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Novi lijekovi (EU) — Hrvatska — rujan 2024.

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
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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.

27. 9. 2024.petak, 27. rujna 2024.

otvori dan ◀ ▶ 1 događaj
Novo odobrenje EU EU Yuvanci
br. EU/1/24/1859 · Yuvanci is indicated as substitution therapy for the long-term treatment of pulmonary arterial hypertension (P… · Janssen-Cilag International NV · Macitentan / Tadalafil · ATC C02KX54
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25. 9. 2024.srijeda, 25. rujna 2024.

otvori dan ◀ ▶ 2 događaja
Novo odobrenje EU EU Otulfi
br. EU/1/24/1863 · Adult Crohn’s Disease Otulfi is indicated for the treatment of adult patients with moderately to severely act… · Fresenius Kabi Deutschland GmbH · ustekinumab · ATC L04AC05
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Novo odobrenje EU EU Fymskina
br. EU/1/24/1862 · Plaque psoriasis Fymskina is indicated for the treatment of moderate to severe plaque psoriasis in adults who… · Formycon AG · ustekinumab · ATC L04AC05
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19. 9. 2024.četvrtak, 19. rujna 2024.

otvori dan ◀ ▶ 10 događaja
Novo odobrenje EU EU Vyloy
br. EU/1/24/1856 · Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first … · Astellas Pharma Europe B.V. · zolbetuximab · ATC L01FX31
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Novo odobrenje EU EU Vevizye
br. EU/1/24/1857 · Treatment of moderate to severe dry eye disease (keratoconjunctivitis sicca) in adult patients, which has not … · Laboratoires Thea · ciclosporin · ATC S01XA18
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Novo odobrenje EU EU Tuznue
br. EU/1/24/1864 · Breast cancer Metastatic breast cancer Tuznue is indicated for the treatment of adult patients with HER2… · Prestige Biopharma Belgium BVBA · trastuzumab · ATC L01FD01
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Novo odobrenje EU EU LOQTORZI
br. EU/1/24/1853 · LOQTORZI, in combination with cisplatin and gemcitabine, is indicated for the first line treatment of adult pa… · Topalliance Biosciences Europe Limited · toripalimab · ATC L01FF13
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Novo odobrenje EU EU KAYFANDA
br. EU/1/24/1854 · KAYFANDA is indicated for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) in patients aged 6… · Ipsen Pharma · Odevixibat · ATC A05AX
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Novo odobrenje EU EU Ituxredi
br. EU/1/24/1861 · Ituxredi is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Ituxredi is … · Reddy Holding GmbH · Rituximab · ATC L01FA01
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Novo odobrenje EU EU Iqirvo
br. EU/1/24/1855 · Iqirvo is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic… · Ipsen Pharma · elafibranor · ATC A05AX06
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Novo odobrenje EU EU Epruvy
br. EU/1/24/1860 · Epruvy is indicated in adults for: • The treatment of neovascular (wet) age-related macular degeneration (A… · Midas Pharma GmbH · ranibizumab · ATC S01LA04
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Novo odobrenje EU EU Axitinib Accord
br. EU/1/24/1847 · Axitinib Accord is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) afte… · Accord Healthcare S.L.U. · axitinib · ATC L01EK01
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Novo odobrenje EU EU Anzupgo
br. EU/1/24/1851 · Anzupgo is indicated for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topi… · LEO Pharma A/S · delgocitinib · ATC D11AH11
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Ukupno 13 događaja u ovoj kategoriji.