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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 odobrenja20 Povlačenje serija1 Novi lijekovi (EU)9 Sigurnost (DHPC)1 Europska unija37

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.

26. 9. 2026.subota, 26. rujna 2026. · jučer

otvori dan ◀ ▶ 7 događaja
Novo odobrenje EU EU Zokovea
br. EU/1/26/2062 · Zokovea is indicated for the post exposure prophylaxis of COVID 19 in adults and adolescents aged 12 years and… · Shionogi B.V. · ensitrelvir · ATC J05AE16
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Novo odobrenje EU EU Ubeslo
br. EU/1/26/2055 · Ubeslo is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or m… · A. Menarini International Licensing S.A. · Obicetrapib · ATC C10AX
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Novo odobrenje EU EU Tafamidis Accord
br. EU/1/26/2065 · Tafamidis Accord is indicated for the treatment of hereditary transthyretin amyloidosis in adult patients with… · Accord Healthcare S.L.U. · tafamidis · ATC N07XX08
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Novo odobrenje EU EU Ruxolitinib Viatris
br. EU/1/26/2064 · Myelofibrosis (MF) Ruxolitinib Viatris is indicated for the treatment of disease-related splenomegaly or … · Viatris Limited · ruxolitinib · ATC L01EJ01
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Novo odobrenje EU EU Riociguat Accord
br. EU/1/26/2059 · Chronic thromboembolic pulmonary hypertension (CTEPH) Riociguat Accord is indicated for the treatment of ad… · Accord Healthcare S.L.U. · riociguat · ATC C02KX05
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Novo odobrenje EU EU Nylaspeg
br. EU/1/26/2051 · Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated wi… · QILU PHARMA SPAIN S.L. · pegfilgrastim · ATC L03AA13
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Novo odobrenje EU EU Evlarco
br. EU/1/26/2056 · Evlarco is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or … · A. Menarini International Licensing S.A. · obicetrapib / ezetimibe
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25. 9. 2026.petak, 25. rujna 2026. · prije 2 dana

otvori dan ◀ ▶ 1 događaj
Odluka Europske komisije EU Aumseqa
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
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21. 9. 2026.ponedjeljak, 21. rujna 2026. · prije 6 dana

otvori dan ◀ ▶ 3 događaja
Odluka Europske komisije EU Wegovy
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
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Odluka Europske komisije EU Svariya
br. EU/1/25/1994 · odobreno 21. 11. 2025. · Rivaroxaban Koanaa 10 mg Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hi… · PGF Pharma International d.o.o. · Rivaroxaban · ATC B01AF01
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Odluka Europske komisije EU ELREXFIO
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
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18. 9. 2026.petak, 18. rujna 2026. · prije 9 dana

otvori dan ◀ ▶ 22 događaja
Novo odobrenje EU EU Susvimo
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
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Novo odobrenje EU EU LYROKAUL
br. EU/1/26/2061 · LYROKAUL is indicated in adults with primary hypercholesterolaemia (heterozygous familial (HeFH) and non-famil… · LIB Therapeutics B.V. · Lerodalcibep · ATC C10AX19
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Odluka Europske komisije EU Yesafili
br. EU/1/23/1751 · odobreno 15. 9. 2023. · Yesafili is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (… · Biosimilar Collaborations Ireland Limited · aflibercept · ATC S01LA05
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Odluka Europske komisije EU Tevimbra
br. EU/1/23/1758 · odobreno 15. 9. 2023. · Non-small cell lung cancer (NSCLC) Tevimbra, in combination with platinum-containing chemotherapy as neoadj… · BeOne Medicines Ireland Limited · tislelizumab · ATC L01FF09
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Odluka Europske komisije EU TRIXEO AEROSPHERE
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
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Odluka Europske komisije EU Rivaroxaban Viatris
br. EU/1/21/1588 · odobreno 12. 11. 2021. · Rivaroxaban Viatris co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticl… · Viatris Limited · rivaroxaban · ATC B01AF01
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Odluka Europske komisije EU Riltrava Aerosphere
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
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Odluka Europske komisije EU Replagal
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
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Odluka Europske komisije EU RINVOQ
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
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Odluka Europske komisije EU Plavix
br. EU/1/98/069 · odobreno 15. 7. 1998. · Secondary prevention of atherothrombotic events Clopidogrel is indicated in: • Adult patients suffering fr… · Sanofi Winthrop Industrie · Clopidogrel · ATC B01AC04
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Odluka Europske komisije EU PAVBLU
br. EU/1/25/1909 · odobreno 4. 4. 2025. · Pavblu is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (AM… · Amgen Technology (Ireland) UC · Aflibercept · ATC S01LA05
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Odluka Europske komisije EU Otulfi
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
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Odluka Europske komisije EU Opuviz
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
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Odluka Europske komisije EU Mylotarg
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
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Odluka Europske komisije EU Lunsumio
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
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Odluka Europske komisije EU Litfulo
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
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Odluka Europske komisije EU Idacio
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
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Odluka Europske komisije EU FABHALTA
br. EU/1/24/1802 · odobreno 17. 5. 2024. · Paroxysmal nocturnal haemoglobinuria FABHALTA is indicated as monotherapy in the treatment of adult patients … · Novartis Europharm Limited · iptacopan · ATC L04AJ08
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Odluka Europske komisije EU Eylea
br. EU/1/12/797 · odobreno 22. 11. 2012. · Eylea 40 mg/mL : Eylea is indicated for adults for the treatment of • neovascular (wet) age-related macul… · Bayer AG · aflibercept · ATC S01LA05
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Odluka Europske komisije EU Eiyzey
br. EU/1/25/1963 · odobreno 14. 8. 2025. · Eiyzey is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (AMD… · Zakłady Farmaceutyczne POLPHARMA S.A. · aflibercept · ATC S01LA05
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Odluka Europske komisije EU BLINCYTO
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
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Odluka Europske komisije EU Ahzantive
br. EU/1/24/1888 · odobreno 13. 1. 2025. · Ahzantive is indicated for adults for the treatment of: • neovascular (wet) age-related macular degeneration … · Formycon AG · Aflibercept · ATC S01LA05
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14. 9. 2026.ponedjeljak, 14. rujna 2026. · prije 13 dana

otvori dan ◀ ▶ 2 događaja
Odluka Europske komisije EU Steqeyma
br. EU/1/24/1844 · odobreno 22. 8. 2024. · 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
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Odluka Europske komisije EU Firazyr
br. EU/1/08/461 · odobreno 11. 7. 2008. · Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adol… · Takeda Pharmaceuticals International AG Ireland Branch · icatibant · ATC B06AC02
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