Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2021 to 30 April 2021 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2021-05-28
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_2021204EN.01000101.xml










28.5.2021   


EN


Official Journal of the European Union


C 204/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2021 to 30 April 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 204/01)
—   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




21.4.2021


Abevmy


bevacizumab







Mylan IRE Healthcare Limited




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






EU/1/20/1515


Concentrate for solution for infusion


L01XC07


22.4.2021




21.4.2021


JEMPERLI


dostarlimab







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/21/1538


Concentrate for solution for infusion


L01XC40


22.4.2021




21.4.2021


Lextemy


bevacizumab







Mylan IRE Healthcare Limited




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






EU/1/20/1516


Concentrate for solution for infusion


L01XC07


22.4.2021




26.4.2021


Abiraterone Accord


abiraterone acetate







Accord Healthcare S.L.U.




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






EU/1/20/1512


Film-coated tablet
Tablet


L02BX03


30.4.2021




30.4.2021


Orladeyo


berotralstat







Biocryst Ireland Limited




Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland






EU/1/21/1544


Capsule, hard


B06AC


4.5.2021




30.4.2021


Sibnayal


potassium citrate/potassium hydrogen carbonate







ADVICENNE




22, rue de la Paix, 75002 Paris, France






EU/1/20/1517


Prolonged-release granules


A12BA30


3.5.2021




—   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




7.4.2021


Effentora







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/08/441


8.4.2021




7.4.2021


Instanyl







Takeda Pharma A/S




Dybendal Alle 10, 2630 Taastrup, Danmark






EU/1/09/531


8.4.2021




7.4.2021


Trimbow







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/17/1208


8.4.2021




8.4.2021


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


8.4.2021




13.4.2021


Aerinaze







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/07/399


16.4.2021




13.4.2021


Deltyba







Otsuka Novel Products GmbH




Erika-Mann-Straße 21, 80636 München, Deutschland






EU/1/13/875


14.4.2021




13.4.2021


Neoclarityn







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/00/161


22.4.2021




13.4.2021


OPDIVO







Bristol-Myers Squibb Pharma EEIG




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






EU/1/15/1014


14.4.2021




13.4.2021


Orgalutran







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/00/130


16.4.2021




13.4.2021


Vantavo







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/09/572


16.4.2021




14.4.2021


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


14.4.2021




15.4.2021


Natpar







Shire Pharmaceuticals Ireland Limited




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






EU/1/15/1078


16.4.2021




15.4.2021


Sarclisa







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/20/1435


16.4.2021




15.4.2021


Xromi







Nova Laboratories Ireland Limited




3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland






EU/1/19/1366


16.4.2021




16.4.2021


Cholestagel







CHEPLAPHARM Arzneimittel GmbH




Ziegelhof 24, 17489 Greifswald, Deutschland






EU/1/03/268


27.4.2021




16.4.2021


Dynastat







Pfizer Europe MA EEIG




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






EU/1/02/209


19.4.2021




16.4.2021


Entecavir Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/17/1227


26.4.2021




16.4.2021


Epidyolex







GW Pharma (International) B.V.




