EMA

medscopeglobal.com · EMA · EPAR

EPAR a stanoviska

Evropské veřejné hodnotící zprávy (EPAR) a stanoviska CHMP.

Schváleno

Kaftrio, ivacaftor, tezacaftor, elexacaftor

EMA · Kaftrio · 31. 7. 2026

European public assessment report (EPAR) for Kaftrio, a medicine containing the active substances ivacaftor, tezacaftor and elexacaftor. It is used to treat cystic fibrosis in patients aged 12 years and older who have at least one F508del mutation in their CFTR gene.

Schváleno

Multaq (dronedarone) - European Public Assessment Report

EMA · Multaq · 31. 7. 2026

This document is a European Public Assessment Report (EPAR) for the medicine Multaq, containing the active substance dronedarone. It details the date of authorisation as 25/11/2009, with a revision number of 23. The status of the medicine is listed as Authorised.

Schváleno

Aspaveli (pegcetacoplan) authorised by EMA

EMA · Aspaveli · 31. 7. 2026

Human medicines European public assessment report (EPAR): Aspaveli, pegcetacoplan, Date of authorisation: 13/12/2021, Revision: 14, Status: Authorised

Schváleno

Iclusig (ponatinib) - European Medicines Agency

EMA · Iclusig · 31. 7. 2026

Iclusig is a medicine used to treat adults with chronic myeloid leukaemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL). It is used when other treatments have not worked or are no longer effective. Iclusig works by blocking the activity of certain proteins that are involved in the growth of cancer cells.

Schváleno

Qoyvolma (ustekinumab) - EMA

EMA · Qoyvolma · 31. 7. 2026

European public assessment report (EPAR) for Qoyvolma, containing information about the medicine ustekinumab. The status of this medicine is listed as Withdrawn.

Schváleno

Xofigo (radium Ra223 dichloride)

EMA · Xofigo · 30. 7. 2026

Human medicines European public assessment report (EPAR): Xofigo, radium Ra223 dichloride, Date of authorisation: 13/11/2013, Revision: 17, Status: Authorised

Schváleno

Gilenya (fingolimod) - European public assessment report

EMA · Gilenya · 30. 7. 2026

Human medicines European public assessment report (EPAR): Gilenya, fingolimod, Date of authorisation: 17/03/2011, Revision: 42, Status: Authorised

Schváleno

Sylvant (siltuximab) authorised by EMA

EMA · Sylvant · 30. 7. 2026

Sylvant (siltuximab) has been authorised by the European Medicines Agency (EMA) on 22/05/2014. This is a revision of the European Public Assessment Report (EPAR).

Schváleno

Boey (trenibotulinumtoxinE) Authorised by EMA

EMA · Boey · 30. 7. 2026

The European Medicines Agency (EMA) has authorised Boey, a medicine containing trenibotulinumtoxinE. The authorisation date was 15/07/2026.

Schváleno

Jascayd (nerandomilast) authorised by EMA

EMA · Jascayd · 30. 7. 2026

The European Medicines Agency (EMA) has authorised Jascayd, a medicine containing the active substance nerandomilast. The authorisation date was 15/07/2026.

Schváleno

Mayzent (siponimod) authorised in the EU

EMA · Mayzent · 30. 7. 2026

Human medicines European public assessment report (EPAR): Mayzent, siponimod, Date of authorisation: 13/01/2020, Revision: 21, Status: Authorised

Schváleno

Human medicines European public assessment report (EPAR): Itvisma, onasemnogene abeparvovec, Date of authorisation: 30/06/2026, Status: Authorised

EMA · Itvisma · 28. 7. 2026

Human medicines European public assessment report (EPAR): Itvisma, onasemnogene abeparvovec, Date of authorisation: 30/06/2026, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Inflectra, infliximab, Date of authorisation: 10/09/2013, Revision: 35, Status: Withdrawn

EMA · Inflectra · 28. 7. 2026

Human medicines European public assessment report (EPAR): Inflectra, infliximab, Date of authorisation: 10/09/2013, Revision: 35, Status: Withdrawn Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Cerdelga, eliglustat, Date of authorisation: 19/01/2015, Revision: 22, Status: Authorised

