| — | 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 | | 4.2.2026 | Actelsar HCT | Actavis Group PTC ehf. Dalshraun 1, 220 Hafnarfjörður, Íceland | EU/1/13/817 | 6.2.2026 | | 4.2.2026 | Lytenava | Outlook Therapeutics NL B.V. Strawinskylaan 569, 1077XX Amsterdam, Nederland | EU/1/24/1798 | 5.2.2026 | | 4.2.2026 | Nucala | GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland | EU/1/15/1043 | 5.2.2026 | | 10.2.2026 | Carbaglu | Recordati Rare Diseases Tour Hekla, 52 Avenue Du General De Gaulle, 92800 Puteaux, France | EU/1/02/246 | 16.2.2026 | | 10.2.2026 | Casgevy | Vertex Pharmaceuticals (Ireland) Limited Unit 49, Block 5, Northwood Court, Northwood Crescent, Dublin 9, D09 T665, Ireland | EU/1/23/1787 | 12.2.2026 | | 10.2.2026 | Emadine | Immedica Pharma AB SE-113 63, Stockholm, Sverige | EU/1/98/095 | 11.2.2026 | | 10.2.2026 | Enspryng | Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/21/1559 | 11.2.2026 | | 10.2.2026 | JEMPERLI | GlaxoSmithKline Trading Services Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland | EU/1/21/1538 | 13.2.2026 | | 10.2.2026 | Kengrexal | Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia | EU/1/15/994 | 17.2.2026 | | 10.2.2026 | Myalepta | Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia | EU/1/18/1276 | 11.2.2026 | | 10.2.2026 | Relistor | Bausch Health Ireland Limited 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland | EU/1/08/463 | 13.2.2026 | | 10.2.2026 | Retsevmo | Eli Lilly Nederland B.V. Orteliuslaan 1000, 3528 BD, Nederland | EU/1/20/1527 | 11.2.2026 | | 10.2.2026 | Uplizna | Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland | EU/1/21/1602 | 11.2.2026 | | 10.2.2026 | Vfend | Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/02/212 | 11.2.2026 | | 12.2.2026 | Akynzeo | Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland | EU/1/15/1001 | 13.2.2026 | | 12.2.2026 | Aptivus | Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/05/315 | 15.2.2026 | | 12.2.2026 | Bronchitol | Pharmaxis Europe Limited 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland | EU/1/12/760 | 16.2.2026 | | 12.2.2026 | Emblaveo | Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/24/1808 | 13.2.2026 | | 12.2.2026 | EndolucinBeta | ITM Medical Isotopes GmbH Lichtenbergstraße 1, 85748 Garching/München, Deutschland | EU/1/16/1105 | 13.2.2026 | | 12.2.2026 | Klisyri | Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España | EU/1/21/1558 | 13.2.2026 | | 12.2.2026 | Mvabea | Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België | EU/1/20/1445 | 13.2.2026 | | 12.2.2026 | Orladeyo | Biocryst Ireland Limited Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland | EU/1/21/1544 | 13.2.2026 | | 12.2.2026 | Pemazyre | Incyte Biosciences Distribution B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/21/1535 | 13.2.2026 | | 12.2.2026 | Ponvory | LABORATOIRES JUVISE PHARMACEUTICALS 149 Boulevard Bataille de Stalingrad, 69100 Villeurbanne, France | EU/1/21/1550 | 18.2.2026 | | 12.2.2026 | Skyrizi | AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/19/1361 | 13.2.2026 | | 12.2.2026 | Veoza | Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/23/1771 | 17.2.2026 | | 12.2.2026 | Yondelis | Pharma Mar S.A. Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España | EU/1/07/417 | 18.2.2026 | | 12.2.2026 | Zynlonta | Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige | EU/1/22/1695 | 13.2.2026 | | 16.2.2026 | Abraxane | Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/07/428 | 17.2.2026 | | 16.2.2026 | SIMBRINZA | Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/933 | 17.2.2026 | | 16.2.2026 | Strensiq | Alexion Europe SAS 103-105 rue Anatole France, 92300 Levallois-Perret, France | EU/1/15/1015 | 18.2.2026 | | 16.2.2026 | Wegovy | Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/21/1608 | 17.2.2026 | | 16.2.2026 | Zabdeno | Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België | EU/1/20/1444 | 17.2.2026 | | 18.2.2026 | BUSULFAN FRESENIUS KABI | Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | EU/1/14/951 | 19.2.2026 | | 18.2.2026 | Dimethyl fumarate Neuraxpharm | Neuraxpharm Pharmaceuticals, S.L. Avda. Barcelona 69, 08970 Sant Joan Despí - Barcelona, España | EU/1/24/1810 | 23.2.2026 | | 18.2.2026 | Irbesartan Zentiva | Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/06/376 | 23.2.2026 | | 18.2.2026 | Jylamvo | Oresund Pharma ApS Orient Plads 1, 2150 Nordhavn, Danmark | EU/1/17/1172 | 20.2.2026 | | 18.2.2026 | Kinzalmono | Bayer AG D-51368 Leverkusen, Deutschland | EU/1/98/091 | 19.2.2026 | | 