ISSN 1977-091X
Official Journal
of the European Union
C 188
English edition
Information and Notices
Volume 61
1 June 2018
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ISSN 1977-091X |
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Official Journal of the European Union |
C 188 |
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English edition |
Information and Notices |
Volume 61 |
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Contents |
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IV Notices |
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NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
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European Commission |
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2018/C 188/01 |
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EN |
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IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
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1.6.2018 |
EN |
Official Journal of the European Union |
C 188/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2018 to 30 April 2018
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2018/C 188/01)
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— |
Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
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Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
|
13.4.2018 |
Alpivab |
peramivir |
BioCryst UK Ltd c/o Morgan Lewis & Bockius, Condor House, 5-10 St. Paul’s Churchyard, London EC4M 8AL, United Kingdom |
EU/1/18/1269 |
Concentrate for solution for infusion |
J05AH03 |
17.4.2018 |
|
19.4.2018 |
Mylotarg |
gemtuzumab ozogamicin |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/18/1277 |
Powder for concentrate for solution for infusion |
L01XC05 |
23.4.2018 |
|
23.4.2018 |
Riarify |
beclometasone/formoterol/glycopyrronium bromide |
Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia |
EU/1/18/1275 |
Pressurised inhalation, solution |
R03AL |
26.4.2018 |
|
26.4.2018 |
Trydonis |
beclometasone/formoterol/glycopyrronium bromide |
Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia |
EU/1/18/1274 |
Pressurised inhalation, solution |
R03AL |
2.5.2018 |
|
— |
Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected |
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
|
6.4.2018 |
EnCyzix |
Renable Pharma Limited 20-22 Bedford Row, London WC1R 4JS, United Kingdom |
— |
23.4.2018 |
|
— |
Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
|
4.4.2018 |
Bondronat |
Atnahs Pharma UK Limited Sovereign House Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom |
EU/1/96/012 |
6.4.2018 |
|
4.4.2018 |
Bonviva |
Atnahs Pharma UK Limited Sovereign House Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom |
EU/1/03/265 |
6.4.2018 |
|
4.4.2018 |
Esbriet |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/11/667 |
6.4.2018 |
|
4.4.2018 |
Kinzalmono |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/98/091 |
6.4.2018 |
|
4.4.2018 |
Lacosamide Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/17/1230 |
6.4.2018 |
|
4.4.2018 |
Lumark |
IDB Holland B.V. Weverstraat 17, 5111 PV Baarle-Nassau, Nederland |
EU/1/15/1013 |
6.4.2018 |
|
4.4.2018 |
Marixino |
KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/13/820 |
6.4.2018 |
|
4.4.2018 |
Pandemic influenza vaccine H5N1 AstraZeneca |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/16/1089 |
6.4.2018 |
|
4.4.2018 |
Tecentriq |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/17/1220 |
6.4.2018 |
|
6.4.2018 |
Fuzeon |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/03/252 |
10.4.2018 |
|
6.4.2018 |
Gazyvaro |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/14/937 |
10.4.2018 |
|
6.4.2018 |
Herceptin |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/00/145 |
10.4.2018 |
|
6.4.2018 |
Kineret |
Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige |
EU/1/02/203 |
10.4.2018 |
|
6.4.2018 |
Revolade |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/10/612 |
10.4.2018 |
|
6.4.2018 |
RoActemra |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/08/492 |
10.4.2018 |
|
6.4.2018 |
Tamiflu |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/02/222 |
10.4.2018 |
|
6.4.2018 |
Tarceva |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/05/311 |
10.4.2018 |
|
6.4.2018 |
Zelboraf |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/12/751 |
