Unione europea — decisioni della Commissione europea
Revoche e sospensioni, ritiri di lotti, farmaci carenti, note di sicurezza, rimborsabilità e nuovi medicinali — ogni giorno, automaticamente. Ultimo aggiornamento: 26/09/2026 08:15.
n. EU/1/26/2062 · Zokovea is indicated for the post exposure prophylaxis of COVID 19 in adults and adolescents aged 12 years and… · Shionogi B.V. · ensitrelvir · ATC J05AE16
n. EU/1/26/2055 · Ubeslo is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or m… · A. Menarini International Licensing S.A. · Obicetrapib · ATC C10AX
n. EU/1/26/2065 · Tafamidis Accord is indicated for the treatment of hereditary transthyretin amyloidosis in adult patients with… · Accord Healthcare S.L.U. · tafamidis · ATC N07XX08
n. EU/1/26/2064 · Myelofibrosis (MF)
Ruxolitinib Viatris is indicated for the treatment of disease-related splenomegaly or … · Viatris Limited · ruxolitinib · ATC L01EJ01
n. EU/1/26/2051 · Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated wi… · QILU PHARMA SPAIN S.L. · pegfilgrastim · ATC L03AA13
n. EU/1/26/2056 · Evlarco is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or … · A. Menarini International Licensing S.A. · obicetrapib / ezetimibe
n. EU/1/25/2006 · autorizzato il 12/02/2026 · Aumseqa as monotherapy is indicated for:
• the first line treatment of adult patients with advanced non small… · SFL Pharmaceuticals Deutschland GmbH · aumolertinib · ATC L01EB11
n. EU/1/21/1608 · autorizzato il 06/01/2022 · Adults
Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for wei… · Novo Nordisk A/S · semaglutide · ATC A10BJ06
n. EU/1/23/1770 · autorizzato il 07/12/2023 · ELREXFIO is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple… · Pfizer Europe MA EEIG · elranatamab · ATC L01FX32
n. EU/1/26/2058 · Susvimo is indicated in adult patients for the treatment of neovascular (wet) age related macular degeneration… · Roche Registration GmbH · ranibizumab · ATC S01LA04
n. EU/1/26/2061 · LYROKAUL is indicated in adults with primary hypercholesterolaemia (heterozygous familial (HeFH) and non-famil… · LIB Therapeutics B.V. · Lerodalcibep · ATC C10AX19
n. EU/1/23/1751 · autorizzato il 15/09/2023 · Yesafili is indicated for adults for the treatment of
• neovascular (wet) age-related macular degeneration (… · Biosimilar Collaborations Ireland Limited · aflibercept · ATC S01LA05
n. EU/1/23/1758 · autorizzato il 15/09/2023 · Non-small cell lung cancer (NSCLC)
Tevimbra, in combination with platinum-containing chemotherapy as neoadj… · BeOne Medicines Ireland Limited · tislelizumab · ATC L01FF09
n. EU/1/20/1498 · autorizzato il 09/12/2020 · Trixeo Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic ob… · AstraZeneca AB · Formoterol / glycopyrronium bromide / budesonide · ATC R03AL11
n. EU/1/21/1588 · autorizzato il 12/11/2021 · Rivaroxaban Viatris co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticl… · Viatris Limited · rivaroxaban · ATC B01AF01
n. EU/1/21/1604 · autorizzato il 06/01/2022 · Riltrava Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic … · AstraZeneca AB · formoterol / glycopyrronium bromide / budesonide · ATC R03AL11
n. EU/1/01/189 · autorizzato il 03/08/2001 · Replagal is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry… · Takeda Pharmaceuticals International AG Ireland Branch · Agalsidase alfa · ATC A16AB03
n. EU/1/19/1404 · autorizzato il 16/12/2019 · Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthriti… · AbbVie Deutschland GmbH & Co. KG · upadacitinib · ATC L04AF03
n. EU/1/25/1909 · autorizzato il 04/04/2025 · Pavblu is indicated for adults for the treatment of
• neovascular (wet) age-related macular degeneration (AM… · Amgen Technology (Ireland) UC · Aflibercept · ATC S01LA05
n. EU/1/24/1863 · autorizzato il 25/09/2024 · Adult Crohn’s disease
Otulfi is indicated for the treatment of adult patients with moderately to severely act… · Fresenius Kabi Deutschland GmbH · ustekinumab · ATC L04AC05
n. EU/1/24/1865 · autorizzato il 13/11/2024 · Opuviz is indicated for adults for the treatment of
• neovascular (wet) age related macular degeneration (AMD… · Samsung Bioepis NL B.V. · Aflibercept · ATC S01LA05
n. EU/1/18/1277 · autorizzato il 19/04/2018 · MYLOTARG is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment … · Pfizer Europe MA EEIG · gemtuzumab ozogamicin · ATC L01FX02
n. EU/1/22/1649 · autorizzato il 03/06/2022 · Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicula… · Roche Registration GmbH · mosunetuzumab · ATC L01FX25
n. EU/1/23/1755 · autorizzato il 15/09/2023 · Litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and… · Pfizer Europe MA EEIG · ritlecitinib · ATC L01EJ
n. EU/1/19/1356 · autorizzato il 02/04/2019 · Rheumatoid arthritis
Idacio in combination with methotrexate, is indicated for:
the treatment of moderate… · Fresenius Kabi Deutschland GmbH · adalimumab · ATC L04AB04
n. EU/1/24/1802 · autorizzato il 17/05/2024 · Paroxysmal nocturnal haemoglobinuria
FABHALTA is indicated as monotherapy in the treatment of adult patients … · Novartis Europharm Limited · iptacopan · ATC L04AJ08
n. EU/1/12/797 · autorizzato il 22/11/2012 · Eylea 40 mg/mL :
Eylea is indicated for adults for the treatment of
• neovascular (wet) age-related macul… · Bayer AG · aflibercept · ATC S01LA05
n. EU/1/25/1963 · autorizzato il 14/08/2025 · Eiyzey is indicated for adults for the treatment of
• neovascular (wet) age-related macular degeneration (AMD… · Zakłady Farmaceutyczne POLPHARMA S.A. · aflibercept · ATC S01LA05
n. EU/1/15/1047 · autorizzato il 23/11/2015 · BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B c… · Amgen Europe B.V. · blinatumomab · ATC L01FX07
n. EU/1/24/1888 · autorizzato il 13/01/2025 · Ahzantive is indicated for adults for the treatment of:
• neovascular (wet) age-related macular degeneration … · Formycon AG · Aflibercept · ATC S01LA05
n. EU/1/24/1844 · autorizzato il 22/08/2024 · Adult Crohn’s Disease
Steqeyma is indicated for the treatment of adult patients with moderately to severely a… · Celltrion Healthcare Hungary Kft. · ustekinumab · ATC L04AC05
n. EU/1/08/461 · autorizzato il 11/07/2008 · Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adol… · Takeda Pharmaceuticals International AG Ireland Branch · icatibant · ATC B06AC02
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