|
28.3.2018 |
DA |
Den Europæiske Unions Tidende |
C 115/1 |
Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. februar 2018 til 28. februar 2018
(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004 (1))
(2018/C 115/01)
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— |
Udstedelse af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt |
|
Dato for afgørelser |
Lægemidlets navn |
INN-navn (International Non-Proprietary Name) |
Indehaver af markedsføringstilladelsen |
Nummer i EF-registret |
Lægemiddelform |
ATC-kode (Anatomical Therapeutic Chemical Code) |
Dato for notifikation |
|
8.2.2018 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka |
efavirenz / emtricitabin / tenofovirdisoproxil |
Krka d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/17/1263 |
Filmovertrukket tablet |
J05AR06 |
12.2.2018 |
|
8.2.2018 |
Ozempic |
semaglutid |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark |
EU/1/17/1251 |
Injektionsvœske, opløsning |
A10BJ06 |
12.2.2018 |
|
9.2.2018 |
Alkindi |
hydrokortison |
Diurnal Ltd Cardiff Medicentre, Heath Park, Cardiff CF14 4UJ, United Kingdom |
EU/1/17/1260 |
Granulat i kapsler, der skal åbnes |
H02AB09 |
13.2.2018 |
|
9.2.2018 |
Herzuma |
trastuzumab |
Celltrion Healthcare Hungary Kft. Bajcsy-Zsilinszky út 12., 4. em. 410, 1051 Budapest, Magyarország |
EU/1/17/1257 |
Pulver til koncentrat til infusionsvæske, opløsning |
L01XC03 |
13.2.2018 |
|
15.2.2018 |
Anagrelide Mylan |
anagrelid |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/17/1256 |
Kapsler, hårde |
L01XX35 |
19.2.2018 |
|
19.2.2018 |
CRYSVITA |
Burosumab |
Kyowa Kirin Limited Galabank Business Park, Galashiels, TD1 1QH, United Kingdom |
EU/1/17/1262 |
Injektionsvœske, opløsning |
M05BX |
21.2.2018 |
|
23.2.2018 |
Hemlibra |
emicizumab |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/18/1271 |
Injektionsvœske, opløsning |
B02BX06 |
27.2.2018 |
|
— |
Ændring af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt |
|
Dato for afgørelser |
Lægemidlets navn |
Indehaver af markedsføringstilladelsen |
Nummer i EF-registret |
Dato for notifikation |
|
5.2.2018 |
Ebilfumin |
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |
EU/1/14/915 |
7.2.2018 |
|
5.2.2018 |
Episalvan |
Amryt AG Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland |
EU/1/15/1069 |
8.2.2018 |
|
5.2.2018 |
NULOJIX |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/11/694 |
7.2.2018 |
|
5.2.2018 |
Pedea |
Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France |
EU/1/04/284 |
8.2.2018 |
|
5.2.2018 |
Pregabalin Sandoz |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/15/1011 |
7.2.2018 |
|
5.2.2018 |
Pregabalin Sandoz GmbH |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/15/1012 |
7.2.2018 |
|
5.2.2018 |
PREZISTA |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/06/380 |
7.2.2018 |
|
5.2.2018 |
Truvada |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/04/305 |
7.2.2018 |
|
5.2.2018 |
Vedrop |
Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France |
EU/1/09/533 |
8.2.2018 |
|
8.2.2018 |
Bosulif |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/13/818 |
12.2.2018 |
|
8.2.2018 |
Daptomycin Hospira |
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom |
EU/1/17/1175 |
12.2.2018 |
|
8.2.2018 |
Esbriet |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/11/667 |
12.2.2018 |
|
8.2.2018 |
Exforge |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/06/370 |
12.2.2018 |
|
8.2.2018 |
Iclusig |
Incyte Biosciences UK Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom |
EU/1/13/839 |
12.2.2018 |
|
8.2.2018 |
Methylthioniniumchlorid Proveblue |
Provepharm S.A.S. 22 rue Marc Donadille, 13013 Marseille, France |
EU/1/11/682 |
15.2.2018 |
|
8.2.2018 |
OLYSIO |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/14/924 |
12.2.2018 |
|
8.2.2018 |
Rezolsta |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/14/967 |
12.2.2018 |
|
8.2.2018 |
Thalidomide Celgene |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/08/443 |
12.2.2018 |
|
8.2.2018 |
VELCADE |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/04/274 |
12.2.2018 |
|
8.2.2018 |
Victrelis |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/11/704 |
12.2.2018 |
|
8.2.2018 |
Voriconazole Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/13/835 |
12.2.2018 |
|
8.2.2018 |
Xtandi |
Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland |
EU/1/13/846 |
12.2.2018 |
|
9.2.2018 |
Caprelsa |
Genzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, Nederland |
EU/1/11/749 |
13.2.2018 |
|
9.2.2018 |
Cymbalta |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/04/296 |
13.2.2018 |
|
9.2.2018 |
Cystadane |
Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France |
EU/1/06/379 |
13.2.2018 |
|
9.2.2018 |
Entyvio |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/14/923 |
13.2.2018 |
|
9.2.2018 |
IMBRUVICA |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/14/945 |
13.2.2018 |
|
9.2.2018 |
Neuraceq |
Piramal Imaging Limited Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom |
EU/1/13/906 |
13.2.2018 |
|
9.2.2018 |
Ventavis |
Bayer Pharma AG D-13342 Berlin, Deutschland |
