ISSN 1977-1045
Uradni list
Evropske unije
C 116
Slovenska izdaja
Informacije in objave
Zvezek 59
1. april 2016
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ISSN 1977-1045 |
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Uradni list Evropske unije |
C 116 |
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Slovenska izdaja |
Informacije in objave |
Zvezek 59 |
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Obvestilo št. |
Vsebina |
Stran |
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IV Informacije |
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INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE |
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Evropska komisija |
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2016/C 116/01 |
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SL |
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IV Informacije
INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE
Evropska komisija
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1.4.2016 |
SL |
Uradni list Evropske unije |
C 116/1 |
Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. februarja 2016 do 29. februarja 2016
(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta (1))
(2016/C 116/01)
— Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena
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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 |
|
2.2.2016 |
TAGRISSO |
osimertinib |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/16/1086 |
Filmsko obložene tablete |
L01XE35 |
4.2.2016 |
|
11.2.2016 |
Caspofungin Accord |
kaspofungin |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/15/1081 |
Prašek za koncentrat za raztopino za infundiranje |
J02AX04 |
15.2.2016 |
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15.2.2016 |
Portrazza |
necitumumab |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland |
EU/1/15/1084 |
Koncentrat za raztopino za infundiranje |
L01XC22 |
18.2.2016 |
|
15.2.2016 |
Vaxelis |
Konjugirano cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno, komponentno), hepatitisu B (rekombinantno), otroški paralizi (inaktivirano) in hemofilusu tipa b (adsorbirano) |
Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/15/1079 |
Suspenzija za injiciranje |
J07CA09 |
17.2.2016 |
|
18.2.2016 |
Feraccru |
železov maltol |
Iron Therapeutics (UK) Ltd Gateshead Quays, NE8 3DF, United Kingdom |
EU/1/15/1075 |
Kapsula, trda |
B03AB10 |
22.2.2016 |
|
18.2.2016 |
Iblias |
oktokog alfa |
Bayer Pharma AG D-13342 Berlin, Deutschland |
EU/1/15/1077 |
Prašek in vehikel za raztopino za injiciranje |
B02BD02 |
22.2.2016 |
|
18.2.2016 |
Kovaltry |
oktokog alfa |
Bayer Pharma AG D-13342 Berlin, Deutschland |
EU/1/15/1076 |
Prašek in vehikel za raztopino za injiciranje |
B02BD02 |
22.2.2016 |
|
18.2.2016 |
Zurampic |
lesinurad |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/15/1080 |
Filmsko obložene tablete |
M04AB05 |
22.2.2016 |
— 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 |
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8.2.2016 |
Hepsera |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/03/251 |
10.2.2016 |
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8.2.2016 |
Irbesartan Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/09/576 |
10.2.2016 |
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8.2.2016 |
Iscover |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/98/070 |
10.2.2016 |
|
8.2.2016 |
Methylthioninium chloride Proveblue |
Provepharm S.A.S. 22 Rue Marc Donadille, 13013 Marseille, France |
EU/1/11/682 |
10.2.2016 |
|
8.2.2016 |
Plavix |
Sanofi Clir SNC 54 rue La Boétie, F-75008 Paris, France |
EU/1/98/069 |
10.2.2016 |
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8.2.2016 |
Zoledronic acid Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/13/834 |
10.2.2016 |
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11.2.2016 |
Sevelamer carbonate Zentiva |
Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland |
EU/1/14/952 |
15.2.2016 |
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11.2.2016 |
Simbrinza |
Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |
EU/1/14/933 |
15.2.2016 |
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11.2.2016 |
Sutent |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/06/347 |
15.2.2016 |
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11.2.2016 |
Truvada |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/04/305 |
15.2.2016 |
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11.2.2016 |
Vitekta |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/13/883 |
15.2.2016 |
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11.2.2016 |
Xigduo |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/13/900 |
15.2.2016 |
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11.2.2016 |
Zoledronska kislina Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/12/771 |
15.2.2016 |
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11.2.2016 |
Zostavax |
Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/06/341 |
15.2.2016 |
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11.2.2016 |
Zydelig |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/14/938 |
15.2.2016 |
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15.2.2016 |
Latuda |
Sunovion Pharmaceuticals Europe Ltd First Floor, Southside, 97-105 Victoria Street, London SW1E 6QT, United Kingdom |
EU/1/14/913 |
17.2.2016 |
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15.2.2016 |
Rivastigmine Actavis |
Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland |
EU/1/11/693 |
17.2.2016 |
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18.2.2016 |
Aldara |
Meda AB Pipers väg 2A, SE-170 73 Solna, Sverige |
EU/1/98/080 |
22.2.2016 |
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18.2.2016 |
Benlysta |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/11/700 |
22.2.2016 |
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18.2.2016 |
Biopoin |
Teva GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
EU/1/09/565 |
22.2.2016 |
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18.2.2016 |
Brilique |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/10/655 |
22.2.2016 |
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18.2.2016 |
BYDUREON |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/11/696 |
22.2.2016 |
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18.2.2016 |
Hizentra |
CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland |
EU/1/11/687 |
22.2.2016 |
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18.2.2016 |
