06/372/037-039	17.1.2010
13.1.2011	INOmax	INO Therapeutics AB SE-181 81 Lidingö, Sverige	EU/1/01/194/001-002	18.1.2011
13.1.2011	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	17.1.2011
13.1.2011	Nimvastid	KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija	EU/1/09/525/001-050	17.1.2011
13.1.2011	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	17.1.2011
17.1.2011	Cancidas	Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/01/196/001 EU/1/01/196/003	19.1.2011
17.1.2011	Kuvan	Merck KGaA Frankfurter Straße 250, 64293 Darmstadt, Deutschland	EU/1/08/481/001-003	19.1.2011
17.1.2011	Nevanac	Alcon Laboratories (UK) Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom	EU/1/07/433/001	19.1.2011
21.1.2011	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	25.1.2011
21.1.2011	Adenuric	Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg	EU/1/08/447/001-004	25.1.2011
21.1.2011	Arzerra	Glaxo Group Ltd Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom	EU/1/10/625/001-002	26.1.2011
21.1.2011	Cubicin	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/05/328/001-004	25.1.2011
21.1.2011	Enbrel	Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom	EU/1/99/126/001-021	25.1.2011
21.1.2011	Humira	Abbott Laboratories Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom	EU/1/03/256/001-010	25.1.2011
21.1.2011	INOmax	INO Therapeutics AB SE-181 81 Lidingö, Sverige	EU/1/01/194/001-002	25.1.2011
21.1.2011	Karvea	Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom	EU/1/97/049/001-039	26.1.2011
21.1.2011	Kuvan	Merck KGaA Frankfurter Straße 250, 64293 Darmstadt, Deutschland	EU/1/08/481/001-003	25.1.2011
21.1.2011	Mixtard	Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark	EU/1/02/231/001-023 EU/1/02/231/036-037	25.1.2011
21.1.2011	Multaq	Sanofi-Aventis 174, avenue de France, F-75013 Paris, France	EU/1/09/591/001-004	25.1.2011
21.1.2011	Olazax Disperzi	Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Ćeská republika	EU/1/09/592/001-005	25.1.2011
21.1.2011	Pandemrix	GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique	EU/1/08/452/001	26.1.2011
21.1.2011	Pradaxa	Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland	EU/1/08/442/001-008	25.1.2011
21.1.2011	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	26.1.2011
21.1.2011	Rasilez	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/07/405/001-040	25.1.2011
21.1.2011	Revatio	Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom	EU/1/05/318/002	25.1.2011
21.1.2011	Revlimid	Celgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom	EU/1/07/391/001-004	26.1.2011
21.1.2011	RotaTeq	Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France	EU/1/06/348/001-002	26.1.2011
21.1.2011	Sprimeo	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/07/407/001-020	26.1.2011
21.1.2011	Temomedac	medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg -Deutschland	EU/1/09/605/001-012	26.1.2011
21.1.2011	Thymanax	Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland	EU/1/08/498/001-008	25.1.2011
21.1.2011	Valdoxan	Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France	EU/1/08/499/001-008	26.1.2011
21.1.2011	Yentreve	Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland	EU/1/04/280/001-008	25.1.2011
24.1.2011	Apidra	Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland	EU/1/04/285/001-036	27.1.2011
24.1.2011	Ceplene	EpiCept GmbH Goethestrasse 4, D-80336 München, Deutschland	EU/1/08/477/001	27.1.2011
24.1.2011	Dafiro	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/06/371/001-039	27.1.2011
24.1.2011	Eucreas	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/07/425/001-018	27.1.2011
24.1.2011	Galvus	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/07/414/001-010 EU/1/07/414/018	27.1.2011
24.1.2011	Isentress	Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/07/436/001-002	27.1.2011
24.1.2011	Jalra	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/08/485/001-011	27.1.2011
24.1.2011	Lantus	Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland	EU/1/00/134/001-037	27.1.2011
24.1.2011	NutropinAq	Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France	EU/1/00/164/003-005	27.1.2011
24.1.2011	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	27.1.2011
24.1.2011	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	27.1.2011
24.1.2011	Optisulin	Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland	EU/1/00/133/001-032	27.1.2011
24.1.2011	Pelzont	Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/08/460/009-011 EU/1/08/460/013-014	26.1.2011
24.1.2011	Rotarix	GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique	EU/1/05/330/001-011	27.1.2011
24.1.2011	SonoVue	Bracco International B.V. Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland	EU/1/01/177/002	27.1.2011
24.1.2011	Synflorix	GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique	EU/1/09/508/001-010	27.1.2011
24.1.2011	Torisel	Wyeth Europa Ltd Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom	EU/1/07/424/001	27.1.2011
24.1.2011	Tredaptive	Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/08/459/009-011 EU/1/08/459/013-014	26.1.2011
24.1.2011	Trevaclyn	Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/08/458/009-011 EU/1/08/458/013-014	26.1.2011
