Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2019 to 31 March 2019 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council 1 1 )
Date: 2019-05-03
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product








C_2019153EN.01000101.xml










3.5.2019   


EN


Official Journal of the European Union


C 153/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2019 to 31 March 2019

(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 153/01)






—



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




25.3.2019


Atazanavir Krka


atazanavir


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


EU/1/19/1353


Capsule, hard


J05AE08


27.3.2019




28.3.2019


AJOVY


fremanezumab


Teva GmbH
Graf-Arco-Straße 3, 89079 Ulm, Deutschland


EU/1/19/1358


Solution for injection


Pending


1.4.2019




28.3.2019


Febuxostat Krka


febuxostat


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


EU/1/18/1347


Film-coated tablet


M04AA03


1.4.2019










—



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




1.3.2019


Docetaxel Accord


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


EU/1/12/769


5.3.2019




1.3.2019


Herzuma


Celltrion Healthcare Hungary Kft.
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország


EU/1/17/1257


5.3.2019




1.3.2019


Lacosamide Accord


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


EU/1/17/1230


5.3.2019




1.3.2019


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


5.3.2019




1.3.2019


Levetiracetam Accord


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


EU/1/11/712


5.3.2019




1.3.2019


Palonosetron Accord


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


EU/1/16/1104


5.3.2019




1.3.2019


Tegsedi


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


EU/1/18/1296


5.3.2019




5.3.2019


Aripiprazole Accord


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


EU/1/15/1045


7.3.2019




5.3.2019


DaTSCAN


GE Healthcare B.V.
De Rondom 8, 5612 AP, Eindhoven, The Netherlands


EU/1/00/135


7.3.2019




5.3.2019


Granpidam


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


EU/1/16/1137


7.3.2019




5.3.2019


Instanyl


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


EU/1/09/531


7.3.2019




5.3.2019


Kiovig


Baxter AG
Industriestraße 67, 1221 Wien, Österreich


EU/1/05/329


7.3.2019




5.3.2019


Levetiracetam Actavis


Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland


EU/1/11/713


7.3.2019




5.3.2019


Pregabalin Accord


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


EU/1/15/1027


7.3.2019




5.3.2019


Tecentriq


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


EU/1/17/1220


7.3.2019




11.3.2019


Actrapid


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


EU/1/02/230


13.3.2019




11.3.2019


Cresemba


Basilea Pharmaceutica Deutschland GmbH
Marie-Curie-Strasse 8, 79539 Loerrach, Baden-Wuerttemberg, Deutschland


EU/1/15/1036


13.3.2019




11.3.2019


Efavirenz/Emtricitabine/Tenofovir disoproxil Krka


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


EU/1/17/1263


13.3.2019




11.3.2019


Ferriprox


Apotex Europe B.V.
Archimedesweg 2, 2333 CN Leiden, Nederland


EU/1/99/108


13.3.2019




11.3.2019


Hemlibra


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


EU/1/18/1271


13.3.2019




11.3.2019


Herceptin


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


EU/1/00/145


13.3.2019




11.3.2019


INOmax


Linde Healthcare AB
SE-181 81 Lidingö, Sverige


EU/1/01/194


13.3.2019




11.3.2019


Intrarosa


Endoceutics S.A.
Rue Belliard 40, 1040 Brussels, Belgium


EU/1/17/1255


15.3.2019




11.3.2019


KEYTRUDA


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


EU/1/15/1024


13.3.2019




11.3.2019


Luminity


Lantheus EU Limited
Atlantic Avenue, Westpark Business Campus, Shannon, Co. Clare, Ireland


EU/1/06/361


13.3.2019




11.3.2019


Mabthera


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


EU/1/98/067


13.3.2019




11.3.2019


Maviret


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


EU/1/17/1213


13.3.2019




11.3.2019


Pelgraz


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


EU/1/18/1313


15.3.2019




11.3.2019


Praluent


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


EU/1/15/1031


13.3.2019




11.3.2019


Pramipexole Accord


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


EU/1/11/728


13.3.2019




11.3.2019


Qarziba


EUSA Pharma (Netherlands) B.V.
Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland


