| — | Modification d'une autorisation de mise sur le marché (article 13 du règlement (CE) n° 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 | | 2.9.2025 | Bronchitol | | Pharmaxis Europe Limited | | 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland | | EU/1/12/760 | 4.9.2025 | | 2.9.2025 | Edarbi | | Takeda Pharma A/S | | Delta Park 45, 2665 Vallensbaek Strand, Danmark | | EU/1/11/734 | 3.9.2025 | | 2.9.2025 | Qoyvolma | | Celltrion Healthcare Hungary Kft. | | Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | | EU/1/25/1925 | 10.9.2025 | | 2.9.2025 | Steglujan | | Merck Sharp & Dohme B.V. | | Waarderweg 39, 2031 BN Haarlem, Nederland | | EU/1/18/1266 | 3.9.2025 | | 2.9.2025 | Tevagrastim | | Teva GmbH | | Graf-Arco-Straße 3, 89079 Ulm, Deutschland | | EU/1/08/445 | 5.9.2025 | | 2.9.2025 | Yuflyma | | Celltrion Healthcare Hungary Kft. | | Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | | EU/1/20/1513 | 3.9.2025 | | 8.9.2025 | Bexsero | | GlaxoSmithKline Vaccines S.r.l. | | Via Fiorentina, 1, 53100 Siena, Italia | | EU/1/12/812 | 9.9.2025 | | 8.9.2025 | Dectova | | GlaxoSmithKline Trading Services Limited | | Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland | | EU/1/18/1349 | 10.9.2025 | | 8.9.2025 | ELREXFIO | | Pfizer Europe MA EEIG | | Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | | EU/1/23/1770 | 10.9.2025 | | 8.9.2025 | Helicobacter Test INFAI | | INFAI GmbH | | An der Kohlenbahn 39, D-58135 Hagen, Deutschland | | EU/1/97/045 | 16.9.2025 | | 8.9.2025 | Jaypirca | | Eli Lilly Nederland B.V. | | Papendorpseweg 83, 3528 BJ Utrecht, Nederland | | EU/1/23/1738 | 12.9.2025 | | 8.9.2025 | Ninlaro | | Takeda Pharma A/S | | Delta Park 45, 2665 Vallensbaek Strand, Danmark | | EU/1/16/1094 | 9.9.2025 | | 8.9.2025 | Otulfi | | Fresenius Kabi Deutschland GmbH | | Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | | EU/1/24/1863 | 10.9.2025 | | 8.9.2025 | Rapamune | | Pfizer Europe MA EEIG | | Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | | EU/1/01/171 | 10.9.2025 | | 8.9.2025 | Rukobia | | ViiV Healthcare BV | | Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland | | EU/1/20/1518 | 9.9.2025 | | 8.9.2025 | Vumerity | | Biogen Netherlands B.V. | | Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | | EU/1/21/1585 | 10.9.2025 | | 11.9.2025 | Azacitidine Kabi | | Fresenius Kabi Deutschland GmbH | | Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | | EU/1/23/1777 | 15.9.2025 | | 11.9.2025 | EVUSHELD | | AstraZeneca AB | | 151 85 Södertälje, Sverige | | EU/1/22/1651 | 12.9.2025 | | 11.9.2025 | Imatinib Accord | | Accord Healthcare S.L.U. | | World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | | EU/1/13/845 | 16.9.2025 | | 11.9.2025 | Imraldi | | Samsung Bioepis NL B.V. | | Olof Palmestraat 10, 2616 LR Delft, Nederland | | EU/1/17/1216 | 15.9.2025 | | 11.9.2025 | Omlyclo | | Celltrion Healthcare Hungary Kft. | | Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | | EU/1/24/1817 | 16.9.2025 | | 11.9.2025 | Pioglitazone Accord | | Accord Healthcare S.L.U. | | World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | | EU/1/11/722 | 16.9.2025 | | 11.9.2025 | Pregabalin Accord | | Accord Healthcare S.L.U. | | World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | | EU/1/15/1027 | 16.9.2025 | | 11.9.2025 | Rivastigmine Actavis | | Actavis Group PTC ehf. | | Dalshraun 1, 220 Hafnarfjörður, Íceland | | EU/1/11/693 | 12.9.2025 | | 11.9.2025 | Segluromet | | Merck Sharp & Dohme B.V. | | Waarderweg 39, 2031 BN Haarlem, Nederland | | EU/1/18/1265 | 12.9.2025 | | 11.9.2025 | Steglatro | | Merck Sharp & Dohme B.V. | | Waarderweg 39, 2031 BN Haarlem, Nederland | | EU/1/18/1267 | 17.9.2025 | | 11.9.2025 | Steqeyma | | Celltrion Healthcare Hungary Kft. | | Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | | EU/1/24/1844 | 12.9.2025 | | 12.9.2025 | IXCHIQ | | Valneva Austria GmbH | | Campus Vienna Biocenter 3, 1030 Wien, Österreich | | EU/1/24/1828 | 15.9.2025 | | 15.9.2025 | Apexelsin | | WhiteOak Pharmaceutical B.V. | | Teleportboulevard 130, Amsterdam, 1043 EJ, Nederland | | EU/1/24/1835 | 18.9.2025 | | 15.9.2025 | AUBAGIO | | Sanofi Winthrop Industrie | | 82 avenue Raspail, 94250 Gentilly, France | | EU/1/13/838 | 16.9.2025 | | 15.9.2025 | JEMPERLI | | GlaxoSmithKline Trading Services Limited | | 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland | | EU/1/21/1538 | 16.9.2025 | | 15.9.2025 | mRESVIA | | MODERNA BIOTECH SPAIN, S.L. | | C/ Julián Camarillo no 31, 28037 Madrid, España | | EU/1/24/1849 | 16.9.2025 | | 15.9.2025 | Ogluo | | Strongbridge Dublin Limited | | 25 North Wall Quay, Dublin 1, Co. Dublin, D01 H104, Ireland | | EU/1/20/1523 | 17.9.2025 | | 15.9.2025 | Ratiograstim | | ratiopharm GmbH | | Graf-Arco-Straße 3, 89079 Ulm, Deutschland | | EU/1/08/444 | 16.9.2025 | | 15.9.2025 | Rybelsus | | Novo Nordisk A/S | | Novo Allé, 2880 Bagsvaerd, Danmark | | EU/1/20/1430 | 16.9.2025 | | 15.9.2025 | Skyclarys | | Biogen Netherlands B.V. | | Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | | EU/1/23/1786 | 16.9.2025 | | 15.9.2025 | Tecfidera | | Biogen Netherlands B.V. | | Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | | EU/1/13/837 | 16.9.2025 | | 15.9.2025 | Zoely | | Theramex Ireland Limited | | 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland | | EU/1/11/690 | 18.9.2025 | | 15.9.2025 | Zyprexa | | CHEPLAPHARM Registration GmbH | | Weiler Straße 5e, 79540 Lörrach, Deutschland | | EU/1/96/022 | 17.9.2025 | | 17.9.2025 | Azacitidine Accord | | Accord Healthcare S.L.U. | | World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | | EU/1/19/1413 | 18.9.2025 | | 17.9.2025 | Cejemly | | CStone Pharmaceuticals Ireland Limited | | 117-126 Sheriff Street Upper Dublin 1, D01 YC43, Ireland | | EU/1/24/1833 | 18.9.2025 | | 17.9.2025 | Efmody | | Neurocrine Netherlands B.V. | | Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland | | EU/1/21/1549 | 29.9.2025 | | 17.9.2025 | Epidyolex | | Jazz Pharmaceuticals Ireland Ltd | | 5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland | | EU/1/19/1389 | 22.9.2025 | | 17.9.2025 | Ervebo | | Merck Sharp & Dohme B.V. | | Waarderweg 39, 2031 BN Haarlem, Nederland | | EU/1/19/1392 | 18.9.2025 | | 17.9.2025 | Evrenzo | | Astellas Pharma Europe B.V. | | Sylviusweg 62, 2333 BE Leiden, Nederland | | EU/1/21/1574 | 3.10.2025 | | 17.9.2025 | Idacio | | Fresenius Kabi Deutschland GmbH | | Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | | EU/1/19/1356 | 18.9.2025 | | 17.9.2025 | Jayempi | | Lipomed GmbH | | Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland | | EU/1/21/1557 | 18.9.2025 | | 17.9.2025 | Kentera | | Teva B.V. | | Swensweg 5, 2031 GA Haarlem, Nederland | | EU/1/03/270 | 18.9.2025 | | 17.9.2025 | Klisyri | | Almirall, S.A. | | Ronda General Mitre, 151, 08022 Barcelona, España | | EU/1/21/1558 | 22.9.2025 | | 17.9.2025 | Lenalidomide Accord | | Accord Healthcare S.L.U. | | World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | | EU/1/18/1316 | 18.9.2025 | | 17.9.2025 | Loargys | | Immedica Pharma AB | | SE-113 63, Stockholm, Sverige | | EU/1/23/1774 | 