EMA · Cerdelga · 27. 7. 2026

Human medicines European public assessment report (EPAR): Cerdelga, eliglustat, Date of authorisation: 19/01/2015, Revision: 22, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Macitentan Accord, macitentan, Date of authorisation: 24/09/2025, Revision: 1, Status: Authorised

EMA · 27. 7. 2026

Human medicines European public assessment report (EPAR): Macitentan Accord, macitentan, Date of authorisation: 24/09/2025, Revision: 1, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Macitentan AccordPharma, macitentan, Date of authorisation: 24/09/2025, Revision: 1, Status: Authorised

EMA · 27. 7. 2026

Human medicines European public assessment report (EPAR): Macitentan AccordPharma, macitentan, Date of authorisation: 24/09/2025, Revision: 1, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Apixaban Accord, apixaban, Date of authorisation: 23/07/2020, Revision: 8, Status: Authorised

EMA · 27. 7. 2026

Human medicines European public assessment report (EPAR): Apixaban Accord, apixaban, Date of authorisation: 23/07/2020, Revision: 8, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop), irbesartan, Date of authorisation: 19/01/2007, Revision: 33, Status: Authorised

EMA · 27. 7. 2026

Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop), irbesartan, Date of authorisation: 19/01/2007, Revision: 33, Status: Authorised Zdroj: EMA

Novinka

Human medicines European public assessment report (EPAR): Cavoley, pegfilgrastim, Status: Opinion

EMA · Cavoley · 24. 7. 2026

Human medicines European public assessment report (EPAR): Cavoley, pegfilgrastim, Status: Opinion Zdroj: EMA

Novinka

Human medicines European public assessment report (EPAR): Qezzaqar, catequentinib

EMA · Qezzaqar · 24. 7. 2026

Human medicines European public assessment report (EPAR): Qezzaqar, catequentinib, Status: Opinion

Novinka

Human medicines European public assessment report (EPAR): Susvimo, ranibizumab, Status: Opinion

EMA · Susvimo · 24. 7. 2026

Human medicines European public assessment report (EPAR): Susvimo, ranibizumab, Status: Opinion Zdroj: EMA

Novinka

Human medicines European public assessment report (EPAR): Ubeslo, obicetrapib, Status: Opinion

EMA · Ubeslo · 24. 7. 2026

Human medicines European public assessment report (EPAR): Ubeslo, obicetrapib, Status: Opinion Zdroj: EMA

Novinka

Human medicines European public assessment report (EPAR): Azacitidine Adienne, azacitidine, Status: Application withdrawn

EMA · 24. 7. 2026

Human medicines European public assessment report (EPAR): Azacitidine Adienne, azacitidine, Status: Application withdrawn Zdroj: EMA

Novinka

Human medicines European public assessment report (EPAR): Lynavoy, Linerixibat, Status: Opinion

EMA · 24. 7. 2026

Human medicines European public assessment report (EPAR): Lynavoy, Linerixibat, Status: Opinion Zdroj: EMA

Novinka

European public assessment report (EPAR): Zokovea, ensitrelvir

EMA · Zokovea · 24. 7. 2026

This product is a new medicine for the treatment of COVID-19. It is a protease inhibitor that works by blocking the virus's ability to replicate. The medicine is administered orally and is intended for use in adults with mild to moderate COVID-19 who are at risk of developing severe disease. The assessment is ongoing and the status is 'Opinion', indicating that the EMA has issued an opinion on the medicine's marketing authorization.

Novinka

Human medicines European public assessment report (EPAR): Lyrokaul, lerodalcibep, Status: Opinion

EMA · Lyrokaul · 24. 7. 2026

Human medicines European public assessment report (EPAR): Lyrokaul, lerodalcibep, Status: Opinion Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Comirnaty, COVID-19 mRNA vaccine, Date of authorisation: 21/12/2020, Revision: 62, Status: Authorised

EMA · 24. 7. 2026

Human medicines European public assessment report (EPAR): Comirnaty, COVID-19 mRNA vaccine, Date of authorisation: 21/12/2020, Revision: 62, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine, Date of authorisation: 06/01/2021, Revision: 61, Status: Authorised

EMA · 24. 7. 2026

Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine, Date of authorisation: 06/01/2021, Revision: 61, Status: Authorised Zdroj: EMA

Novinka

Human medicines European public assessment report (EPAR): Meplyffa, arimoclomol, Status: Opinion

