|
26.6.2015 |
SL |
Uradni list Evropske unije |
C 211/1 |
Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. maja 2015 do 31. maja 2015
(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta (1))
(2015/C 211/01)
— Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena
|
Datum sprejetja sklepa |
Ime zdravila |
INN (mednarodno nelastniško ime) |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Farmacevtska oblika |
ATC (anatomsko terapevtska kemijska oznaka) |
Datum obvestila |
|
6.5.2015 |
Zykadia |
ceritinib |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/15/999 |
Kapsula, trda |
L01XE |
8.5.2015 |
|
27.5.2015 |
Akynzeo |
netupitant/palonosetron |
Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland |
EU/1/15/1001 |
Kapsula, trda |
A04AA55 |
29.5.2015 |
|
27.5.2015 |
Jinarc |
tolvaptan |
Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |
EU/1/15/1000 |
Tableta |
Pending |
29.5.2015 |
|
27.5.2015 |
Synjardy |
empagliflozin/metmorfin |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/15/1003 |
Filmsko obložene tablete |
A10BD20 |
29.5.2015 |
|
27.5.2015 |
Vorikonazol Hospira |
vorikonazol |
Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |
EU/1/15/1004 |
Prašek za raztopino za infundiranje |
J02AC03 |
29.5.2015 |
|
28.5.2015 |
Lenvima |
lenvatinib |
Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom |
EU/1/15/1002 |
Kapsula, trda |
L01XE29 |
1.6.2015 |
— Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena
|
Datum sprejetja sklepa |
Ime zdravila |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Datum obvestila |
|
5.5.2015 |
Copalia |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/06/372 |
7.5.2015 |
|
5.5.2015 |
Copalia HCT |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/575 |
7.5.2015 |
|
5.5.2015 |
Dafiro |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/06/371 |
7.5.2015 |
|
5.5.2015 |
Dafiro HCT |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/574 |
7.5.2015 |
|
5.5.2015 |
Erivedge |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/13/848 |
8.5.2015 |
|
5.5.2015 |
Exforge |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/06/370 |
7.5.2015 |
|
5.5.2015 |
Exforge HCT |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/569 |
7.5.2015 |
|
5.5.2015 |
Imprida |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/06/373 |
7.5.2015 |
|
5.5.2015 |
INCRELEX |
Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France |
EU/1/07/402 |
7.5.2015 |
|
5.5.2015 |
Irbesartan/hidroklorotiazid Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/09/583 |
8.5.2015 |
|
5.5.2015 |
Orfadin |
Swedish Orphan Biovitrum International AB SE-112 76 Stockholm, Sverige |
EU/1/04/303 |
8.5.2015 |
|
5.5.2015 |
Sycrest |
Organon N.V. Kloosterstraat 6, NL-5349 AB Oss, Nederland |
EU/1/10/640 |
7.5.2015 |
|
5.5.2015 |
Tamiflu |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/02/222 |
8.5.2015 |
|
5.5.2015 |
Telzir |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/04/282 |
7.5.2015 |
|
5.5.2015 |
Tyverb |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/07/440 |
7.5.2015 |
|
5.5.2015 |
Voncento |
CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland |
EU/1/13/857 |
7.5.2015 |
|
5.5.2015 |
Votrient |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/10/628 |
7.5.2015 |
|
5.5.2015 |
Zoledronska kislina Teva Pharma |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/12/772 |
7.5.2015 |
|
5.5.2015 |
Zypadhera |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland |
EU/1/08/479 |
7.5.2015 |
|
6.5.2015 |
Arzerra |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/10/625 |
8.5.2015 |
|
6.5.2015 |
Celsentri |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/07/418 |
8.5.2015 |
|
6.5.2015 |
Celvapan |
Baxter AG Industriestraße 67, A-1221 Wien, Österreich |
EU/1/08/506 |
8.5.2015 |
|
6.5.2015 |
Clopidogrel Krka |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/09/556 |
8.5.2015 |
|
6.5.2015 |
Imatinib Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/12/808 |
8.5.2015 |
|
6.5.2015 |
Optaflu |