24.1.2011	Vistide	Gilead Sciences International Limited Cambridge, CB21 6GT, United Kingdom	EU/1/97/037/001	27.1.2011
24.1.2011	Xarelto	Bayer Schering Pharma AG 13342 Berlin, Deutschland	EU/1/08/472/001-010	27.1.2011
24.1.2011	Xiliarx	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/08/486/001-011	27.1.2011
26.1.2011	Naglazyme	BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom	EU/1/05/324/001-002	27.1.2011
27.1.2011	Adrovance	Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/06/364/001-009	1.2.2011
27.1.2011	Alimta	Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland	EU/1/04/290/001-002	1.2.2011
27.1.2011	Cymbalta	Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland	EU/1/04/296/001-009	31.1.2011
27.1.2011	Herceptin	Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom	EU/1/00/145/001	1.2.2011
27.1.2011	Icandra	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/08/484/001-018	1.2.2011
27.1.2011	Menveo	Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia	EU/1/10/614/001	31.1.2011
27.1.2011	Nonafact	Sanquin Plesmanlaan 125, Amsterdam 1066 CX, Nederland	EU/1/01/186/001-002	1.2.2011
27.1.2011	Orgalutran	N.V. Organon P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland	EU/1/00/130/001-002	31.1.2011
27.1.2011	Ranexa	Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg	EU/1/08/462/001-012	1.2.2011
27.1.2011	Rasilez HCT	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/08/491/001-080	1.2.2011
27.1.2011	Regranex	Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse -België	EU/1/99/101/001	31.1.2011
27.1.2011	Remicade	Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland	EU/1/99/116/001-005	1.2.2011
27.1.2011	Ribavirin Mylan	Three Rivers Global Pharma Limited 20-22 Bedford Row, London WC1R4JS, United Kingdom	EU/1/10/634/001-004	23.2.2011
27.1.2011	RotaTeq	Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France	EU/1/06/348/001-002	1.2.2011
27.1.2011	Sebivo	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/07/388/001-003	1.2.2011
27.1.2011	Simponi	Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland	EU/1/09/546/001-004	31.1.2011
27.1.2011	Xeristar	Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland	EU/1/04/297/001-008	1.2.2011
27.1.2011	Zomarist	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/08/483/001-018	1.2.2011
1.2.2011	Ariclaim	Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland	EU/1/04/283/008-012	3.2.2011
1.2.2011	Emend	Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/03/262/001-008	3.2.2011
1.2.2011	Exforge	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/06/370/001-039	3.2.2011
1.2.2011	Fosavance	Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/05/310/001-009	3.2.2011
1.2.2011	Imprida	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/06/373/001-039	3.2.2011
1.2.2011	INCRELEX	Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France	EU/1/07/402/001	3.2.2011
1.2.2011	Insulin Human Winthrop	Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland	EU/1/06/368/001-168	3.2.2011
1.2.2011	Insuman	Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland	EU/1/97/030/028-195	3.2.2011
1.2.2011	Irbesartan Teva	Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland	EU/1/09/576/001-039	3.2.2011
1.2.2011	Nivestim	Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom	EU/1/10/631/001-009	3.2.2011
1.2.2011	Orfadin	Swedish Orphan Biovitrum International AB SE-112 76 Stockholm, Sweden	EU/1/04/303/001-003	3.2.2011
1.2.2011	Riprazo	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/07/409/001-020	3.2.2011
1.2.2011	Votrient	Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom	EU/1/10/628/001-004	3.2.2011
2.2.2011	Nplate	Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland	EU/1/08/497/001-008	4.2.2011
2.2.2011	Prevenar	Wyeth-Lederle Vaccines S.A. Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium	EU/1/00/167/001-008	4.2.2011
2.2.2011	Prolia	Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland	EU/1/10/618/001-004	4.2.2011
2.2.2011	Replagal	Shire Human Genetic Therapies AB Svärdvägen 11D, 182 33 Danderyd, Sverige	EU/1/01/189/001-006	4.2.2011
2.2.2011	Vantavo	Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/09/572/001-009	4.2.2011
8.2.2011	Biopoin	CT Arzneimittel GmbH Lengeder Straße 42a, D-13407 Berlin, Deutschland	EU/1/09/565/001-028	10.2.2011
8.2.2011	Temodal	Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België	EU/1/98/096/001-025	14.2.2011
9.2.2011	Cimzia	UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België	EU/1/09/544/001-002	11.2.2011
9.2.2011	Karvezide	Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom	EU/1/98/085/001-034	11.2.2011
9.2.2011	Olazax	Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Ćeská republika	EU/1/09/597/001-005	11.2.2011
9.2.2011	Peyona	CHIESI FARMACEUTICI SpA Via Palermo 26/A, I-43100 Parma, ITALIA	EU/1/09/528/001-002	11.2.2011
9.2.2011	Tesavel	Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/07/435/001-018	11.2.2011
9.2.2011	Xelevia	Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/07/382/001-018	11.2.2011
11.2.2011	Aprovel	Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France	EU/1/97/046/001-039	15.2.2011