EMA · Meplyffa · 24. 7. 2026

Human medicines European public assessment report (EPAR): Meplyffa, arimoclomol, Status: Opinion Zdroj: EMA

Novinka

Human medicines European public assessment report (EPAR): Nezglyal, leriglitazone, Status: Opinion

EMA · Nezglyal · 24. 7. 2026

Human medicines European public assessment report (EPAR): Nezglyal, leriglitazone, Status: Opinion Zdroj: EMA

Novinka

Summary of opinion: Trodelvy, 23/07/2026 Positive

EMA · 23. 7. 2026

Summary of opinion: Trodelvy, 23/07/2026 Positive Zdroj: EMA

Schváleno

European Medicines Agency (EMA) Authorises Ryjunea (atropine sulfate)

EMA · Ryjunea · 22. 7. 2026

Human medicines European public assessment report (EPAR): Ryjunea, atropine sulfate, Date of authorisation: 02/06/2025, Revision: 1, Status: Authorised

Novinka

Lumykras : EPAR - Risk management plan

EMA · 22. 7. 2026

The European Medicines Agency (EMA) has published a Risk Management Plan (RMP) for Lumykras. The RMP outlines the strategies to identify, characterize, and minimize potential risks associated with the use of the drug. It includes information on the drug's safety profile, monitoring procedures, and risk minimization measures.

Schváleno

Human medicines European public assessment report (EPAR): Padcev, enfortumab vedotin, Date of authorisation: 13/04/2022, Revision: 8, Status: Authorised

EMA · Padcev · 22. 7. 2026

Human medicines European public assessment report (EPAR): Padcev, enfortumab vedotin, Date of authorisation: 13/04/2022, Revision: 8, Status: Authorised Zdroj: EMA

Schváleno

Opdualag, relatlimab, nivolumab

EMA · Opdualag · 21. 7. 2026

European public assessment report (EPAR) for Opdualag, containing information on the active substances relatlimab and nivolumab. The drug was authorised on 15/09/2022.

Schváleno

Human medicines European public assessment report (EPAR): Flucelvax, influenza vaccine (surface antigen, inactivated, prepared in cell cultures), Date of authorisation: 15/11/2024, Revision: 4, Status: Authorised

EMA · Flucelvax · 17. 7. 2026

Human medicines European public assessment report (EPAR): Flucelvax, influenza vaccine (surface antigen, inactivated, prepared in cell cultures), Date of authorisation: 15/11/2024, Revision: 4, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Hukyndra, adalimumab, Date of authorisation: 15/11/2021, Revision: 12, Status: Authorised

EMA · Hukyndra · 17. 7. 2026

Human medicines European public assessment report (EPAR): Hukyndra, adalimumab, Date of authorisation: 15/11/2021, Revision: 12, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Inaqovi, cedazuridine,decitabine, Date of authorisation: 15/09/2023, Revision: 4, Status: Authorised

EMA · Inaqovi · 17. 7. 2026

Human medicines European public assessment report (EPAR): Inaqovi, cedazuridine,decitabine, Date of authorisation: 15/09/2023, Revision: 4, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Anzupgo, delgocitinib, Date of authorisation: 19/09/2024, Revision: 4, Status: Authorised

EMA · Anzupgo · 17. 7. 2026

Human medicines European public assessment report (EPAR): Anzupgo, delgocitinib, Date of authorisation: 19/09/2024, Revision: 4, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Zemcelpro, allogeneic umbilical cord-derived CD34- cells, non-expanded,dorocubicel, Date of authorisation: 25/08/2025, Revision: 3, Status: Authorised

EMA · Zemcelpro · 16. 7. 2026

Human medicines European public assessment report (EPAR): Zemcelpro, allogeneic umbilical cord-derived CD34- cells, non-expanded,dorocubicel, Date of authorisation: 25/08/2025, Revision: 3, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Trodelvy, sacituzumab govitecan, Date of authorisation: 22/11/2021, Revision: 6, Status: Authorised

EMA · Trodelvy · 16. 7. 2026

Human medicines European public assessment report (EPAR): Trodelvy, sacituzumab govitecan, Date of authorisation: 22/11/2021, Revision: 6, Status: Authorised Zdroj: EMA

Novinka

Human medicines European public assessment report (EPAR): Xervyteg, Allogeneic faecal microbiota, pooled, Status: Opinion

