Ukinuta odobrenja, povlačenje serija lijekova, pisma zdravstvenim radnicima i novi lijekovi EU — svakodnevno, automatski. Zadnje ažuriranje: 13. 11. 2026. 08:55
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/1/24/1856 · 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
br. EU/1/24/1849 · mRESVIA is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caus… · MODERNA BIOTECH SPAIN, S.L. · Single-stranded 5' capped mRNA encoding the respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation · ATC J07BX05
br. EU/1/24/1850 · Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the tre… · Merck Sharp & Dohme B.V. · sotatercept · ATC C02KX06
br. EU/1/24/1799 · This medicinal product is for diagnostic use only.
Flortaucipir (18F) is a radiopharmaceutical indicated for … · Eli Lilly Nederland B.V. · Flortaucipir (18F) · ATC V09AX07
br. EU/1/24/1844 · Adult Crohn’s Disease
Steqeyma is indicated for the treatment of adult patients with moderately to severely a… · Celltrion Healthcare Hungary Kft. · ustekinumab · ATC L04AC05
br. EU/1/24/1848 · Piasky as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age or older… · Roche Registration GmbH · crovalimab · ATC L04AJ07
br. EU/1/24/1843 · • Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicu… · Regeneron Ireland Designated Activity Company (DAC) · odronextamab · ATC L01FX34
br. EU/1/24/1842 · Enzalutamide Viatris is indicated:
• as monotherapy or in combination with androgen deprivation therapy for t… · Viatris Limited · enzalutamide · ATC L02BB04
br. EU/1/24/1846 · EURneffy is indicated in the emergency treatment of allergic reactions (anaphylaxis) due to insect stings or b… · ALK-Abelló A/S · Epinephrine · ATC C01CA24
br. EU/1/24/1841 · Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic uroth… · Janssen-Cilag International NV · erdafitinib · ATC L01EN01
br. EU/1/24/1840 · AKANTIOR is indicated for the treatment of Acanthamoeba keratitis in adults and children from 12 years of age. · SIFI S.p.A. · polihexanide · ATC S01AX24
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