|
30.10.2015 |
HR |
Službeni list Europske unije |
C 361/1 |
Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. rujna 2015. do 30. rujna 2015.
(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1))
(2015/C 361/01)
— Izdavanje odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno
|
Datum odluke |
Naziv lijeka |
INN (medunarodni nezašticeni naziv lijeka) |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Farmaceutski oblik |
Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) |
Datum obavijesti |
|
8.9.2015. |
Ivabradine Anpharm |
ivabradin |
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A. ul. Annopol 6B, 03–236 Warszawa, Polska |
EU/1/15/1041 |
Filmom obložena tableta |
C01EB17 |
10.9.2015. |
|
8.9.2015. |
Raxone |
idebenon |
Santhera Pharmaceuticals (Deutschland) GmbH Marie-Curie Strasse 8, 79539 Lörrach, Deutschland |
EU/1/15/1020 |
Filmom obložena tableta |
N07 |
10.9.2015. |
|
14.9.2015. |
Pemetrexed Lilly |
pemetreksed |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland |
EU/1/15/1034 |
Primjena u venu |
L01BA04 |
16.9.2015. |
|
17.9.2015. |
Intuniv |
gvanfacin |
Shire Pharmaceuticals Ireland Limited 5 River Walk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/15/1040 |
Tablete s produženim oslobađanjem |
C02AC02 |
21.9.2015. |
|
18.9.2015. |
Pemetrexed Sandoz |
pemetreksed |
Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich |
EU/1/15/1037 |
Prašak za koncentrat za otopinu za infuziju |
L01BA04 |
23.9.2015. |
|
18.9.2015. |
Zalviso |
Sufentanil |
Grünenthal GmbH Zieglerstrasse 6, D-52078, Aachen, Deutschland |
EU/1/15/1042 |
Sublingvalno |
N01AH03 |
22.9.2015. |
|
18.9.2015. |
Zerbaxa |
ceftolozan/tazobaktam |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/15/1032 |
Prašak za koncentrat za otopinu za infuziju |
J01DI54 |
22.9.2015. |
|
23.9.2015. |
Fexeric |
ijzercitraat-coördinatiecomplex |
Keryx Biopharma UK Ltd. Riverbank House, 2 Swan Lane, London, EC4R 3TT, United Kingdom |
EU/1/15/1039 |
Filmom obložena tableta |
V03AE |
28.9.2015. |
|
23.9.2015. |
Praluent |
alirokumab |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Pariz, France |
EU/1/15/1031 |
Otopina za injekciju |
C10 |
25.9.2015. |
— Izmjena odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno
|
Datum odluke |
Naziv lijeka |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Datum obavijesti |
|
8.9.2015. |
ATryn |
GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Kingdom |
EU/1/06/355 |
10.9.2015. |
|
8.9.2015. |
Daklinza |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/14/939 |
10.9.2015. |
|
8.9.2015. |
Ebixa |
H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark |
EU/1/02/219 |
10.9.2015. |
|
8.9.2015. |
Enbrel |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/99/126 |
10.9.2015. |
|
8.9.2015. |
Esbriet |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/11/667 |
10.9.2015. |
|
8.9.2015. |
Extavia |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/08/454 |
10.9.2015. |
|
8.9.2015. |
Grastofil |
Apotex Europe B.V. Darwinweg 20, NL- 2333 CR Leiden, Nederland |
EU/1/13/877 |
10.9.2015. |
|
8.9.2015. |
Hirobriz Breezhaler |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/594 |
10.9.2015. |
|
8.9.2015. |
Plegridy |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
EU/1/14/934 |
10.9.2015. |
|
8.9.2015. |
Xofigo |
Bayer Pharma AG D-13342 Berlin, Deutschland |
EU/1/13/873 |
10.9.2015. |
|
8.9.2015. |
Xyrem |
UCB Pharma Ltd 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom |
EU/1/05/312 |
10.9.2015. |
|
10.9.2015. |
ADCETRIS |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/12/794 |
14.9.2015. |
|
14.9.2015. |
Betmiga |
Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland |
EU/1/12/809 |
16.9.2015. |
|
14.9.2015. |
Elaprase |
Shire Human Genetic Therapies AB Svärdvägen 11D, SE-182 33 Danderyd, Sverige |
EU/1/06/365 |
16.9.2015. |
|
14.9.2015. |
Quinsair |
Aptalis Pharma SAS Route de Bû, F-78550 Houdan, France |
EU/1/14/973 |
16.9.2015. |
|
18.9.2015. |
Evoltra |
Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland |
EU/1/06/334 |
22.9.2015. |
|
18.9.2015. |
Iclusig |
ARIAD Pharma Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom |
EU/1/13/839 |
22.9.2015. |
|
18.9.2015. |
Imvanex |