Lamivudine Teva Pharma B.V. |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/09/596 |
22.2.2016 |
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18.2.2016 |
Lojuxta |
Aegerion Pharmaceuticals Limited Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom |
EU/1/13/851 |
22.2.2016 |
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18.2.2016 |
Methylthioninium chloride Proveblue |
Provepharm S.A.S. 22 Rue Marc Donadille, 13013 Marseille, France |
EU/1/11/682 |
22.2.2016 |
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18.2.2016 |
Mycophenolate mofetil Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/07/439 |
22.2.2016 |
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18.2.2016 |
Myfenax |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/07/438 |
22.2.2016 |
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18.2.2016 |
NULOJIX |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/11/694 |
22.2.2016 |
|
18.2.2016 |
TOBI Podhaler |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/10/652 |
22.2.2016 |
|
18.2.2016 |
Trajenta |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/11/707 |
22.2.2016 |
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18.2.2016 |
Victrelis |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/11/704 |
22.2.2016 |
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22.2.2016 |
Azilect |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/04/304 |
24.2.2016 |
|
22.2.2016 |
Constella |
Allergan Pharmaceuticals International Ltd. Clonshaugh Business & Technology Park Coolock Dublin D17 E400, Ireland |
EU/1/12/801 |
24.2.2016 |
|
22.2.2016 |
Eporatio |
ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
EU/1/09/573 |
24.2.2016 |
|
22.2.2016 |
Fasturtec |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/00/170 |
24.2.2016 |
|
22.2.2016 |
Herceptin |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/00/145 |
24.2.2016 |
|
22.2.2016 |
Ketoconazole HRA |
Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France |
EU/1/14/965 |
24.2.2016 |
|
22.2.2016 |
Scintimun |
CIS bio international Boîte postale 32, F-91192 Gif-sur-Yvette, France |
EU/1/09/602 |
24.2.2016 |
|
22.2.2016 |
Tygacil |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/06/336 |
24.2.2016 |
|
22.2.2016 |
Vizarsin |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/09/551 |
24.2.2016 |
|
22.2.2016 |
Zolendronska kislina Mylan |
Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France |
EU/1/12/786 |
24.2.2016 |
|
24.2.2016 |
Afinitor |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/538 |
26.2.2016 |
|
24.2.2016 |
Brintellix |
H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark |
EU/1/13/891 |
26.2.2016 |
|
24.2.2016 |
Firdapse |
BioMarin Europe Ltd. 10 Bloomsbury Way, London WC1A 2SL, United Kingdom |
EU/1/09/601 |
26.2.2016 |
|
24.2.2016 |
Odomzo |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/15/1030 |
26.2.2016 |
|
24.2.2016 |
Peyona |
Chiesi Farmaceutici S.P.A. Via Palermo 26/A, 43122 Parma, Italia |
EU/1/09/528 |
26.2.2016 |
|
24.2.2016 |
Ravicti |
Horizon Pharma Ireland Limited Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland |
EU/1/15/1062 |
3.3.2016 |
|
24.2.2016 |
Silodyx |
Recordati Ireland Ltd Raheens East, Ringaskiddy Co. Cork, Ireland |
EU/1/09/607 |
26.2.2016 |
|
24.2.2016 |
Stribild |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/13/830 |
26.2.2016 |
|
24.2.2016 |
Vylaer Spiromax |
Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland |
EU/1/14/949 |
26.2.2016 |
|
24.2.2016 |
Xultophy |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/14/947 |
26.2.2016 |
|
25.2.2016 |
Cerdelga |
Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland |
EU/1/14/974 |
1.3.2016 |
|
26.2.2016 |
Bridion |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/08/466 |
1.3.2016 |
|
26.2.2016 |
Clopidogrel/Acetylsalicylic acid Zentiva (ex DuoCover) |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/10/623 |
1.3.2016 |
|
26.2.2016 |
Jentadueto |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/12/780 |
1.3.2016 |
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26.2.2016 |
PREZISTA |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/06/380 |
1.3.2016 |
|
26.2.2016 |
Urorec |
Recordati Ireland Ltd Raheens East, Ringaskiddy Co. Cork, Ireland |
EU/1/09/608 |
1.3.2016 |
|
26.2.2016 |
Vibativ |
Clinigen Healthcare Limited Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom |
EU/1/11/705 |
2.3.2016 |
|
26.2.2016 |
Viread |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/01/200 |
1.3.2016 |
— Ukinitev dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)
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Datum sprejetja sklepa |
Ime zdravila |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Datum obvestila |
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24.2.2016 |
Kepivance |
Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sverige |
EU/1/05/314 |
29.2.2016 |
— Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena
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Datum sprejetja sklepa |
Ime zdravila |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Datum obvestila |
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10.2.2016 |
Zactran |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/08/082 |
12.2.2016 |
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25.2.2016 |
Activyl Tick Plus |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/11/137 |
29.2.2016 |
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25.2.2016 |
Vectra 3D |
CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France |
EU/2/13/156 |
29.2.2016 |
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25.2.2016 |
Vectra Felis |
CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France |
EU/2/14/165 |
29.2.2016 |
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26.2.2016 |
Econor |
Elanco Europe Ltd. Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom |
EU/2/98/010 |
1.3.2016 |
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26.2.2016 |
Trifexis |
Eli Lilly and Company Ltd, Elanco Animal Health Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom |
EU/2/13/155 |
1.3.2016 |
Kdor želi dobiti vpogled v javno poročilo o oceni zadevnih zdravil ter o zadevnih sklepih o zdravilih, se lahko obrne na naslov:
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European Medicines Agency |
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30 Churchill Place |
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Canary Wharf |
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London E14 5EU |
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United Kingdom |
(1) UL L 136, 30.4.2004, str. 1.