Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2022 to 31 May 2022 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
Date: 2022-06-30
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_2022249EN.01000101.xml










30.6.2022   


EN


Official Journal of the European Union


C 249/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2022 to 31 May 2022
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1)
 or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (2)
)
(2022/C 249/01)
—   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




5.5.2022


Amversio


betaine anhydrous







SERB S.A.




Avenue Louise 480, 1050 Bruxelles, Belgique / Louizalaan 480, 1050 Brussel, België






EU/1/22/1640


Powder for oral solution


A16AA06


6.5.2022




13.5.2022


Dimethyl fumarate Mylan


dimethyl fumarate







Mylan Ireland Limited




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






EU/1/22/1634


Gastro-resistant capsule, hard


L04AX07


16.5.2022




13.5.2022


Dimethyl fumarate Neuraxpharm


dimethyl fumarate







Laboratorios Lesvi, S.L.




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






EU/1/22/1637


Gastro-resistant capsule, hard


L04AX07


16.5.2022




13.5.2022


Dimethyl fumarate Polpharma


dimethyl fumarate







Zakłady Farmaceutyczne POLPHARMA S.A.




ul. Pelplińska 19, 83-200 Starogard Gdański, Polska






EU/1/22/1635


Gastro-resistant capsule, hard


L04AX07


13.5.2022




17.5.2022


Zolgensma


onasemnogene abeparvovec







Novartis Gene Therapies EU Limited




Block B, The Crescent Building, Northwood, Santry, Dublin 9, D09 C6X8, Ireland






EU/1/20/1443


Solution for infusion


M09AX09


18.5.2022




19.5.2022


Amifampridine SERB


amifampridine







SERB S.A.




Avenue Louise 480, 1050 Bruxelles, Belgique / Louizalaan 480, 1050 Brussel, België






EU/1/22/1646


Tablet


N07XX05


23.5.2022




24.5.2022


ADCETRIS


Brentuximab vedotin







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/12/794


Powder for concentrate for solution for infusion


L01FX05


25.5.2022




24.5.2022


Camcevi


leuprorelin







Accord Healthcare S.L.U.




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






EU/1/22/1647


Prolonged-release suspension for injection


L02AE02


26.5.2022




24.5.2022


Polivy


polatuzumab vedotin







Roche Registration GmbH




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






EU/1/19/1388


Powder for concentrate for solution for infusion


L01FX14


25.5.2022




25.5.2022


CARVYKTI


ciltacabtagene autoleucel







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/22/1648


Dispersion for infusion


Pending


30.5.2022




31.5.2022


ZOLSKETIL pegylated liposomal


doxorubicin







Accord Healthcare S.L.U.




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






EU/1/22/1629


Concentrate for dispersion for infusion


L01DB01


2.6.2022




—   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




4.5.2022


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


4.5.2022




4.5.2022


Rubraca







Clovis Oncology Ireland Limited




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






EU/1/17/1250


4.5.2022




5.5.2022


Enerzair Breezhaler







Novartis Europharm Limited




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






EU/1/20/1438


6.5.2022




5.5.2022


Hepsera







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/03/251


6.5.2022




5.5.2022


Invega







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/07/395


6.5.2022




5.5.2022


Opsumit







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/893


6.5.2022




5.5.2022


Pazenir







ratiopharm GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/18/1317


6.5.2022




5.5.2022


Prolia







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/10/618


9.5.2022




5.5.2022


Ravicti







Immedica Pharma AB




SE-113 29 Stockholm, Sverige






EU/1/15/1062


10.5.2022




5.5.2022


Sapropterin Dipharma







Dipharma B.V.




Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland






EU/1/21/1620


6.5.2022




5.5.2022


Ziextenzo







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1327


9.5.2022




13.5.2022


Buccolam







Laboratorios Lesvi, S.L.




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






EU/1/11/709


18.5.2022




13.5.2022


Genvoya







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/15/1061


16.5.2022




13.5.2022


Imatinib Actavis







Actavis Group PTC ehf.




Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland






EU/1/13/825


17.5.2022




13.5.2022


Lumigan







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/02/205


20.5.2022




13.5.2022


NEXPOVIO







Karyopharm Europe GmbH




Franziska-Bilek-Weg 9, 80339 München, Deutschland






EU/1/21/1537


17.5.2022




13.5.2022


Odomzo







Sun Pharmaceutical Industries Europe BV




Polarisavenue 87, 2132 JH Hoofddorp, Nederland






EU/1/15/1030


19.5.2022




13.5.2022


Tecfidera







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/13/837


13.5.2022




17.5.2022


Cinryze







Takeda Manufacturing Austria AG




Industriestraße 67, 1221 Wien, Österreich






EU/1/11/688


18.5.2022




17.5.2022


COVID-19 Vaccine Janssen







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


18.5.2022




17.5.2022


Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/17/1210


18.5.2022




17.5.2022


Revestive







Takeda Pharmaceuticals International AG Ireland Branch




50-58 Baggot Street Lower, Block 3 Miesian Plaza, Dublin 2, Co Dublin, D02 Y754, Ireland






