Ukinuta odobrenja, povlačenje serija lijekova, pisma zdravstvenim radnicima i novi lijekovi EU — svakodnevno, automatski. Zadnje ažuriranje: 11. 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/1/00/156 · 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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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