EMA · 16. 7. 2026

Human medicines European public assessment report (EPAR): Xervyteg, Allogeneic faecal microbiota, pooled, Status: Opinion Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Elocta, efmoroctocog alfa, Date of authorisation: 18/11/2015, Revision: 16, Status: Authorised

EMA · Elocta · 16. 7. 2026

Human medicines European public assessment report (EPAR): Elocta, efmoroctocog alfa, Date of authorisation: 18/11/2015, Revision: 16, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Vaxneuvance, pneumococcal polysaccharide conjugate vaccine (adsorbed), Date of authorisation: 13/12/2021, Revision: 9, Status: Authorised

EMA · Vaxneuvance · 16. 7. 2026

Human medicines European public assessment report (EPAR): Vaxneuvance, pneumococcal polysaccharide conjugate vaccine (adsorbed), Date of authorisation: 13/12/2021, Revision: 9, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Date of authorisation: 15/09/2016, Revision: 32, Status: Authorised

EMA · Inhixa · 16. 7. 2026

Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Date of authorisation: 15/09/2016, Revision: 32, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Maviret, glecaprevir,pibrentasvir, Date of authorisation: 26/07/2017, Revision: 24, Status: Authorised

EMA · Maviret · 15. 7. 2026

Human medicines European public assessment report (EPAR): Maviret, glecaprevir,pibrentasvir, Date of authorisation: 26/07/2017, Revision: 24, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Saphnelo, anifrolumab, Date of authorisation: 14/02/2022, Revision: 10, Status: Authorised

EMA · Saphnelo · 15. 7. 2026

Human medicines European public assessment report (EPAR): Saphnelo, anifrolumab, Date of authorisation: 14/02/2022, Revision: 10, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Erbitux, cetuximab, Date of authorisation: 29/06/2004, Revision: 36, Status: Authorised

EMA · Erbitux · 15. 7. 2026

Human medicines European public assessment report (EPAR): Erbitux, cetuximab, Date of authorisation: 29/06/2004, Revision: 36, Status: Authorised Zdroj: EMA

Novinka

Human medicines European public assessment report (EPAR): Yartemlea, Narsoplimab, Status: Opinion under re-examination

EMA · 15. 7. 2026

Human medicines European public assessment report (EPAR): Yartemlea, Narsoplimab, Status: Opinion under re-examination Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Veyvondi, vonicog alfa, Date of authorisation: 31/08/2018, Revision: 15, Status: Authorised

EMA · Veyvondi · 15. 7. 2026

Human medicines European public assessment report (EPAR): Veyvondi, vonicog alfa, Date of authorisation: 31/08/2018, Revision: 15, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Paxneury, guanfacine, Date of authorisation: 26/02/2025, Revision: 1, Status: Authorised

EMA · Paxneury · 15. 7. 2026

Human medicines European public assessment report (EPAR): Paxneury, guanfacine, Date of authorisation: 26/02/2025, Revision: 1, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Bilprevda, denosumab, Date of authorisation: 17/09/2025, Revision: 3, Status: Authorised

EMA · Bilprevda · 14. 7. 2026

Human medicines European public assessment report (EPAR): Bilprevda, denosumab, Date of authorisation: 17/09/2025, Revision: 3, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Qaialdo, spironolactone, Date of authorisation: 26/05/2023, Revision: 6, Status: Authorised

EMA · Qaialdo · 14. 7. 2026

Human medicines European public assessment report (EPAR): Qaialdo, spironolactone, Date of authorisation: 26/05/2023, Revision: 6, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Bildyos, denosumab, Date of authorisation: 17/09/2025, Revision: 4, Status: Authorised

EMA · Bildyos · 14. 7. 2026

Human medicines European public assessment report (EPAR): Bildyos, denosumab, Date of authorisation: 17/09/2025, Revision: 4, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Ekterly, sebetralstat, Date of authorisation: 17/09/2025, Revision: 1, Status: Authorised

EMA · Ekterly · 14. 7. 2026

Human medicines European public assessment report (EPAR): Ekterly, sebetralstat, Date of authorisation: 17/09/2025, Revision: 1, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Tuznue, trastuzumab, Date of authorisation: 19/09/2024, Revision: 4, Status: Authorised

