Ukinuta odobrenja, povlačenje serija lijekova, pisma zdravstvenim radnicima i novi lijekovi EU — svakodnevno, automatski. Zadnje ažuriranje: 15. 10. 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/1/25/2006 · odobreno 12. 2. 2026. · Aumseqa as monotherapy is indicated for:
• the first line treatment of adult patients with advanced non small… · SFL Pharmaceuticals Deutschland GmbH · aumolertinib · ATC L01EB11
br. EU/1/26/2066 · Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated wi… · CuraTeQ Biologics s.r.o · Pegfilgrastim · ATC L03AA13
br. EU/1/10/638 · odobreno 27. 7. 2010. · OZURDEX is indicated for the treatment of adult patients with:
• Visual impairment due to diabetic macular oe… · AbbVie Deutschland GmbH & Co. KG · dexamethasone · ATC S01BA01
br. EU/1/23/1732 · odobreno 31. 5. 2023. · Lacosamide Adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secon… · Extrovis EU Kft. · lacosamide · ATC N03AX18
br. EU/1/15/1064 · odobreno 16. 12. 2015. · Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly me… · Amgen Europe B.V. · talimogene laherparepvec · ATC L01XL02
br. EU/1/25/2006 · odobreno 12. 2. 2026. · Aumseqa as monotherapy is indicated for:
• the first line treatment of adult patients with advanced non small… · SFL Pharmaceuticals Deutschland GmbH · aumolertinib · ATC L01EB11
br. EU/1/26/2060 · Nezglyal is indicated for the treatment of Cerebral Adrenoleukodystrophy (cALD) in males with Adrenoleukodystr… · Minoryx Therapeutics S.L. · leriglitazone · ATC A16AX23
br. EU/1/24/1833 · odobreno 25. 7. 2024. · Cejemly in combination with platinum-based chemotherapy is indicated for the first line treatment of adults wi… · CStone Pharmaceuticals Ireland Limited · sugemalimab · ATC L01FF11
br. EU/1/21/1608 · odobreno 6. 1. 2022. · Adults
Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for wei… · Novo Nordisk A/S · semaglutide · ATC A10BJ06
br. EU/1/23/1770 · odobreno 7. 12. 2023. · ELREXFIO is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple… · Pfizer Europe MA EEIG · elranatamab · ATC L01FX32
br. EU/1/26/2063 · ICOTYDE is indicated for the treatment of moderate to severe plaque psoriasis in adults, and adolescents 12 ye… · Janssen-Cilag International N.V. · icotrokinra hydrochloride
br. EU/1/26/2058 · Susvimo is indicated in adult patients for the treatment of neovascular (wet) age related macular degeneration… · Roche Registration GmbH · ranibizumab · ATC S01LA04
br. EU/1/21/1599 · odobreno 24. 1. 2022. · VYEPTI is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month. · H. Lundbeck A/S · eptinezumab · ATC N02CD05
br. EU/1/22/1684 · odobreno 15. 9. 2022. · NULIBRY is indicated for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A. · Integral Pharma Solutions EU Limited · fosdenopterin · ATC A16AX
br. EU/1/12/780 · odobreno 20. 7. 2012. · Jentadueto is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve … · Boehringer Ingelheim International GmbH · linagliptin/metformin hydrochloride · ATC A10BD11
br. EU/1/16/1146 · odobreno 11. 11. 2016. · Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and ol… · Boehringer Ingelheim International GmbH · empagliflozin/linagliptin · ATC A10BD19
br. EU/1/22/1700 · odobreno 16. 12. 2022. · Ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older wi… · Pierre Fabre Medicament · Tabelecleucel · ATC L01XL09
br. EU/1/26/2030 · odobreno 6. 5. 2026. · For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of nor… · Sandoz GmbH · Insulin lispro · ATC A10AB04
br. EU/1/20/1498 · odobreno 9. 12. 2020. · Trixeo Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic ob… · AstraZeneca AB · Formoterol / glycopyrronium bromide / budesonide · ATC R03AL11
br. EU/1/21/1604 · odobreno 6. 1. 2022. · Riltrava Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic … · AstraZeneca AB · formoterol / glycopyrronium bromide / budesonide · ATC R03AL11
br. EU/1/01/189 · odobreno 3. 8. 2001. · Replagal is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry… · Takeda Pharmaceuticals International AG Ireland Branch · Agalsidase alfa · ATC A16AB03
br. EU/1/19/1404 · odobreno 16. 12. 2019. · Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthriti… · AbbVie Deutschland GmbH & Co. KG · upadacitinib · ATC L04AF03
br. EU/1/24/1863 · odobreno 25. 9. 2024. · 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/1/24/1865 · odobreno 13. 11. 2024. · Opuviz is indicated for adults for the treatment of
• neovascular (wet) age related macular degeneration (AMD… · Samsung Bioepis NL B.V. · Aflibercept · ATC S01LA05
br. EU/1/18/1277 · odobreno 19. 4. 2018. · MYLOTARG is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment … · Pfizer Europe MA EEIG · gemtuzumab ozogamicin · ATC L01FX02
br. EU/1/22/1649 · odobreno 3. 6. 2022. · Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicula… · Roche Registration GmbH · mosunetuzumab · ATC L01FX25
br. EU/1/23/1755 · odobreno 15. 9. 2023. · Litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and… · Pfizer Europe MA EEIG · ritlecitinib · ATC L01EJ
br. EU/1/19/1356 · odobreno 2. 4. 2019. · Rheumatoid arthritis
Idacio in combination with methotrexate, is indicated for:
the treatment of moderate… · Fresenius Kabi Deutschland GmbH · adalimumab · ATC L04AB04
br. EU/1/15/1047 · odobreno 23. 11. 2015. · BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B c… · Amgen Europe B.V. · blinatumomab · ATC L01FX07
br. EU/1/12/768 · odobreno 7. 5. 2012. · Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotroph… · Zentiva k.s. · Riluzole · ATC N07XX02
br. EU/1/06/359 · odobreno 26. 9. 2006. · Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological tre… · Indivior Europe Limited · buprenorphine / naloxone · ATC N07BC51
br. EU/1/10/618 · odobreno 26. 5. 2010. · Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal… · Amgen Europe B.V. · denosumab · ATC M05BX04
br. EU/1/13/891 · odobreno 18. 12. 2013. · Brintellix is indicated for the treatment of major depressive episodes in adults · H. Lundbeck A/S · vortioxetine · ATC N06AX26
br. EU/1/04/307 · odobreno 10. 3. 2005. · Zonegran is indicated as:
- monotherapy in the treatment of partial seizures, with or without secondary gener… · Amdipharm Limited · zonisamide · ATC N03AX15
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