Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2022 to 30 November 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 496/01)

— 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 7.11.2022 Melatonin Neurim melatonin RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux, 75002 Paris, France EU/1/22/1694 Prolonged-release tablet N05CH01 8.11.2022 9.11.2022 LIVTENCITY maribavir Takeda Pharmaceuticals International AG Ireland Branch 50-58 Baggot Street Lower, Block 3 Miesian Plaza, Dublin 2, Co Dublin, D02 Y754, Ireland EU/1/22/1672 Film-coated tablet J05AX10 10.11.2022 9.11.2022 Pyrukynd mitapivat Agios Netherlands B.V. Zuidplein 36, Regus Amsterdam WTC, 1077XV Amsterdam, Nederland EU/1/22/1662 Film-coated tablet B06AX04 10.11.2022 9.11.2022 Rubraca rucaparib Clovis Oncology Ireland Limited 1st Floor, Building Two, The Green, Dublin Airport Central, Dublin Airport, Swords, Co. Dublin, K67 E2H3, Ireland. EU/1/17/1250 Film-coated tablet L01XK03 10.11.2022 9.11.2022 Sorafenib Accord sorafenib Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/22/1696 Film-coated tablet L01EX02 10.11.2022 9.11.2022 Teriflunomide Accord teriflunomide Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/22/1693 Film-coated tablet L04AA31 10.11.2022 9.11.2022 Teriflunomide Mylan teriflunomide Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/22/1698 Film-coated tablet L04AA31 10.11.2022 9.11.2022 Ximluci ranibizumab STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Deutschland EU/1/22/1691 Solution for injection S01LA04 11.11.2022 15.11.2022 Enjaymo sutimlimab Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/22/1687 Solution for infusion L04AA55 23.11.2022 18.11.2022 Teriparatide SUN teriparatide Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87, 2132JH Hoofddorp, Nederland EU/1/22/1697 Solution for injection H05AA02 22.11.2022 28.11.2022 Caprelsa vandetanib Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/11/749 Film-coated tablet L01EX04 30.11.2022