11.2.2011	Azarga	Alcon Laboratories (UK) Ltd. Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom	EU/1/08/482/001-002	15.2.2011
11.2.2011	Brinavess	Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/10/645/001-002	15.2.2011
11.2.2011	Clopidogrel Krka	KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija	EU/1/09/556/001-011	15.2.2011
11.2.2011	CoAprovel	Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France	EU/1/98/086/001-034	15.2.2011
11.2.2011	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	15.2.2011
11.2.2011	Eporatio	ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland	EU/1/09/573/001-028	15.2.2011
11.2.2011	Januvia	Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/07/383/001-018	15.2.2011
11.2.2011	Rilonacept Regeneron	Regeneron UK Limited 40 Bank Street, E14 5DS London, United Kingdom	EU/1/09/582/001	15.2.2011
11.2.2011	Zutectra	Biotest Pharma GmbH Landsteinerstr.5, 63303 Dreieich, Deutschland	EU/1/09/600/001	15.2.2011
11.2.2011	Zyllt	KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija	EU/1/09/553/001-010	15.2.2011
18.2.2011	Actrapid	Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark	EU/1/02/230/001-007 EU/1/02/230/016-017	22.2.2011
18.2.2011	Elaprase	Shire Human Genetic Therapies AB Svärdvägen 11D, 182 33 Danderyd, Sverige	EU/1/06/365/001-003	22.2.2011
18.2.2011	Keppra	UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België	EU/1/00/146/001-032	22.2.2011
18.2.2011	Mimpara	Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland	EU/1/04/292/001-012	22.2.2011
18.2.2011	Optaflu	Novartis Vaccines and Diagnostics GmbH Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland	EU/1/07/394/001-009	22.2.2011
18.2.2011	Renagel	Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland	EU/1/99/123/005-013	22.2.2011
21.2.2011	Arzerra	Glaxo Group Ltd Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom	EU/1/10/625/001-003	25.2.2011
21.2.2011	Baraclude	Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom	EU/1/06/343/001-007	28.2.2011
21.2.2011	Cervarix	GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique	EU/1/07/419/001-012	25.2.2011
21.2.2011	Cialis	Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland	EU/1/02/237/001-009	23.2.2011
21.2.2011	Clopidogrel Teva	Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland	EU/1/09/540/001-016	24.2.2011
21.2.2011	Competact	Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom	EU/1/06/354/001-011	23.2.2011
21.2.2011	Conbriza	Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom	EU/1/09/511/001-005	23.2.2011
21.2.2011	Dukoral	Crucell Sweden AB SE-105 21 Stockholm, Sweden	EU/1/03/263/001-003	1.3.2011
21.2.2011	Dynastat	Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom	EU/1/02/209/001-008	23.2.2011
21.2.2011	Efficib	Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/08/457/001-016	24.2.2011
21.2.2011	Enbrel	Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom	EU/1/99/126/001-021	25.2.2011
21.2.2011	Firazyr	Jerini AG Invalidenstr. 130, D-10115 Berlin, Deutschland	EU/1/08/461/001-002	24.2.2011
21.2.2011	Glivec	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/01/198/001-013	28.2.2011
21.2.2011	Humira	Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom	EU/1/03/256/001-010	23.2.2011
21.2.2011	Insulatard	Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark	EU/1/02/233/005-007	25.2.2011
21.2.2011	Intanza	Sanofi Pasteur MSD SNC 8, rue Jonas Salk, Lyon 69007, France	EU/1/08/505/001-006	23.2.2011
21.2.2011	Ivemend	Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/07/437/001-004	24.2.2011
21.2.2011	Janumet	Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/08/455/001-016	24.2.2011
21.2.2011	Kineret	Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige	EU/1/02/203/001-004	25.2.2011
21.2.2011	Levemir	Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark	EU/1/04/278/001-003	28.2.2011
21.2.2011	Myozyme	Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland	EU/1/06/333/001-003	28.2.2011
21.2.2011	Neupro	Schwarz Pharma Ltd Shannon, Industrial Estate, Co.Clare, Ireland	EU/1/05/331/001-055	25.2.2011
21.2.2011	Pritor	Bayer Schering Pharma AG 13342 Berlin, Deutschland	EU/1/98/089/001-022	25.2.2011
21.2.2011	PritorPlus	Bayer Schering Pharma AG 13342 Berlin, Deutschland	EU/1/02/215/001-021	28.2.2011
21.2.2011	Protaphane	Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark	EU/1/02/234/005-007	25.2.2011
21.2.2011	Protopic	Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland	EU/1/02/201/001-006	28.2.2011
21.2.2011	Qutenza	Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland	EU/1/09/524/001-002	25.2.2011
21.2.2011	Ranexa	Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg	EU/1/08/462/001-012	25.2.2011
21.2.2011	Rasilez	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/07/405/001-040	25.2.2011
21.2.2011	Rasilez HCT	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/08/491/001-080	25.2.2011
21.2.2011	Remicade	Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland	EU/1/99/116/001-005	25.2.2011
21.2.2011	Ribavirin Teva	Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland	EU/1/09/509/001-004	24.2.2011
21.2.2011	Ribavirin Teva Pharma BV	Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland	EU/1/09/527/001-016	24.2.2011
