| — | 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 | | 3.7.2024 | Comirnaty | | BioNTech Manufacturing GmbH | | An der Goldgrube 12, 55131 Mainz, Deutschland | | EU/1/20/1528 | 4.7.2024 | | 5.7.2024 | Aldara | | Viatris Healthcare Limited | | Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland | | EU/1/98/080 | 8.7.2024 | | 5.7.2024 | Carbaglu | | Recordati Rare Diseases | | Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | | EU/1/02/246 | 10.7.2024 | | 5.7.2024 | Cosentyx | | Novartis Europharm Limited | | Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | | EU/1/14/980 | 8.7.2024 | | 5.7.2024 | Darunavir Viatris | | Viatris Limited | | Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland | | EU/1/16/1140 | 8.7.2024 | | 5.7.2024 | Inrebic | | Bristol-Myers Squibb Pharma EEIG | | Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | | EU/1/20/1514 | 8.7.2024 | | 5.7.2024 | Iressa | | AstraZeneca AB | | 151 85 Södertälje, Sverige | | EU/1/09/526 | 8.7.2024 | | 5.7.2024 | Jylamvo | | Oresund Pharma ApS | | Orient Plads 1, 2150 Nordhavn, Hovedstaden, Danmark | | EU/1/17/1172 | 8.7.2024 | | 5.7.2024 | Lonquex | | Teva B.V. | | Swensweg 5, 2031 GA Haarlem, Nederland | | EU/1/13/856 | 8.7.2024 | | 5.7.2024 | Neulasta | | Amgen Europe B.V. | | Minervum 7061, 4817 ZK Breda, Nederland | | EU/1/02/227 | 8.7.2024 | | 5.7.2024 | NovoMix | | Novo Nordisk A/S | | Novo Allé, 2880 Bagsvaerd, Danmark | | EU/1/00/142 | 8.7.2024 | | 5.7.2024 | Pergoveris | | Merck Europe B.V. | | Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | | EU/1/07/396 | 8.7.2024 | | 5.7.2024 | Ristaben | | Merck Sharp & Dohme B.V. | | Waarderweg 39, 2031 BN Haarlem, Nederland | | EU/1/10/621 | 9.7.2024 | | 5.7.2024 | Ronapreve | | Roche Registration GmbH | | Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | | EU/1/21/1601 | 8.7.2024 | | 5.7.2024 | Saxenda | | Novo Nordisk A/S | | Novo Allé, 2880 Bagsvaerd, Danmark | | EU/1/15/992 | 8.7.2024 | | 5.7.2024 | Sibnayal | | ADVICENNE | | 262, rue du Faubourg Saint Honoré 75008 Paris, France | | EU/1/20/1517 | 8.7.2024 | | 5.7.2024 | 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 | 8.7.2024 | | 5.7.2024 | Tigecycline Accord | | Accord Healthcare S.L.U. | | World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | | EU/1/19/1394 | 8.7.2024 | | 5.7.2024 | TUKYSA | | Pfizer Europe MA EEIG | | Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | | EU/1/20/1526 | 11.7.2024 | | 5.7.2024 | ZTALMY | | Marinus Pharmaceuticals Emerald Limited | | 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland | | EU/1/23/1743 | 10.7.2024 | | 8.7.2024 | Sugammadex Amomed | | AOP Orphan Pharmaceuticals GmbH | | Leopold-Ungar-Platz 2, 1190 Wien, Österreich | | EU/1/22/1708 | 11.7.2024 | | 8.7.2024 | Tevimbra | | BeiGene Ireland Limited | | 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland | | EU/1/23/1758 | 9.7.2024 | | 8.7.2024 | Victoza | | Novo Nordisk A/S | | Novo Allé, 2880 Bagsvaerd, Danmark | | EU/1/09/529 | 9.7.2024 | | 12.7.2024 | Ocaliva | | ADVANZ PHARMA Limited | | Suite 