10.4.2018 |
|
12.4.2018 |
Actraphane |
Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark |
EU/1/02/229 |
16.4.2018 |
|
12.4.2018 |
Actrapid |
Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark |
EU/1/02/230 |
16.4.2018 |
|
12.4.2018 |
Azopt |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/00/129 |
16.4.2018 |
|
12.4.2018 |
Extavia |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/08/454 |
16.4.2018 |
|
12.4.2018 |
Farydak |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/15/1023 |
16.4.2018 |
|
12.4.2018 |
Ferriprox |
Apotex Europe B.V. Darwinweg 20, 2333 CR Leiden, Nederland |
EU/1/99/108 |
16.4.2018 |
|
12.4.2018 |
Fiasp |
Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark |
EU/1/16/1160 |
16.4.2018 |
|
12.4.2018 |
Forxiga |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/12/795 |
16.4.2018 |
|
12.4.2018 |
Galafold |
Amicus Therapeutics UK Ltd Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom |
EU/1/15/1082 |
16.4.2018 |
|
12.4.2018 |
Icandra |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/08/484 |
16.4.2018 |
|
12.4.2018 |
Kinzalkomb |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/02/214 |
16.4.2018 |
|
12.4.2018 |
Kisqali |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/17/1221 |
16.4.2018 |
|
12.4.2018 |
Lumigan |
Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland |
EU/1/02/205 |
16.4.2018 |
|
12.4.2018 |
Mekinist |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/14/931 |
16.4.2018 |
|
12.4.2018 |
Neparvis |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/16/1103 |
16.4.2018 |
|
12.4.2018 |
Pemetrexed Lilly |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/15/1034 |
16.4.2018 |
|
12.4.2018 |
Ravicti |
Horizon Pharma Ireland Limited Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland |
EU/1/15/1062 |
16.4.2018 |
|
12.4.2018 |
RoActemra |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/08/492 |
16.4.2018 |
|
12.4.2018 |
Sebivo |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/07/388 |
16.4.2018 |
|
12.4.2018 |
Sialanar |
Proveca Limited Neo, Charlotte Street, Manchester, M1 4ET, United Kingdom |
EU/1/16/1135 |
17.4.2018 |
|
12.4.2018 |
Signifor |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/12/753 |
16.4.2018 |
|
12.4.2018 |
Simulect |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/98/084 |
16.4.2018 |
|
12.4.2018 |
Sylvant |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/14/928 |
16.4.2018 |
|
12.4.2018 |
Tadalafil Mylan |
Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |
EU/1/14/961 |
16.4.2018 |
|
12.4.2018 |
Vidaza |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/08/488 |
16.4.2018 |
|
12.4.2018 |
Zomarist |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/08/483 |
16.4.2018 |
|
13.4.2018 |
Bretaris Genuair |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/12/781 |
17.4.2018 |
|
13.4.2018 |
Eklira Genuair |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/12/778 |
17.4.2018 |
|
13.4.2018 |
Memantine ratiopharm |
ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland |
EU/1/13/836 |
17.4.2018 |
|
13.4.2018 |
Pritor |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/98/089 |
17.4.2018 |
|
13.4.2018 |
PritorPlus |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/02/215 |
17.4.2018 |
|
13.4.2018 |
Sialanar |
Proveca Limited Neo, Charlotte Street, Manchester, M1 4ET, United Kingdom |
EU/1/16/1135 |
17.4.2018 |
|
13.4.2018 |
Travatan |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/01/199 |
17.4.2018 |
|
19.4.2018 |
Aclasta |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/05/308 |
23.4.2018 |
|
19.4.2018 |
Azarga |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/08/482 |
23.4.2018 |
|
19.4.2018 |
Blincyto |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/15/1047 |
23.4.2018 |
|
19.4.2018 |
Comtan |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/98/081 |
23.4.2018 |
|
19.4.2018 |
Deltyba |
Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München, Deutschland |
EU/1/13/875 |
23.4.2018 |
|
19.4.2018 |
Descovy |
Gilead Sciences International Limited Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom |
EU/1/16/1099 |
23.4.2018 |
|
19.4.2018 |
Exjade |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/06/356 |
23.4.2018 |
|
19.4.2018 |
Imatinib Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/13/845 |
23.4.2018 |
|
19.4.2018 |
Imatinib Medac |