— 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 7.11.2022 Efavirenz/Emtricitabine/Tenofovir disoproxil Krka KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1263 9.11.2022 7.11.2022 EXPAREL liposomal Pacira Ireland Ltd Unit 13, Classon House, Dundrum Business Park, Dundrum, Dublin 14, D14W9Y3, Ireland EU/1/20/1489 9.11.2022 9.11.2022 Aclasta Sandoz Pharmaceuticals d.d. Verovškova ulica 57, 1000 Ljubljana, Slovenija EU/1/05/308 11.11.2022 9.11.2022 Adempas Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/907 10.11.2022 9.11.2022 ADYNOVI Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich EU/1/17/1247 10.11.2022 9.11.2022 Alkindi Diurnal Europe B.V. Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland EU/1/17/1260 10.11.2022 9.11.2022 Darunavir Krka KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1249 15.11.2022 9.11.2022 Dexmedetomidine Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/19/1418 10.11.2022 9.11.2022 Elaprase Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/06/365 10.11.2022 9.11.2022 Eylea Bayer AG D-51368 Leverkusen, Deutschland EU/1/12/797 10.11.2022 9.11.2022 GHRYVELIN Consilient Health Ltd 5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland EU/1/18/1337 16.11.2022 9.11.2022 Hycamtin Sandoz Pharmaceuticals d.d. Verovškova ulica 57, 1000 Ljubljana, Slovenija EU/1/96/027 11.11.2022 9.11.2022 Incruse Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/922 10.11.2022 9.11.2022 Isturisa Recordati Rare Diseases Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/19/1407 10.11.2022 9.11.2022 Kentera Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/03/270 14.11.2022 9.11.2022 Laventair Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/899 10.11.2022 9.11.2022 Lucentis Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/374 11.11.2022 9.11.2022 Memantine ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/13/836 11.11.2022 9.11.2022 Rilutek Sanofi Mature IP 54 rue La Boétie, 75008, Paris, France EU/1/96/010 14.11.2022 9.11.2022 Rolufta Ellipta GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland EU/1/17/1174 14.11.2022 9.11.2022 Segluromet Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1265 11.11.2022 9.11.2022 Stelara Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/08/494 10.11.2022 9.11.2022 Stocrin Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/99/111 11.11.2022 9.11.2022 Talzenna Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/19/1377 10.11.2022 9.11.2022 Torisel Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/07/424 10.11.2022 9.11.2022 Vargatef Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/954 10.11.2022 9.11.2022 Vyndaqel Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/11/717 10.11.2022 10.11.2022 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 11.11.2022 10.11.2022 Spikevax MODERNA BIOTECH SPAIN, S.L. Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España EU/1/20/1507 11.11.2022 11.11.2022 JCOVDEN Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/20/1525 14.11.2022 15.11.2022 Brukinsa BeiGene Ireland Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Co. Dublin, Ireland EU/1/21/1576 16.11.2022 15.11.2022 Caprelsa Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/11/749 18.11.2022 15.11.2022 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/945 16.11.2022 15.11.2022 Lamivudine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/566 21.11.2022 15.11.2022 Mylotarg Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/18/1277 16.11.2022 15.11.2022 Riluzole Zentiva Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika EU/1/12/768 18.11.2022 15.11.2022 Steglatro Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1267 17.11.2022 15.11.2022 Tecartus Kite Pharma EU B.V. Tufsteen 1, 2132 NT Hoofddorp, Nederland EU/1/20/1492 22.11.2022 15.11.2022 Xevudy GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland EU/1/21/1562 16.11.2022 18.11.2022 Anoro Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/898 22.11.2022 18.11.2022 Aripiprazole Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/15/1045 22.11.2022 18.11.2022 Byfavo PAION Deutschland GmbH Heussstraße 25, 52078 Aachen, Deutschland EU/1/20/1505 22.11.2022 18.11.2022 Fasturtec Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/00/170 22.11.2022 18.11.2022 Kevzara Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/17/1196 22.11.2022 18.11.2022 Latuda Aziende Chimiche Riunite Angelini Francesco — A.C.R.A.F. S.p.A. Viale Amelia 70, 00181 Roma, Italia EU/1/14/913 22.11.2022 18.11.2022 LIBTAYO Regeneron Ireland Designated Activity Company (DAC) One Warrington Place, Dublin 2, D02 HH27 Ireland EU/1/19/1376 21.11.2022 18.11.2022 Lyumjev Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/20/1422 22.11.2022 18.11.2022 Matever Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/11/711 22.11.2022 18.11.2022 Methylthioninium chloride Proveblue Provepharm S.A.S. 22 rue Marc Donadille, 13013 Marseille, France EU/1/11/682 23.11.2022 18.11.2022 Vaborem Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Luxembourg EU/1/18/1334 23.11.2022 18.11.2022 Yselty Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland EU/1/21/1606 23.11.2022 18.11.2022 Zeposia Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/20/1442 21.11.2022 21.11.2022 Aldara Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland EU/1/98/080 22.11.2022 21.11.2022 Anagrelide Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/17/1256 22.11.2022 21.11.2022 AUBAGIO Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/13/838 22.11.2022 21.11.2022 Biktarvy Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/18/1289 22.11.2022 21.11.2022 Eucreas Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/425 22.11.2022 21.11.2022 Imatinib Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/808 22.11.2022 21.11.2022 Jylamvo Therakind (Europe) Limited Paramount Court, Corrig Road, Sandyford Business Park, Dublin 18, D18 R9C7, Ireland EU/1/17/1172 24.11.2022 21.11.2022 Lumykras Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/21/1603 23.11.2022 21.11.2022 Multaq Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/09/591 22.11.2022 21.11.2022 Obiltoxaximab SFL SFL Pharmaceuticals Deutschland GmbH Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland EU/1/20/1485 28.11.2022 21.11.2022 Qtern AstraZeneca AB 151 85 Södertälje, Sverige EU/1/16/1108 22.11.2022 21.11.2022 Skyrizi AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/19/1361 22.11.2022 21.11.2022 Tasmar Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland EU/1/97/044 22.11.2022 21.11.2022 Veklury Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/20/1459 21.11.2022 21.11.2022 Voncento CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/13/857 22.11.2022 21.11.2022 ZALTRAP Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/12/814 22.11.2022 25.11.2022 COVID-19 Vaccine (inactivated, adjuvanted) Valneva Valneva Austria GmbH Campus Vienna Biocenter 3, 1030 Wien, Österreich EU/1/21/1624 25.11.2022 28.11.2022 Adenuric Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Luxembourg EU/1/08/447 29.11.2022 28.11.2022 Beromun BELPHARMA s.a. 2, Rue Albert 1er, L-1117, Luxembourg, Luxembourg EU/1/99/097 29.11.2022 28.11.2022 Deferasirox Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/19/1386 29.11.2022 28.11.2022 Dengvaxia Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France EU/1/18/1338 29.11.2022 28.11.2022 Dimethyl fumarate Polpharma Zakłady Farmaceutyczne POLPHARMA S.A. ul. Pelplińska 19, 83-200 Starogard Gdański, Polska EU/1/22/1635 2.12.2022 28.11.2022 Docetaxel Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/12/769 30.11.2022 28.11.2022 IKERVIS Santen Oy Niittyhaankatu 20, 33720 Tampere, Suomi EU/1/15/990 30.11.2022 28.11.2022 Kivexa ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/04/298 30.11.2022 28.11.2022 Mircera Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/07/400 30.11.2022 28.11.2022 Nityr Cycle Pharmaceuticals (Europe) Ltd 70 Sir John Rogerson's Quay, Dublin 2, Ireland EU/1/18/1290 29.11.2022 28.11.2022 Nordimet Nordic Group B.V. Siriusdreef 41, 2132 WT Hoofddorp, Nederland EU/1/16/1124 29.11.2022 28.11.2022 Olanzapine Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/08/475 29.11.2022 28.11.2022 Onpattro Alnylam Netherlands B.V. Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland EU/1/18/1320 2.12.2022 28.11.2022 Paxlovid Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/22/1625 28.11.2022 28.11.2022 Pegasys zr pharma& GmbH Hietzinger Hauptstrasse 37, 1130 Wien, Österreich EU/1/02/221 29.11.2022 28.11.2022 Potactasol Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/10/660 29.11.2022 28.11.2022 Praluent Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/15/1031 29.11.2022 28.11.2022 Sixmo L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A Strada Statale 67, 50018 Scandicci (Firenze), Italia EU/1/19/1369 29.11.2022 28.11.2022 Stivarga Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/858 29.11.2022 28.11.2022 Taltz Eli Lilly and Company (Ireland) Limited Dunderrow, Kinsale, Co. Cork, Ireland EU/1/15/1085 2.12.2022 28.11.2022 Zessly Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1280 29.11.2022 28.11.2022 Zoely Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland EU/1/11/690 6.12.2022