21.2.2011	Riprazo	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/07/409/001-020	28.2.2011
21.2.2011	Ristaben	Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/10/621/001-018	24.2.2011
21.2.2011	Ristfor	Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/10/620/001-016	24.2.2011
21.2.2011	Simponi	Janssen Biologics B.V. Einsteinweg 101, CB Leiden 2333, Nederland	EU/1/09/546/001-004	23.2.2011
21.2.2011	Sprimeo	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/07/407/001-020	28.3.2011
21.2.2011	Stocrin	Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/99/111/001-005 EU/1/99/111/008-011	25.2.2011
21.2.2011	Tamiflu	Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom	EU/1/02/222/001-004	23.2.2011
21.2.2011	Tysabri	Elan Pharma International Ltd. Monksland, Athlone, County Westmeath, Ireland	EU/1/06/346/001	23.2.2011
21.2.2011	Velmetia	Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/08/456/001-016	24.2.2011
21.2.2011	Ventavis	Bayer Schering Pharma AG Müllerstrasse 170-178, D - 13342 Berlin, Deutschland	EU/1/03/255/001-008	23.2.2011
21.2.2011	Volibris	Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom	EU/1/08/451/001-004	2.3.2011
21.2.2011	Zylagren	KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija	EU/1/09/558/001-010	28.2.2011
21.2.2011	Zyprexa	Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland	EU/1/96/022/016-017	23.2.2011
28.2.2011	Altargo	Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom	EU/1/07/390/001-004	4.3.2011
28.2.2011	Aranesp	Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland	EU/1/01/185/001-022 EU/1/01/185/031-111	4.3.2011
28.2.2011	Arixtra	Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom	EU/1/02/206/001-035	2.3.2011
28.2.2011	Avastin	Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom	EU/1/04/300/001-002	4.3.2011
28.2.2011	Baraclude	Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom	EU/1/06/343/001-007	3.3.2011
28.2.2011	Clopidogrel Qualimed	Qualimed 117, Allée des Parcs, 69 800 Saint Priest, France	EU/1/09/557/001-010	4.3.2011
28.2.2011	Clopidogrel TAD	TAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland	EU/1/09/555/001-009	4.3.2011
28.2.2011	Fabrazyme	Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland	EU/1/01/188/001-006	4.3.2011
28.2.2011	Firazyr	Jerini AG Invalidenstr. 130, D-10115 Berlin, Deutschland	EU/1/08/461/001-002	4.3.2011
28.2.2011	IDflu	Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France	EU/1/08/507/001-006	3.3.2011
28.2.2011	Ilaris	Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom	EU/1/09/564/001-002	4.3.2011
28.2.2011	Invanz	Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/02/216/001-002	3.3.2011
28.2.2011	Kaletra	Abbott Laboratories Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom	EU/1/01/172/001-008	4.3.2011
28.2.2011	Kinzalkomb	Bayer Schering Pharma AG D-13342 Berlin, Deutschland	EU/1/02/214/001-015	2.3.2011
28.2.2011	Kinzalmono	Bayer Schering Pharma AG D-13342 Berlin, Deutschland	EU/1/98/091/001-014	2.3.2011
28.2.2011	Micardis	Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland	EU/1/98/090/001-020	2.3.2011
28.2.2011	MicardisPlus	Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland	EU/1/02/213/001-023	3.3.2011
28.2.2011	NovoMix	Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark	EU/1/00/142/004-005 EU/1/00/142/009-025	3.3.2011
28.2.2011	Omnitrope	Sandoz GmbH Biochemiestrasse 10, Kundl 6250, Österreich	EU/1/06/332/001-009	2.3.2011
28.2.2011	Onglyza	Bristol Myers S q uibb/AstraZeneca EEIG Bristol Myers Suibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom	EU/1/09/545/011-015	3.3.2011
28.2.2011	Onglyza	Bristol Myers S q uibb/AstraZeneca EEIG Bristol Myers Suibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom	EU/1/09/545/001-010	3.3.2011
28.2.2011	Osigraft	Howmedica International S. de R.L. Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland	EU/1/01/179/001	4.3.2011
28.2.2011	Osseor	Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France	EU/1/04/287/001-006	4.3.2011
28.2.2011	PegIntron	Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België	EU/1/00/131/001-050	3.3.2011
28.2.2011	PREZISTA	Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse -België	EU/1/06/380/001-005	4.3.2011
28.2.2011	ProQuad	Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France	EU/1/05/323/001-013	2.3.2011
28.2.2011	Protelos	Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France	EU/1/04/288/001-006	4.3.2011
28.2.2011	Quadramet	CIS bio international Boite Postale 32 - F-91192 Gif-sur-Yvette - France	EU/1/97/057/001	4.4.2011
28.2.2011	RotaTeq	Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France	EU/1/06/348/001-002	3.3.2011
28.2.2011	Siklos	ADDMEDICA 101, rue Saint Lazare, Paris 75009, France	EU/1/07/397/001-004	3.3.2011
28.2.2011	Tracleer	Actelion Registration Ltd BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom	EU/1/02/220/001-006	3.3.2011
28.2.2011	Vedrop	Orphan Europe SARL Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92 800 Puteaux - France	EU/1/09/533/001-003	3.3.2011
28.2.2011	Ytracis	CIS bio international Boite Postale 32 - F-91192 Gif-sur- Yvette Cedex- France	EU/1/03/250/001	4.3.2011

