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EPAR a stanoviska

Evropské veřejné hodnotící zprávy (EPAR) a stanoviska CHMP.

Human medicines European public assessment report (EPAR): Palsonify, paltusotine, Date of authorisation: 23/04/2026, Revision: 1, Status: Authorised

EMA · Palsonify · 15. 6. 2026

Human medicines European public assessment report (EPAR): Palsonify, paltusotine, Date of authorisation: 23/04/2026, Revision: 1, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Opzelura, ruxolitinib, Date of authorisation: 19/04/2023, Revision: 6, Status: Authorised

EMA · Opzelura · 15. 6. 2026

Human medicines European public assessment report (EPAR): Opzelura, ruxolitinib, Date of authorisation: 19/04/2023, Revision: 6, Status: Authorised Zdroj: EMA

Schváleno

EMA authorises Rezzayo (rezafungin)

EMA · Rezzayo · 15. 6. 2026

The European Medicines Agency (EMA) has granted marketing authorization for Rezzayo, a novel antifungal agent rezafungin, effective from 22 December 2023.

Schváleno

Human medicines European public assessment report (EPAR): Entyvio, vedolizumab

EMA · Entyvio · 15. 6. 2026

Entyvio (vedolizumab) is a medicine used to treat adults with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) who have had an inadequate response or lost response to at least one prior biologic therapy.

Schváleno

Lenalidomide Mylan

EMA · 12. 6. 2026

Human medicines European public assessment report (EPAR): Lenalidomide Mylan, lenalidomide, Date of authorisation: 18/12/2020, Revision: 14, Status: Authorised

Schváleno

Sugammadex Mylan

EMA · 12. 6. 2026

Human medicines European public assessment report (EPAR): Sugammadex Mylan, sugammadex, Date of authorisation: 15/11/2021, Revision: 7, Status: Authorised

Novinka

Lonquex : EPAR - Public assessment report

EMA · 12. 6. 2026

Lonquex is an antiviral medicine used to treat adults with hepatitis C genotype 1 infection. Lonquex is used in combination with other medicines, such as ribavirin and peginterferon alfa, to treat hepatitis C infection.

Schváleno

Byannli

EMA · 10. 6. 2026

Human medicines European public assessment report (EPAR): Byannli (previously Paliperidone Janssen-Cilag International), paliperidone, Date of authorisation: 18/06/2020, Revision: 5, Status: Authorised

Schváleno

Oczyesa

EMA · Oczyesa · 10. 6. 2026

Human medicines European public assessment report (EPAR): Oczyesa, octreotide, Date of authorisation: 30/06/2025, Revision: 2, Status: Authorised

Schváleno

Vargatef

EMA · Vargatef · 10. 6. 2026

Lék Vargatef (nintedanib) je určen pro léčbu dospělých pacientů s idiopatickou plicní fibrózou.

Schváleno

Crysvita

EMA · Crysvita · 10. 6. 2026

Human medicines European public assessment report (EPAR): Crysvita, burosumab, Date of authorisation: 19/02/2018, Revision: 18, Status: Authorised

Novinka

Human medicines European public assessment report (EPAR): Liraglutide STADA

EMA · 22. 5. 2026

Liraglutide STADA is a medicine used to treat adults with type 2 diabetes. It contains the active substance liraglutide.

Novinka

Human medicines European public assessment report (EPAR): Colchicine Agepha Pharma

EMA · 22. 5. 2026

Human medicines European public assessment report (EPAR): Colchicine Agepha Pharma, colchicine, Status: Opinion

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