Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2024 to 30 June 2024 (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: 2024-07-31
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_202404646EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/4646


31.7.2024






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2024 to 30 June 2024
         


(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)
)


(C/2024/4646)







—



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




3.6.2024


Fluenz


Influenza vaccine (live attenuated, nasal)







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/24/1816


Nasal spray, suspension


J07BB03


4.6.2024




17.6.2024


ALTUVOCT


efanesoctocog alfa







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/24/1824


Powder and solvent for solution for injection


B02BD02


18.6.2024




17.6.2024


Sirturo


bedaquiline







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/901


Tablet


J04AK05


18.6.2024




17.6.2024


Truqap


capivasertib







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/24/1820


Film-coated tablet


L01EX27


18.6.2024




20.6.2024


FRUZAQLA


fruquintinib







Takeda Pharmaceuticals International AG Ireland Branch




Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland






EU/1/24/1827


Capsule, hard


L01EK


25.6.2024




20.6.2024


Tofidence


tocilizumab







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/24/1825


Concentrate for solution for infusion


L04AC07


21.6.2024




20.6.2024


Wezenla


Ustekinumab







Amgen Technology (Ireland) UC




Pottery Road, Dun Laoghaire, Co. Dublin, Ireland






EU/1/24/1823


Concentrate for solution for infusion
Solution for injection
Solution for injection in a pre-filled syringe


L04AC05


22.6.2024




27.6.2024


Eribulin Baxter


eribulin







Baxter Holding B.V.




Kobaltweg 49, 3542 CE Utrecht, Nederland






EU/1/24/1819


Solution for injection


L01XX41


1.7.2024




27.6.2024


JERAYGO


aprocitentan







Idorsia Pharmaceuticals Deutschland GmbH




Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland






EU/1/24/1818


Film-coated tablet


C02KN01


28.6.2024




27.6.2024


Obgemsa


Vibegron







PIERRE FABRE MEDICAMENT




Les Cauquillous, 81500 Lavaur, France






EU/1/24/1822


Film-coated tablet


G04BD15


28.6.2024




27.6.2024


Rybrevant


amivantamab







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/21/1594


Concentrate for solution for infusion


L01FX18


28.6.2024




28.6.2024


IXCHIQ


Chikungunya vaccine (live)







Valneva Austria GmbH




Campus Vienna Biocenter 3, 1030 Wien, Österreich






EU/1/24/1828


Powder and solvent for solution for injection


Pending


28.6.2024














—



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




6.6.2024


Alecensa







Roche Registration GmbH




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






EU/1/16/1169


7.6.2024




6.6.2024


Cinqaero







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/16/1125


11.6.2024




6.6.2024


Efavirenz/Emtricitabine/Tenofovir disoproxil Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/17/1263


17.6.2024




6.6.2024


Fasenra







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/17/1252


7.6.2024




6.6.2024


Lymphoseek







Navidea Biopharmaceuticals Europe Ltd.




Kilminion South, Ballinroad, Dungarvan, Co. Waterford, X35 WP70, Ireland






EU/1/14/955


7.6.2024




6.6.2024


Pedmarqsi







Norgine B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/23/1734


7.6.2024




6.6.2024


Ritonavir Mylan







Mylan Pharmaceuticals Limited




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






EU/1/17/1242


7.6.2024




6.6.2024


Suliqua







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/16/1157


7.6.2024




6.6.2024


Sunlenca







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/22/1671


7.6.2024




6.6.2024


Synflorix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/09/508


10.6.2024




6.6.2024


Tepmetko







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/21/1596


10.6.2024




6.6.2024


Twynsta







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/10/648


17.6.2024




6.6.2024


Veltassa







Vifor Fresenius Medical Care Renal Pharma France




100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France






EU/1/17/1179


7.6.2024




10.6.2024


AMGLIDIA







AMMTeK




8 rue campagne première, 75014 Paris, France






EU/1/18/1279


12.6.2024




10.6.2024


Ozempic







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/17/1251


11.6.2024




10.6.2024


Respreeza







CSL Behring GmbH




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






EU/1/15/1006


26.6.2024




10.6.2024


Wegovy







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/21/1608


11.6.2024




13.6.2024


Atazanavir Viatris







Mylan Pharmaceuticals Limited




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






EU/1/16/1091


14.6.2024




13.6.2024


Darunavir Viatris







Mylan Pharmaceuticals Limited




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






EU/1/16/1140


14.6.2024




13.6.2024


Inbrija







Acorda Therapeutics Ireland Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/19/1390