EU/1/03/255 |
13.2.2018 |
|
15.2.2018 |
Emselex |
Merus Labs Luxco II S.à R.L. 26-28, rue Edward Steichen, 2540 Luxembourg |
EU/1/04/294 |
19.2.2018 |
|
15.2.2018 |
Fosavance |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/05/310 |
19.2.2018 |
|
15.2.2018 |
Vantavo |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/09/572 |
19.2.2018 |
|
16.2.2018 |
Esmya |
Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország |
EU/1/12/750 |
20.2.2018 |
|
19.2.2018 |
Adcirca |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/08/476 |
21.2.2018 |
|
19.2.2018 |
Aerivio Spiromax |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/16/1122 |
21.2.2018 |
|
19.2.2018 |
Airexar Spiromax |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/16/1123 |
21.2.2018 |
|
19.2.2018 |
Anoro |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/14/898 |
21.2.2018 |
|
19.2.2018 |
Gardasil 9 |
MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/15/1007 |
21.2.2018 |
|
19.2.2018 |
Icandra |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/08/484 |
21.2.2018 |
|
19.2.2018 |
Lyrica |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/04/279 |
21.2.2018 |
|
19.2.2018 |
Mycamine |
Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland |
EU/1/08/448 |
21.2.2018 |
|
19.2.2018 |
Neulasta |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/02/227 |
21.2.2018 |
|
19.2.2018 |
Nucala |
GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland |
EU/1/15/1043 |
21.2.2018 |
|
19.2.2018 |
Olanzapine Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/07/427 |
21.2.2018 |
|
19.2.2018 |
Ongentys |
Bial — Portela & Ca, SA À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal |
EU/1/15/1066 |
22.2.2018 |
|
19.2.2018 |
Orkambi |
Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom |
EU/1/15/1059 |
21.2.2018 |
|
19.2.2018 |
PegIntron |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/00/131 |
21.2.2018 |
|
19.2.2018 |
Rebetol |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/99/107 |
21.2.2018 |
|
19.2.2018 |
Senshio |
Shionogi Limited 33 Kingsway, London WC2B 6UF, United Kingdom |
EU/1/14/978 |
21.2.2018 |
|
19.2.2018 |
Simulect |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/98/084 |
21.2.2018 |
|
19.2.2018 |
Talmanco |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/16/1153 |
21.2.2018 |
|
19.2.2018 |
Tenofovir disoproxil Mylan |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/16/1129 |
21.2.2018 |
|
19.2.2018 |
Vfend |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/02/212 |
21.2.2018 |
|
19.2.2018 |
ViraferonPeg |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/00/132 |
21.2.2018 |
|
19.2.2018 |
Wilzin |
Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France |
EU/1/04/286 |
21.2.2018 |
|
19.2.2018 |
Zyprexa Velotab |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/99/125 |
21.2.2018 |
|
22.2.2018 |
Dynastat |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/02/209 |
26.2.2018 |
|
22.2.2018 |
Eucreas |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/07/425 |
26.2.2018 |
|
22.2.2018 |
NutropinAq |
Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France |
EU/1/00/164 |
26.2.2018 |
|
22.2.2018 |
Trulicity |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/14/956 |
26.2.2018 |
|
22.2.2018 |
Zurampic |
Grünenthal GmbH Zieglerstraße 6, 52078, Aachen, Deutschland |
EU/1/15/1080 |
26.2.2018 |
|
27.2.2018 |
Abasaglar |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/14/944 |
1.3.2018 |
|
27.2.2018 |
Omnitrope |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/06/332 |
1.3.2018 |
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— |
Udstedelse af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt |
|
Dato for afgørelser |
Lægemidlets navn |
INN-navn (International Non-Proprietary Name) |
Indehaver af markedsføringstilladelsen |
Nummer i EF-registret |
Lægemiddelform |
ATC-kode (Anatomical Therapeutic Chemical Code) |
Dato for notifikation |
|
7.2.2018 |
Suvaxyn Circo |
Porcint circovirus vaccine (inaktiveret, rekombinant) |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/17/223 |
Injektionsvœske, emulsion |
QI09AA07 |
9.2.2018 |
|
— |
Ændring af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt |
|
Dato for afgørelser |
Lægemidlets navn |
Indehaver af markedsføringstilladelsen |
Nummer i EF-registret |
Dato for notifikation |
|
20.2.2018 |
Advocate |
Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland |
EU/2/03/039 |
22.2.2018 |
|
20.2.2018 |
Porcilis PCV |
Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/08/091 |
22.2.2018 |
|
20.2.2018 |
Porcilis PCV M Hyo |
Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/14/175 |
22.2.2018 |
|
20.2.2018 |
Vectormune ND |
CEVA-Phylaxia Co. Ltd. Szállás u. 5, 1107 Budapest, Magyarország |
EU/2/15/188 |
22.2.2018 |
Alle interesserede kan ved henvendelse på nedenstående adresse få tilsendt den offentlige evalueringsrapport om de pågældende lægemidler og de afgørelser, der er truffet vedrørende disse:
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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) EUT L 136 af 30.4.04, s. 1.