18.9.2025 | | 17.9.2025 | Minjuvi | | Incyte Biosciences Distribution B.V. | | Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | | EU/1/21/1570 | 18.9.2025 | | 17.9.2025 | Orkambi | | Vertex Pharmaceuticals (Ireland) Limited | | Unit 49, Block 5, Northwood Court, Northwood Crescent, Dublin 9, D09 T665, Ireland | | EU/1/15/1059 | 18.9.2025 | | 17.9.2025 | Ozempic | | Novo Nordisk A/S | | Novo Allé, 2880 Bagsvaerd, Danmark | | EU/1/17/1251 | 18.9.2025 | | 17.9.2025 | Padcev | | Astellas Pharma Europe B.V. | | Sylviusweg 62, 2333 BE Leiden, Nederland | | EU/1/21/1615 | 18.9.2025 | | 17.9.2025 | Tevimbra | | BeOne Medicines Ireland Limited | | 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland | | EU/1/23/1758 | 18.9.2025 | | 17.9.2025 | TUKYSA | | Pfizer Europe MA EEIG | | Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | | EU/1/20/1526 | 18.9.2025 | | 19.9.2025 | BIMERVAX | | Hipra Human Health, S.L.U. | | Avda. la Selva, 135, 17170 Amer (Girona), España | | EU/1/22/1709 | 22.9.2025 | | 22.9.2025 | Hepcludex | | Gilead Sciences Ireland UC | | Carrigtohill, County Cork, T45 DP77, Ireland | | EU/1/20/1446 | 23.9.2025 | | 22.9.2025 | Kinzalkomb | | Bayer AG | | D-51368 Leverkusen, Deutschland | | EU/1/02/214 | 24.9.2025 | | 22.9.2025 | Phesgo | | Roche Registration GmbH | | Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | | EU/1/20/1497 | 23.9.2025 | | 24.9.2025 | Biktarvy | | Gilead Sciences Ireland UC | | Carrigtohill, County Cork, T45 DP77, Ireland | | EU/1/18/1289 | 25.9.2025 | | 24.9.2025 | Dovprela | | Mylan IRE Healthcare Limited | | Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland | | EU/1/20/1437 | 29.9.2025 | | 24.9.2025 | Gliolan | | photonamic GmbH & Co. KG | | Eggerstedter Weg 12, 25421 Pinneberg, Deutschland | | EU/1/07/413 | 25.9.2025 | | 24.9.2025 | Ilaris | | Novartis Europharm Limited | | Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | | EU/1/09/564 | 25.9.2025 | | 24.9.2025 | Imatinib Teva | | Teva B.V. | | Swensweg 5, 2031 GA Haarlem, Nederland | | EU/1/12/808 | 25.9.2025 | | 24.9.2025 | Lytenava | | Outlook Therapeutics Limited | | 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland | | EU/1/24/1798 | 25.9.2025 | | 24.9.2025 | Onivyde pegylated liposomal | | Les Laboratoires Servier | | 50 rue Carnot, 92284 Suresnes Cedex, France | | EU/1/16/1130 | 29.9.2025 | | 24.9.2025 | Opfolda | | Amicus Therapeutics Europe Limited | | Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin D15 AKK1, Ireland | | EU/1/23/1737 | 26.9.2025 | | 24.9.2025 | PritorPlus | | Bayer AG | | D-51368 Leverkusen, Deutschland | | EU/1/02/215 | 2.10.2025 | | 24.9.2025 | Spikevax | | MODERNA BIOTECH SPAIN, S.L. | | C/ Julián Camarillo no 31, 28037 Madrid, España | | EU/1/20/1507 | 25.9.2025 | | 24.9.2025 | Vyndaqel | | Pfizer Europe MA EEIG | | Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | | EU/1/11/717 | 26.9.2025 | | 29.9.2025 | Orphacol | | THERAVIA | | 16 Rue Montrosier, 92200 Neuilly-sur-Seine, France | | EU/1/13/870 | 16.10.2025 | | 29.9.2025 | Stayveer | | Janssen-Cilag International NV | | Turnhoutseweg 30, 2340 Beerse, België | | EU/1/13/832 | 30.9.2025 | | 29.9.2025 | Striascan | | CIS bio international | | RN 306 – Saclay, B.P. 32, F-91192 Gif-sur-Yvette Cedex, France | | EU/1/19/1372 | 1.10.2025 | | 29.9.2025 | Tracleer | | Janssen-Cilag International NV | | Turnhoutseweg 30, 2340 Beerse, België | | EU/1/02/220 | 30.9.2025 | | 30.9.2025 | LEQEMBI | | Eisai GmbH | | Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland | | EU/1/24/1891 | 30.9.2025 | |
