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Europska unija — odluke Europske komisije

Ukinuta odobrenja, povlačenje serija lijekova, pisma zdravstvenim radnicima i novi lijekovi EU — svakodnevno, automatski. Zadnje ažuriranje: 3. 10. 2026. 08:55

Sve Ukinuta odobrenja15 Povlačenje serija1 Novi lijekovi (EU)9 Sigurnost (DHPC)1 Europska unija37

Izvori: promjene pratimo na temelju informacija Agencije za lijekove i medicinske proizvode (HALMED) — rješenja o ukidanju odobrenja, obavijesti o povlačenju serija i pisma zdravstvenim radnicima. Odluke o centralizirano odobrenim lijekovima dolaze iz registra Unije Europske komisije (oznaka EU). Nestašice i liste lijekova HZZO-a ovdje (još) nisu uključene.

22. 8. 2024.četvrtak, 22. kolovoza 2024.

11 događaja
Novo odobrenje EU EU mRESVIA
br. EU/1/24/1849 · mRESVIA is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caus… · MODERNA BIOTECH SPAIN, S.L. · Single-stranded 5' capped mRNA encoding the respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation · ATC J07BX05
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Novo odobrenje EU EU Winrevair
br. EU/1/24/1850 · Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the tre… · Merck Sharp & Dohme B.V. · sotatercept · ATC C02KX06
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Novo odobrenje EU EU Tauvid
br. EU/1/24/1799 · This medicinal product is for diagnostic use only. Flortaucipir (18F) is a radiopharmaceutical indicated for … · Eli Lilly Nederland B.V. · Flortaucipir (18F) · ATC V09AX07
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Novo odobrenje EU EU Steqeyma
br. EU/1/24/1844 · 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
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Novo odobrenje EU EU Piasky
br. EU/1/24/1848 · Piasky as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age or older… · Roche Registration GmbH · crovalimab · ATC L04AJ07
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Novo odobrenje EU EU Ordspono
br. EU/1/24/1843 · • Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicu… · Regeneron Ireland Designated Activity Company (DAC) · odronextamab · ATC L01FX34
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Novo odobrenje EU EU Nilotinib Accord
br. EU/1/24/1845 · Nilotinib Accord is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Phil… · Accord Healthcare S.L.U. · nilotinib · ATC L01EA03
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Novo odobrenje EU EU Enzalutamide Viatris
br. EU/1/24/1842 · Enzalutamide Viatris is indicated: • as monotherapy or in combination with androgen deprivation therapy for t… · Viatris Limited · enzalutamide · ATC L02BB04
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Novo odobrenje EU EU EURneffy
br. EU/1/24/1846 · EURneffy is indicated in the emergency treatment of allergic reactions (anaphylaxis) due to insect stings or b… · ALK-Abelló A/S · Epinephrine · ATC C01CA24
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Novo odobrenje EU EU Balversa
br. EU/1/24/1841 · Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic uroth… · Janssen-Cilag International NV · erdafitinib · ATC L01EN01
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Novo odobrenje EU EU AKANTIOR
br. EU/1/24/1840 · AKANTIOR is indicated for the treatment of Acanthamoeba keratitis in adults and children from 12 years of age. · SIFI S.p.A. · polihexanide · ATC S01AX24
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Ukupno 11 događaja ovog dana.