EU/1/17/1191


13.3.2019




11.3.2019


Senshio


Shionogi B.V.
Kingsfordweg 151, 1043GR Amsterdam, Nederland


EU/1/14/978


13.3.2019




11.3.2019


Slenyto


RAD Neurim Pharmaceuticals EEC SARL
4 rue de Marivaux, 75002 Paris, France


EU/1/18/1318


13.3.2019




11.3.2019


Stayveer


Janssen Pharmaceutica N.V.
Turnhoutseweg 30, 2340 Beerse, België


EU/1/13/832


13.3.2019




11.3.2019


Varuby


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


EU/1/17/1180


13.3.2019




11.3.2019


Zoledronic acid Accord


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


EU/1/13/834


15.3.2019




11.3.2019


Zykadia


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


EU/1/15/999


13.3.2019




13.3.2019


NovoMix


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


EU/1/00/142


15.3.2019




13.3.2019


Ongentys


Bial — Portela & Ca, SA
À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal


EU/1/15/1066


15.3.2019




13.3.2019


Reyataz


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


EU/1/03/267


15.3.2019




13.3.2019


Rubraca


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


EU/1/17/1250


15.3.2019




20.3.2019


Edistride


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/15/1052


22.3.2019




20.3.2019


Forxiga


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/12/795


22.3.2019




20.3.2019


SCENESSE


Clinuvel Europe Limited
10 Earlsfort Terrace, Dublin 2, Ireland


EU/1/14/969


22.3.2019




25.3.2019


ADYNOVI


Baxalta Innovations GmbH
Industriestraße 67, 1221 Wien, Österreich


EU/1/17/1247


27.3.2019




25.3.2019


Baraclude


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


EU/1/06/343


27.3.2019




25.3.2019


Clopidogrel Mylan


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


EU/1/09/559


27.3.2019




25.3.2019


Clopidogrel ratiopharm GmbH


Archie Samuel s.r.o.
Slunná 16, 61700 Brno, Česká republika


EU/1/09/541


27.3.2019




25.3.2019


Daklinza


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


EU/1/14/939


27.3.2019




25.3.2019


Edarbi


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


EU/1/11/734


27.3.2019




25.3.2019


Levemir


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


EU/1/04/278


27.3.2019




25.3.2019


Lutathera


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


EU/1/17/1226


27.3.2019




25.3.2019


Nordimet


Nordic Group B.V.
Siriusdreef 22, 2132 WT Hoofddorp, Nederland


EU/1/16/1124


27.3.2019




25.3.2019


Omidria


Omeros Ireland Limited
Ormond Building, 31-36 Ormond Quay Upper, Dublin 7, Ireland


EU/1/15/1018


27.3.2019




25.3.2019


Plegridy


Biogen Netherlands B.V.
Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland


EU/1/14/934


27.3.2019




25.3.2019


Rotarix


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


EU/1/05/330


27.3.2019




25.3.2019


Spinraza


Biogen Netherlands B.V.
Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland


EU/1/17/1188


27.3.2019




25.3.2019


Velphoro


Vifor Fresenius Medical Care Renal Pharma France
100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France


EU/1/14/943


27.3.2019




25.3.2019


Zyllt


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


EU/1/09/553


27.3.2019




28.3.2019


AMGEVITA


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


EU/1/16/1164


1.4.2019




28.3.2019


Bexsero


GlaxoSmithKline Vaccines S.r.l.
Via Fiorentina, 1, 53100 Siena, Italia


EU/1/12/812


1.4.2019




28.3.2019


Clopidogrel Krka


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


EU/1/09/556


1.4.2019




28.3.2019


Coagadex


BPL Bioproducts Laboratory GmbH
Dornhofstrasse 34, 63263 Neu-Isenburg, Deutschland


EU/1/16/1087


29.3.2019




28.3.2019


Cometriq


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


EU/1/13/890


1.4.2019




28.3.2019


Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva


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


EU/1/17/1210


1.4.2019




28.3.2019


EndolucinBeta


ITG Isotope Technologies Garching GmbH
Lichtenbergstraße 1, 85748 Garching, Deutschland


