Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2018 to 31 December 2018 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2019-01-25
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2019032EN.01000101.xml










25.1.2019   


EN


Official Journal of the European Union


C 32/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2018 to 31 December 2018
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2019/C 32/01)






—



Issuing 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


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




12.12.2018


Dengvaxia


dengue tetravalent vaccine (live, attenuated)


Sanofi Pasteur
14 Espace Henry Vallée, 69007 Lyon, France


EU/1/18/1338


Powder and solvent for suspension for injection


J07BX


14.12.2018




12.12.2018


Flucelvax Tetra


influenza vaccine (surface antigen, inactivated, prepared in cell cultures)


Seqirus Netherlands B.V.
Hullenbergweg 89 1101 CL Amsterdam, Nederland


EU/1/18/1326


Suspension for injection


J07BB02


14.12.2018




12.12.2018


Ogivri


trastuzumab


Mylan S.A.S.
117 allée des Parcs, 69800 Saint Priest, France


EU/1/18/1341


Powder for concentrate for solution for infusion


L01XC03


14.12.2018




18.12.2018


Bevespi Aerosphere


glycopyrronium bromide / formoterol


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/18/1339


Pressurised inhalation, suspension


R03AL07


20.12.2018




18.12.2018


Namuscla


Mexiletine


Lupin Europe GmbH
Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland


EU/1/18/1325


Capsule, hard


C01BB02


20.12.2018










—



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




6.12.2018


Exondys


AVI BioPharma International Ltd
Tower Bridge House, St Katharine’s Way, London E1W 1DD, United Kingdom


—


10.12.2018










—



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




6.12.2018


Anoro Ellipta


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


EU/1/14/898


10.12.2018




6.12.2018


Avamys


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


EU/1/07/434


10.12.2018




6.12.2018


Darunavir Mylan


Mylan S.A.S.
117 allée des Parcs, 69800 Saint Priest, France


EU/1/16/1140


10.12.2018




7.12.2018


Elocta


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


EU/1/15/1046


12.12.2018




7.12.2018


EVOTAZ


Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/15/1025


12.12.2018




7.12.2018


Onivyde


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


EU/1/16/1130


11.12.2018




7.12.2018


Rubraca


Clovis Oncology Ireland Limited
Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland


EU/1/17/1250


11.12.2018




7.12.2018


Tenofovir disoproxil Zentiva


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


EU/1/16/1127


11.12.2018




7.12.2018


Toujeo


Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main, Deutschland


EU/1/00/133


11.12.2018




7.12.2018


Ucedane


Eurocept International B.V.
Trapgans 5, 1244 RL Ankeveen, Nederland


EU/1/17/1202


11.12.2018




7.12.2018


Xermelo


Ipsen Pharma
65 quai Georges Gorse, 92100 Boulogne-Billancourt, France


EU/1/17/1224


11.12.2018




7.12.2018


Ziagen


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


EU/1/99/112


11.12.2018




10.12.2018


Daklinza


Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/14/939


12.12.2018




10.12.2018


Darunavir Krka


Krka d. d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/17/1249


12.12.2018




10.12.2018


Oncaspar


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


EU/1/15/1070


12.12.2018




10.12.2018


Xolair


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


EU/1/05/319


12.12.2018




12.12.2018


Desloratadine Teva


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


EU/1/11/732


14.12.2018




12.12.2018


Entyvio


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


EU/1/14/923


14.12.2018




12.12.2018


Evoltra


Genzyme Europe B.V.
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland


EU/1/06/334


14.12.2018




12.12.2018


Kengrexal


Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italia


EU/1/15/994


14.12.2018




12.12.2018


Kevzara


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


EU/1/17/1196


14.12.2018




12.12.2018


KEYTRUDA


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


EU/1/15/1024


14.12.2018




12.12.2018


Mimpara


Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland


EU/1/04/292


14.12.2018




12.12.2018


Moventig


Kyowa Kirin Holdings B.V.
Bloemlaan 2, 2132 NP Hoofddorp, Nederland


EU/1/14/962


14.12.2018




12.12.2018


OCALIVA


Intercept Pharma Ltd
2 Pancras Square, London N1C 4AG, United Kingdom


EU/1/16/1139


17.12.2018




12.12.2018


Pandemic influenza vaccine H5N1 BAXTER


Ology Bioservices Ireland LTD
Wilton Park House, Wilton Place, Dublin 2, D02P447, Ireland