18.2.2026 | Livmarli | Mirum Pharmaceuticals International B.V. Kingsfordweg 151, 1043 GR Amsterdam, Noord-Holland, Nederland | EU/1/22/1704 | 19.2.2026 | | 18.2.2026 | Micardis | Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/98/090 | 19.2.2026 | | 18.2.2026 | Natpar | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland | EU/1/15/1078 | 20.2.2026 | | 18.2.2026 | Pritor | Bayer AG D-51368 Leverkusen, Deutschland | EU/1/98/089 | 19.2.2026 | | 18.2.2026 | Xevudy | GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland | EU/1/21/1562 | 19.2.2026 | | 20.2.2026 | Rybrevant | Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België | EU/1/21/1594 | 23.2.2026 | | 23.2.2026 | Afinitor | Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/538 | 24.2.2026 | | 23.2.2026 | Atazanavir Krka | KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/19/1353 | 25.2.2026 | | 23.2.2026 | Balversa | Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België | EU/1/24/1841 | 24.2.2026 | | 23.2.2026 | Copalia | Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/372 | 24.2.2026 | | 23.2.2026 | Dafiro | Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/371 | 24.2.2026 | | 23.2.2026 | Evkeeza | Ultragenyx Germany GmbH Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland | EU/1/21/1551 | 24.2.2026 | | 23.2.2026 | Kadcyla | Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/885 | 24.2.2026 | | 23.2.2026 | Obgemsa | PIERRE FABRE MEDICAMENT Les Cauquillous, 81500 Lavaur, France | EU/1/24/1822 | 2.3.2026 | | 23.2.2026 | Ravicti | Immedica Pharma AB SE-113 63, Stockholm, Sverige | EU/1/15/1062 | 2.3.2026 | | 23.2.2026 | Sitagliptin Accord | Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/22/1633 | 25.2.2026 | | 23.2.2026 | Tabrecta | Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/22/1650 | 24.2.2026 | | 23.2.2026 | TAKHZYRO | Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland | EU/1/18/1340 | 24.2.2026 | | 23.2.2026 | Telmisartan Actavis | Actavis Group PTC ehf. Dalshraun 1, 220 Hafnarfjörður, Íceland | EU/1/10/639 | 25.2.2026 | | 23.2.2026 | Trazimera | Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/18/1295 | 24.2.2026 | | 23.2.2026 | Vectibix | Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland | EU/1/07/423 | 24.2.2026 | | 23.2.2026 | Viagra | Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland | EU/1/98/077 | 10.3.2026 | | 23.2.2026 | Vokanamet | Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/918 | 24.2.2026 | | 23.2.2026 | Wilzin | Recordati Rare Diseases Tour Hekla, 52 avenue du Général de Gaulle, F-92800 Puteaux, France | EU/1/04/286 | 24.2.2026 | | 25.2.2026 | Bimzelx | UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/21/1575 | 2.3.2026 | | 25.2.2026 | Bortezomib Fresenius Kabi | Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | EU/1/19/1397 | 26.2.2026 | | 25.2.2026 | Exforge HCT | Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/569 | 26.2.2026 | | 25.2.2026 | Neoatricon | BrePco Biopharma Ltd. Suite One, The Avenue, Beacon Court, Sandyford, Dublin D18HX31, Ireland | EU/1/24/1804 | 27.2.2026 | | 25.2.2026 | Nexium Control | Haleon Ireland Dungarvan Limited Knockbrack,Dungarvan, Co. Waterford, Ireland | EU/1/13/860 | 3.3.2026 | | 25.2.2026 | Nimenrix | Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/12/767 | 26.2.2026 | | 25.2.2026 | Orgovyx | Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | EU/1/22/1642 | 26.2.2026 | | 25.2.2026 | Oslif Breezhaler | Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/586 | 26.2.2026 | | 25.2.2026 | Strimvelis | Fondazione Telethon ETS Via Varese 16/B, 00185 Roma, Italia | EU/1/16/1097 | 26.2.2026 | | 25.2.2026 | Suliqua | Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France | EU/1/16/1157 | 26.2.2026 | | 25.2.2026 | Ultibro Breezhaler | Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/862 | 26.2.2026 | | 26.2.2026 | Copalia HCT | Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/575 | 27.2.2026 | | 26.2.2026 | Dafiro HCT | Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/574 | 27.2.2026 | | 26.2.2026 | Exforge | Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/370 | 27.2.2026 | | 26.2.2026 | Incellipan | Seqirus Netherlands B.V. Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland | EU/1/24/1807 | 2.3.2026 | | 26.2.2026 | Pepaxti | Oncopeptides AB (publ) Luntmakargatan 46, 111 37 Stockholm, Sverige | EU/1/22/1669 | 3.3.2026 | | 26.2.2026 | Thiotepa Riemser | Esteve Pharmaceuticals GmbH Hohenzollerndamm 150-151, 14199 Berlin, Deutschland | EU/1/21/1536 | 27.2.2026 | |
