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Europska unija — odluke Europske komisije — veljača 2026.

Ukinuta odobrenja, povlačenje serija lijekova, pisma zdravstvenim radnicima i novi lijekovi EU — svakodnevno, automatski. Zadnje ažuriranje: 27. 9. 2026. 13:39

Sve Ukinuta odobrenja19 Povlačenje serija1 Novi lijekovi (EU)9 Sigurnost (DHPC)1 Europska unija36
poništi

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.

23. 2. 2026.ponedjeljak, 23. veljače 2026.

otvori dan ◀ ▶ 4 događaja · 4 važnih
Povučeno u EU EU Zegalogue
br. EU/1/24/1829 · odobreno 24. 7. 2024. · Zegalogue is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 6 y… · Zealand Pharma A/S · Dasiglucagon · ATC H04AA02
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Povučeno u EU EU Flucelvax Tetra
br. EU/1/18/1326 · odobreno 12. 12. 2018. · Prophylaxis of influenza in adults and children from 6 months of age. Flucelvax Tetra should be used in ac… · Seqirus Netherlands B.V. · influenza vaccine (surface antigen, inactivated, prepared in cell cultures) · ATC J07BB02
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Povučeno u EU EU Fluad Tetra
br. EU/1/20/1433 · odobreno 20. 5. 2020. · Prophylaxis of influenza in adults 50 years of age and older. Fluad Tetra should be used in accordance with… · Seqirus Netherlands B.V. · influenza vaccine (surface antigen, inactivated, adjuvanted) · ATC J07BB02
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Povučeno u EU EU Atazanavir Krka
br. EU/1/19/1353 · odobreno 25. 3. 2019. · Atazanavir Krka capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1 in… · KRKA d d., Novo mesto · atazanavir · ATC J05AE08
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18. 2. 2026.srijeda, 18. veljače 2026.

otvori dan ◀ ▶ 2 događaja · 1 važnih
Povučeno u EU EU Xevudy
br. EU/1/21/1562 · odobreno 17. 12. 2021. · Xevudy is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least … · GlaxoSmithKline Trading Services Limited · sotrovimab · ATC J06BD05
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Novo odobrenje EU EU Melatomed and associated names
Melatonin is an endogenous neurohormone that plays a key role in the regulation of circadian rhythms and the s… · Fairmed Healthcare GmbH · melatonin
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16. 2. 2026.ponedjeljak, 16. veljače 2026.

otvori dan ◀ ▶ 1 događaj
Novo odobrenje EU EU ANKTIVA
br. EU/1/25/2002 · ANKTIVA in combination with Bacillus Calmette Guérin (BCG) for the treatment of adult patients with BCG-unresp… · ImmunityBio Ireland Limited · nogapendekin alfa inbakicept · ATC L03AC03
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12. 2. 2026.četvrtak, 12. veljače 2026.

otvori dan ◀ ▶ 4 događaja
Novo odobrenje EU EU mNEXSPIKE
br. EU/1/25/2010 · mNEXSPIKE is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 year… · MODERNA BIOTECH SPAIN, S.L. · COVID-19 mRNA vaccine · ATC J07BN01
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Novo odobrenje EU EU MYQORZO
br. EU/1/25/2014 · MYQORZO is indicated for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstruc… · Cytokinetics (Ireland) Limited · aficamten · ATC Pending
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Novo odobrenje EU EU EXDENSUR
br. EU/1/25/2007 · Asthma EXDENSUR is indicated as add-on maintenance treatment for severe asthma with type 2 inflammation cha… · GlaxoSmithKline Trading Services Limited · Depemokimab · ATC R03DX12
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Novo odobrenje EU EU Aumseqa
br. EU/1/25/2006 · 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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10. 2. 2026.utorak, 10. veljače 2026.

otvori dan ◀ ▶ 2 događaja
Novo odobrenje EU EU Ranluspec
br. EU/1/25/2012 · Ranluspec is indicated in adults for: • The treatment of neovascular (wet) age-related macular degeneration (… · Lupin Europe GmbH · ranibizumab · ATC S01LA04
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Novo odobrenje EU EU Gotenfia
br. EU/1/25/2009 · Rheumatoid arthritis (RA) Gotenfia, in combination with methotrexate (MTX), is indicated for: • the treatmen… · STADA Arzneimittel AG · golimumab · ATC L04AB06
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Ukupno 13 događaja u ovoj kategoriji.