Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2021 to 28 February 2021 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2021-03-26
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_2021105EN.01000101.xml










26.3.2021   


EN


Official Journal of the European Union


C 105/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2021 to 28 February 2021
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2021/C 105/01)
—   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




4.2.2021


Rukobia


fostemsavir







ViiV Healthcare BV




Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland






EU/1/20/1518


Prolonged-release tablet


J05AX29


5.2.2021




5.2.2021


Kixelle


Insulin aspart







Mylan IRE Healthcare Limited




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






EU/1/20/1506


Solution for injection


A10AB05


8.2.2021




8.2.2021


Inrebic


fedratinib







Celgene Europe B.V.




Winthontlaan 6 N, 3526 KV Utrecht, Nederland






EU/1/20/1514


Capsule, hard


L01XE57


9.2.2021




8.2.2021


Lumoxiti


moxetumomab pasudotox







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/20/1522


Powder for concentrate and solution for solution for infusion


L01XC34


9.2.2021




11.2.2021


Lenalidomide Krka


lenalidomide







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/20/1520


Capsule, hard


L04AX04


15.2.2021




11.2.2021


Lenalidomide Krka d.d.


lenalidomide







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/20/1521


Capsule, hard


L04AX04


2.3.2021




11.2.2021


Lenalidomide Krka d.d. Novo mesto


lenalidomide







KRKA, d.d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/20/1519


Capsule, hard


L04AX04


12.2.2021




11.2.2021


Ogluo


glucagon







Xeris Pharmaceuticals Ireland Limited




8th Floor Block East, Iveagh Court, Harcourt Road, Dublin 2, Ireland






EU/1/20/1523


Solution for injection in a pre-filled syringe
Solution for injection in pre-filled pen


H04AA01


17.2.2021




11.2.2021


Retsevmo


selpercatinib







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1527


Capsule, hard


L01EX22


12.2.2021




11.2.2021


Sunitinib Accord


sunitinib







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España






EU/1/20/1511


Capsule, hard


L01XE04


12.2.2021




11.2.2021


TUKYSA


tucatinib







Seagen B.V.




Evert van de Beekstraat 1-140, 1118CL Schiphol, Nederland






EU/1/20/1526


Film-coated tablet


L01EH03


12.2.2021




11.2.2021


Yuflyma


adalimumab







Celltrion Healthcare Hungary Kft.




Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország






EU/1/20/1513


Solution for injection


L04AB04


12.2.2021




18.2.2021


Heplisav B


hepatitis B surface antigen







Dynavax GmbH




Eichsfelder Strasse 11, D-40595 Düsseldorf, Deutschland






EU/1/20/1503


Solution for injection


J07BC01


19.2.2021




—   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




1.2.2021


Rizmoic







Shionogi B.V.




Kingsfordweg 151, 1043 GR Amsterdam, Nederland






EU/1/18/1291


11.2.2021




1.2.2021


Rotarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/05/330


4.2.2021




2.2.2021


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


2.2.2021




4.2.2021


Clopidogrel ratiopharm







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/14/975


8.2.2021




4.2.2021


Gazyvaro







Roche Registration GmbH




Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland






EU/1/14/937


10.2.2021




4.2.2021


HALAVEN







Eisai GmbH




Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland






EU/1/11/678


5.2.2021




4.2.2021


IDELVION







CSL Behring GmbH




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






EU/1/16/1095


5.2.2021




4.2.2021


Juluca







ViiV Healthcare B.V.




Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands






EU/1/18/1282


5.2.2021




4.2.2021


Kuvan







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork, Ireland






EU/1/08/481


5.2.2021




4.2.2021


Mycamine







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/08/448


10.2.2021




4.2.2021


Reblozyl







Bristol-Myers Squibb Pharma EEIG




Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland






EU/1/20/1452


8.2.2021




4.2.2021


Spravato







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/19/1410


5.2.2021




4.2.2021


Sycrest







Organon N.V.