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland |
EU/1/13/876 |
23.4.2018 |
|
19.4.2018 |
Kyprolis |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/15/1060 |
23.4.2018 |
|
19.4.2018 |
Movymia |
STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Deutschland |
EU/1/16/1161 |
23.4.2018 |
|
19.4.2018 |
Natpar |
Shire Pharmaceuticals Ireland Limited 5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/15/1078 |
23.4.2018 |
|
19.4.2018 |
Opatanol |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/02/217 |
23.4.2018 |
|
19.4.2018 |
Peyona |
Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia |
EU/1/09/528 |
23.4.2018 |
|
19.4.2018 |
Repatha |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/15/1016 |
23.4.2018 |
|
19.4.2018 |
Simbrinza |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/14/933 |
23.4.2018 |
|
19.4.2018 |
Stribild |
Gilead Sciences International Limited Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom |
EU/1/13/830 |
23.4.2018 |
|
19.4.2018 |
Suliqua |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/16/1157 |
23.4.2018 |
|
19.4.2018 |
Sutent |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/06/347 |
23.4.2018 |
|
19.4.2018 |
Volibris |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/08/451 |
23.4.2018 |
|
19.4.2018 |
Xadago |
Zambon S.p.A. Via Lillo del Duca 10, 20 091 Bresso (MI), Italia |
EU/1/14/984 |
23.4.2018 |
|
19.4.2018 |
Yargesa |
JensonR+ Limited Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom |
EU/1/17/1176 |
23.4.2018 |
|
23.4.2018 |
Aerinaze |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/07/399 |
25.4.2018 |
|
23.4.2018 |
Bosulif |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/13/818 |
25.4.2018 |
|
23.4.2018 |
Daxas |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/10/636 |
25.4.2018 |
|
23.4.2018 |
Desloratadine Actavis |
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |
EU/1/11/745 |
25.4.2018 |
|
23.4.2018 |
Duloxetine Zentiva |
Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika |
EU/1/15/1028 |
25.4.2018 |
|
23.4.2018 |
Emadine |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/98/095 |
25.4.2018 |
|
23.4.2018 |
Entresto |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/15/1058 |
25.4.2018 |
|
23.4.2018 |
Eucreas |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/07/425 |
25.4.2018 |
|
23.4.2018 |
Exelon |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/98/066 |
25.4.2018 |
|
23.4.2018 |
Fycompa |
Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
EU/1/12/776 |
25.4.2018 |
|
23.4.2018 |
GILENYA |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/11/677 |
25.4.2018 |
|
23.4.2018 |
Humira |
AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland |
EU/1/03/256 |
25.4.2018 |
|
23.4.2018 |
Hycamtin |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/96/027 |
25.4.2018 |
|
23.4.2018 |
Imnovid |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/13/850 |
25.4.2018 |
|
23.4.2018 |
Imvanex |
Bavarian Nordic A/S Hejreskovvej 10a, 3490 Kvistgaard, Danmark |
EU/1/13/855 |
25.4.2018 |
|
23.4.2018 |
Lojuxta |
Aegerion Pharmaceuticals Limited Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom |
EU/1/13/851 |
25.4.2018 |
|
23.4.2018 |
NeuroBloc |
Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
EU/1/00/166 |
25.4.2018 |
|
23.4.2018 |
Nevanac |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/07/433 |
25.4.2018 |
|
23.4.2018 |
Onbrez Breezhaler |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/593 |
25.4.2018 |
|
23.4.2018 |
Opdivo |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/15/1014 |
25.4.2018 |
|
23.4.2018 |
Pregabalin Zentiva |
Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika |
EU/1/15/1021 |
25.4.2018 |
|
23.4.2018 |
Spedra |
Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg |
EU/1/13/841 |
25.4.2018 |
|
23.4.2018 |
TOBI Podhaler |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/10/652 |
25.4.2018 |
|
23.4.2018 |
Viread |
Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom |
EU/1/01/200 |
25.4.2018 |
|
23.4.2018 |
Zydelig |
Gilead Sciences International Limited Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom |
EU/1/14/938 |
25.4.2018 |
|
23.4.2018 |
Zykadia |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/15/999 |
25.4.2018 |
|
26.4.2018 |
Aloxi |
Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland |
EU/1/04/306 |
30.4.2018 |
|
26.4.2018 |
Avonex |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
