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.
Nositelj odobrenja Baxter Holding B.V. je u suradnji s Agencijom za lijekove i medicinske proizvode (HALMED) i Europskom agencijom za lijekove (EMA) uputio pismo zdravstvenim radnicima o dodatnim mjer…
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
Lekoskop