Databankweg 26, 3821AL Amersfoort, Nederland






EU/1/19/1389


20.4.2021




16.4.2021


EVOTAZ







Bristol-Myers Squibb/Pfizer EEIG




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






EU/1/15/1025


19.4.2021




16.4.2021


Imvanex







Bavarian Nordic A/S




Philip Heymans Allé 3, DK-2900 Hellerup, Danmark






EU/1/13/855


27.4.2021




16.4.2021


Kyprolis







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1060


20.4.2021




16.4.2021


Macimorelin Consilient Health







Consilient Health Ltd




5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland






EU/1/18/1337


26.4.2021




16.4.2021


Maviret







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/17/1213


20.4.2021




16.4.2021


Pegasys







Roche Registration GmbH




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






EU/1/02/221


26.4.2021




16.4.2021


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


20.4.2021




16.4.2021


Pemetrexed Lilly







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/15/1034


19.4.2021




16.4.2021


SANCUSO







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






EU/1/12/766


26.4.2021




16.4.2021


Taxotere







Sanofi Mature IP




54 rue La Boétie, 75008, Paris, France






EU/1/95/002


29.4.2021




16.4.2021


Xaluprine







Nova Laboratories Ireland Limited




3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland






EU/1/11/727


19.4.2021




16.4.2021


Xerava







PAION Deutschland GmbH




Heussstraße 25, 52078 Aachen, Deutschland






EU/1/18/1312


19.4.2021




21.4.2021


Adrovance







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/06/364


26.4.2021




21.4.2021


Avamys







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/07/434


28.4.2021




21.4.2021


CABOMETYX







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/16/1136


22.4.2021




21.4.2021


Fosavance







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/05/310


26.4.2021




21.4.2021


Fycompa







Eisai GmbH




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






EU/1/12/776


22.4.2021




21.4.2021


INCRELEX







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/07/402


22.4.2021




21.4.2021


Insulin aspart Sanofi







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/20/1447


22.4.2021




21.4.2021


Lyumjev







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1422


22.4.2021




21.4.2021


Macimorelin Consilient Health







Consilient Health Ltd




5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland






EU/1/18/1337


23.4.2021




21.4.2021


Mvasi







Amgen Technology (Ireland) UC




Pottery Road, Dun Laoghaire, Co. Dublin, Ireland






EU/1/17/1246


26.2.2021




21.4.2021


Mvasi







Amgen Technology (Ireland) UC




Pottery Road, Dun Laoghaire, Co. Dublin, Ireland






EU/1/17/1246


22.4.2021




21.4.2021


NUBEQA







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/20/1432


22.4.2021




21.4.2021


Ontruzant







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/17/1241


23.4.2021




21.4.2021


OPDIVO







Bristol-Myers Squibb Pharma EEIG




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






EU/1/15/1014


26.4.2021




21.4.2021


Oslif Breezhaler







Novartis Europharm Limited




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






EU/1/09/586


22.4.2021




21.4.2021


Pemetrexed Fresenius Kabi







Fresenius Kabi Deutschland GmbH




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






EU/1/16/1115


23.4.2021




21.4.2021


Qtern







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/16/1108


22.4.2021




21.4.2021


Ritonavir Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/17/1242


23.4.2021




21.4.2021


RoActemra







Roche Registration GmbH




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






EU/1/08/492


23.4.2021




21.4.2021


Slenyto







RAD Neurim Pharmaceuticals EEC SARL




4 rue de Marivaux, 75002 Paris, France






EU/1/18/1318


28.4.2021




21.4.2021


Stocrin







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/99/111


26.4.2021




21.4.2021


Tegsedi







Akcea Therapeutics Ireland Ltd




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






EU/1/18/1296


22.4.2021




21.4.2021


Trogarzo







Theratechnologies Europe Limited




4th Floor, 2 Hume Street, Dublin 2, D02 DV24, Ireland






EU/1/19/1359


26.4.2021




21.4.2021


Valdoxan







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes CEDEX, France






EU/1/08/499


22.4.2021




21.4.2021


Vosevi







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/17/1223


22.4.2021




22.4.2021


COVID-19 Vaccine Janssen







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


22.4.2021




26.4.2021


Aerius







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/00/160


30.4.2021




26.4.2021


Atazanavir Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/16/1091


27.4.2021




26.4.2021


Kaftrio







Vertex Pharmaceuticals (Ireland) Limited




28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland






EU/1/20/1468


5.5.2021




26.4.2021


Kalydeco







Vertex Pharmaceuticals (Ireland) Limited




28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland






EU/1/12/782


5.5.2021




26.4.2021


Levetiracetam Hospira







Pfizer Europe MA EEIG




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






EU/1/13/889


28.4.2021




26.4.2021


Saxenda







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/15/992


5.5.2021




28.4.2021


Bortezomib Hospira







Pfizer Europe MA EEIG




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






EU/1/16/1114


29.4.2021




30.4.2021


Benlysta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/11/700


4.5.2021




30.4.2021


Cervarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/07/419


4.5.2021




30.4.2021


Dasselta







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/11/739


4.5.2021




30.4.2021


Desloratadine Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/11/732


3.5.2021




30.4.2021


Jardiance







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/14/930


4.5.2021




30.4.2021


Kigabeq







ORPHELIA Pharma SAS




85 boulevard Saint-Michel, 75005 Paris, France






EU/1/18/1302


4.5.2021




30.4.2021


Mylotarg







Pfizer Europe MA EEIG




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






EU/1/18/1277


4.5.2021




30.4.2021


NULOJIX







Bristol-Myers Squibb Pharma EEIG




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






EU/1/11/694


4.5.2021




30.4.2021


Remsima







Celltrion Healthcare Hungary Kft.




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






EU/1/13/853


3.5.2021




30.4.2021


Sprycel







Bristol-Myers Squibb Pharma EEIG




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






EU/1/06/363


4.5.2021




30.4.2021


Strimvelis







Orchard Therapeutics (Netherlands) B.V.




Prins Bernhardplein 200, 1097 JB, Noord-Holland, Amsterdam, Nederland






EU/1/16/1097


4.5.2021




30.4.2021


Tecentriq







Roche Registration GmbH




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






EU/1/17/1220


3.5.2021




30.4.2021


Xtandi







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/13/846


3.5.2021




—   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




21.4.2021


PegIntron







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/00/131


26.4.2021




—   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




14.4.2021


Credelio Plus


lotilaner / milbemycin oxime







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/21/271


Chewable tablet


QP54AB51


15.4.2021




20.4.2021


Ultifend ND IBD


Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant)







Ceva-Phylaxia Co. Ltd.




Szállás u. 5, 1107 Budapest, Magyarország






EU/2/21/272


Concentrate and solvent for suspension for injection


Pending


22.4.2021




—   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




14.4.2021


Suprelorin







VIRBAC S.A.




1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France






EU/2/07/072


19.4.2021




20.4.2021


Convenia







Zoetis Belgium S.A.




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






EU/2/06/059


27.4.2021




20.4.2021


Cortavance







VIRBAC S.A.




1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France






EU/2/06/069


26.4.2021




20.4.2021


Proteq West Nile







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/11/129


4.5.2021




20.4.2021


Sevohale







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/16/196


28.4.2021




20.4.2021


Zactran







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/08/082


22.4.2021




26.4.2021


Coliprotec F4/F18







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/16/202


30.4.2021




26.4.2021


Credelio







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/17/206


28.4.2021




26.4.2021


Emdocam







Emdoka bvba




J. Lijsenstraat 16, 2321 Hoogstraten, België






EU/2/11/128


27.4.2021




26.4.2021


Enteroporc Coli







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/20/268


28.4.2021




26.4.2021


Neptra







Bayer Animal Health GmbH




D-51368 Leverkusen, Deutschland






EU/2/19/246


6.5.2021




26.4.2021


Stelfonta







QBiotics Netherlands B.V.




Prinses Margrietplantsoen 33, 2595 AM Den Haag, Nederland






EU/2/19/248


27.4.2021




26.4.2021


Trocoxil







Zoetis Belgium S.A.




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






EU/2/08/084


27.4.2021




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.