|
27.3.2015 |
SK |
Úradný vestník Európskej únie |
C 104/1 |
Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. februára 2015 do 28. februára 2015
[Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004 (1)]
(2015/C 104/01)
— Udelenie povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004): Prijaté
|
Dátum rozhodnutia |
Názov lieku |
INN (medzinárodný neregistrovaný názov) |
Držiteľ povolenia na uvedenie na trh |
Číslo záznamu v registri Spoločenstva |
Lieková forma |
Kód ATC (anatomicko-terapeuticko-chemický kód) |
Dátum oznámenia |
|
17.2.2015 |
Holoclar |
Autológne epitelové bunky ľudskej rohovky expandované ex vivo obsahujúce kmeňové bunky |
Chiesi Farmaceutici S.P.A. Via Palermo 26/A, 43122 Parma, Italia |
EU/1/14/987 |
Transplantát |
S01XA19 |
19.2.2015 |
|
17.2.2015 |
Tyverb |
lapatinib |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/07/440 |
Filmom obalená tableta |
L01XE07 |
19.2.2015 |
|
19.2.2015 |
Clopidogrel ratiopharm |
klopidogrel |
Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland |
EU/1/14/975 |
Filmom obalená tableta |
B01AC04 |
24.2.2015 |
|
19.2.2015 |
Xydalba |
Dalbavancín |
Durata Therapeutics International B.V. Spaces Zuidas II, Barbara Strozzilaan 101, 1083 HN Amsterdam, Nederland |
EU/1/14/986 |
Prášok na prípravu infúzneho koncentrátu |
J01XA04 |
23.2.2015 |
|
24.2.2015 |
Xadago |
safinamid |
Zambon S.p.A. Via Lillo del Duca 10, 20 091 Bresso (MI), Italia |
EU/1/14/984 |
Filmom obalená tableta |
Pending |
26.2.2015 |
|
26.2.2015 |
Tasermity |
sevelamériumchlorid |
Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland |
EU/1/14/953 |
Filmom obalená tableta |
V03AE02 |
2.3.2015 |
— Zmena povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004): Prijaté
|
Dátum rozhodnutia |
Názov lieku |
Držiteľ povolenia na uvedenie na trh |
Číslo záznamu v registri Spoločenstva |
Dátum oznámenia |
|
3.2.2015 |
Levetiracetam Teva |
Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland |
EU/1/11/701 |
5.2.2015 |
|
3.2.2015 |
Pergoveris |
Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom |
EU/1/07/396 |
6.2.2015 |
|
6.2.2015 |
Adenuric |
Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg |
EU/1/08/447 |
10.2.2015 |
|
6.2.2015 |
Bridion |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/08/466 |
10.2.2015 |
|
6.2.2015 |
Ceplene |
Meda AB Box 906, SE-170 09 Solna, Sverige |
EU/1/08/477 |
10.2.2015 |
|
6.2.2015 |
Filgrastim Hexal |
Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland |
EU/1/08/496 |
10.2.2015 |
|
6.2.2015 |
Firazyr |
Shire Orphan Therapies GmbH Friedrichstraße 149, D-10117 Berlin, Deutschland |
EU/1/08/461 |
10.2.2015 |
|
6.2.2015 |
Herceptin |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/00/145 |
10.2.2015 |
|
6.2.2015 |
Leflunomide ratiopharm |
ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
EU/1/10/654 |
10.2.2015 |
|
6.2.2015 |
Levetiracetam SUN |
Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland |
EU/1/11/741 |
10.2.2015 |
|
6.2.2015 |
Opgenra |
Olympus Biotech International Limited 40 Upper Mount Street, Dublin 2, Ireland |
EU/1/08/489 |
10.2.2015 |
|
6.2.2015 |
Raloxifene Teva |
Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland |
EU/1/10/627 |
11.2.2015 |
|
6.2.2015 |
Vimpat |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
EU/1/08/470 |
10.2.2015 |
|
6.2.2015 |
Zarzio |
Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich |
EU/1/08/495 |
10.2.2015 |
|
10.2.2015 |
Replagal |
Shire Human Genetic Therapies AB Svärdvägen 11D, SE-182 33 Danderyd, Sverige |
EU/1/01/189 |
12.2.2015 |
|
10.2.2015 |
Telmisartan Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/09/610 |
12.2.2015 |
|
10.2.2015 |
Telmisartan Teva Pharma |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/11/719 |
12.2.2015 |
|
10.2.2015 |
Tybost |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/13/872 |
12.2.2015 |
|
11.2.2015 |
Champix |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/06/360 |
13.2.2015 |
|
11.2.2015 |
HBVAXPRO |
Sanofi Pasteur MSD, SNC 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/01/183 |
13.2.2015 |
|
11.2.2015 |
Hepsera |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/03/251 |
13.2.2015 |
|
11.2.2015 |
Olanzapine Apotex |
Apotex Europe B.V. Darwinweg 20, NL-2333 CR Leiden, Nederland |
EU/1/10/635 |
16.2.2015 |
|
11.2.2015 |
Ribavirin Mylan |
Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |
EU/1/10/634 |
13.2.2015 |
|
11.2.2015 |
Somavert |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/02/240 |
13.2.2015 |
|
11.2.2015 |
Tyverb |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/07/440 |
13.2.2015 |
|
11.2.2015 |
Vitekta |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/13/883 |
13.2.2015 |
|
11.2.2015 |
Zoledronic acid Hospira |
Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |
EU/1/12/800 |
13.2.2015 |
|
12.2.2015 |
Esbriet |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/11/667 |
16.2.2015 |
|
17.2.2015 |
Arzerra |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/10/625 |
