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Novi lijekovi (EU) — Hrvatska

Ukinuta odobrenja, povlačenje serija lijekova, pisma zdravstvenim radnicima i novi lijekovi EU — svakodnevno, automatski. Zadnje ažuriranje: 15. 10. 2026. 08:55

Sve Ukinuta odobrenja3 Povlačenje serija3 Novi lijekovi (EU)12 Sigurnost (DHPC)2 Europska unija63

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.

21. 5. 2026.četvrtak, 21. svibnja 2026.

otvori dan ◀ ▶ 1 događaj
Novo odobrenje EU EU Joenja
br. EU/1/26/2034 · Joenja is indicated for the treatment of activated phosphoinositide 3 kinase delta syndrome (APDS) in adults a… · Pharming Technologies B.V. · leniolisib · ATC L03AX22
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6. 5. 2026.srijeda, 6. svibnja 2026.

otvori dan ◀ ▶ 1 događaj
Novo odobrenje EU EU Bysumlog
br. EU/1/26/2030 · For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of nor… · Gan & Lee Pharmaceuticals Europe GmbH · Insulin lispro · ATC A10AB04
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27. 4. 2026.ponedjeljak, 27. travnja 2026.

otvori dan ◀ ▶ 5 događaja
Novo odobrenje EU EU Zandoriah
br. EU/1/26/2031 · Teriparatide is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increa… · CINNAGEN CO, UNIPESSOAL LDA. · teriparatide · ATC H05AA02
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Novo odobrenje EU EU Xolremdi
br. EU/1/26/2017 · Xolremdi is indicated in patients 12 years of age and older for the treatment of WHIM syndrome (warts, hypogam… · Norgine B.V. · mavorixafor · ATC L03AX24
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Novo odobrenje EU EU Tuyory
br. EU/1/26/2022 · Rheumatoid arthritis (RA) Tuyory, in combination with methotrexate (MTX), is indicated for: • the treatment … · Gedeon Richter Plc. · tocilizumab · ATC L04AC07
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Novo odobrenje EU EU Onerji
br. EU/1/26/2026 · Onerji is indicated for the treatment of motor fluctuations in patients with advanced Parkinson's disease whic… · Tanabe Pharma GmbH · levodopa/carbidopa · ATC N04BA02
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Novo odobrenje EU EU Dazparda
br. EU/1/26/2029 · Dazparda is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and a… · Gan & Lee Pharmaceuticals Europe GmbH · insulin aspart · ATC A10AB05
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23. 4. 2026.četvrtak, 23. travnja 2026.

otvori dan ◀ ▶ 4 događaja
Novo odobrenje EU EU Rhapsido
br. EU/1/26/2024 · Rhapsido is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequa… · Novartis Europharm Limited · remibrutinib · ATC L04AA60
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Novo odobrenje EU EU Poherdy
br. EU/1/25/2008 · Early breast cancer Poherdy is indicated for use in combination with trastuzumab and chemotherapy in: • the … · N.V. Organon · pertuzumab · ATC L01FD02
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Novo odobrenje EU EU Palsonify
br. EU/1/26/2021 · Palsonify is indicated for the medical treatment of adult patients with acromegaly. · Crinetics Pharmaceuticals Europe GmbH · paltusotine · ATC H01CB06
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Novo odobrenje EU EU Fubelv
br. EU/1/26/2023 · Rheumatoid arthritis Fubelv in combination with methotrexate is indicated for the treatment of moderate to … · Biocon Biologics Ireland Limited · etanercept · ATC L04AB01
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20. 4. 2026.ponedjeljak, 20. travnja 2026.

otvori dan ◀ ▶ 2 događaja
Novo odobrenje EU EU mCOMBRIAX
br. EU/1/26/2028 · mCOMBRIAX is indicated for active immunisation for the prevention of influenza disease and COVID-19 caused by … · Moderna Biotech Spain S.L. · Influenza and COVID 19, mRNA vaccine · ATC Pending
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Novo odobrenje EU EU Ojemda
br. EU/1/26/2025 · Ojemda is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low… · Ipsen Pharma · tovorafenib · ATC L01EC04
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Ukupno 272 događaja u ovoj kategoriji.