14.6.2024




13.6.2024


Lopinavir/Ritonavir Viatris







Mylan Pharmaceuticals Limited




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






EU/1/15/1067


14.6.2024




13.6.2024


Ritonavir Viatris







Mylan Pharmaceuticals Limited




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






EU/1/17/1242


14.6.2024




13.6.2024


TALVEY







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/23/1748


14.6.2024




13.6.2024


TECVAYLI







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/22/1675


14.6.2024




13.6.2024


Telmisartan Actavis







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/10/639


14.6.2024




17.6.2024


Eviplera







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/11/737


18.6.2024




17.6.2024


Forxiga







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/12/795


18.6.2024




17.6.2024


Galafold







Amicus Therapeutics Europe Limited




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






EU/1/15/1082


19.6.2024




17.6.2024


Giotrif







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/13/879


18.6.2024




17.6.2024


Givlaari







Alnylam Netherlands B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/20/1428


18.6.2024




17.6.2024


Kinpeygo







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/22/1657


20.6.2024




17.6.2024


Mektovi







Pierre Fabre Médicament




Les Cauquillous, 81500 Lavaur, France






EU/1/18/1315


18.6.2024




17.6.2024


Pioglitazone Actavis







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/12/755


18.6.2024




17.6.2024


Rasagiline Viatris







Mylan Pharmaceuticals Limited




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






EU/1/16/1090


18.6.2024




17.6.2024


Renagel







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/99/123


19.6.2024




17.6.2024


Verzenios







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/18/1307


18.6.2024




17.6.2024


Vfend







Pfizer Europe MA EEIG




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






EU/1/02/212


18.6.2024




17.6.2024


Xultophy







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/14/947


19.6.2024




17.6.2024


Yentreve







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/04/280


18.6.2024




17.6.2024


Zometa







Phoenix Labs Unlimited Company




Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Ireland






EU/1/01/176


18.6.2024




20.6.2024


Abecma







Bristol-Myers Squibb Pharma EEIG




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






EU/1/21/1539


26.6.2024




20.6.2024


Abiraterone Mylan







Mylan Ireland Limited




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






EU/1/21/1571


21.6.2024




20.6.2024


Bridion







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/08/466


24.6.2024




20.6.2024


Cinacalcet Accordpharma







Accord Healthcare S.L.U.




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






EU/1/20/1429


21.6.2024




20.6.2024


CONTROLOC Control







Takeda GmbH




Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland






EU/1/09/515


25.6.2024




20.6.2024


Cymbalta







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/04/296


25.6.2024




20.6.2024


Duloxetine Lilly







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/14/972


24.6.2024




20.6.2024


Ifirmacombi







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/11/673


26.6.2024




20.6.2024


Kesimpta







Novartis Ireland Limited




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






EU/1/21/1532


21.6.2024




20.6.2024


Livmarli







Mirum Pharmaceuticals International B.V.




Kingsfordweg 151, 1043 GR Amsterdam, Noord-Holland, Nederland






EU/1/22/1704


21.6.2024




20.6.2024


Ocrevus







Roche Registration GmbH




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






EU/1/17/1231


21.6.2024




20.6.2024


Olanzapine Mylan







Mylan Pharmaceuticals Limited




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






EU/1/08/475


21.6.2024




20.6.2024


PANTOZOL Control







Takeda GmbH




Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland






EU/1/09/517


25.6.2024




20.6.2024


SOMAC Control







Takeda GmbH




Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland






EU/1/09/516


25.6.2024




20.6.2024


Spravato







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/19/1410


24.6.2024




20.6.2024


Tivicay







ViiV Healthcare BV




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






EU/1/13/892


21.6.2024




20.6.2024


TOBI Podhaler







Viatris Healthcare Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/10/652


21.6.2024




20.6.2024


Vabysmo







Roche Registration GmbH




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






EU/1/22/1683


21.6.2024




20.6.2024


Voriconazole Accord







Accord Healthcare S.L.U.




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






EU/1/13/835


21.6.2024




20.6.2024


Voriconazole Hikma







Hikma Farmacêutica (Portugal), S.A.




Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal






EU/1/15/1004


28.6.2024




20.6.2024


Voxzogo







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland






EU/1/21/1577


24.6.2024




20.6.2024


Xaluprine







Nova Laboratories Ireland Limited




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






EU/1/11/727


21.6.2024




20.6.2024


Xerava







PAION Deutschland GmbH




Heussstraße 25, 52078 Aachen, Deutschland






EU/1/18/1312


24.6.2024




20.6.2024


Xtandi







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/13/846


21.6.2024




20.6.2024


Zabdeno







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1444


21.6.2024




20.6.2024


Zyclara







Viatris Healthcare Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/12/783


24.6.2024




20.6.2024


Zydelig







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/14/938


21.6.2024




27.6.2024


Byetta







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/06/362


28.6.2024




27.6.2024


Levetiracetam Accord







Accord Healthcare S.L.U.




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






EU/1/11/712


28.6.2024




27.6.2024


Mepact







Takeda France SAS




112 avenue Kléber, 75116 Paris, France






EU/1/08/502


2.7.2024




27.6.2024


Nucala







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/15/1043


1.7.2024




27.6.2024


Rozlytrek







Roche Registration GmbH




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






EU/1/20/1460


28.6.2024




27.6.2024


Stribild







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/13/830


28.6.2024




27.6.2024


Tavneos







Vifor Fresenius Medical Care Renal Pharma France




100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France






EU/1/21/1605


28.6.2024




27.6.2024


Vokanamet







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/14/918


28.6.2024




27.6.2024


Xospata







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/19/1399


28.6.2024




27.6.2024


Zoledronic acid medac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/12/779


28.6.2024




28.6.2024


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


1.7.2024




28.6.2024


CRYSVITA







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






EU/1/17/1262


2.7.2024




28.6.2024


Dovprela







Mylan IRE Healthcare Limited




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






EU/1/20/1437


1.7.2024




28.6.2024


Dupixent







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/17/1229


1.7.2024




28.6.2024


Edistride







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/15/1052


1.7.2024




28.6.2024


Emtricitabine/Tenofovir disoproxil Mylan







Mylan Pharmaceuticals Limited




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






EU/1/16/1133


1.7.2024




28.6.2024


Invokana







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/884


1.7.2024




28.6.2024


Isturisa







Recordati Rare Diseases




Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800  Puteaux, France






EU/1/19/1407


1.7.2024




28.6.2024


Kineret







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/02/203


9.7.2024




28.6.2024


Livmarli







Mirum Pharmaceuticals International B.V.




Kingsfordweg 151, 1043 GR Amsterdam, Noord-Holland, Nederland






EU/1/22/1704


1.7.2024




28.6.2024


Matever







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/11/711


3.7.2024




28.6.2024


Relvar Ellipta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/13/886


1.7.2024




28.6.2024


Revinty Ellipta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/14/929


1.7.2024




28.6.2024


Rotarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/05/330


2.7.2024




28.6.2024


Supemtek







Sanofi Pasteur




14 Espace Henry Vallée, 69007 Lyon, France






EU/1/20/1484


1.7.2024




28.6.2024


TAGRISSO







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/16/1086


1.7.2024




28.6.2024


Zonisamide Mylan







Mylan Pharmaceuticals Limited




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






EU/1/16/1093


1.7.2024














—



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




6.6.2024


Nityr







Cycle Pharmaceuticals (Europe) Ltd




70 Sir John Rogerson's Quay, Dublin 2, D02 R296, Ireland






EU/1/18/1290


7.6.2024




10.6.2024


Lymphoseek







Navidea Biopharmaceuticals Europe Ltd.




Kilminion South, Ballinroad, Dungarvan, Co. Waterford, X35 WP70, Ireland






EU/1/14/955


13.6.2024




28.6.2024


Pemetrexed Krka







KRKA, d.d.




Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/18/1283


4.7.2024














—



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




6.6.2024


Arti-Cell Forte







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/18/228


7.6.2024




6.6.2024


Coxevac







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/10/110


7.6.2024




6.6.2024


Tessie







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/2/21/276


7.6.2024




13.6.2024


Eurican Herpes 205







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/01/029


17.6.2024




13.6.2024


Versican Plus Pi







Zoetis Belgium




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






EU/2/14/168


18.6.2024








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, ELI: https://data.europa.eu/eli/reg/2004/726/oj.

(2)  
            OJ L 4, 7.1.2019, p. 43, ELI: https://data.europa.eu/eli/reg/2019/6/oj.


ELI: http://data.europa.eu/eli/C/2024/4646/oj
ISSN 1977-091X (electronic edition)