– Wycofanie pozwolenia na dopuszczenie do obrotu (art. 13 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady)

Data wydania decyzji	Nazwa produktu leczniczego	Posiadacz pozwolenia na dopuszczenie do obrotu	Numer pozycji w rejestrze wspólnotowym	Data notyfikacji
6.1.2011	Thelin	Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom	EU/1/06/353/001-005	11.1.2011
1.2.2011	Clopidogrel 1A Pharma	Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland	EU/1/09/542/001-007	3.2.2011

– Wydanie pozwolenia na dopuszczenie do obrotu (art. 38 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady⁽²⁾): Zatwierdzenie

Data wydania decyzji	Nazwa produktu leczniczego	INN (międzynarodowa niezastrzeżona nazwa)	Posiadacz pozwolenia na dopuszczenie do obrotu	Numer pozycji w rejestrze wspólnotowym	Postać farmaceutyczna	Kod ATC (klasyfikacja anatomiczno-terapeutyczno-chemiczna)	Data notyfikacji
27.1.2011	Hiprabovis IBR Marker Live	Żywy podwójnie delecyjny gE<sup>-</sup>, tk<sup>-</sup> Herpeswirus Bydlęcy (BoHV-1), szczep CEDDEL	Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170- Amer (Girona), España	EU/2/10/114/001-002	Liofilizat do sporządzania zawiesiny	QI02AD01	1.2.2011
11.2.2011	Comfortis	spinosad	Eli Lilly and Company Ltd Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom	EU/2/10/115/001-010	Tabletki do żucia	QP53BX03	15.2.2011
18.2.2011	Activyl	indoksakarbu	Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland	EU/2/10/118/001-014	Roztwór do nakrapiania	QP53AX27	22.2.2011
18.2.2011	Cimalgex	Cimikoksyb	Vétoquinol SA Magny-Vernois - 70200 LURE - France	EU/2/10/119/001-012	Tabletki	QM01AH93	24.2.2011
18.2.2011	Purevax Rabies	Rekombinowany w wirusie Canarypox antygen (vCP65) wirusa wścieklizny	MERIAL 29 avenue Tony Garnier, 69007 LYON, France	EU/2/10/117/001-002	Zawiesina do wstrzykiwań	QI06AX	22.2.2011
21.2.2011	Melosus	Meloksykam	CP-Pharma Handelsgesellschaft mbH Ostlandring 13, D-31303 Burgdorf, Deutschland	EU/2/10/116/001-004	Zawiesina doustna	QM01AC06	24.2.2011