EMA · Tuznue · 14. 7. 2026

Human medicines European public assessment report (EPAR): Tuznue, trastuzumab, Date of authorisation: 19/09/2024, Revision: 4, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Hemgenix, etranacogene dezaparvovec, Date of authorisation: 20/02/2023, Revision: 8, Status: Authorised

EMA · Hemgenix · 14. 7. 2026

Human medicines European public assessment report (EPAR): Hemgenix, etranacogene dezaparvovec, Date of authorisation: 20/02/2023, Revision: 8, Status: Authorised Zdroj: EMA

Schváleno

Veterinary medicines European public assessment report (EPAR): Poulvac Procerta HVT-ND, Marek’s disease and Newcastle disease vaccine (live recombinant), Status: Authorised

EMA · 14. 7. 2026

Veterinary medicines European public assessment report (EPAR): Poulvac Procerta HVT-ND, Marek’s disease and Newcastle disease vaccine (live recombinant), Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Abasaglar (previously Abasria), insulin glargine, Date of authorisation: 09/09/2014, Revision: 14, Status: Authorised

EMA · 13. 7. 2026

Human medicines European public assessment report (EPAR): Abasaglar (previously Abasria), insulin glargine, Date of authorisation: 09/09/2014, Revision: 14, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Humalog, insulin lispro, Date of authorisation: 30/04/1996, Revision: 37, Status: Authorised

EMA · Humalog · 13. 7. 2026

Human medicines European public assessment report (EPAR): Humalog, insulin lispro, Date of authorisation: 30/04/1996, Revision: 37, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Idacio, adalimumab, Date of authorisation: 02/04/2019, Revision: 15, Status: Authorised

EMA · Idacio · 13. 7. 2026

Human medicines European public assessment report (EPAR): Idacio, adalimumab, Date of authorisation: 02/04/2019, Revision: 15, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Libmyris, adalimumab, Date of authorisation: 12/11/2021, Revision: 10, Status: Authorised

EMA · Libmyris · 13. 7. 2026

Human medicines European public assessment report (EPAR): Libmyris, adalimumab, Date of authorisation: 12/11/2021, Revision: 10, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Kostaive, zapomeran, Date of authorisation: 12/02/2025, Revision: 5, Status: Authorised

EMA · Kostaive · 13. 7. 2026

Human medicines European public assessment report (EPAR): Kostaive, zapomeran, Date of authorisation: 12/02/2025, Revision: 5, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Hetronifly, serplulimab, Date of authorisation: 03/02/2025, Revision: 6, Status: Authorised

EMA · Hetronifly · 13. 7. 2026

Human medicines European public assessment report (EPAR): Hetronifly, serplulimab, Date of authorisation: 03/02/2025, Revision: 6, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Fendrix, hepatitis B (rDNA) vaccine (adjuvanted, adsorbed), Date of authorisation: 02/02/2005, Revision: 13, Status: Authorised

EMA · Fendrix · 10. 7. 2026

Human medicines European public assessment report (EPAR): Fendrix, hepatitis B (rDNA) vaccine (adjuvanted, adsorbed), Date of authorisation: 02/02/2005, Revision: 13, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Natpar, parathyroid hormone, Date of authorisation: 24/04/2017, Revision: 18, Status: Withdrawn

EMA · Natpar · 10. 7. 2026

Human medicines European public assessment report (EPAR): Natpar, parathyroid hormone, Date of authorisation: 24/04/2017, Revision: 18, Status: Withdrawn Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Venclyxto, venetoclax, Date of authorisation: 04/12/2016, Revision: 23, Status: Authorised

EMA · Venclyxto · 10. 7. 2026

Human medicines European public assessment report (EPAR): Venclyxto, venetoclax, Date of authorisation: 04/12/2016, Revision: 23, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Vaxchora, cholera vaccine, oral, live, Date of authorisation: 01/04/2020, Revision: 11, Status: Authorised

EMA · Vaxchora · 10. 7. 2026

Human medicines European public assessment report (EPAR): Vaxchora, cholera vaccine, oral, live, Date of authorisation: 01/04/2020, Revision: 11, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Neofordex, dexamethasone, Date of authorisation: 16/03/2016, Revision: 15, Status: Authorised