Novartis Influenza Vaccines Marburg GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland |
EU/1/07/394 |
8.5.2015 |
|
6.5.2015 |
Revolade |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/10/612 |
8.5.2015 |
|
6.5.2015 |
Tafinlar |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/13/865 |
8.5.2015 |
|
13.5.2015 |
Cayston |
Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom |
EU/1/09/543 |
19.5.2015 |
|
13.5.2015 |
Efficib |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/08/457 |
19.5.2015 |
|
13.5.2015 |
Granupas |
Lucane Pharma 172 rue de Charonne, 75011 Paris, France |
EU/1/13/896 |
19.5.2015 |
|
13.5.2015 |
Janumet |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/08/455 |
19.5.2015 |
|
13.5.2015 |
Leflunomide ratiopharm |
ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
EU/1/10/654 |
19.5.2015 |
|
13.5.2015 |
Luminity |
Lantheus MI UK Limited Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom |
EU/1/06/361 |
19.5.2015 |
|
13.5.2015 |
Memantine Merz |
Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland |
EU/1/12/799 |
19.5.2015 |
|
13.5.2015 |
Ovitrelle |
Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom |
EU/1/00/165 |
19.5.2015 |
|
13.5.2015 |
Trizivir |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/00/156 |
19.5.2015 |
|
13.5.2015 |
Velmetia |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/08/456 |
19.5.2015 |
|
13.5.2015 |
Vyndaqel |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/11/717 |
19.5.2015 |
|
27.5.2015 |
Aflunov |
Novartis Vaccines Influenza S.r.l. Via Fiorentina, 1, 53100 Siena, Italia |
EU/1/10/658 |
29.5.2015 |
|
27.5.2015 |
Ariclaim |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland |
EU/1/04/283 |
29.5.2015 |
|
27.5.2015 |
Brinavess |
Cardiome UK Limited Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom |
EU/1/10/645 |
29.5.2015 |
|
27.5.2015 |
Clopidogrel TAD |
TAD Pharma GmbH Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland |
EU/1/09/555 |
29.5.2015 |
|
27.5.2015 |
Cometriq |
TMC Pharma Services Ltd Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom |
EU/1/13/890 |
29.5.2015 |
|
27.5.2015 |
Cymbalta |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland |
EU/1/04/296 |
29.5.2015 |
|
27.5.2015 |
Erivedge |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/13/848 |
29.5.2015 |
|
27.5.2015 |
Esmya |
Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magyarország |
EU/1/12/750 |
29.5.2015 |
|
27.5.2015 |
Foclivia |
Novartis Vaccines Influenza S.r.l. Via Fiorentina, 1, 53100 Siena, Italia |
EU/1/09/577 |
29.5.2015 |
|
27.5.2015 |
Gardasil |
Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/06/357 |
29.5.2015 |
|
27.5.2015 |
Imnovid |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/13/850 |
29.5.2015 |
|
27.5.2015 |
INCRELEX |
Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France |
EU/1/07/402 |
29.5.2015 |
|
27.5.2015 |
Jentadueto |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/12/780 |
29.5.2015 |
|
27.5.2015 |
Levemir |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/04/278 |
29.5.2015 |
|
27.5.2015 |
Levetiracetam Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/11/712 |
29.5.2015 |
|
27.5.2015 |
Myclausen |
Herbert J. Passauer GmbH & Co. KG Stubenrauchstrasse 33, D-14167 Berlin, Deutschland |
EU/1/10/647 |
29.5.2015 |
|
27.5.2015 |
Nexium Control |
Pfizer Consumer Healthcare Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |
EU/1/13/860 |
29.5.2015 |
|
27.5.2015 |
Nivestim |
Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |
EU/1/10/631 |
29.5.2015 |
|
27.5.2015 |
Prepandrix |
GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique |
EU/1/08/453 |
29.5.2015 |
|
27.5.2015 |
Raloxifene Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/10/627 |
29.6.2015 |
|
27.5.2015 |
Relistor |
TMC Pharma Services Ltd Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom |
EU/1/08/463 |
29.5.2015 |
|
27.5.2015 |
Resolor |
Shire Pharmaceuticals Ireland Limited 5 River Walk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/09/581 |
29.5.2015 |
|
27.5.2015 |
Selincro |
H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark |
EU/1/12/815 |
29.5.2015 |
|
27.5.2015 |
Silgard |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/06/358 |
29.5.2015 |
|
27.5.2015 |
Sonata |
Meda AB Pipers väg 2A, S-170 09 Solna, Sverige |
EU/1/99/102 |
29.5.2015 |
|
27.5.2015 |
Sovaldi |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/13/894 |
29.5.2015 |
|
27.5.2015 |
Targretin |
Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
EU/1/01/178 |
29.5.2015 |
|
27.5.2015 |
Temodal |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/98/096 |
29.5.2015 |
|
27.5.2015 |
Temozolomide Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/10/615 |
29.5.2015 |
|
27.5.2015 |
Thalidomide Celgene |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/08/443 |
29.5.2015 |
|
27.5.2015 |
Tolucombi |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/13/821 |
29.5.2015 |
|
27.5.2015 |
Volibris |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/08/451 |
29.5.2015 |
|
27.5.2015 |
Xeristar |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland |
EU/1/04/297 |
29.5.2015 |
|
27.5.2015 |
Xtandi |
Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland |
EU/1/13/846 |
29.5.2015 |
|
27.5.2015 |
Yentreve |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland |
EU/1/04/280 |
29.5.2015 |
|
27.5.2015 |
Yondelis |
Pharma Mar S.A. Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España |
EU/1/07/417 |
29.5.2015 |
|
28.5.2015 |
Aclasta |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/05/308 |
1.6.2015 |
|
28.5.2015 |
alli |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/07/401 |
1.6.2015 |
|
28.5.2015 |
Dificlir |
Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland |
EU/1/11/733 |
1.6.2015 |
|
28.5.2015 |
Invega |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/07/395 |
1.6.2015 |
|
28.5.2015 |
Januvia |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/07/383 |
1.6.2015 |
|
28.5.2015 |
Lonquex |
UAB „Sicor Biotech“ Molėtų pl. 5, LT-08409 Vilnius, Lietuva |
EU/1/13/856 |
1.6.2015 |
|
28.5.2015 |
Ristaben |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/10/621 |
1.6.2015 |
|
28.5.2015 |
Topotecan Hospira |
Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |
EU/1/10/633 |
1.6.2015 |
|
28.5.2015 |
Tygacil |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/06/336 |
1.6.2015 |
— Ukinitev dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)
|
Datum sprejetja sklepa |
Ime zdravila |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Datum obvestila |
|
5.5.2015 |
Clopidogrel DURA |
Mylan dura GmbH Wittichstraße 6, D-64295 Darmstadt, Deutschland |
EU/1/09/560 |
7.5.2015 |
|
6.5.2015 |
Provenge |
Dendreon UK Limited 41 Chalton Street, London NW1 1JD, United Kingdom |
EU/1/13/867 |
8.5.2015 |
— Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena
|
Datum sprejetja sklepa |
Ime zdravila |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Datum obvestila |
|
5.5.2015 |
Cepivo MS-H |
Pharmsure International Ltd Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom |
EU/2/11/126 |
7.5.2015 |
|
5.5.2015 |
Purevax RCP |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/04/052 |
7.5.2015 |
|
13.5.2015 |
Nobilis IB 4-91 |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/98/006 |
19.5.2015 |
|
13.5.2015 |
Rheumocam |
Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland |
EU/2/07/078 |
19.5.2015 |
|
27.5.2015 |
Meloxivet |
Eli Lilly and Company Limited Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom |
EU/2/07/077 |
29.5.2015 |
|
27.5.2015 |
Purevax FeLV |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/00/019 |
29.5.2015 |
|
27.5.2015 |
Purevax RCPCh |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/04/050 |
29.5.2015 |
|
27.5.2015 |
Suprelorin |
VIRBAC S.A. 1ère Avenue – 2065 m – L.I.D., F-06516 Carros Cedex, France |
EU/2/07/072 |
29.5.2015 |
Kdor želi dobiti vpogled v javno poročilo o oceni zadevnih zdravil ter o zadevnih sklepih o zdravilih, se lahko obrne na naslov:
|
The European Medicines Agency |
|
30, Churchill Place, Canary Wharf |
|
UK – LONDON E14 5EU |
(1) UL L 136, 30.4.2004, str. 1.