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: 10/11/2026 08:15.
n. EU/1/24/1859 · autorizzato il 27/09/2024 · Yuvanci is indicated as substitution therapy for the long-term treatment of pulmonary arterial hypertension (P… · Janssen-Cilag International NV · Macitentan / Tadalafil · ATC C02KX54
n. EU/1/13/904 · autorizzato il 21/02/2014 · Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients. · Galderma S.A.,the Netherlands Branch · brimonidine · ATC D11AX21
n. EU/1/13/880 · autorizzato il 04/12/2013 · Treatment of patients with moderate to severe Alzheimer's disease. · Accord Healthcare S.L.U. · memantine · ATC N06DX01
n. EU/1/15/1076 · autorizzato il 18/02/2016 · Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Kova… · Bayer AG · octocog alfa · ATC B02BD02
n. EU/1/24/1873 · autorizzato il 12/02/2025 · Kostaive is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years… · Arcturus Therapeutics Europe B.V. · zapomeran · ATC J07BX03
n. EU/1/24/1866 · autorizzato il 14/11/2024 · ELAHERE as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) posit… · AbbVie Deutschland GmbH & Co. KG · mirvetuximab soravtansine · ATC L01FX26
n. EU/1/26/2029 · autorizzato il 27/04/2026 · Dazparda is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and a… · Sandoz GmbH · insulin aspart · ATC A10AB05
n. EU/1/10/636 · autorizzato il 05/07/2010 · Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post… · AstraZeneca AB · roflumilast · ATC R03DX07
n. EU/1/21/1579 · autorizzato il 24/06/2022 · Nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of p… · Sanofi B.V. · avalglucosidase alfa · ATC A16AB22
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/1/16/1156 · 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/1/14/941 · autorizzato il 22/08/2014 · This medicinal product is for diagnostic use only.
VIZAMYL is a radiopharmaceutical indicated for Positron Em… · GE Healthcare AS · flutemetamol (18F) · ATC V09AX04
n. EU/1/15/1079 · autorizzato il 15/02/2016 · Vaxelis (DTaP-HB-IPV-Hib) is indicated for primary and booster vaccination in infants and toddlers from the ag… · MCM Vaccine B.V. · Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) · ATC J07CA09
n. EU/1/16/1135 · autorizzato il 15/09/2016 · Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3… · Proveca Pharma Limited · glycopyrronium bromide · ATC A03AB02
n. EU/1/25/1947 · autorizzato il 28/07/2025 · RIULVY is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing … · Neuraxpharm Pharmaceuticals, S.L. · Tegomil fumarate · ATC L04AX10
n. EU/1/23/1730 · autorizzato il 31/05/2023 · Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with… · Neuraxpharm Pharmaceuticals, S.L. · ublituximab · ATC L04AG14
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
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