EU/1/12/787


18.5.2022




19.5.2022


Adcirca







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/08/476


23.5.2022




19.5.2022


Aranesp







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/01/185


23.5.2022




19.5.2022


Azarga







Novartis Europharm Limited




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






EU/1/08/482


20.5.2022




19.5.2022


Bronchitol







Pharmaxis Europe Limited




108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland






EU/1/12/760


24.5.2022




19.5.2022


Comtess







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/1/98/082


20.5.2022




19.5.2022


Cresemba







Basilea Pharmaceutica Deutschland GmbH




Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland






EU/1/15/1036


23.5.2022




19.5.2022


DuoTrav







Novartis Europharm Limited




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






EU/1/06/338


20.5.2022




19.5.2022


Epclusa







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/16/1116


20.5.2022




19.5.2022


Glubrava







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/07/421


25.5.2022




19.5.2022


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


23.5.2022




19.5.2022


Maviret







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/17/1213


20.5.2022




19.5.2022


Pelmeg







Mundipharma Corporation (Ireland) Limited




Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland






EU/1/18/1328


23.5.2022




19.5.2022


Peyona







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/09/528


6.6.2022




19.5.2022


Toujeo







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/00/133


2.6.2022




19.5.2022


Trogarzo







Theratechnologies Europe Limited




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






EU/1/19/1359


2.6.2022




19.5.2022


Zimbus Breezhaler







Novartis Europharm Limited




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






EU/1/20/1440


20.5.2022




20.5.2022


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


20.5.2022




24.5.2022


Adjupanrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/09/578


31.5.2022




24.5.2022


Cabazitaxel Accord







Accord Healthcare S.L.U.




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






EU/1/20/1448


26.5.2022




24.5.2022


Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/17/1222


25.5.2022




24.5.2022


Kesimpta







Novartis Ireland Limited




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






EU/1/21/1532


25.5.2022




24.5.2022


NovoSeven







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/96/006


25.5.2022




24.5.2022


Symtuza







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/17/1225


25.5.2022




25.5.2022


JCOVDEN







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


25.5.2022




25.5.2022


Regkirona







Celltrion Healthcare Hungary Kft.




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






EU/1/21/1597


25.5.2022




30.5.2022


Aerinaze







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/07/399


31.5.2022




30.5.2022


Aerius







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/00/160


31.5.2022




30.5.2022


Azomyr







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/00/157


31.5.2022




30.5.2022


BLENREP







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/20/1474


31.5.2022




30.5.2022


Bydureon







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/11/696


31.5.2022




30.5.2022


Dasselta







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/11/739


1.6.2022




30.5.2022


Desloratadine ratiopharm







ratiopharm GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/11/746


31.5.2022




30.5.2022


Desloratadine Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/11/732


31.5.2022




30.5.2022


Harvoni







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/14/958


31.5.2022




30.5.2022


JEVTANA







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/11/676


31.5.2022




30.5.2022


Neoclarityn







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/00/161


31.5.2022




30.5.2022


Rinvoq







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1404


31.5.2022




30.5.2022


Rozlytrek







Roche Registration GmbH




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






EU/1/20/1460


31.5.2022




30.5.2022


Rydapt







Novartis Europharm Limited




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






EU/1/17/1218


31.5.2022




30.5.2022


Sovaldi







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/13/894


31.5.2022




30.5.2022


Tysabri







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/06/346


31.5.2022




30.5.2022


Vosevi







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/17/1223


31.5.2022




30.5.2022


Zejula







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/17/1235


31.5.2022




—   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




16.5.2022


Imatinib Actavis







Actavis Group PTC ehf.




Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland






EU/1/13/825


17.5.2022




24.5.2022


Glubrava







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/07/421


25.5.2022




—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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




5.5.2022


Advocate







Bayer Animal Health GmbH




D-51368 Leverkusen, Deutschland






EU/2/03/039


6.5.2022




5.5.2022


Zeleris







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/17/210


10.5.2022




18.5.2022


Hydrocortisone aceponate Ecuphar







Ecuphar NV




Legeweg 157-i, 8020 Oostkamp, België






EU/2/18/230


23.5.2022




18.5.2022


Locatim







Biokema Anstalt




Pflugstrasse 12, 9490 Vaduz, Fürstentum Liechtenstein






EU/2/99/011


23.5.2022




30.5.2022


Pirsue







Zoetis Belgium S.A.




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






EU/2/00/027


31.5.2022




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.

(2)  OJ L 4, 7.1.2019, p. 43.