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Promjene na tržištu lijekova u Hrvatskoj

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 serija2 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.

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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16. 10. 2026.petak, 16. listopada 2026.

otvori dan ◀ ▶ 16 događaja
Odobrenje se ukida temeljem poslovne odluke nositelja odobrenja. · HR-H-883715895 · AS Kalceks · midazolamklorid
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Odluka Europske komisije EU Tygacil
br. EU/1/06/336 · odobreno 24. 4. 2006. · Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following … · Pfizer Europe MA EEIG · Tigecycline · ATC J01AA12
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Odluka Europske komisije EU Pradaxa
br. EU/1/08/442 · odobreno 18. 3. 2008. · Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total h… · Boehringer Ingelheim International GmbH · dabigatran etexilate mesilate · ATC B01AE07
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Odluka Europske komisije EU Celsentri
br. EU/1/07/418 · odobreno 18. 9. 2007. · CELSENTRI, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced… · ViiV Healthcare BV · maraviroc · ATC J05AX09
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Odluka Europske komisije EU Zutectra
br. EU/1/09/600 · odobreno 30. 11. 2009. · Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one w… · Biotest Pharma GmbH · Human Hepatitis B Immunoglobulin · ATC J06BB04
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Odluka Europske komisije EU WAYRILZ
br. EU/1/25/1974 · odobreno 22. 12. 2025. · WAYRILZ is indicated for the treatment of immune thrombocytopenia (ITP) in adult patients who are refractory t… · Sanofi B.V. · rilzabrutinib · ATC Pending
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Odluka Europske komisije EU Vydura
br. EU/1/22/1645 · odobreno 25. 4. 2022. · Vydura is indicated for the • Acute treatment of migraine with or without aura in adults; • Preventive trea… · Pfizer Europe MA EEIG · rimegepant · ATC N02CD
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Odluka Europske komisije EU Vocabria
br. EU/1/20/1481 · odobreno 17. 12. 2020. · Vocabria injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunod… · ViiV Healthcare BV · cabotegravir · ATC J05AJ04
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Odluka Europske komisije EU Reblozyl
br. EU/1/20/1452 · odobreno 25. 6. 2020. · Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and in… · Bristol-Myers Squibb Pharma EEIG · luspatercept · ATC B03XA06
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Odluka Europske komisije EU Qarziba
br. EU/1/17/1191 · odobreno 8. 5. 2017. · Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who ha… · Recordati Netherlands B.V. · dinutuximab beta · ATC L01FX06
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Odluka Europske komisije EU KEYTRUDA
br. EU/1/15/1024 · odobreno 17. 7. 2015. · Melanoma KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and o… · Merck Sharp & Dohme B.V. · pembrolizumab · ATC L01FF02
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Odluka Europske komisije EU GHRYVELIN
br. EU/1/18/1337 · odobreno 11. 1. 2019. · This medicinal product is for diagnostic use only. GHRYVELIN is indicated for the diagnosis of growth hormone… · Atnahs Pharma Netherlands B.V. · macimorelin · ATC V04CD06
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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> Enhertu in combination with pertuzumab is indicate… · Daiichi Sankyo Europe GmbH · trastuzumab deruxtecan · ATC L01FD04
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Odluka Europske komisije EU Cerezyme
br. EU/1/97/053 · odobreno 17. 11. 1997. · Cerezyme (imiglucerase) is indicated for use as long-term enzyme replacement therapy in patients with a confir… · Sanofi B.V. · imiglucerase · ATC A16AB02
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Odluka Europske komisije EU Anzupgo
br. EU/1/24/1851 · odobreno 19. 9. 2024. · Anzupgo is indicated for the treatment of moderate to severe chronic hand eczema (CHE) in adults and adolescen… · LEO Pharma A/S · delgocitinib · ATC D11AH11
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Odluka Europske komisije EU AYVAKYT
br. EU/1/20/1473 · odobreno 24. 9. 2020. · Unresectable or metastatic gastrointestinal stromal tumour (GIST) AYVAKYT is indicated as monotherapy for the… · Blueprint Medicines (Netherlands) B.V. · avapritinib · ATC L01EX18
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15. 10. 2026.četvrtak, 15. listopada 2026.

otvori dan ◀ ▶ 6 događaja
Odluka Europske komisije EU Padcev
br. EU/1/21/1615 · odobreno 13. 4. 2022. · <u>Muscle invasive bladder cancer (MIBC)</u> Padcev, in combination with pembrolizumab, as neoadjuvant trea… · Astellas Pharma Europe B.V. · enfortumab vedotin · ATC L01FX13
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Odluka Europske komisije EU Ocrevus
br. EU/1/17/1231 · odobreno 8. 1. 2018. · Ocrevus is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with … · Roche Registration GmbH · ocrelizumab · ATC L04AG08
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Odluka Europske komisije EU JEVTANA
br. EU/1/11/676 · odobreno 17. 3. 2011. · JEVTANA in combination with prednisone or prednisolone is indicated for the treatment of adult patients with m… · Sanofi Winthrop Industrie · cabazitaxel · ATC L01CD04
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Odluka Europske komisije EU Idefirix
br. EU/1/20/1471 · odobreno 25. 8. 2020. · Idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with… · SERB S.A. · imlifidase · ATC L04AA
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Odluka Europske komisije EU IMULDOSA
br. EU/1/24/1872 · odobreno 12. 12. 2024. · Adult Crohn’s disease IMULDOSA is indicated for the treatment of adult patients with moderately to severely … · Accord Healthcare S.L.U. · ustekinumab · ATC L04AC05
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Odluka Europske komisije EU Apretude
br. EU/1/23/1760 · odobreno 15. 9. 2023. · Apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce th… · ViiV Healthcare BV · cabotegravir · ATC J05AJ04
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14. 10. 2026.srijeda, 14. listopada 2026.

otvori dan ◀ ▶ 2 događaja · 2 važnih
do razine ljekarne
Serije: 001A01K, E003B01K
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moguće pojave stranih čestica
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12. 10. 2026.ponedjeljak, 12. listopada 2026.

otvori dan ◀ ▶ 2 događaja
Odluka Europske komisije EU Vgenfli
br. EU/1/25/1961 · odobreno 14. 8. 2025. · Vgenfli is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (AM… · Zakłady Farmaceutyczne POLPHARMA S.A. · aflibercept · ATC S01LA05
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Odluka Europske komisije EU Ozempic
br. EU/1/17/1251 · odobreno 8. 2. 2018. · Ozempic is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an… · Novo Nordisk A/S · semaglutide · ATC A10BJ06
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Ukupno 972 događaja.