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Novi lijekovi (EU) — Hrvatska

Ukinuta odobrenja, povlačenje serija lijekova, pisma zdravstvenim radnicima i novi lijekovi EU — svakodnevno, automatski. Zadnje ažuriranje: 11. 11. 2026. 08:55

Sve Ukinuta odobrenja6 Povlačenje serija2 Novi lijekovi (EU) Sigurnost (DHPC)1 Europska unija39

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.

26. 9. 2026.subota, 26. rujna 2026.

otvori dan ◀ ▶ 7 događaja
Novo odobrenje EU EU Zokovea
br. 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
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Novo odobrenje EU EU Ubeslo
br. 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
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Novo odobrenje EU EU Tafamidis Accord
br. 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
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Novo odobrenje EU EU Ruxolitinib Viatris
br. EU/1/26/2064 · Myelofibrosis (MF) Ruxolitinib Viatris is indicated for the treatment of disease-related splenomegaly or … · Viatris Limited · ruxolitinib · ATC L01EJ01
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Novo odobrenje EU EU Riociguat Accord
br. EU/1/26/2059 · Chronic thromboembolic pulmonary hypertension (CTEPH) Riociguat Accord is indicated for the treatment of ad… · Accord Healthcare S.L.U. · riociguat · ATC C02KX05
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Novo odobrenje EU EU Nylaspeg
br. 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
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Novo odobrenje EU EU Evlarco
br. 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
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25. 9. 2026.petak, 25. rujna 2026.

otvori dan ◀ ▶ 1 događaj
Novo odobrenje EU EU Cavoley
br. 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
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21. 9. 2026.ponedjeljak, 21. rujna 2026.

otvori dan ◀ ▶ 1 događaj
Novo odobrenje EU EU Nezglyal
br. 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
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18. 9. 2026.petak, 18. rujna 2026.

otvori dan ◀ ▶ 3 događaja
Novo odobrenje EU EU ICOTYDE
br. 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
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Novo odobrenje EU EU Susvimo
br. 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
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Novo odobrenje EU EU LYROKAUL
br. 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
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20. 8. 2026.četvrtak, 20. kolovoza 2026.

otvori dan ◀ ▶ 4 događaja
Novo odobrenje EU EU Onswik
br. EU/1/26/2049 · Treatment of type 2 diabetes mellitus in adults. · Eli Lilly Nederland B.V. · Insulin efsitora alfa · ATC Pending
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Novo odobrenje EU EU Hopledo
br. EU/1/26/2054 · Hopledo is indicated for the treatment of adult patients with Parkinson’s disease and moderate to severe motor… · Zambon S.p.A. · levodopa / carbidopa · ATC N04BA02
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Novo odobrenje EU EU Daybu
br. EU/1/26/2045 · Daybu is indicated for the treatment of neurobehavioural symptoms of Rett syndrome in adults and paediatric pa… · Acadia Pharmaceuticals (Netherlands) B.V. · trofinetide · ATC N07XX24
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Novo odobrenje EU EU Aujemflu
br. EU/1/26/2050 · Prophylaxis of influenza in adults 50 years of age and older. Aujemflu should be used in accordance with of… · Seqirus Netherlands B.V. · influenza vaccine (surface antigen, inactivated, adjuvanted, prepared in cell cultures) · ATC J07BB02
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Ukupno 272 događaja u ovoj kategoriji.