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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: 27. 9. 2026. 13:39

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

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.

19. 4. 2024.petak, 19. travnja 2024.

9 događaja · 1 važnih
Povučeno u EU EU Telmisartan Teva Pharma
br. EU/1/11/719 · odobreno 3. 10. 2011. · Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardio… · Teva B.V. · telmisartan · ATC C09CA07
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Novo odobrenje EU EU ZYNYZ
br. EU/1/24/1800 · Squamous cell carcinoma of the anal canal (SCAC) ZYNYZ is indicated in combination with carboplatin and pacli… · Incyte Biosciences Distribution B.V. · retifanlimab · ATC L01FF10
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Novo odobrenje EU EU Voydeya
br. EU/1/24/1792 · Voydeya is indicated as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxy… · Alexion Europe SAS · danicopan · ATC L04AJ09
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Novo odobrenje EU EU Pyzchiva
br. EU/1/24/1801 · Plaque psoriasis Pyzchiva is indicated for the treatment of moderate to severe plaque psoriasis in adults who… · Samsung Bioepis NL B.V. · ustekinumab · ATC L04AC05
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Novo odobrenje EU EU Nintedanib Accord
br. EU/1/24/1803 · Nintedanib Accord is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib… · Accord Healthcare S.L.U. · nintedanib · ATC L01EX09
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Novo odobrenje EU EU Incellipan
br. EU/1/24/1807 · Incellipan is indicated for active immunisation against influenza in an officially declared pandemic. Incel… · Seqirus Netherlands B.V. · Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures) · ATC J07BB02
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Novo odobrenje EU EU Filspari
br. EU/1/23/1788 · Filspari is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urin… · Vifor France · Sparsentan · ATC C09XX01
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Novo odobrenje EU EU Celldemic
br. EU/1/24/1806 · Celldemic is indicated for active immunisation against H5N1 subtype of Influenza A virus in adults and infants… · Seqirus Netherlands B.V. · Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures) · ATC J07BB02
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Novo odobrenje EU EU Apremilast Accord
br. EU/1/24/1796 · Psoriatic arthritis Apremilast Accord, alone or in combination with Disease Modifying Antirheumatic Drugs (… · Accord Healthcare S.L.U. · apremilast · ATC L04AA32
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Ukupno 9 događaja ovog dana.