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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: 13. 11. 2026. 08:55

Sve Ukinuta odobrenja8 Povlačenje serija 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.

20. 2. 2025.četvrtak, 20. veljače 2025.

otvori dan ◀ ▶ 1 događaj
Novo odobrenje EU EU Lyvdelzi
br. EU/1/24/1898 · Seladelpar Gilead is indicated for the treatment of primary biliary cholangitis (PBC) in combination with urso… · Gilead Sciences Ireland UC · seladelpar · ATC A05AX07
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14. 2. 2025.petak, 14. veljače 2025.

otvori dan ◀ ▶ 4 događaja
Novo odobrenje EU EU Yesintek
br. EU/1/24/1892 · Adult Crohn’s Disease Yesintek is indicated for the treatment of adult patients with moderately to severely a… · Biosimilar Collaborations Ireland Limited · ustekinumab · ATC L04AC05
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Novo odobrenje EU EU Stoboclo
br. EU/1/24/1905 · Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal… · Celltrion Healthcare Hungary Kft. · Denosumab · ATC M05BX04
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Novo odobrenje EU EU Osenvelt
br. EU/1/24/1904 · Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or su… · Celltrion Healthcare Hungary Kft. · Denosumab · ATC M05BX04
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Novo odobrenje EU EU Avtozma
br. EU/1/24/1896 · Avtozma, in combination with methotrexate (MTX), is indicated for: • the treatment of severe, active and pr… · Celltrion Healthcare Hungary Kft. · tocilizumab · ATC L04AC07
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12. 2. 2025.srijeda, 12. veljače 2025.

otvori dan ◀ ▶ 8 događaja
Novo odobrenje EU EU Zefylti
br. EU/1/24/1899 · Zefylti is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia… · CuraTeQ Biologics (Malta) Limited · Filgrastim · ATC L03AA02
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Novo odobrenje EU EU Xbryk
br. EU/1/24/1889 · Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or su… · Samsung Bioepis NL B.V. · denosumab · ATC M05BX04
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Novo odobrenje EU EU WELIREG
br. EU/1/24/1893 · <u>Renal cell carcinoma (RCC)</u> WELIREG is indicated as monotherapy for the treatment of adult patients… · Merck Sharp & Dohme B.V. · belzutifan · ATC L01XX74
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Novo odobrenje EU EU Obodence
br. EU/1/24/1890 · Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal… · Samsung Bioepis NL B.V. · Denosumab · ATC M05BX04
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Novo odobrenje EU EU Nemluvio
br. EU/1/24/1901 · Atopic dermatitis (AD) Nemluvio is indicated for the treatment of moderate-to-severe atopic dermatitis in p… · Galderma International · Nemolizumab · ATC D11AH12
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Novo odobrenje EU EU Kostaive
br. EU/1/24/1873 · Kostaive is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years… · Seqirus Netherlands B.V. · zapomeran · ATC J07BX03
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Novo odobrenje EU EU Eydenzelt
br. EU/1/24/1895 · Eydenzelt is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (… · Celltrion Healthcare Hungary Kft. · Aflibercept · ATC S01LA05
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Novo odobrenje EU EU Emcitate
br. EU/1/24/1897 · Emcitate is indicated for the treatment of peripheral thyrotoxicosis in patients with monocarboxylate transpor… · Rare Thyroid Therapeutics International AB · Tiratricol · ATC H03AA04
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10. 2. 2025.ponedjeljak, 10. veljače 2025.

otvori dan ◀ ▶ 3 događaja
Novo odobrenje EU EU Korjuny
br. EU/1/24/1826 · Korjuny is indicated for the intraperitoneal treatment of malignant ascites in adults with epithelial cellular… · Atnahs Pharma Netherlands B. V. · catumaxomab · ATC L01FX03
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Novo odobrenje EU EU BEYONTTRA
br. EU/1/24/1906 · BEYONTTRA is indicated for the treatment of wild-type or variant transthyretin amyloidosis in adult patients w… · Bayer AG · acoramidis · ATC C01EB25
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Novo odobrenje EU EU ANDEMBRY
br. EU/1/24/1885 · Andembry is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and … · CSL Behring GmbH · garadacimab · ATC B06AC07
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3. 2. 2025.ponedjeljak, 3. veljače 2025.

otvori dan ◀ ▶ 1 događaj
Novo odobrenje EU EU HETRONIFLY
br. EU/1/24/1870 · Small cell lung cancer (SCLC) HETRONIFLY in combination with carboplatin and etoposide is indicated for the… · Accord Healthcare S.L.U. · serplulimab · ATC L01FF12
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Ukupno 496 događaja u ovoj kategoriji.