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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: 13. 11. 2026. 08:55

Sve Ukinuta odobrenja8 Povlačenje serija Novi lijekovi (EU) Sigurnost (DHPC)1 Europska unija39

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.

23. 10. 2026.petak, 23. listopada 2026.

otvori dan ◀ ▶ 7 događaja · 1 važnih
Povučeno u EU EU Trizivir
br. EU/1/00/156 · odobreno 28. 12. 2000. · Trizivir is indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in adults (see section… · ViiV Healthcare BV · abacavir, lamivudine, zidovudine · ATC J05AR02
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Odluka Europske komisije EU Zynlonta
br. EU/1/22/1695 · odobreno 20. 12. 2022. · Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse l… · Swedish Orphan Biovitrum AB (publ) · loncastuximab tesirine · ATC L01FX22
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Odluka Europske komisije EU Pyzchiva
br. EU/1/24/1801 · odobreno 19. 4. 2024. · 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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Odluka Europske komisije EU Juluca
br. EU/1/18/1282 · odobreno 16. 5. 2018. · Juluca is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who a… · ViiV Healthcare B.V. · dolutegravir / rilpivirine · ATC J05AR21
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Odluka Europske komisije EU Entacapone Orion
br. EU/1/11/708 · odobreno 18. 8. 2011. · Entacapone is indicated as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa f… · Orion Corporation · entacapone · ATC N04BX02
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Odluka Europske komisije EU Enhertu
br. EU/1/20/1508 · odobreno 18. 1. 2021. · <u>Breast cancer</u> <i>HER2-positive breast cancer</i> <u>Early breast cancer</u> Enhertu as monothera… · Daiichi Sankyo Europe GmbH · trastuzumab deruxtecan · ATC L01FD04
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Odluka Europske komisije EU Besremi
br. EU/1/18/1352 · odobreno 15. 2. 2019. · Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic sple… · AOP Orphan Pharmaceuticals GmbH · ropeginterferon alfa-2b · ATC L03AB15
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22. 10. 2026.četvrtak, 22. listopada 2026.

otvori dan ◀ ▶ 7 događaja
Odluka Europske komisije EU Voriconazole Hikma
br. EU/1/15/1004 · odobreno 27. 5. 2015. · Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 yea… · Hikma Farmacêutica (Portugal), S.A. · voriconazole · ATC J02AC03
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Odluka Europske komisije EU TECVAYLI
br. EU/1/22/1675 · odobreno 23. 8. 2022. · TECVAYLI is indicated • in combination with daratumumab for the treatment of adult patients with relapsed or… · Janssen-Cilag International NV · teclistamab · ATC L01F
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Odluka Europske komisije EU Plegridy
br. EU/1/14/934 · odobreno 18. 7. 2014. · Plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis · Biogen Netherlands B.V. · peginterferon beta-1a · ATC L03AB13
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Odluka Europske komisije EU Comtess
br. EU/1/98/082 · odobreno 16. 9. 1998. · Entacapone is indicated as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa f… · Orion Corporation · entacapone · ATC N04BX02
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Odluka Europske komisije EU YERVOY
br. EU/1/11/698 · odobreno 13. 7. 2011. · Melanoma YERVOY as monotherapy or in combination with nivolumab is indicated for the treatment of advanced … · Bristol-Myers Squibb Pharma EEIG · ipilimumab · ATC L01FX04
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Odluka Europske komisije EU Brukinsa
br. EU/1/21/1576 · odobreno 22. 11. 2021. · BRUKINSA as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia… · BeOne Medicines Netherlands B.V. · zanubrutinib · ATC L01EL03
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Odluka Europske komisije EU Abiraterone Mylan
br. EU/1/21/1571 · odobreno 20. 8. 2021. · Abiraterone Mylan is indicated with prednisone or prednisolone for: • the treatment of newly diagnosed meta… · Mylan Pharmaceuticals Limited · abiraterone acetate · ATC L02BX03
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19. 10. 2026.ponedjeljak, 19. listopada 2026.

otvori dan ◀ ▶ 4 događaja
Odluka Europske komisije EU Glivec
br. EU/1/01/198 · odobreno 27. 8. 2001. · Glivec is indicated for the treatment of - adult and paediatric patients with newly diagnosed Philadelphia ch… · Novartis Europharm Limited · Imatinib · ATC L01EA01
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Odluka Europske komisije EU Bemrist Breezhaler
br. EU/1/20/1441 · odobreno 30. 5. 2020. · Bemrist Breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age… · Novartis Europharm Limited · indacaterol / mometasone furoate · ATC R03AK
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Odluka Europske komisije EU Hyrimoz
br. EU/1/18/1286 · odobreno 26. 7. 2018. · <u>Rheumatoid arthritis</u> Hyrimoz in combination with methotrexate, is indicated for: • the treatment … · Sandoz GmbH · adalimumab · ATC L04AB04
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Odluka Europske komisije EU Cosentyx
br. EU/1/14/980 · odobreno 15. 1. 2015. · Adult plaque psoriasis Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adul… · Novartis Europharm Limited · secukinumab · ATC L04AC10
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