Unione europea — decisioni della Commissione europea — settembre 2026
Revoche e sospensioni, ritiri di lotti, farmaci carenti, note di sicurezza, rimborsabilità e nuovi medicinali — ogni giorno, automaticamente. Ultimo aggiornamento: 15/10/2026 08:15.
n. EU/1/16/1156 · autorizzato il 18/01/2017 · ZINPLAVA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in adult an… · Merck Sharp & Dohme B.V. · bezlotoxumab · ATC J06BC03
n. EU/1/19/1409 · autorizzato il 19/12/2019 · Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated wi… · Mundipharma Corporation (Ireland) Limited · pegfilgrastim · ATC L03AA13
n. EU/1/24/1887 · autorizzato il 13/01/2025 · Baiama is indicated for adults for the treatment of
• neovascular (wet) age-related macular degeneration (AMD… · Formycon AG · Aflibercept · ATC S01LA05
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/1/26/2066 · Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated wi… · CuraTeQ Biologics s.r.o · Pegfilgrastim · ATC L03AA13
n. EU/1/25/1957 · autorizzato il 14/08/2025 · Adult Crohn’s Disease
Usymro is indicated for the treatment of adult patients with moderately to severely ac… · Gedeon Richter Plc. · ustekinumab · ATC L04AC05
n. EU/1/10/638 · autorizzato il 27/07/2010 · OZURDEX is indicated for the treatment of adult patients with:
• Visual impairment due to diabetic macular oe… · AbbVie Deutschland GmbH & Co. KG · dexamethasone · ATC S01BA01
n. EU/1/23/1732 · autorizzato il 31/05/2023 · Lacosamide Adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secon… · Extrovis EU Kft. · lacosamide · ATC N03AX18
n. EU/1/15/1064 · autorizzato il 16/12/2015 · Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly me… · Amgen Europe B.V. · talimogene laherparepvec · ATC L01XL02
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/1/26/2060 · Nezglyal is indicated for the treatment of Cerebral Adrenoleukodystrophy (cALD) in males with Adrenoleukodystr… · Minoryx Therapeutics S.L. · leriglitazone · ATC A16AX23
n. EU/1/21/1615 · autorizzato il 13/04/2022 · <u>Muscle invasive bladder cancer (MIBC)</u>
Padcev, in combination with pembrolizumab, as neoadjuvant trea… · Astellas Pharma Europe B.V. · enfortumab vedotin · ATC L01FX13
n. EU/1/24/1833 · autorizzato il 25/07/2024 · Cejemly in combination with platinum-based chemotherapy is indicated for the first line treatment of adults wi… · CStone Pharmaceuticals Ireland Limited · sugemalimab · ATC L01FF11
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/1/26/2063 · ICOTYDE is indicated for the treatment of moderate to severe plaque psoriasis in adults, and adolescents 12 ye… · Janssen-Cilag International N.V. · icotrokinra hydrochloride
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/1/21/1599 · autorizzato il 24/01/2022 · VYEPTI is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month. · H. Lundbeck A/S · eptinezumab · ATC N02CD05
n. EU/1/13/821 · autorizzato il 13/03/2013 · Treatment of essential hypertension. Tolucombi fixed dose combination (40 mg telmisartan/12.5 mg hydrochloroth… · KRKA d d., Novo mesto · telmisartan/hydrochlorothiazide · ATC C09DA07
n. EU/1/16/1152 · autorizzato il 20/04/2017 · Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with … · Berlin-Chemie AG · edoxaban · ATC B01AF03
n. EU/1/09/586 · autorizzato il 30/11/2009 · Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patient… · Novartis Europharm Limited · indacaterol · ATC R03AC18
n. EU/1/22/1684 · autorizzato il 15/09/2022 · NULIBRY is indicated for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A. · Integral Pharma Solutions EU Limited · fosdenopterin · ATC A16AX
n. EU/1/25/1964 · autorizzato il 18/08/2025 · MYNZEPLI is indicated for adults for the treatment of
- neovascular (wet) age-related macular degeneration (A… · Advanz Pharma Limited · aflibercept · ATC S01LA05
n. EU/1/20/1468 · autorizzato il 21/08/2020 · Kaftrio tablets are indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF… · Vertex Pharmaceuticals (Ireland) Limited · ivacaftor / tezacaftor / elexacaftor · ATC R07AX32
n. EU/1/12/780 · autorizzato il 20/07/2012 · Jentadueto is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve … · Boehringer Ingelheim International GmbH · linagliptin/metformin hydrochloride · ATC A10BD11
n. EU/1/23/1723 · autorizzato il 15/05/2023 · Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adu… · Plusultra pharma GmbH · sirolimus · ATC L01EG04
n. EU/1/09/594 · autorizzato il 30/11/2009 · Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult pati… · Novartis Europharm Limited · indacaterol · ATC R03AC18
n. EU/1/16/1146 · autorizzato il 11/11/2016 · Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and ol… · Boehringer Ingelheim International GmbH · empagliflozin/linagliptin · ATC A10BD19
n. EU/1/25/1972 · autorizzato il 15/09/2025 · Eyluxvi is indicated for adults for the treatment of
• neovascular (wet) age-related macular degeneration (AM… · Biolitec Pharma Limited Zweigniederlassung Jena · aflibercept · ATC S01LA05
n. EU/1/20/1438 · autorizzato il 03/07/2020 · Enerzair Breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately control… · Novartis Europharm Limited · indacaterol / glycopyrronium bromide / mometasone · ATC R03AL12
n. EU/1/22/1700 · autorizzato il 16/12/2022 · Ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older wi… · Pierre Fabre Medicament · Tabelecleucel · ATC L01XL09
n. EU/1/26/2030 · autorizzato il 06/05/2026 · For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of nor… · Sandoz GmbH · Insulin lispro · ATC A10AB04
n. EU/1/25/1965 · autorizzato il 18/08/2025 · Afiveg is indicated for adults for the treatment of
- neovascular (wet) age-related macular degeneration (AMD… · STADA Arzneimittel AG · aflibercept · ATC S01LA05
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
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