EMA · Neofordex · 10. 7. 2026

Human medicines European public assessment report (EPAR): Neofordex, dexamethasone, Date of authorisation: 16/03/2016, Revision: 15, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Esbriet, pirfenidone, Date of authorisation: 28/02/2011, Revision: 38, Status: Authorised

EMA · Esbriet · 10. 7. 2026

Human medicines European public assessment report (EPAR): Esbriet, pirfenidone, Date of authorisation: 28/02/2011, Revision: 38, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Ztalmy, ganaxolone, Date of authorisation: 26/07/2023, Revision: 8, Status: Authorised

EMA · Ztalmy · 9. 7. 2026

Human medicines European public assessment report (EPAR): Ztalmy, ganaxolone, Date of authorisation: 26/07/2023, Revision: 8, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Evenity, romosozumab, Date of authorisation: 09/12/2019, Revision: 9, Status: Authorised

EMA · Evenity · 9. 7. 2026

Human medicines European public assessment report (EPAR): Evenity, romosozumab, Date of authorisation: 09/12/2019, Revision: 9, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Ryzneuta, efbemalenograstim alfa, Date of authorisation: 21/03/2024, Revision: 5, Status: Authorised

EMA · Ryzneuta · 9. 7. 2026

Human medicines European public assessment report (EPAR): Ryzneuta, efbemalenograstim alfa, Date of authorisation: 21/03/2024, Revision: 5, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Cervarix, human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed), Date of authorisation: 20/09/2007, Revision: 43, Status: Authorised

EMA · Cervarix · 9. 7. 2026

Human medicines European public assessment report (EPAR): Cervarix, human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed), Date of authorisation: 20/09/2007, Revision: 43, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Adynovi, rurioctocog alfa pegol, Date of authorisation: 08/01/2018, Revision: 16, Status: Authorised

EMA · Adynovi · 9. 7. 2026

Human medicines European public assessment report (EPAR): Adynovi, rurioctocog alfa pegol, Date of authorisation: 08/01/2018, Revision: 16, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Zavesca, miglustat, Date of authorisation: 20/11/2002, Date of refusal: 16/06/2009, Revision: 36, Status: Authorised

EMA · Zavesca · 9. 7. 2026

Human medicines European public assessment report (EPAR): Zavesca, miglustat, Date of authorisation: 20/11/2002, Date of refusal: 16/06/2009, Revision: 36, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Tolura, telmisartan, Date of authorisation: 04/06/2010, Revision: 15, Status: Authorised

EMA · Tolura · 8. 7. 2026

Human medicines European public assessment report (EPAR): Tolura, telmisartan, Date of authorisation: 04/06/2010, Revision: 15, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Ebixa, memantine, Date of authorisation: 15/05/2002, Revision: 27, Status: Authorised

EMA · Ebixa · 8. 7. 2026

Human medicines European public assessment report (EPAR): Ebixa, memantine, Date of authorisation: 15/05/2002, Revision: 27, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Trazimera, trastuzumab, Date of authorisation: 26/07/2018, Revision: 17, Status: Authorised

EMA · Trazimera · 8. 7. 2026

Human medicines European public assessment report (EPAR): Trazimera, trastuzumab, Date of authorisation: 26/07/2018, Revision: 17, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Wyost, denosumab, Date of authorisation: 17/05/2024, Revision: 4, Status: Authorised

EMA · Wyost · 8. 7. 2026

Human medicines European public assessment report (EPAR): Wyost, denosumab, Date of authorisation: 17/05/2024, Revision: 4, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Mepsevii, vestronidase alfa, Date of authorisation: 23/08/2018, Revision: 9, Status: Authorised

EMA · Mepsevii · 8. 7. 2026

Human medicines European public assessment report (EPAR): Mepsevii, vestronidase alfa, Date of authorisation: 23/08/2018, Revision: 9, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Telmisartan Actavis, telmisartan, Date of authorisation: 29/09/2010, Revision: 16, Status: Authorised

EMA · 7. 7. 2026

Human medicines European public assessment report (EPAR): Telmisartan Actavis, telmisartan, Date of authorisation: 29/09/2010, Revision: 16, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Abevmy, bevacizumab, Date of authorisation: 21/04/2021, Revision: 14, Status: Authorised

EMA · Abevmy · 7. 7. 2026

Human medicines European public assessment report (EPAR): Abevmy, bevacizumab, Date of authorisation: 21/04/2021, Revision: 14, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Onpattro, patisiran, Date of authorisation: 27/08/2018, Revision: 15, Status: Authorised

