Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2020 to 30 June 2020 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2020-07-31
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, withdrawal from the market








C_2020253EN.01000101.xml










31.7.2020   


EN


Official Journal of the European Union


C 253/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2020 to 30 June 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 253/01)
—   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




18.6.2020


Paliperidone Janssen-Cilag International


paliperidone


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


EU/1/20/1453


Prolonged release suspension for injection


N05AX13


19.6.2020




25.6.2020


Fingolimod Accord


fingolimod


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


EU/1/20/1450


Capsule, hard


L04AA27


6.7.2020




25.6.2020


Insulin aspart Sanofi


insulin aspart


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


EU/1/20/1447


Solution for injection


A10AB05


26.6.2020




25.6.2020


Reblozyl


luspatercept


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


EU/1/20/1452


Powder for solution for injection


B03XA06


26.6.2020




26.6.2020


Daurismo


glasdegib


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


EU/1/20/1451


Film-coated tablet


L01XX63


29.6.2020




—   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




2.6.2020


AMGEVITA


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


EU/1/16/1164


3.6.2020




2.6.2020


Aripiprazole Zentiva


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


EU/1/15/1009


14.6.2020




2.6.2020


Braftovi


Pierre Fabre Médicament
45, place Abel Gance, 92100 Boulogne-Billancourt, France


EU/1/18/1314


3.6.2020




2.6.2020


Brinavess


Correvio
15 rue du Bicentenaire, 92800 Puteaux, France


EU/1/10/645


3.6.2020




2.6.2020


Cinacalcet Mylan


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


EU/1/15/1054


8.6.2020




2.6.2020


Clopidogrel TAD


TAD Pharma GmbH
Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland


EU/1/09/555


4.6.2020




2.6.2020


Constella


Allergan Pharmaceuticals International Limited
Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland


EU/1/12/801


3.6.2020




2.6.2020


Efavirenz/Emtricitabine/Tenofovir disoproxil Krka


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


EU/1/17/1263


4.6.2020




2.6.2020


Farydak


Secura Bio Limited
32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland


EU/1/15/1023


8.6.2020




2.6.2020


KEYTRUDA


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


EU/1/15/1024


11.6.2020




2.6.2020


Lyrica


Upjohn EESV
Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland


EU/1/04/279


3.6.2020




2.6.2020


Memantine Accord


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


EU/1/13/880


3.6.2020




2.6.2020


Multaq


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


EU/1/09/591


3.6.2020




2.6.2020


Nustendi


Daiichi Sankyo Europe GmbH
Zielstattstraße 48, 81379 München, Deutschland


EU/1/20/1424


3.6.2020




2.6.2020


Pemetrexed Lilly


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


EU/1/15/1034


3.6.2020




2.6.2020


Praluent


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


EU/1/15/1031


4.6.2020




2.6.2020


Pregabalin Pfizer


Upjohn EESV
Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland


EU/1/14/916


3.6.2020




2.6.2020


Revatio


Upjohn EESV
Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland


EU/1/05/318


3.6.2020




2.6.2020


Revlimid


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


EU/1/07/391


3.6.2020




2.6.2020


Taltz


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


EU/1/15/1085


11.6.2020




2.6.2020


Thalidomide Celgene


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


EU/1/08/443


3.6.2020




2.6.2020


Viagra


Upjohn EESV
Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland


EU/1/98/077


3.6.2020




3.6.2020


Carmustine Obvius


Obvius Investment B.V.
De Cuserstraat 93, 1081 CN Amsterdam, Nederland


EU/1/18/1278


4.6.2020




3.6.2020


Darzalex


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


EU/1/16/1101


4.6.2020




3.6.2020


Ecalta


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


EU/1/07/416


4.6.2020




3.6.2020


Imnovid


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


EU/1/13/850


4.6.2020




3.6.2020


Zyllt


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


EU/1/09/553


8.6.2020




9.6.2020


Cablivi


Ablynx N.V.
Technologiepark 21, 9052 Zwijnaarde, België


EU/1/18/1305


11.6.2020




9.6.2020


Granupas


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


EU/1/13/896


10.6.2020




9.6.2020


Jakavi


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


EU/1/12/773


10.6.2020




9.6.2020


Kalydeco


Vertex Pharmaceuticals (Ireland) Limited
28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland


EU/1/12/782


10.6.2020




9.6.2020


Kiovig


Takeda Manufacturing Austria AG
Industriestraße 67, 1221 Wien, Österreich


EU/1/05/329


6.7.2020




9.6.2020


Qarziba


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


EU/1/17/1191


6.7.2020




9.6.2020


Zoely


Theramex Ireland Limited
3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland


EU/1/11/690


10.6.2020




12.6.2020


Buvidal


Camurus AB
Ideon Science Park, 223 70 Lund, Sverige


EU/1/18/1336


15.6.2020




12.6.2020


Deferiprone Lipomed


Lipomed GmbH
Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland


EU/1/18/1310


15.6.2020




12.6.2020


Duloxetine Lilly


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


EU/1/14/972


15.6.2020




12.6.2020


Eviplera


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


EU/1/11/737


15.6.2020




12.6.2020


Holoclar


Holostem Terapie Avanzate S.r.l.
Via Glauco Gottardi 100, Modena, MO 41125, Italia


EU/1/14/987


15.6.2020




12.6.2020


Memantine Merz


Merz Pharmaceuticals GmbH
Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland


EU/1/12/799


15.6.2020




12.6.2020


Nilemdo


Daiichi Sankyo Europe GmbH
Zielstattstraße 48, 81379 München, Deutschland


EU/1/20/1425


17.6.2020




12.6.2020


PHEBURANE


Eurocept International BV
Trapgans 5, 1244 RL Ankeveen, Nederland


EU/1/13/822


29.6.2020




17.6.2020


Exforge HCT


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


EU/1/09/569


18.6.2020




17.6.2020


Ogivri


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


EU/1/18/1341


18.6.2020




17.6.2020


Ratiograstim


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


EU/1/08/444


18.6.2020




18.6.2020


Copalia HCT


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


EU/1/09/575


19.6.2020




18.6.2020


Dafiro HCT


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


EU/1/09/574


22.6.2020




18.6.2020


Hexacima


Sanofi Pasteur
14 Espace Henry Vallée, 69007 Lyon, France


EU/1/13/828


19.6.2020




18.6.2020


Hexyon


Sanofi Pasteur
14 Espace Henry Vallée, 69007 Lyon, France


EU/1/13/829


19.6.2020




18.6.2020


Idacio


Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland


EU/1/19/1356


19.6.2020




18.6.2020


IDELVION


CSL Behring GmbH
Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland


EU/1/16/1095


25.6.2020




18.6.2020


Ovaleap


Theramex Ireland Limited
3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland


EU/1/13/871


19.6.2020




18.6.2020


PecFent


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


EU/1/10/644


19.6.2020




18.6.2020


Tevagrastim


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


EU/1/08/445


19.6.2020




18.6.2020


Trumenba


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


EU/1/17/1187


19.6.2020




18.6.2020


VPRIV


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


EU/1/10/646


19.6.2020




18.6.2020


Xagrid


Shire Pharmaceuticals Ireland Limited
Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland


EU/1/04/295


19.6.2020




19.6.2020


Pregabalin Sandoz


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/15/1011


6.7.2020




19.6.2020


Pregabalin Sandoz GmbH


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/15/1012


3.7.2020




25.6.2020


Aflunov


Seqirus S.r.l.
Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italy


EU/1/10/658


29.6.2020




25.6.2020


Cotellic


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


EU/1/15/1048


26.6.2020




25.6.2020


Dupixent


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


EU/1/17/1229


26.6.2020




25.6.2020


Entresto


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


EU/1/15/1058


29.6.2020




25.6.2020


Erbitux


Merck Europe B.V.
Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland


EU/1/04/281


29.6.2020




25.6.2020


Intuniv


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


EU/1/15/1040


26.6.2020




25.6.2020


Kisplyx


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


EU/1/16/1128


4.7.2020




25.6.2020


Kyprolis


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


EU/1/15/1060


29.6.2020




25.6.2020


Mysildecard


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


EU/1/16/1134


6.7.2020




25.6.2020


Neofordex


Laboratoires CTRS
63 rue de l’Est, 92100 Boulogne-Billancourt, France


EU/1/15/1053


29.6.2020




25.6.2020


Olanzapine Apotex


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


EU/1/10/635


1.7.2020




25.6.2020


Sovaldi


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


EU/1/13/894


26.6.2020




25.6.2020


Ultomiris


Alexion Europe SAS
103-105 Rue Anatole France, 92300 Levallois-Perret, France


EU/1/19/1371


26.6.2020




25.6.2020


Wakix


Bioprojet Pharma
9 rue Rameau, 75002 Paris, France


EU/1/15/1068


26.6.2020




25.6.2020


Zejula


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


EU/1/17/1235


26.6.2020




26.6.2020


AJOVY


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


EU/1/19/1358


30.6.2020




26.6.2020


Aripiprazole Sandoz


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/15/1029


30.6.2020




26.6.2020


Benlysta


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


EU/1/11/700


6.7.2020




26.6.2020


Cimzia


UCB Pharma S.A.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België


EU/1/09/544


30.6.2020




26.6.2020


Copalia


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


EU/1/06/372


29.6.2020




26.6.2020


Dafiro


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


EU/1/06/371


29.6.2020




26.6.2020


Invokana


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


EU/1/13/884


29.6.2020




26.6.2020


LIBTAYO


Regeneron Ireland Designated Activity Company (DAC)
Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland


EU/1/19/1376


29.6.2020




26.6.2020


Pramipexole Teva


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


EU/1/08/490


30.6.2020




26.6.2020


Sivextro


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


EU/1/15/991


7.7.2020




26.6.2020


Taltz


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


EU/1/15/1085


30.6.2020




26.6.2020


Talzenna


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


EU/1/19/1377


29.6.2020




—   Withdrawal of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




22.6.2020


Zerit


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


EU/1/96/009


25.6.2020




—   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




5.6.2020


Recocam


Bimeda Animal Health Limited
2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland


EU/2/11/133


9.6.2020




17.6.2020


Profender


Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland


EU/2/05/054


18.6.2020




17.6.2020


Zulvac 1 + 8 Ovis


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


EU/2/11/120


19.6.2020




24.6.2020


Aivlosin


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


EU/2/04/044


25.6.2020




24.6.2020


Mirataz


Dechra Regulatory B.V.
Handelsweg 25, 5531 AE Bladel, Nederland


EU/2/19/247


25.6.2020




24.6.2020


UpCard


Vétoquinol SA
Magny-Vernois, 70200 Lure, France


EU/2/15/184


1.7.2020




24.6.2020


Zulvac BTV


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


EU/2/17/207


29.6.2020




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.