Official Journal of the European Union

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.