19.2.2015 |
|
17.2.2015 |
Lantus |
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland |
EU/1/00/134 |
19.2.2015 |
|
17.2.2015 |
Oprymea |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/08/469 |
19.2.2015 |
|
17.2.2015 |
Optisulin |
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland |
EU/1/00/133 |
19.2.2015 |
|
17.2.2015 |
Renagel |
Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland |
EU/1/99/123 |
19.2.2015 |
|
17.2.2015 |
Sutent |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/06/347 |
19.2.2015 |
|
17.2.2015 |
Vidaza |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom |
EU/1/08/488 |
19.2.2015 |
|
19.2.2015 |
Abilify |
Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |
EU/1/04/276 |
23.2.2015 |
|
19.2.2015 |
EVARREST |
Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, B-1831 Diegem, België |
EU/1/13/868 |
23.2.2015 |
|
19.2.2015 |
Fertavid |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/09/510 |
23.2.2015 |
|
19.2.2015 |
Memantine Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/13/880 |
23.2.2015 |
|
19.2.2015 |
Mixtard |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/02/231 |
23.2.2015 |
|
19.2.2015 |
NeuroBloc |
Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
EU/1/00/166 |
23.2.2015 |
|
19.2.2015 |
Revlimid |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/07/391 |
23.2.2015 |
|
19.2.2015 |
Reyataz |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/03/267 |
23.2.2015 |
|
19.2.2015 |
RotaTeq |
Sanofi Pasteur MSD, SNC 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/06/348 |
23.2.2015 |
|
19.2.2015 |
Victrelis |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/11/704 |
23.2.2015 |
|
24.2.2015 |
Aloxi |
Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland |
EU/1/04/306 |
26.2.2015 |
|
24.2.2015 |
Eylea |
Bayer Pharma AG D-13342 Berlin, Deutschland |
EU/1/12/797 |
26.2.2015 |
|
24.2.2015 |
Hexacima |
Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France |
EU/1/13/828 |
26.2.2015 |
|
24.2.2015 |
Hexyon |
Sanofi Pasteur MSD, SNC 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/13/829 |
26.2.2015 |
|
26.2.2015 |
Abraxane |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom |
EU/1/07/428 |
2.3.2015 |
|
26.2.2015 |
Bosulif |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/13/818 |
2.3.2015 |
|
26.2.2015 |
Brimica Genuair |
Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España |
EU/1/14/963 |
2.3.2015 |
|
26.2.2015 |
Duaklir Genuair |
Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España |
EU/1/14/964 |
2.3.2015 |
|
26.2.2015 |
Epivir |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/96/015 |
2.3.2015 |
|
26.2.2015 |
Lysodren |
Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France |
EU/1/04/273 |
2.3.2015 |
|
26.2.2015 |
Prevenar 13 |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/09/590 |
2.3.2015 |
|
26.2.2015 |
Yellox |
PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 Česká republika |
EU/1/11/692 |
2.3.2015 |
|
26.2.2015 |
Ziagen |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/99/112 |
2.3.2015 |
— Odňatie povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004)
|
Dátum rozhodnutia |
Názov lieku |
Držiteľ povolenia na uvedenie na trh |
Číslo záznamu v registri Spoločenstva |
Dátum oznámenia |
|
11.2.2015 |
Pumarix |
GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique |
EU/1/10/664 |
13.2.2015 |
— Udelenie povolenia na uvedenie na trh (článok 38 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004): Prijaté
|
Dátum rozhodnutia |
Názov lieku |
INN (medzinárodný neregistrovaný názov) |
Držiteľ povolenia na uvedenie na trh |
Číslo záznamu v registri Spoločenstva |
Lieková forma |
Kód ATC (anatomicko-terapeuticko-chemický kód) |
Dátum oznámenia |
|
6.2.2015 |
Zulvac SBV |
Inaktivovaný Schmallenbergský vírus, kmeň BH80/11-4 |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/14/178 |
Injekčná suspenzia |
QI02AA |
10.2.2015 |
— Zmena povolenia na uvedenie na trh (článok 38 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004): Prijaté
|
Dátum rozhodnutia |
Názov lieku |
Držiteľ povolenia na uvedenie na trh |
Číslo záznamu v registri Spoločenstva |
Dátum oznámenia |
|
17.2.2015 |
BTVPUR AlSap 1 |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/10/112 |
19.2.2015 |
|
17.2.2015 |
BTVPUR AlSap 1-8 |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/10/113 |
19.2.2015 |
|
19.2.2015 |
Nobivac Myxo-RHD |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/11/132 |
23.2.2015 |
|
26.2.2015 |
CERTIFECT |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/11/125 |
2.3.2015 |
|
26.2.2015 |
ECOPORC SHIGA |
IDT Biologika GmbH Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland |
EU/2/13/149 |
2.3.2015 |
Ak sa chcete oboznámiť s verejnou hodnotiacou správou o príslušných liekoch a s ňou súvisiacimi rozhodnutiami, môžete kontaktovať:
|
The European Medicines Agency |
|
30, Churchill Place, Canary Wharf |
|
UK – LONDON E14 5EU |
(1) Ú. v. EÚ L 136, 30.4.2004, s. 1.