EU/1/97/033 |
30.4.2018 |
|
26.4.2018 |
Cosentyx |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/14/980 |
30.4.2018 |
|
26.4.2018 |
Elonva |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/09/609 |
30.4.2018 |
|
26.4.2018 |
Firazyr |
Shire Orphan Therapies GmbH Friedrichstraße 149, 10117 Berlin, Deutschland |
EU/1/08/461 |
30.4.2018 |
|
26.4.2018 |
Galvus |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/07/414 |
30.4.2018 |
|
26.4.2018 |
Jalra |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/08/485 |
30.4.2018 |
|
26.4.2018 |
Lucentis |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/06/374 |
30.4.2018 |
|
26.4.2018 |
Maviret |
AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom |
EU/1/17/1213 |
30.4.2018 |
|
26.4.2018 |
Tasigna |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/07/422 |
30.4.2018 |
|
26.4.2018 |
Truxima |
Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |
EU/1/16/1167 |
2.5.2018 |
|
26.4.2018 |
Voncento |
CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland |
EU/1/13/857 |
30.4.2018 |
|
26.4.2018 |
Xiliarx |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/08/486 |
30.4.2018 |
|
26.4.2018 |
Xolair |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/05/319 |
30.4.2018 |
|
26.4.2018 |
Zometa |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/01/176 |
30.4.2018 |
|
30.4.2018 |
Avamys |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/07/434 |
3.5.2018 |
|
30.4.2018 |
Clopidogrel Zentiva |
Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika |
EU/1/08/465 |
3.5.2018 |
|
30.4.2018 |
Entresto |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/15/1058 |
3.5.2018 |
|
30.4.2018 |
Hemlibra |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/18/1271 |
3.5.2018 |
|
30.4.2018 |
Perjeta |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/13/813 |
3.5.2018 |
|
30.4.2018 |
Pramipexole Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/08/490 |
3.5.2018 |
|
30.4.2018 |
Remsima |
Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |
EU/1/13/853 |
3.5.2018 |
|
30.4.2018 |
Rydapt |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/17/1218 |
3.5.2018 |
|
— |
Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
|
Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
|
13.4.2018 |
Clevor |
Ropinirole |
Orion Corporation Orionintie 1, 02200 Espoo, Suomi |
EU/2/17/222 |
Eye drops, solution |
QN04BC04 |
17.4.2018 |
|
— |
Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
|
4.4.2018 |
Convenia |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/06/059 |
6.4.2018 |
|
4.4.2018 |
Stronghold |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/99/014 |
6.4.2018 |
|
4.4.2018 |
Zulvac 1 Bovis |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/11/130 |
6.4.2018 |
|
4.4.2018 |
Zulvac 1 Ovis |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/11/131 |
6.4.2018 |
|
4.4.2018 |
Zulvac 8 Bovis |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/09/105 |
6.4.2018 |
|
6.4.2018 |
Apoquel |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/13/154 |
10.4.2018 |
|
6.4.2018 |
Stronghold Plus |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/16/204 |
10.4.2018 |
|
11.4.2018 |
Zulvac 8 Ovis |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/09/104 |
13.4.2018 |
|
13.4.2018 |
Equip WNV |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/08/086 |
17.4.2018 |
|
13.4.2018 |
ProZinc |
Boehringer Ingelheim Vetmedica GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/2/13/152 |
17.4.2018 |
|
16.4.2018 |
BTVPUR |
Merial 29 avenue Tony Garnier, 69007 Lyon, France |
EU/2/10/113 |
18.4.2018 |
|
16.4.2018 |
Equilis West Nile |
Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/13/151 |
18.4.2018 |
|
20.4.2018 |
Meloxidolor |
Le Vet Beheer B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland |
EU/2/13/148 |
24.4.2018 |
|
26.4.2018 |
Naxcel |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/05/053 |
30.4.2018 |
|
26.4.2018 |
Onsior |
Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom |
EU/2/08/089 |
30.4.2018 |
|
— |
Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
|
26.4.2018 |
CERTIFECT |
Merial 29 avenue Tony Garnier, 69007 Lyon, France |
EU/2/11/125 |
30.4.2018 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
|
European Medicines Agency |
|
30 Churchill Place |
|
Canary Wharf |
|
London E14 5EU |
|
United Kingdom |
(1) OJ L 136, 30.4.2004, p. 1.