17, Northwood House, Northwood Avenue, Santry, Dublin 9, Ireland | | EU/1/16/1139 | 15.7.2024 | | 12.7.2024 | Ristfor | | Merck Sharp & Dohme B.V. | | Waarderweg 39, 2031 BN Haarlem, Nederland | | EU/1/10/620 | 16.7.2024 | | 12.7.2024 | Soliris | | Alexion Europe SAS | | 103-105 rue Anatole France, 92300 Levallois-Perret, France | | EU/1/07/393 | 15.7.2024 | | 17.7.2024 | Accofil | | Accord Healthcare S.L.U. | | World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | | EU/1/14/946 | 18.7.2024 | | 17.7.2024 | Fluenz | | AstraZeneca AB | | 151 85 Södertälje, Sverige | | EU/1/24/1816 | 18.7.2024 | | 17.7.2024 | Galvus | | Novartis Europharm Limited | | Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | | EU/1/07/414 | 18.7.2024 | | 17.7.2024 | GAVRETO | | Blueprint Medicines (Netherlands) B.V. | | Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland | | EU/1/21/1555 | 18.7.2024 | | 17.7.2024 | Minjuvi | | Incyte Biosciences Distribution B.V. | | Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | | EU/1/21/1570 | 18.7.2024 | | 17.7.2024 | Rekovelle | | Ferring Pharmaceuticals A/S | | Amager Strandvej 405, 2770 Kastrup, Danmark | | EU/1/16/1150 | 23.7.2024 | | 17.7.2024 | Ritonavir Viatris | | Viatris Limited | | Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland | | EU/1/17/1242 | 18.7.2024 | | 17.7.2024 | Tepkinly | | AbbVie Deutschland GmbH & Co. KG | | Knollstrasse, 67061 Ludwigshafen, Deutschland | | EU/1/23/1759 | 18.7.2024 | | 18.7.2024 | Levetiracetam SUN | | Sun Pharmaceutical Industries Europe BV | | Polarisavenue 87, 2132 JH Hoofddorp, Nederland | | EU/1/11/741 | 25.7.2024 | | 18.7.2024 | Retacrit | | Pfizer Europe MA EEIG | | Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | | EU/1/07/431 | 18.7.2024 | | 19.7.2024 | Hyrimoz | | Sandoz GmbH | | Biochemiestrasse 10, 6250 Kundl, Österreich | | EU/1/18/1286 | 22.7.2024 | | 19.7.2024 | Piqray | | Novartis Europharm Limited | | Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | | EU/1/20/1455 | 22.7.2024 | | 19.7.2024 | Pregabalin Viatris | | Viatris Limited | | Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland | | EU/1/15/997 | 24.7.2024 | | 19.7.2024 | Scemblix | | Novartis Europharm Limited | | Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | | EU/1/22/1670 | 22.7.2024 | | 19.7.2024 | Votrient | | Novartis Europharm Limited | | Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | | EU/1/10/628 | 22.7.2024 | | 22.7.2024 | Avonex | | Biogen Netherlands B.V. | | Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | | EU/1/97/033 | 23.7.2024 | | 22.7.2024 | Byfavo | | PAION Pharma GmbH | | Heussstraße 25, 52078 Aachen, Deutschland | | EU/1/20/1505 | 25.7.2024 | | 22.7.2024 | Deferasirox Mylan | | Mylan Pharmaceuticals Limited | | Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland | | EU/1/19/1386 | 23.7.2024 | | 22.7.2024 | Norvir | | AbbVie Deutschland GmbH & Co. KG | | Knollstrasse, 67061 Ludwigshafen, Deutschland | | EU/1/96/016 | 23.7.2024 | | 22.7.2024 | Slenyto | | RAD Neurim Pharmaceuticals EEC SARL | | 4 