| — | Modification d’une autorisation de mise sur le marché (article 13 du règlement (CE) no 726/2004 du Parlement européen et du Conseil): Accepté | Date de la décision | Nom du médicament | Titulaire d’une autorisation de mise sur le marché | Numéro de l’entrée dans le registre communautaire | Date de notification | | 2.7.2026 | Levetiracetam Actavis Group | | Actavis Group PTC ehf. | | Dalshraun 1, 220 Hafnarfjörður, Íceland | | EU/1/11/738 | 3.7.2026 | | 2.7.2026 | Orfadin | | Swedish Orphan Biovitrum International AB | | 112 76 Stockholm, Sverige | | EU/1/04/303 | 3.7.2026 | | 2.7.2026 | Tepkinly | | AbbVie Deutschland GmbH & Co. KG | | Knollstrasse, 67061 Ludwigshafen, Deutschland | | EU/1/23/1759 | 3.7.2026 | | 2.7.2026 | Zavesca | | Advanz Pharma Limited | | Suite 17, Northwood House, Northwood Crescent, Northwood, Dublin 9, Co. Dublin, D09 V504, Ireland | | EU/1/02/238 | 3.7.2026 | | 3.7.2026 | 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 | 6.7.2026 | | 3.7.2026 | Fasenra | | AstraZeneca AB | | 151 85 Södertälje, Sverige | | EU/1/17/1252 | 6.7.2026 | | 3.7.2026 | Ibuprofène Gen.Orph | | Gen.Orph | | 185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France | | EU/1/23/1791 | 9.7.2026 | | 3.7.2026 | Idefirix | | Hansa Biopharma AB | | P.O. Box 785, 220 07 Lund, Sverige | | EU/1/20/1471 | 6.7.2026 | | 3.7.2026 | Levetiracetam Hospira | | Pfizer Europe MA EEIG | | Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | | EU/1/13/889 | 6.7.2026 | | 3.7.2026 | Libmyris | | STADA Arzneimittel AG | | Stadastraße 2-18, 61118 Bad Vilbel, Deutschland | | EU/1/21/1590 | 8.7.2026 | | 3.7.2026 | Ordspono | | Regeneron Ireland Designated Activity Company (DAC) | | One Warrington Place, Dublin 2, D02 HH27, Ireland | | EU/1/24/1843 | 6.7.2026 | | 3.7.2026 | Xolremdi | | Norgine B.V. | | Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland | | EU/1/26/2017 | 13.7.2026 | | 8.7.2026 | AYVAKYT | | Blueprint Medicines (Netherlands) B.V. | | Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland | | EU/1/20/1473 | 9.7.2026 | | 8.7.2026 | Betmiga | | Astellas Pharma Europe B.V. | | Sylviusweg 62, 2333 BE Leiden, Nederland | | EU/1/12/809 | 9.7.2026 | | 8.7.2026 | Febuxostat Viatris | | Viatris Limited | | Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland | | EU/1/17/1194 | 9.7.2026 | | 8.7.2026 | VITRAKVI | | Bayer AG | | D-51368 Leverkusen, Deutschland | | EU/1/19/1385 | 9.7.2026 | | 8.7.2026 | Zemcelpro | | Cordex Biologics International Limited | | 5th Floor, Block E, Iveagh Court, Harcourt Road, Dublin, Ireland | | EU/1/25/1960 | 14.7.2026 | | 9.7.2026 | SomaKit TOC | | Novartis Europharm Limited | | Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | | EU/1/16/1141 | 10.7.2026 | | 9.7.2026 | Sondelbay | | Accord Healthcare S.L.U. | | World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | | EU/1/22/1628 | 10.7.2026 | | 14.7.2026 | Rivaroxaban Viatris | | Viatris Limited | | Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland | | EU/1/21/1588 | 15.7.2026 | | 14.7.2026 | Trepulmix | | SciPharm Sàrl | | 7, Fausermillen, 6689 Mertert, Luxembourg | | EU/1/19/1419 | 16.7.2026 | | 14.7.2026 | Tyenne | | Fresenius Kabi Deutschland GmbH | | Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | | EU/1/23/1754 | 15.7.2026 | | 14.7.2026 | Vaxneuvance | | Merck Sharp & Dohme B.V. | | Waarderweg 39, 2031 BN Haarlem, Nederland | | EU/1/21/1591 | 15.7.2026 | | 14.7.2026 | Wegovy | | Novo Nordisk A/S | | Novo Allé, 2880 Bagsvaerd, Danmark | | EU/1/21/1608 | 20.7.2026 | | 15.7.2026 | ARIKAYCE liposomal | | Insmed Netherlands B.V. | | Stadsplateau 7, 3521 AZ Utrecht, Nederland | | EU/1/20/1469 | 20.7.2026 | | 15.7.2026 | Axumin | | Blue Earth Diagnostics Ireland Ltd | | 6th Floor, 2 Grand Canal Square, Dublin 2, Ireland | | EU/1/17/1186 | 22.7.2026 | | 15.7.2026 | Brukinsa | | BeOne Medicines Ireland Limited | | 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland | | EU/1/21/1576 | 16.7.2026 | | 15.7.2026 | Enurev Breezhaler | | Novartis Europharm Limited | | Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | | EU/1/12/789 | 22.7.2026 | | 15.7.2026 | Fluad | | Seqirus Netherlands B.V. | | Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland | | EU/1/24/1878 | 16.7.2026 | | 15.7.2026 | Flucelvax | | Seqirus Netherlands B.V. | | Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland | | EU/1/24/1879 | 17.7.2026 | | 15.7.2026 | Fluenz | | AstraZeneca AB | | 151 85 Södertälje, Sverige | | EU/1/24/1816 | 17.7.2026 | | 15.7.2026 | Glivec | | Novartis Europharm Limited | | Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | | EU/1/01/198 | 16.7.2026 | | 15.7.2026 | GOBIVAZ | | Advanz Pharma Limited | | Unit 17, Northwood House, Northwood Crescent, Dublin 9, D09 V504, Ireland | | EU/1/25/1988 | 16.7.2026 | | 15.7.2026 | Hukyndra | | STADA Arzneimittel AG | | Stadastraße 2-18, 61118 Bad Vilbel, Deutschland | | EU/1/21/1589 | 16.7.2026 | | 15.7.2026 | Iclusig | | Incyte Biosciences Distribution B.V. | | Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | | EU/1/13/839 | 16.7.2026 | | 15.7.2026 | Latuda | | Angelini Pharma S.p.A. | | Viale Amelia 70, 00181 Roma, Italia | | EU/1/14/913 | 16.7.2026 | | 15.7.2026 | Lutathera | | Novartis Europharm Limited | | Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | | EU/1/17/1226 | 17.7.2026 | | 15.7.2026 | Minjuvi | | Incyte Biosciences Distribution B.V. | | Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | | EU/1/21/1570 | 16.7.2026 | | 15.7.2026 | Pemetrexed Accord | | Accord Healthcare S.L.U. | | World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | | EU/1/15/1071 | 17.7.2026 | | 15.7.2026 | Rapamune | | Pfizer Europe MA EEIG | | Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | | EU/1/01/171 | 16.7.2026 | | 15.7.2026 | Samsca | | Otsuka Pharmaceutical Netherlands B.V. | | Herikerbergweg 292, 1101 CT, Amsterdam, Nederland | | EU/1/09/539 | 3.8.2026 | | 15.7.2026 | Vantobra | | PARI Pharma GmbH | | Moosstraße 3, 82319 Starnberg, Deutschland | | EU/1/18/1350 | 21.7.2026 | | 15.7.2026 | Vumerity | | Biogen Netherlands B.V. | | Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | | EU/1/21/1585 | 21.7.2026 | | 15.7.2026 | Yondelis | | Pharma Mar S.A. | | Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España | | EU/1/07/417 | 27.7.2026 | | 15.7.2026 | ZTALMY | | Immedica Pharma AB | | SE-113 63, Stockholm, Sverige | | EU/1/23/1743 | 16.7.2026 | | 20.7.2026 | ASPAVELI | | Swedish Orphan Biovitrum AB (publ) | | 112 76 Stockholm, Sverige | | EU/1/21/1595 | 23.7.2026 | | 20.7.2026 | Avtozma | | Celltrion Healthcare Hungary Kft. | | Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | | EU/1/24/1896 | 24.7.2026 | | 20.7.2026 | Axura | | Merz Pharmaceuticals GmbH | | Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland | | EU/1/02/218 | 22.7.2026 | | 20.7.2026 | Baiama | | Formycon AG | | Fraunhoferstraße 15, 82152 Martinsried/Planegg, Deutschland | | EU/1/24/1887 | 22.7.2026 | | 20.7.2026 | Capecitabine Teva | | Teva B.V. | | Swensweg 5, 2031 GA Haarlem, Nederland | | EU/1/12/761 | 23.7.2026 | | 20.7.2026 | Pemetrexed medac | | medac Gesellschaft für klinische Spezialpräparate mbH | | Theaterstraße 6, 22880 Wedel, Deutschland | | EU/1/15/1038 | 22.7.2026 | | 20.7.2026 | 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 | 27.7.2026 | | 20.7.2026 | Wyost | | Sandoz GmbH | | Biochemiestrasse 10, 6250 Kundl, Österreich | | EU/1/24/1812 | 22.7.2026 | | 23.7.2026 | Conbriza | | Pfizer Europe MA EEIG | | Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | | EU/1/09/511 | 24.7.2026 | | 23.7.2026 | Komboglyze | | AstraZeneca AB | | 151 85 Södertälje, Sverige | | EU/1/11/731 | 24.7.2026 | | 23.7.2026 | Stelara | | Janssen-Cilag International NV | | Turnhoutseweg 30, 2340 Beerse, België | | EU/1/08/494 | 27.7.2026 | | 23.7.2026 | Temozolomide Accord | | Accord Healthcare S.L.U. | | World Trade Center, Moll de Barcelona, s/n, Edifici Est, 6a planta, 08039 Barcelona, España | | EU/1/10/615 | 27.7.2026 | | 23.7.2026 | Trodelvy | | Gilead Sciences Ireland UC | | Carrigtohill, County Cork, T45 DP77, Ireland | | EU/1/21/1592 | 24.7.2026 | | 24.7.2026 | Bortezomib Accord | | Accord Healthcare S.L.U. | | World Trade Center, Moll de Barcelona, s/n, Edifici Est, 6a planta, 08039 Barcelona, España | | EU/1/15/1019 | 27.7.2026 | | 24.7.2026 | Herzuma | | Celltrion Healthcare Hungary Kft. | | Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | | EU/1/17/1257 | 27.7.2026 | | 24.7.2026 | Instanyl | | Istituto Gentili S.r.l. | | Via San Giuseppe Cottolengo 15, 20143 Milano, Italia | | EU/1/09/531 | 30.7.2026 | | 24.7.2026 | Jaypirca | | Eli Lilly Nederland B.V. | | Orteliuslaan 1000, 3528 BD Utrecht, Nederland | | EU/1/23/1738 | 28.7.2026 | | 24.7.2026 | MenQuadfi | | Sanofi Winthrop Industrie | | 82 avenue Raspail, 94250 Gentilly, France | | EU/1/20/1483 | 28.7.2026 | | 24.7.2026 | Opzelura | | Incyte Biosciences Distribution B.V. | | Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | | EU/1/23/1726 | 30.7.2026 | | 24.7.2026 | RINVOQ | | AbbVie Deutschland GmbH & Co. KG | | Knollstrasse, 67061 Ludwigshafen, Deutschland | | EU/1/19/1404 | 27.7.2026 | | 24.7.2026 | Xgeva | | Amgen Europe B.V. | | Minervum 7061, 4817 ZK Breda, Nederland | | EU/1/11/703 | 27.7.2026 | | 24.7.2026 | Xtandi | | Astellas Pharma Europe B.V. | | Sylviusweg 62, 2333 BE Leiden, Nederland | | EU/1/13/846 | 28.7.2026 | | 24.7.2026 | Yargesa | | Piramal Critical Care B.V. | | Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland | | EU/1/17/1176 | 28.7.2026 | | 28.7.2026 | BIMERVAX | | Hipra Human Health, S.L.U. | | Avda. la Selva, 135, 17170 Amer (Girona), España | | EU/1/22/1709 | 30.7.2026 | | 28.7.2026 | Comirnaty | | BioNTech Manufacturing GmbH | | An der Goldgrube 12, 55131 Mainz, Deutschland | | EU/1/20/1528 | 29.7.2026 | | 28.7.2026 | Nuvaxovid | | Sanofi Winthrop Industrie | | 82 avenue Raspail, 94250 Gentilly, France | | EU/1/21/1618 | 29.7.2026 | | 28.7.2026 | Spikevax | | MODERNA BIOTECH SPAIN, S.L. | | C/ Julián Camarillo no 31, 28037 Madrid, España | | EU/1/20/1507 | 29.7.2026 | | 29.7.2026 | Datroway | | Daiichi Sankyo Europe GmbH | | Zielstattstraße 48, 81379 München, Deutschland | | EU/1/25/1915 | 30.7.2026 | | 29.7.2026 | Ezmekly | | Merck Europe B.V. | | Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | | EU/1/25/1950 | 3.8.2026 | | 29.7.2026 | Iqirvo | | Ipsen Pharma | | 70 rue Balard, 75015 Paris, France | | EU/1/24/1855 | 30.7.2026 | | 29.7.2026 | Kostaive | | Seqirus Netherlands B.V. | | Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland | | EU/1/24/1873 | 3.8.2026 | | 29.7.2026 | Kyntheum | | Leo Pharma A/S | | Industriparken 55, 2750 Ballerup, Danmark | | EU/1/16/1155 | 3.8.2026 | | 29.7.2026 | ORSERDU | | Stemline Therapeutics B.V. | | Basisweg 10, 1043 AP, Amsterdam, Noord-Holland, Nederland | | EU/1/23/1757 | 30.7.2026 | | 29.7.2026 | QINLOCK | Strawinskylaan 3051, 1077ZX Amsterdam, Nederland | EU/1/21/1569 | 3.8.2026 | | 29.7.2026 | Sitagliptin/Metformin hydrochloride Mylan | | Mylan Pharmaceuticals Limited | | Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland | | EU/1/21/1619 | 30.7.2026 | | 29.7.2026 | Vyjuvek | | Krystal Biotech Netherlands B.V. | | Atrium Gebouw, Strawinskylaan 3051, 1077 ZX Amsterdam, Noord-Holland, Nederland | | EU/1/25/1918 | 3.8.2026 | | 29.7.2026 | Vyxeos liposomal | | Jazz Pharmaceuticals Ireland Ltd | | 5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland | | EU/1/18/1308 | 6.8.2026 | |