EU/1/16/1105


1.4.2019




28.3.2019


EVOTAZ


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


EU/1/15/1025


1.4.2019




28.3.2019


Galafold


Amicus Therapeutics Europe Limited
Block 1 Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland


EU/1/15/1082


1.4.2019




28.3.2019


Genvoya


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


EU/1/15/1061


1.4.2019




28.3.2019


Glivec


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


EU/1/01/198


1.4.2019




28.3.2019


Imatinib Teva


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


EU/1/12/808


1.4.2019




28.3.2019


Insulatard


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


EU/1/02/233


1.4.2019




28.3.2019


Jylamvo


Therakind (Europe) Limited
3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland


EU/1/17/1172


1.4.2019




28.3.2019


KEYTRUDA


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


EU/1/15/1024


1.4.2019




28.3.2019


Lamivudine/Zidovudine Teva


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


EU/1/10/663


1.4.2019




28.3.2019


Mixtard


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


EU/1/02/231


1.4.2019




28.3.2019


Nerlynx


Puma Biotechnology B.V.
Beechavenue 54, 1119 PW Schiphol-Rijk, Nederland


EU/1/18/1311


29.3.2019




28.3.2019


NovoRapid


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


EU/1/99/119


1.4.2019




28.3.2019


Opdivo


Bristol-Myers Squibb/Pfizer EEIG
Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom


EU/1/15/1014


1.4.2019




28.3.2019


Perjeta


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


EU/1/13/813


1.4.2019




28.3.2019


Qutenza


Grünenthal GmbH
Zieglerstraße 6, 52078, Aachen, Deutschland


EU/1/09/524


1.4.2019




28.3.2019


Segluromet


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


EU/1/18/1265


1.4.2019




28.3.2019


Sialanar


Proveca Pharma Limited
Marine House, Clanwilliam Place, Dublin 2, Ireland


EU/1/16/1135


1.4.2019




28.3.2019


Sprycel


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


EU/1/06/363


1.4.2019




28.3.2019


Strensiq


Alexion Europe SAS
1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France


EU/1/15/1015


1.4.2019




28.3.2019


Sustiva


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


EU/1/99/110


1.4.2019




28.3.2019


VPRIV


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


EU/1/10/646


1.4.2019




28.3.2019


Xeloda


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


EU/1/00/163


1.4.2019




29.3.2019


Jylamvo


Therakind (Europe) Limited
3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland


EU/1/17/1172


2.4.2019










—



Issuing 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


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




29.3.2019


Arti-Cell Forte


Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells


Global Stem cell Technology (G.S.T.) NV
Noorwegenstraat 4, 9940 Evergem, België


EU/2/18/228


Suspension for injection


Pending


2.4.2019










—



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




1.3.2019


Melosus


CP-Pharma Handelsgesellschaft mbH
Ostlandring 13, 31303 Burgdorf, Deutschland


EU/2/10/116


5.3.2019




1.3.2019


Prevomax


Le Vet Beheer B.V.
Wilgenweg 7, 3421 TV Oudewater, Nederland


EU/2/17/211


5.3.2019




12.3.2019


Aivlosin


ECO Animal Health Europe Limited
6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland


EU/2/04/044


14.3.2019




12.3.2019


Reconcile


Pegasus Laboratories Ireland Limited
10 McCurtain Hill, Clonakilty, County Cork, Ireland


EU/2/08/080


14.3.2019




12.3.2019


Suprelorin


VIRBAC S.A.
1ère Avenue - 2065 m — L.I.D., 06516 Carros Cedex, France


EU/2/07/072


14.3.2019




14.3.2019


Fungitraxx


Avimedical B.V.
Abbinkdijk 1, 7255 LX Hengelo (Gld), Nederland


EU/2/13/160


19.3.2019




14.3.2019


Loxicom


Norbrook Laboratories (Ireland) Limited
Rossmore Industrial Estate, Monaghan, Ireland


EU/2/08/090


19.3.2019




27.3.2019


Activyl Tick Plus


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


EU/2/11/137


29.3.2019




27.3.2019


Versican Plus DHPPi


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/14/169


29.3.2019




27.3.2019


Versican Plus Pi


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/14/168


29.3.2019




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.