rue de Marivaux, 75002 Paris, France | | EU/1/18/1318 | 25.7.2024 | | 22.7.2024 | Teriflunomide Mylan | | Mylan Pharmaceuticals Limited | | Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland | | EU/1/22/1698 | 23.7.2024 | | 22.7.2024 | VITRAKVI | | Bayer AG | | D-51368 Leverkusen, Deutschland | | EU/1/19/1385 | 23.7.2024 | | 23.7.2024 | Prometax | | Almirall, S.A. | | Ronda General Mitre, 151, 08022 Barcelona, España | | EU/1/98/092 | 25.7.2024 | | 24.7.2024 | AUBAGIO | | Sanofi Winthrop Industrie | | 82 avenue Raspail, 94250 Gentilly, France | | EU/1/13/838 | 25.7.2024 | | 24.7.2024 | Buvidal | | Camurus AB | | Ideon Science Park, 223 70 Lund, Sverige | | EU/1/18/1336 | 25.7.2024 | | 24.7.2024 | Bydureon | | AstraZeneca AB | | 151 85 Södertälje, Sverige | | EU/1/11/696 | 25.7.2024 | | 24.7.2024 | Bylvay | | Ipsen Pharma | | 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | | EU/1/21/1566 | 29.7.2024 | | 24.7.2024 | Caprelsa | | Sanofi B.V. | | Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | | EU/1/11/749 | 25.7.2024 | | 24.7.2024 | Fluad Tetra | | Seqirus Netherlands B.V. | | Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland | | EU/1/20/1433 | 25.7.2024 | | 24.7.2024 | Flucelvax Tetra | | Seqirus Netherlands B.V. | | Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland | | EU/1/18/1326 | 25.7.2024 | | 24.7.2024 | Idefirix | | Hansa Biopharma AB | | P.O. Box 785, 220 07 Lund, Sverige | | EU/1/20/1471 | 25.7.2024 | | 24.7.2024 | Ilumetri | | Almirall, S.A. | | Ronda General Mitre, 151, 08022 Barcelona, España | | EU/1/18/1323 | 29.7.2024 | | 24.7.2024 | JCOVDEN | | Janssen-Cilag International NV | | Turnhoutseweg 30, 2340 Beerse, België | | EU/1/20/1525 | 25.7.2024 | | 24.7.2024 | Kaletra | | AbbVie Deutschland GmbH & Co. KG | | Knollstrasse, 67061 Ludwigshafen, Deutschland | | EU/1/01/172 | 25.7.2024 | | 24.7.2024 | Leflunomide medac | | medac Gesellschaft für klinische Spezialpräparate mbH | | Theaterstraße 6, 22880 Wedel, Deutschland | | EU/1/10/637 | 25.7.2024 | | 24.7.2024 | Leflunomide Zentiva | | Zentiva k.s. | | U kabelovny 130, 102 37 Praha 10, Česká republika | | EU/1/09/604 | 29.7.2024 | | 24.7.2024 | Mvabea | | Janssen-Cilag International NV | | Turnhoutseweg 30, 2340 Beerse, België | | EU/1/20/1445 | 25.7.2024 | | 24.7.2024 | Nexavar | | Bayer AG | | D-51368 Leverkusen, Deutschland | | EU/1/06/342 | 25.7.2024 | | 24.7.2024 | Pregabalin Viatris | | Viatris Limited | | Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland | | EU/1/15/997 | 25.7.2024 | | 24.7.2024 | Pyzchiva | | Samsung Bioepis NL B.V. | | Olof Palmestraat 10, 2616 LR Delft, Nederland | | EU/1/24/1801 | 30.7.2024 | | 24.7.2024 | Skyrizi | | AbbVie Deutschland GmbH & Co. KG | | Knollstrasse, 67061 Ludwigshafen, Deutschland | | EU/1/19/1361 | 25.7.2024 | | 24.7.2024 | Suboxone | | Indivior Europe Limited | | 27 Windsor Place, Dublin 2, D02 DK44, Ireland | | EU/1/06/359 | 25.7.2024 | | 24.7.2024 | TUKYSA | | Pfizer Europe MA EEIG | | Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | | EU/1/20/1526 | 