– Zmiana pozwolenia na dopuszczenie do obrotu (art. 38 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady): Zatwierdzenie

Data wydania decyzji	Nazwa produktu leczniczego	Posiadacz pozwolenia na dopuszczenie do obrotu	Numer pozycji w rejestrze wspólnotowym	Data notyfikacji
6.1.2011	Econor	Novartis Animal Health Austria GmbH Biochemiestrasse 10, 6250 Kundl, Österreich	EU/2/98/010/004-006 EU/2/98/010/017-018 EU/2/98/010/021-025	11.1.2011
13.1.2011	Duvaxyn WNV	Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom	EU/2/08/086/001-003	18.1.2011
13.1.2011	Palladia	Pfizer Ltd Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom	EU/2/09/100/001-003	17.1.2011
17.1.2011	Zolvix	Novartis Healthcare A/S Lyngbyvej 172, DK-2100 Copenhagen, Denmark	EU/2/09/101/001-010	19.1.2011
21.1.2011	Dicural	Fort Dodge Animal Health Holland C.J. van Houtenlaan 36, 1381 CP Weesp, Nederland	EU/2/97/003/001-018	25.1.2011
21.1.2011	Zulvac 8 Ovis	Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom	EU/2/09/104/001-002	26.1.2011
24.1.2011	Poulvac FluFend H5N3 RG	Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom	EU/2/06/060/001-002	27.1.2011
24.1.2011	Rheumocam	Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, IRELAND	EU/2/07/078/001-010	26.1.2011
27.1.2011	Ingelvac CircoFLEX	Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland	EU/2/07/079/001-004	1.2.2011
27.1.2011	Meloxidyl	CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France	EU/2/06/070/005-007	1.2.2011
11.2.2011	SevoFlo	Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM	EU/2/02/035/007	15.2.2011

– Zawieszenie pozwolenia na dopuszczenie do obrotu (art. 45 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady)

Data wydania decyzji	Nazwa produktu leczniczego	Posiadacz pozwolenia na dopuszczenie do obrotu	Numer pozycji w rejestrze wspólnotowym	Data notyfikacji
24.1.2011	Acticam	Ecuphar NV Legeweg 157-I, B-8020 Oostkamp, Belgïe	EU/2/08/088/001-003	26.1.2011

Osoby zainteresowane dostępem do publicznego sprawozdania oceniającego dla danego produktu leczniczego oraz do związanych z nim decyzji prosimy o kontakt z:

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK - LONDON E14 4H

______

⁽¹⁾ Dz.U. L 136 z 30.4.04, s. 1.

⁽²⁾ Dz.U. L 136 z 30.4.04, s. 1.

• Identyfikator: Dz.U.UE.C.2011.128.1
• Rodzaj: Informacja
• Tytuł: Zestawienie decyzji Unii Europejskiej w sprawie pozwoleń na dopuszczenie do obrotu produktów leczniczych w okresie od dnia 1 stycznia 2011 r. do dnia 28 lutego 2011 r.
• Data aktu: 29/04/2011
• Data ogłoszenia: 29/04/2011