EMA · Onpattro · 7. 7. 2026

Human medicines European public assessment report (EPAR): Onpattro, patisiran, Date of authorisation: 27/08/2018, Revision: 15, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Ixchiq, Chikungunya vaccine (live), Date of authorisation: 28/06/2024, Revision: 6, Status: Authorised

EMA · 7. 7. 2026

Human medicines European public assessment report (EPAR): Ixchiq, Chikungunya vaccine (live), Date of authorisation: 28/06/2024, Revision: 6, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Sarclisa, isatuximab, Date of authorisation: 30/05/2020, Revision: 15, Status: Authorised

EMA · Sarclisa · 7. 7. 2026

Human medicines European public assessment report (EPAR): Sarclisa, isatuximab, Date of authorisation: 30/05/2020, Revision: 15, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Fluenz, influenza vaccine (live attenuated, nasal), Date of authorisation: 03/06/2024, Revision: 6, Status: Authorised

EMA · Fluenz · 7. 7. 2026

Human medicines European public assessment report (EPAR): Fluenz, influenza vaccine (live attenuated, nasal), Date of authorisation: 03/06/2024, Revision: 6, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Alprolix, eftrenonacog alfa, Date of authorisation: 12/05/2016, Revision: 12, Status: Authorised

EMA · Alprolix · 6. 7. 2026

Human medicines European public assessment report (EPAR): Alprolix, eftrenonacog alfa, Date of authorisation: 12/05/2016, Revision: 12, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Enhertu, trastuzumab deruxtecan, Date of authorisation: 18/01/2021, Revision: 20, Status: Authorised

EMA · Enhertu · 6. 7. 2026

Human medicines European public assessment report (EPAR): Enhertu, trastuzumab deruxtecan, Date of authorisation: 18/01/2021, Revision: 20, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Tysabri, natalizumab, Date of authorisation: 27/06/2006, Revision: 53, Status: Authorised

EMA · Tysabri · 6. 7. 2026

Human medicines European public assessment report (EPAR): Tysabri, natalizumab, Date of authorisation: 27/06/2006, Revision: 53, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Altuvoct, efanesoctocog alfa, Date of authorisation: 17/06/2024, Revision: 3, Status: Authorised

EMA · Altuvoct · 6. 7. 2026

Human medicines European public assessment report (EPAR): Altuvoct, efanesoctocog alfa, Date of authorisation: 17/06/2024, Revision: 3, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Calquence, acalabrutinib, Date of authorisation: 05/11/2020, Revision: 12, Status: Authorised

EMA · Calquence · 6. 7. 2026

Human medicines European public assessment report (EPAR): Calquence, acalabrutinib, Date of authorisation: 05/11/2020, Revision: 12, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Pyzchiva, ustekinumab, Date of authorisation: 19/04/2024, Revision: 15, Status: Authorised

EMA · Pyzchiva · 3. 7. 2026

Human medicines European public assessment report (EPAR): Pyzchiva, ustekinumab, Date of authorisation: 19/04/2024, Revision: 15, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Cejemly, sugemalimab, Date of authorisation: 24/07/2024, Revision: 7, Status: Authorised

EMA · Cejemly · 3. 7. 2026

Human medicines European public assessment report (EPAR): Cejemly, sugemalimab, Date of authorisation: 24/07/2024, Revision: 7, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Opuviz, aflibercept, Date of authorisation: 13/11/2024, Revision: 4, Status: Authorised

EMA · Opuviz · 3. 7. 2026

Human medicines European public assessment report (EPAR): Opuviz, aflibercept, Date of authorisation: 13/11/2024, Revision: 4, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Retsevmo, selpercatinib, Date of authorisation: 11/02/2021, Revision: 21, Status: Authorised

EMA · Retsevmo · 3. 7. 2026

Human medicines European public assessment report (EPAR): Retsevmo, selpercatinib, Date of authorisation: 11/02/2021, Revision: 21, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Redemplo, plozasiran, Date of authorisation: 19/06/2026, Status: Authorised

EMA · Redemplo · 3. 7. 2026

Human medicines European public assessment report (EPAR): Redemplo, plozasiran, Date of authorisation: 19/06/2026, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Rexatilux, ranibizumab, Date of authorisation: 19/06/2026, Status: Authorised