30.7.2024 | | 26.7.2024 | Artesunate Amivas | | Amivas Ireland Ltd | | Suite 5, Second Floor, Station House, Railway Square, Waterford, Ireland | | EU/1/21/1582 | 31.7.2024 | | 26.7.2024 | AYVAKYT | | Blueprint Medicines (Netherlands) B.V. | | Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland | | EU/1/20/1473 | 29.7.2024 | | 26.7.2024 | Efficib | | Merck Sharp & Dohme B.V. | | Waarderweg 39, 2031 BN Haarlem, Nederland | | EU/1/08/457 | 29.7.2024 | | 26.7.2024 | Eliquis | | Bristol-Myers Squibb/Pfizer EEIG | | Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland | | EU/1/11/691 | 29.7.2024 | | 26.7.2024 | Epidyolex | | Jazz Pharmaceuticals Ireland Ltd | | 5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland | | EU/1/19/1389 | 30.7.2024 | | 26.7.2024 | Fareston | | Orion Corporation | | Orionintie 1, 02200 Espoo, Suomi | | EU/1/96/004 | 29.7.2024 | | 26.7.2024 | Imcivree | | Rhythm Pharmaceuticals Netherlands B.V. | | Radarweg 29, 1043 NX Amsterdam, Nederland | | EU/1/21/1564 | 29.7.2024 | | 26.7.2024 | Imfinzi | | AstraZeneca AB | | 151 85 Södertälje, Sverige | | EU/1/18/1322 | 29.7.2024 | | 26.7.2024 | Janumet | | Merck Sharp & Dohme B.V. | | Waarderweg 39, 2031 BN Haarlem, Nederland | | EU/1/08/455 | 29.7.2024 | | 26.7.2024 | Orladeyo | | Biocryst Ireland Limited | | Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland | | EU/1/21/1544 | 29.7.2024 | | 26.7.2024 | Quinsair | | Chiesi Farmaceutici S.p.A. | | Via Palermo 26/A, 43122 Parma, Italia | | EU/1/14/973 | 31.7.2024 | | 26.7.2024 | Teriflunomide Accord | | Accord Healthcare S.L.U. | | World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | | EU/1/22/1693 | 29.7.2024 | | 26.7.2024 | Vabysmo | | Roche Registration GmbH | | Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | | EU/1/22/1683 | 29.7.2024 | | 26.7.2024 | Velmetia | | Merck Sharp & Dohme B.V. | | Waarderweg 39, 2031 BN Haarlem, Nederland | | EU/1/08/456 | 29.7.2024 | | 26.7.2024 | Vumerity | | Biogen Netherlands B.V. | | Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | | EU/1/21/1585 | 31.7.2024 | | 26.7.2024 | Zubsolv | | Accord Healthcare S.L.U. | | World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | | EU/1/17/1233 | 29.7.2024 | | 29.7.2024 | Atazanavir Viatris | | Viatris Limited | | Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland | | EU/1/16/1091 | 30.7.2024 | | 29.7.2024 | Jalra | | Novartis Europharm Limited | | Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | | EU/1/08/485 | 1.8.2024 | | 29.7.2024 | Lopinavir/Ritonavir Viatris | | Viatris Limited | | Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland | | EU/1/15/1067 | 30.7.2024 | | 29.7.2024 | Myalepta | | Chiesi Farmaceutici S.p.A. | | Via Palermo 26/A, 43122 Parma, Italia | | EU/1/18/1276 | 30.7.2024 | | 29.7.2024 | Rasagiline Viatris | | Viatris Limited | | Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland | | EU/1/16/1090 | 30.7.2024 | | 29.7.2024 | Xiliarx | | Novartis Europharm Limited | | Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | | EU/1/08/486 | 1.8.2024 | |