EU/1/09/571


18.12.2018




12.12.2018


Praluent


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


EU/1/15/1031


14.12.2018




12.12.2018


Pregabalin Pfizer


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


EU/1/14/916


14.12.2018




12.12.2018


Reagila


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


EU/1/17/1209


14.12.2018




12.12.2018


Relvar Ellipta


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


EU/1/13/886


14.12.2018




12.12.2018


Revinty Ellipta


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


EU/1/14/929


14.12.2018




12.12.2018


RXULTI


Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292, 1101 CT, Amsterdam, Nederland


EU/1/18/1294


14.12.2018




12.12.2018


Trevicta


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


EU/1/14/971


14.12.2018




12.12.2018


Triumeq


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


EU/1/14/940


14.12.2018




12.12.2018


Valdoxan


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


EU/1/08/499


14.12.2018




12.12.2018


Vfend


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


EU/1/02/212


14.12.2018




17.12.2018


Dupixent


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


EU/1/17/1229


19.12.2018




17.12.2018


Elaprase


Shire Human Genetic Therapies AB
Vasagatan 7, 111 20 Stockholm, Sverige


EU/1/06/365


19.12.2018




17.12.2018


Emtricitabine/Tenofovir disoproxil Mylan


Mylan S.A.S.
117 allée des Parcs, 69800 Saint Priest, France


EU/1/16/1133


19.12.2018




17.12.2018


Epivir


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


EU/1/96/015


19.12.2018




17.12.2018


Hexacima


Sanofi Pasteur
14 Espace Henry Vallée, 69007 Lyon, France


EU/1/13/828


19.12.2018




17.12.2018


Hexyon


Sanofi Pasteur
14 Espace Henry Vallée, 69007 Lyon, France


EU/1/13/829


19.12.2018




17.12.2018


Kisqali


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


EU/1/17/1221


19.12.2018




17.12.2018


Zejula


TESARO Bio Netherlands B.V.
Joop Geeskinkweg, 901, 1114AB, Amsterdam-Duisvendrecht, Nederland


EU/1/17/1235


19.12.2018




17.12.2018


Zubsolv


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


EU/1/17/1233


19.12.2018




18.12.2018


Alimta


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


EU/1/04/290


19.12.2018




18.12.2018


Amyvid


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


EU/1/12/805


20.12.2018




18.12.2018


Darzalex


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


EU/1/16/1101


20.12.2018




18.12.2018


Granupas


Eurocept International B.V.
Trapgans 5, 1244 RL Ankeveen, Nederland


EU/1/13/896


20.12.2018




18.12.2018


Ledaga


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


EU/1/16/1171


20.12.2018




18.12.2018


Mabthera


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


EU/1/98/067


20.12.2018




18.12.2018


Otezla


Celgene Europe B.V.
Winthontlaan 6 N, 3526 KV Utrecht, Nederland


EU/1/14/981


20.12.2018




18.12.2018


Ravicti


Horizon Pharma Ireland Limited
Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland


EU/1/15/1062


20.12.2018




18.12.2018


Vectibix


Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland


EU/1/07/423


20.12.2018




18.12.2018


Vokanamet


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


EU/1/14/918


20.12.2018




20.12.2018


Panretin


Eisai GmbH
Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland


EU/1/00/149


2.1.2019




20.12.2018


Vihuma


Octapharma AB
Lars Forssells gata 23, 112 75 Stockholm, Sverige


EU/1/16/1168


27.12.2018










—



Withdrawal of a marketing authorization (Article 13 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




6.12.2018


Ivabradine JensonR


JensonR+ Limited
Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom


EU/1/16/1145


10.12.2018




17.12.2018


Macugen


PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c, 17000 Praha 7 Česká republika


EU/1/05/325


19.12.2018










—



Issuing of a marketing authorization (Article 38 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




12.12.2018


LONGRANGE


Merial
29 avenue Tony Garnier, 69007 Lyon, France


—


14.12.2018










—



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




7.12.2018


Aivlosin


ECO Animal Health Ltd
78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom


EU/2/04/044


11.12.2018




7.12.2018


Imrestor


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


EU/2/15/193


11.12.2018




12.12.2018


Aftovaxpur Doe


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/13/153


14.12.2018




17.12.2018


Bovela


Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein, Deutschland


EU/2/14/176


19.12.2018




17.12.2018


Coxevac


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


EU/2/10/110


20.12.2018




17.12.2018


Ingelvac CircoFLEX


Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein, Deutschland


EU/2/07/079


19.12.2018




17.12.2018


Nobilis IB 4-91


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


EU/2/98/006


19.12.2018




18.12.2018


Nobilis IB Primo QX


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


EU/2/14/174


20.12.2018




19.12.2018


NexGard


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/13/159


21.12.2018




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.