Europska unija — odluke Europske komisije — rujan 2024.
Ukinuta odobrenja, povlačenje serija lijekova, pisma zdravstvenim radnicima i novi lijekovi EU — svakodnevno, automatski. Zadnje ažuriranje: 27. 9. 2026. 13:39
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.
br. EU/1/18/1321 · odobreno 27. 9. 2018. · Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metas… · Mylan Pharmaceuticals Limited · gefitinib · ATC L01EB01
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
br. EU/1/14/982 · odobreno 15. 1. 2015. · Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (C… · AbbVie Deutschland GmbH & Co. KG · ombitasvir / paritaprevir / ritonavir · ATC J05AP53
br. EU/1/14/983 · odobreno 15. 1. 2015. · Exviera is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CH… · AbbVie Deutschland GmbH & Co. KG · dasabuvir · ATC J05AP09
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
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
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
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
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
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
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
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
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
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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