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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 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.

otvori sve danezatvori sve dane

25. 9. 2026.petak, 25. rujna 2026.

otvori dan ◀ ▶ 14 događaja · 1 važnih
Ukinuto u EU 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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Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Novo odobrenje EU EU Cavoley
br. EU/1/26/2066 · Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated wi… · CuraTeQ Biologics s.r.o · Pegfilgrastim · ATC L03AA13
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Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Vizamyl
br. EU/1/14/941 · odobreno 22. 8. 2014. · This medicinal product is for diagnostic use only. VIZAMYL is a radiopharmaceutical indicated for Positron Em… · GE Healthcare AS · flutemetamol (18F) · ATC V09AX04
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Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Vaxelis
br. EU/1/15/1079 · odobreno 15. 2. 2016. · Vaxelis (DTaP-HB-IPV-Hib) is indicated for primary and booster vaccination in infants and toddlers from the ag… · MCM Vaccine B.V. · Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) · ATC J07CA09
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Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Sialanar
br. EU/1/16/1135 · odobreno 15. 9. 2016. · Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3… · Proveca Pharma Limited · glycopyrronium bromide · ATC A03AB02
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Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU RIULVY
br. EU/1/25/1947 · odobreno 28. 7. 2025. · RIULVY is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing … · Neuraxpharm Pharmaceuticals, S.L. · Tegomil fumarate · ATC L04AX10
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Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Champix
br. EU/1/06/360 · odobreno 26. 9. 2006. · indicated for smoking cessation in adults · Pfizer Europe MA EEIG · varenicline tartrate · ATC N07BA03
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Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Briumvi
br. EU/1/23/1730 · odobreno 31. 5. 2023. · Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with… · Neuraxpharm Pharmaceuticals, S.L. · ublituximab · ATC L04AG14
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Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Usymro
br. EU/1/25/1957 · odobreno 14. 8. 2025. · Adult Crohn’s Disease Usymro is indicated for the treatment of adult patients with moderately to severely ac… · Gedeon Richter Plc. · ustekinumab · ATC L04AC05
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Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Ozurdex
br. EU/1/10/638 · odobreno 27. 7. 2010. · OZURDEX is indicated for the treatment of adult patients with: • Visual impairment due to diabetic macular oe… · AbbVie Deutschland GmbH & Co. KG · dexamethasone · ATC S01BA01
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Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Lacosamide Adroiq
br. EU/1/23/1732 · odobreno 31. 5. 2023. · Lacosamide Adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secon… · Extrovis EU Kft. · lacosamide · ATC N03AX18
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Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Imlygic
br. EU/1/15/1064 · odobreno 16. 12. 2015. · Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly me… · Amgen Europe B.V. · talimogene laherparepvec · ATC L01XL02
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Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Humira
br. EU/1/03/256 · odobreno 8. 9. 2003. · Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Humira in combination with met… · AbbVie Deutschland GmbH & Co. KG · Adalimumab · ATC L04AB04
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
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
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije

21. 9. 2026.ponedjeljak, 21. rujna 2026.

otvori dan ◀ ▶ 9 događaja · 2 važnih
Povučeno u EU EU Xyrem
br. EU/1/05/312 · odobreno 13. 10. 2005. · Treatment of narcolepsy with cataplexy in adult patients, adolescents and children from the age of 7 years. · UCB Pharma S.A. · Sodium oxybate · ATC N07XX04
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Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Povučeno u EU EU Ibandronic Acid Teva
br. EU/1/10/642 · odobreno 17. 9. 2010. · Ibandronic Acid Teva is indicated in adults for the prevention of skeletal events (pathological fractures, bon… · Teva B.V. · Ibandronic acid · ATC M05BA06
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Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Novo odobrenje EU EU Nezglyal
br. EU/1/26/2060 · Nezglyal is indicated for the treatment of Cerebral Adrenoleukodystrophy (cALD) in males with Adrenoleukodystr… · Minoryx Therapeutics S.L. · leriglitazone · ATC A16AX23
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Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Daptomycin Hospira
br. EU/1/17/1175 · odobreno 22. 3. 2017. · Daptomycin is indicated for the treatment of the following infections (see sections 4.4 and 5.1). - Adult an… · Pfizer Europe MA EEIG · daptomycin · ATC J01XX09
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Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
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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Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Cejemly
br. EU/1/24/1833 · odobreno 25. 7. 2024. · Cejemly in combination with platinum-based chemotherapy is indicated for the first line treatment of adults wi… · CStone Pharmaceuticals Ireland Limited · sugemalimab · ATC L01FF11
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Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
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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Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
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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Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
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
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije

18. 9. 2026.petak, 18. rujna 2026.

