Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2020 to 31 March 2020 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2020-04-24
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product








C_2020135EN.01000101.xml










24.4.2020   


EN


Official Journal of the European Union


C 135/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2020 to 31 March 2020
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2020/C 135/01)
—   Issuing of a marketing authorisation (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


INN (International Non-Proprietary Name)


Holder of the marketing authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




2.3.2020


Givlaari


givosiran


Alnylam Netherlands B.V.
Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland


EU/1/20/1428


Solution for injection


Pending


4.3.2020




24.3.2020


Azacitidine Betapharm


Azacitidine


betapharm Arzneimittel GmbH
Kobelweg 95, 86156 Augsburg, Deutschland


EU/1/19/1416


Powder for suspension for injection


L01BC07


25.3.2020




24.3.2020


Liumjev


Insulin lispro


Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland


EU/1/20/1422


Solution for injection


A10AB04


26.3.2020




27.3.2020


Azacitidine Mylan


Azacitidine


Mylan Ireland Limited
Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland


EU/1/20/1426


Powder for suspension for injection


L01BC07


30.3.2020




27.3.2020


NUBEQA


darolutamide


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/20/1432


Film-coated tablet


L02BB06


30.3.2020




27.3.2020


Nustendi


bempedoic acid/ezetimibe


FGK Representative Service GmbH
Heimeranstraße 35, 80339 München, Deutschland


EU/1/20/1424


Film-coated tablet


Pending


31.3.2020




27.3.2020


Staquis


crisaborole


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/19/1421


Ointment


D11AH06


1.4.2020




—   Modification of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




3.3.2020


Mabthera


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/98/067


5.3.2020




3.3.2020


Maviret


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/17/1213


5.3.2020




9.3.2020


Alkindi


Diurnal Europe B.V.
Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland


EU/1/17/1260


11.3.2020




9.3.2020


Ameluz


Biofrontera Bioscience GmbH
Hemmelrather Weg 201, 51377 Leverkusen, Deutschland


EU/1/11/740


11.3.2020




9.3.2020


BiResp Spiromax


Teva Pharma B.V.
Swensweg 5, 2031GA Haarlem, Nederland


EU/1/14/921


11.3.2020




9.3.2020


Cervarix


GlaxoSmithKline Biologicals S.A.
rue de l’Institut 89, 1330 Rixensart, Belgique


EU/1/07/419


11.3.2020




9.3.2020


Duloxetine Zentiva


Zentiva, k.s.
U Kabelovny 130, 102 37 Praha 10, Česká republika


EU/1/15/1028


11.3.2020




9.3.2020


DuoResp Spiromax


Teva Pharma B.V.
Swensweg 5, 2031GA Haarlem, Nederland


EU/1/14/920


11.3.2020




9.3.2020


Fortacin


Recordati Ireland Ltd
Raheens East, Ringaskiddy Co. Cork, Ireland


EU/1/13/881


11.3.2020




9.3.2020


IKERVIS


Santen Oy
Niittyhaankatu 20, 33720 Tampere, Suomi


EU/1/15/990


11.3.2020




9.3.2020


Imvanex


Bavarian Nordic A/S
Hejreskovvej 10a, 3490 Kvistgaard, Danmark


EU/1/13/855


11.3.2020




9.3.2020


Integrilin


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/99/109


11.3.2020




9.3.2020


Iressa


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/09/526


11.3.2020




9.3.2020


Kineret


Swedish Orphan Biovitrum AB (publ)
112 76 Stockholm, Sverige


EU/1/02/203


11.3.2020




9.3.2020


Lojuxta


Amryt Pharmaceuticals DAC
90 Harcourt Street, Dublin 2, Ireland


EU/1/13/851


11.3.2020




9.3.2020


Luxturna


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/18/1331


11.3.2020




9.3.2020


Nyxoid


Mundipharma Corporation (Ireland) Limited
Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland


EU/1/17/1238


11.3.2020




9.3.2020


Oncaspar


Les Laboratoires Servier
50 rue Carnot, 92284 Suresnes Cedex, France


EU/1/15/1070


11.3.2020




9.3.2020


Onpattro


Alnylam Netherlands B.V.
Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland


EU/1/18/1320


11.3.2020




9.3.2020


Ozurdex


Allergan Pharmaceuticals Ireland
Castlebar Road, Westport, County Mayo, Ireland


EU/1/10/638


11.3.2020




9.3.2020


Pelmeg


Mundipharma Corporation (Ireland) Limited
Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland


EU/1/18/1328


11.3.2020




9.3.2020


Pregabalin Pfizer


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/14/916


11.3.2020




9.3.2020


Qtern


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/16/1108


11.3.2020




9.3.2020


Rezolsta


Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België


EU/1/14/967


11.3.2020




9.3.2020


Ristaben


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/10/621


18.3.2020




9.3.2020


Selincro


H. Lundbeck A/S
Ottiliavej 9, 2500 Valby, Danmark


EU/1/12/815


11.3.2020




9.3.2020


Suliqua


Sanofi-Aventis groupe
54 rue La Boétie, 75008 Paris, France


EU/1/16/1157


11.3.2020




9.3.2020


TAKHZYRO


Shire Pharmaceuticals Ireland Limited
Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland


EU/1/18/1340


11.3.2020




9.3.2020


Terrosa


Gedeon Richter Plc.
Gyömrői út 19-21., 1103 Budapest, Magyarország


EU/1/16/1159


11.3.2020




9.3.2020


Tesavel


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/07/435


11.3.2020




9.3.2020


Trajenta


Boehringer Ingelheim International GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland


EU/1/11/707


11.3.2020




9.3.2020


Tybost


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/13/872


11.3.2020




9.3.2020


Ulunar Breezhaler


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/14/917


11.3.2020




9.3.2020


Venclyxto


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/16/1138


11.3.2020




9.3.2020


XALKORI


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/12/793


11.3.2020




9.3.2020


Xelevia


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/07/382


11.3.2020




9.3.2020


Xoterna Breezhaler


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/13/863


11.3.2020




10.3.2020


Epivir


ViiV Healthcare BV
Huis ter Heideweg 62, 3705 LZ Zeist, Nederland


EU/1/96/015


12.3.2020




10.3.2020


Ixiaro


Valneva Austria GmbH
Campus Vienna Biocenter 3, 1030 Wien, Österreich


EU/1/08/501


12.3.2020




10.3.2020


Pemetrexed Sandoz


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/15/1037


12.3.2020




10.3.2020


Ranexa


Menarini International Operations Luxembourg S.A.
1 avenue de la Gare, 1611 Luxembourg, Luxembourg


EU/1/08/462


12.3.2020




16.3.2020


Akynzeo


Helsinn Birex Pharmaceuticals Ltd
Damastown, Mulhuddart, Dublin 15, Ireland


EU/1/15/1001


18.3.2020




16.3.2020


Olazax Disperzi


Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b, 14078 Praha 4, Česká republika


EU/1/09/592


18.3.2020




16.3.2020


Pandemic influenza vaccine H5N1 AstraZeneca


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/16/1089


18.3.2020




16.3.2020


Waylivra


Akcea Therapeutics Ireland Limited
Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland


EU/1/19/1360


18.3.2020




24.3.2020


Dacogen


Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België


EU/1/12/792


25.3.2020




24.3.2020


Epclusa


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/16/1116


25.3.2020




24.3.2020


KEYTRUDA


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/15/1024


30.3.2020




24.3.2020


Rapiscan


GE Healthcare AS
Nycoveien 1, 0485, Oslo, Norge


EU/1/10/643


26.3.2020




24.3.2020


Shingrix


GlaxoSmithKline Biologicals S.A.
rue de l’Institut 89, 1330 Rixensart, Belgique


EU/1/18/1272


25.3.2020




24.3.2020


Voriconazole Hikma


Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal


EU/1/15/1004


26.3.2020




27.3.2020


Alofisel


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/17/1261


6.4.2020




27.3.2020


EVOTAZ


Bristol-Myers Squibb Pharma EEIG
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland


EU/1/15/1025


6.4.2020




27.3.2020


Halimatoz


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/18/1288


5.4.2020




27.3.2020


Hefiya


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/18/1287


6.4.2020




27.3.2020


Hyrimoz


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/18/1286


5.4.2020




27.3.2020


Lenalidomide Accord


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/18/1316


31.3.2020




27.3.2020


Ozempic


Novo Nordisk A/S
Novo Allé, 2880 Bagsvaerd, Danmark


EU/1/17/1251


31.3.2020




27.3.2020


SomaKit TOC


Advanced Accelerator Applications
20 rue Diesel, 01630 Saint-Genis-Pouilly, France


EU/1/16/1141


6.4.2020




27.3.2020


Vaborem


Menarini International Operations Luxembourg S.A.
1 avenue de la Gare, 1611 Luxembourg, Luxembourg


EU/1/18/1334


30.3.2020




—   Suspension of a marketing authorisation (Article 20 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 authorisation


Number of the entry in the Community Register


Date of notification




25.3.2020


Esmya


Gedeon Richter Plc.
Gyömrői út 19-21., 1103 Budapest, Magyarország


EU/1/12/750


27.3.2020




—   Modification of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




4.3.2020


Rabitec


IDT Biologika GmbH
Am Pharmapark, 06861 Dessau-Rosslau, Deutschland


EU/2/17/219


6.3.2020




4.3.2020


Respiporc Flu3


Ceva Santé Animale
10 avenue de La Ballastière, 33500 Libourne, France


EU/2/09/103


6.3.2020




9.3.2020


Activyl Tick Plus


Intervet International B.V.
Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland


EU/2/11/137


11.3.2020




9.3.2020


Clomicalm


Elanco GmbH
Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland


EU/2/98/007


11.3.2020




9.3.2020


ECOPORC SHIGA


Ceva Santé Animale
10 avenue de La Ballastière, 33500 Libourne, France


EU/2/13/149


11.3.2020




24.3.2020


Activyl


Intervet International B.V.
Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland


EU/2/10/118


25.3.2020




27.3.2020


CLYNAV


Elanco GmbH
Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland


EU/2/16/197


31.3.2020




27.3.2020


MS-H vaccine


Pharmsure Veterinary Products Europe Ltd
4 Ormond Quay Upper, DO7 PF53, Dublin, Ireland


EU/2/11/126


31.3.2020




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




Domenico Scarlattilaan 6




1083 HS Amsterdam




NETHERLANDS






(1)  OJ L 136, 30.4.2004, p. 1.