— 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 18.11.2022 Hepsera Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/03/251 22.11.2022

— Issuing 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 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 22.11.2022 Mometamax Ultra gentamicin, posaconazole, mometasone furoate Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/22/289 Ear drops, suspension Pending 24.11.2022 30.11.2022 DogStem equine umbilical cord mesenchymal stem cells EquiCord S.L. 103-D Loeches, Polígono Industrial Ventorro del Cano, Alcorcón, 28925 Madrid, España EU/2/22/285 Suspension for injection QM09AX90 1.12.2022

— 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 9.11.2022 BROADLINE Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/13/157 11.11.2022 9.11.2022 Purevax RCPCh FeLV Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/047 10.11.2022 9.11.2022 Zuprevo Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/11/124 10.11.2022 11.11.2022 Bravecto Plus Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/18/224 15.11.2022 11.11.2022 Librela Zoetis Belgium SA Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/20/261 14.11.2022 11.11.2022 Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/07/078 15.11.2022 11.11.2022 Simparica Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/15/191 15.11.2022 18.11.2022 Bravecto Plus Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/18/224 21.11.2022 18.11.2022 CircoMax Myco Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/20/264 22.11.2022 18.11.2022 MiPet Easecto Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/220 21.11.2022 30.11.2022 Arti-Cell Forte Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/18/228 1.12.2022 30.11.2022 CircoMax Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/21/281 1.12.2022 30.11.2022 Meloxoral Dechra Regulatory B.V. Handelsweg 25, 5531 AE Bladel, Nederland EU/2/10/111 1.12.2022 30.11.2022 ProZinc Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/13/152 8.12.2022 30.11.2022 Simparica Trio Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/19/243 2.12.2022

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.