Bavarian Nordic A/S Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark |
EU/1/13/855 |
22.9.2015. |
|
18.9.2015. |
INOmax |
Linde Healthcare AB SE-181 81 Lidingö, Sverige |
EU/1/01/194 |
22.9.2015. |
|
18.9.2015. |
Metalyse |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/00/169 |
22.9.2015. |
|
18.9.2015. |
Perjeta |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/13/813 |
22.9.2015. |
|
18.9.2015. |
Ruconest |
Pharming Group N.V. Darwinweg 24, NL-2333 CR Leiden, Nederland |
EU/1/10/641 |
22.9.2015. |
|
18.9.2015. |
Sebivo |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/07/388 |
22.9.2015. |
|
18.9.2015. |
Spedra |
Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg |
EU/1/13/841 |
22.9.2015. |
|
18.9.2015. |
TachoSil |
Takeda Austria GmbH St.-Peter-Strasse 25, A-4020 Linz, Österreich |
EU/1/04/277 |
22.9.2015. |
|
18.9.2015. |
Visudyne |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/00/140 |
22.9.2015. |
|
23.9.2015. |
Ilaris |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/564 |
28.10.2015. |
|
23.9.2015. |
Inflectra |
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom |
EU/1/13/854 |
25.9.2015. |
|
23.9.2015. |
Toviaz |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/07/386 |
25.9.2015. |
|
23.9.2015. |
Trajenta |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/11/707 |
25.9.2015. |
|
23.9.2015. |
Viagra |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/98/077 |
28.9.2015. |
|
30.9.2015. |
Arixtra |
Aspen Pharma Trading Limited 3016 Lake Drive Citywest Business Campus Dublin 24 Ireland |
EU/1/02/206 |
2.10.2015. |
|
30.9.2015. |
Iasibon |
Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |
EU/1/10/659 |
2.10.2015. |
|
30.9.2015. |
Sifrol |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/97/050 |
2.10.2015. |
|
30.9.2015. |
Vibativ |
Clinigen Healthcare Limited Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom |
EU/1/11/705 |
2.10.2015. |
— Povlačenje odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)
|
Datum odluke |
Naziv lijeka |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Datum obavijesti |
|
23.9.2015. |
Biograstim |
AbZ-Pharma GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
EU/1/08/450 |
25.9.2015. |
— Izdavanje odobrenja za stavljanje u promet (članak 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno
|
Datum odluke |
Naziv lijeka |
INN (medunarodni nezašticeni naziv lijeka) |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Farmaceutski oblik |
Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) |
Datum obavijesti |
|
8.9.2015. |
FORTEKOR PLUS |
pimobendan/benazepril |
Elanco Europe Ltd. Lilly House, Priestley Road, Basingstoke, Hampshire, RG 24 9NL, United Kingdom |
EU/2/15/185 |
Tableta |
QC09BX90 |
10.9.2015. |
|
8.9.2015. |
Novaquin |
meloksikam |
Le Vet Beheer B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland |
EU/2/15/186 |
Peroralna suspenzija |
QM01AC06 |
10.9.2015. |
|
8.9.2015. |
Vectormune ND |
Stanično vezani živi rekombinantni herpesvirus purana (rHVT/ND) izražen kao fuzijski protein lentogenog soja virusa D-26 newcastleske bolesti |
CEVA-Phylaxia Co. Ltd. Budapest, Szállás u. 5, 1107 MAGYARORSZÁG |
EU/2/15/188 |
Suspenzija i otapalo za suspenziju za injekciju |
QI01AD |
10.9.2015. |
— Izmjena odobrenja za stavljanje u promet (članak 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno
|
Datum odluke |
Naziv lijeka |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Datum obavijesti |
|
8.9.2015. |
BTVPUR AlSap 1 |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/10/112 |
10.9.2015. |
|
8.9.2015. |
BTVPUR AlSap 1-8 |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/10/113 |
10.9.2015. |
|
8.9.2015. |
Meloxoral |
Le Vet B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland |
EU/2/10/111 |
10.9.2015. |
|
18.9.2015. |
Onsior |
Elanco Europe Ltd. Lilly House, Priestley Road, Basingstoke, Hampshire, RG 24 9NL, United Kingdom |
EU/2/08/089 |
22.9.2015. |
Zainteresirane osobe koje žele na uvid dobiti javno izvješće o procjeni predmetnih lijekova i odluka koje se na njih odnose trebale bi se obratiti:
|
The European Medicines Agency |
|
7, Westferry Circus, Canary Wharf |
|
UK – LONDON E14 4H |
(1) SL L 136, 30.4.2004., str. 1.