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/10/640


23.2.2021




4.2.2021


TOOKAD







Steba Biotech S.A




7 Place du Théâtre, 2613 Luxembourg, Luxembourg






EU/1/17/1228


5.2.2021




4.2.2021


VEYVONDI







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/18/1298


5.2.2021




4.2.2021


Waylivra







Akcea Therapeutics Ireland Limited




Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland






EU/1/19/1360


8.2.2021




4.2.2021


Xtandi







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/13/846


10.2.2021




8.2.2021


Clopidogrel BGR







Laboratoires BIOGARAN




15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France






EU/1/09/558


16.2.2021




8.2.2021


EndolucinBeta







ITM Medical Isotopes GmbH




Lichtenbergstraße 1, 85748 Garching, Deutschland






EU/1/16/1105


9.2.2021




8.2.2021


Zavesca







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/02/238


9.2.2021




11.2.2021


ALPROLIX







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/16/1098


12.2.2021




11.2.2021


Bortezomib Hospira







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/16/1114


12.2.2021




11.2.2021


Bosulif







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/13/818


12.2.2021




11.2.2021


Clopidogrel Taw Pharma







Taw Pharma (Ireland) Limited




104 Lower Baggot Street, Dublin 2, Ireland






EU/1/09/568


26.2.2021




11.2.2021


Cometriq







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/13/890


9.3.2021




11.2.2021


Descovy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/16/1099


17.2.2021




11.2.2021


Galafold







Amicus Therapeutics Europe Limited




Block 1 Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland






EU/1/15/1082


12.2.2021




11.2.2021


Neparvis







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/16/1103


12.2.2021




11.2.2021


Omnitrope







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/06/332


15.2.2021




11.2.2021


Xerava







Tetraphase Pharmaceuticals Ireland Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/18/1312


22.2.2021




11.2.2021


Zavicefta







Pfizer Ireland Pharmaceuticals




Operations Support Group, Ringaskiddy, County Cork, Ireland






EU/1/16/1109


12.2.2021




12.2.2021


Amlodipine/Valsartan Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/16/1092


23.2.2021




12.2.2021


Clopidogrel Taw Pharma







Taw Pharma (Ireland) Limited




104 Lower Baggot Street, Dublin 2, Ireland






EU/1/09/568


25.2.2021




12.2.2021


Copalia







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/06/372


15.2.2021




12.2.2021


Dafiro







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/06/371


15.2.2021




12.2.2021


Exforge HCT







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/09/569


15.2.2021




12.2.2021


Karvea







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/97/049


15.2.2021




12.2.2021


Karvezide







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/98/085


15.2.2021




12.2.2021


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


15.2.2021




17.2.2021


Opsumit







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/893


18.2.2021




18.2.2021


Bortezomib Accord







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España






EU/1/15/1019


22.2.2021




18.2.2021


Bortezomib Fresenius Kabi







Fresenius Kabi Deutschland GmbH




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






EU/1/19/1397


22.2.2021




18.2.2021


Bortezomib SUN







Sun Pharmaceutical Industries Europe BV




Polarisavenue 87, 2132 JH Hoofddorp, Nederland






EU/1/16/1102


22.2.2021




18.2.2021


CellCept







Roche Registration GmbH




Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland






EU/1/96/005


19.2.2021




18.2.2021


Emselex







zr pharma& GmbH




Hietzinger Hauptstrasse 37, 1130 Wien, Österreich






EU/1/04/294


26.2.2021




18.2.2021


Ifirmacombi







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/11/673


22.2.2021




18.2.2021


Mabthera







Roche Registration GmbH




Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland






EU/1/98/067


19.2.2021




18.2.2021


Myclausen







Passauer Pharma GmbH




Eiderstedter Weg 3, 14129 Berlin, Deutschland






EU/1/10/647


22.2.2021




18.2.2021


Nimenrix







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/12/767


19.2.2021




18.2.2021


NutropinAq







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/00/164


19.2.2021




18.2.2021


Ongentys







Bial — Portela & Ca, SA




À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal






EU/1/15/1066


19.2.2021




18.2.2021


VELCADE







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/04/274


19.2.2021




19.2.2021


Aprovel







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/97/046


24.2.2021




19.2.2021


CoAprovel







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/98/086


24.2.2021




19.2.2021


Copalia HCT







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/09/575


22.2.2021




19.2.2021


Dafiro HCT







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/09/574


22.2.2021




19.2.2021


Entresto







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/15/1058


23.2.2021




19.2.2021


Envarsus







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/14/935


23.2.2021




19.2.2021


Exforge







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/06/370


22.2.2021




19.2.2021


Hefiya







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1287


22.2.2021




19.2.2021


Ifirmasta







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/08/480


2.3.2021




19.2.2021


INOmax







Linde Healthcare AB




SE-181 81 Lidingö, Sverige






EU/1/01/194


23.2.2021




19.2.2021


Irbesartan HCT Zentiva







Zentiva k.s.




U kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/06/377


22.2.2021




19.2.2021


Irbesartan / Hydrochlorothiazide Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/583


22.2.2021




19.2.2021


Irbesartan Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/576


1.3.2021




19.2.2021


Irbesartan Zentiva







Zentiva k.s.




U kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/06/376


22.2.2021




19.2.2021


Mycophenolate mofetil Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/07/439


1.3.2021




19.2.2021


Myfenax







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/07/438


1.3.2021




19.2.2021


Neparvis







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/16/1103


22.2.2021




19.2.2021


Ondexxya







Alexion Europe S.A.S.




103 Rue Anatole France, 92300 Levallois Perret, France






EU/1/18/1345


24.2.2021




19.2.2021


Soliris







Alexion Europe SAS




103-105 rue Anatole France, 92300 Levallois-Perret, France






EU/1/07/393


24.2.2021




19.2.2021


TAKHZYRO







Shire Pharmaceuticals Ireland Limited




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






EU/1/18/1340


22.2.2021




19.2.2021


Tamiflu







Roche Registration GmbH




Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland






EU/1/02/222


22.2.2021




23.2.2021


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


23.2.2021




25.2.2021


Buccolam







Laboratorios Lesvi, S.L.




Avda. Barcelona 69, 08970 Sant Joan Despí — Barcelona, España






EU/1/11/709


26.2.2021




25.2.2021


Clopidogrel/Acetylsalicylic acid Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/19/1395


1.3.2021




26.2.2021


Pazenir







ratiopharm GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/18/1317


1.3.2021




26.2.2021


Spravato







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/19/1410


1.3.2021




26.2.2021


Vaxchora







Emergent Netherlands B.V.




Strawinskylaan 411, 1077 XX Amsterdam, Nederland






EU/1/20/1423


1.3.2021




—   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




4.2.2021


Udenyca







ERA Consulting GmbH




Lange Straße 70, 29664 Walsrode, Deutschland






EU/1/18/1303


5.2.2021




—   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




17.2.2021


Solensia


frunevetmab







Zoetis Belgium SA




Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique






EU/2/20/269


Solution for injection


Pending


18.2.2021




—   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




1.2.2021


Meloxoral







Le Vet B.V.




Wilgenweg 7, 3421 TV Oudewater, Nederland






EU/2/10/111


3.2.2021




9.2.2021


BTVPUR







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/10/113


18.2.2021




9.2.2021


Cerenia







Zoetis Belgium S.A.




rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique






EU/2/06/062


11.2.2021




9.2.2021


Draxxin







Zoetis Belgium S.A.




rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique






EU/2/03/041


11.2.2021




9.2.2021


Emdocam







Emdoka bvba




J. Lijsenstraat 16, 2321 Hoogstraten, België






EU/2/11/128


11.2.2021




9.2.2021


LETIFEND







Laboratorios LETI, S.L.unipersonal




C/ Del Sol 5, Polígono Industrial Norte, Tres Cantos, 28760 Madrid, España






EU/2/16/195


11.2.2021




9.2.2021


Nobivac Bb







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/02/034


12.2.2021




9.2.2021


Porcilis PCV M Hyo







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/14/175


19.2.2021




9.2.2021


Reconcile







Pegasus Laboratories Ireland Limited




10 McCurtain Hill, Clonakilty, County Cork, P85 K230, Ireland






EU/2/08/080


11.3.2021




12.2.2021


Evalon







Laboratorios Hipra, S.A.




Avda. La Selva, 135, 17170 Amer (Girona), España






EU/2/16/194


17.2.2021




12.2.2021


Halagon







Emdoka bvba




J. Lijsenstraat 16, 2321 Hoogstraten, België






EU/2/16/201


15.2.2021




26.2.2021


Enteroporc Coli AC







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/20/262


1.3.2021




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.