otvori dan ◀ ▶ 44 događaja · 2 važnih
Povučeno u EU 2
Povučeno u EU EU Hirobriz Breezhaler
br. EU/1/09/594 · odobreno 30. 11. 2009. · Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult pati… · Novartis Europharm Limited · indacaterol · ATC R03AC18
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Povučeno u EU EU Oslif Breezhaler
br. EU/1/09/586 · odobreno 30. 11. 2009. · Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patient… · Novartis Europharm Limited · indacaterol · ATC R03AC18
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Ponovno važeće u EU EU Oslif Breezhaler
br. EU/1/09/586 · odobreno 30. 11. 2009. · Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patient… · Novartis Europharm Limited · indacaterol · ATC R03AC18
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Novo odobrenje EU EU ICOTYDE
br. EU/1/26/2063 · ICOTYDE is indicated for the treatment of moderate to severe plaque psoriasis in adults, and adolescents 12 ye… · Janssen-Cilag International N.V. · icotrokinra hydrochloride
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
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
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
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
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Rapiscan
br. EU/1/10/643 · odobreno 6. 9. 2010. · This medicinal product is for diagnostic use only. Rapiscan is a selective coronary vasodilator for use in … · GE Healthcare AS · regadenoson · ATC C01EB21
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Eydenzelt
br. EU/1/24/1895 · odobreno 12. 2. 2025. · Eydenzelt is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (… · Celltrion Healthcare Hungary Kft. · Aflibercept · ATC S01LA05
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Novo odobrenje EU 3
Povučeno u EU EU Hirobriz Breezhaler
br. EU/1/09/594 · odobreno 30. 11. 2009. · Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult pati… · Novartis Europharm Limited · indacaterol · ATC R03AC18
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Povučeno u EU EU Oslif Breezhaler
br. EU/1/09/586 · odobreno 30. 11. 2009. · Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patient… · Novartis Europharm Limited · indacaterol · ATC R03AC18
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Ponovno važeće u EU EU Oslif Breezhaler
br. EU/1/09/586 · odobreno 30. 11. 2009. · Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patient… · Novartis Europharm Limited · indacaterol · ATC R03AC18
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Novo odobrenje EU EU ICOTYDE
br. EU/1/26/2063 · ICOTYDE is indicated for the treatment of moderate to severe plaque psoriasis in adults, and adolescents 12 ye… · Janssen-Cilag International N.V. · icotrokinra hydrochloride
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
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
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
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
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Rapiscan
br. EU/1/10/643 · odobreno 6. 9. 2010. · This medicinal product is for diagnostic use only. Rapiscan is a selective coronary vasodilator for use in … · GE Healthcare AS · regadenoson · ATC C01EB21
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Eydenzelt
br. EU/1/24/1895 · odobreno 12. 2. 2025. · Eydenzelt is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (… · Celltrion Healthcare Hungary Kft. · Aflibercept · ATC S01LA05
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Ponovno važeće u EU 1
Povučeno u EU EU Hirobriz Breezhaler
br. EU/1/09/594 · odobreno 30. 11. 2009. · Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult pati… · Novartis Europharm Limited · indacaterol · ATC R03AC18
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Povučeno u EU EU Oslif Breezhaler
br. EU/1/09/586 · odobreno 30. 11. 2009. · Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patient… · Novartis Europharm Limited · indacaterol · ATC R03AC18
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Ponovno važeće u EU EU Oslif Breezhaler
br. EU/1/09/586 · odobreno 30. 11. 2009. · Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patient… · Novartis Europharm Limited · indacaterol · ATC R03AC18
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Novo odobrenje EU EU ICOTYDE
br. EU/1/26/2063 · ICOTYDE is indicated for the treatment of moderate to severe plaque psoriasis in adults, and adolescents 12 ye… · Janssen-Cilag International N.V. · icotrokinra hydrochloride
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
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
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
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
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Rapiscan
br. EU/1/10/643 · odobreno 6. 9. 2010. · This medicinal product is for diagnostic use only. Rapiscan is a selective coronary vasodilator for use in … · GE Healthcare AS · regadenoson · ATC C01EB21
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Eydenzelt
br. EU/1/24/1895 · odobreno 12. 2. 2025. · Eydenzelt is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (… · Celltrion Healthcare Hungary Kft. · Aflibercept · ATC S01LA05
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije 38
Povučeno u EU EU Hirobriz Breezhaler
br. EU/1/09/594 · odobreno 30. 11. 2009. · Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult pati… · Novartis Europharm Limited · indacaterol · ATC R03AC18
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Povučeno u EU EU Oslif Breezhaler
br. EU/1/09/586 · odobreno 30. 11. 2009. · Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patient… · Novartis Europharm Limited · indacaterol · ATC R03AC18
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Ponovno važeće u EU EU Oslif Breezhaler
br. EU/1/09/586 · odobreno 30. 11. 2009. · Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patient… · Novartis Europharm Limited · indacaterol · ATC R03AC18
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Novo odobrenje EU EU ICOTYDE
br. EU/1/26/2063 · ICOTYDE is indicated for the treatment of moderate to severe plaque psoriasis in adults, and adolescents 12 ye… · Janssen-Cilag International N.V. · icotrokinra hydrochloride
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
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
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
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
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Rapiscan
br. EU/1/10/643 · odobreno 6. 9. 2010. · This medicinal product is for diagnostic use only. Rapiscan is a selective coronary vasodilator for use in … · GE Healthcare AS · regadenoson · ATC C01EB21
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
Odluka Europske komisije EU Eydenzelt
br. EU/1/24/1895 · odobreno 12. 2. 2025. · Eydenzelt is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (… · Celltrion Healthcare Hungary Kft. · Aflibercept · ATC S01LA05
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
sve: Odluka Europske komisije (38) →

17. 9. 2026.četvrtak, 17. rujna 2026.

otvori dan ◀ ▶ 1 događaj
Odluka Europske komisije EU Afqlir
br. EU/1/24/1867 · odobreno 14. 11. 2024. · Afqlir is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (AM… · Sandoz GmbH · aflibercept · ATC S01LA05
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije

14. 9. 2026.ponedjeljak, 14. rujna 2026.

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
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
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
Što to znači, detalji

Učitavanje…

Stranica lijeka na EMA-i ↗ Europska komisija — registar Unije
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