EMA · Rexatilux · 3. 7. 2026

Human medicines European public assessment report (EPAR): Rexatilux, ranibizumab, Date of authorisation: 19/06/2026, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Lunsumio, mosunetuzumab, Date of authorisation: 03/06/2022, Revision: 8, Status: Authorised

EMA · Lunsumio · 2. 7. 2026

Human medicines European public assessment report (EPAR): Lunsumio, mosunetuzumab, Date of authorisation: 03/06/2022, Revision: 8, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Xofluza, baloxavir marboxil, Date of authorisation: 07/01/2021, Revision: 10, Status: Authorised

EMA · Xofluza · 2. 7. 2026

Human medicines European public assessment report (EPAR): Xofluza, baloxavir marboxil, Date of authorisation: 07/01/2021, Revision: 10, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Suliqua, insulin glargine,lixisenatide, Date of authorisation: 11/01/2017, Revision: 15, Status: Authorised

EMA · Suliqua · 2. 7. 2026

Human medicines European public assessment report (EPAR): Suliqua, insulin glargine,lixisenatide, Date of authorisation: 11/01/2017, Revision: 15, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Trimbow, beclometasone,formoterol,glycopyrronium bromide, Date of authorisation: 17/07/2017, Revision: 11, Status: Authorised

EMA · Trimbow · 2. 7. 2026

Human medicines European public assessment report (EPAR): Trimbow, beclometasone,formoterol,glycopyrronium bromide, Date of authorisation: 17/07/2017, Revision: 11, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Xtandi, enzalutamide, Date of authorisation: 21/06/2013, Date of refusal: 26/04/2013, Revision: 28, Status: Authorised

EMA · Xtandi · 2. 7. 2026

Human medicines European public assessment report (EPAR): Xtandi, enzalutamide, Date of authorisation: 21/06/2013, Date of refusal: 26/04/2013, Revision: 28, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Aquipta, atogepant, Date of authorisation: 11/08/2023, Revision: 6, Status: Authorised

EMA · Aquipta · 2. 7. 2026

Human medicines European public assessment report (EPAR): Aquipta, atogepant, Date of authorisation: 11/08/2023, Revision: 6, Status: Authorised Zdroj: EMA

Novinka

Human medicines European public assessment report (EPAR): Onswik, Insulin efsitora alfa, Status: Opinion

EMA · 26. 6. 2026

Human medicines European public assessment report (EPAR): Onswik, Insulin efsitora alfa, Status: Opinion Zdroj: EMA

Novinka

Human medicines European public assessment report (EPAR): Tacquell, Autologous melanoma-derived tumor infiltrating lymphocytes, ex vivo-expanded, Status: Opinion

EMA · 26. 6. 2026

Human medicines European public assessment report (EPAR): Tacquell, Autologous melanoma-derived tumor infiltrating lymphocytes, ex vivo-expanded, Status: Opinion Zdroj: EMA

Novinka

Human medicines European public assessment report (EPAR): Denosumab Ascend, denosumab, Status: Opinion

EMA · 26. 6. 2026

Human medicines European public assessment report (EPAR): Denosumab Ascend, denosumab, Status: Opinion Zdroj: EMA

Novinka

Human medicines European public assessment report (EPAR): Hopledo, levodopa,carbidopa, Status: Opinion

EMA · Hopledo · 26. 6. 2026

Human medicines European public assessment report (EPAR): Hopledo, levodopa,carbidopa, Status: Opinion Zdroj: EMA

Novinka

Human medicines European public assessment report (EPAR): Nylaspeg, pegfilgrastim, Status: Opinion

EMA · Nylaspeg · 26. 6. 2026

Human medicines European public assessment report (EPAR): Nylaspeg, pegfilgrastim, Status: Opinion Zdroj: EMA

Novinka

Human medicines European public assessment report (EPAR): Aujemflu, Influenza vaccine (surface antigen, inactivated, adjuvanted, prepared in cell culture), Status: Opinion

EMA · 26. 6. 2026

Human medicines European public assessment report (EPAR): Aujemflu, Influenza vaccine (surface antigen, inactivated, adjuvanted, prepared in cell culture), Status: Opinion Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Lynkuet, elinzanetant, Date of authorisation: 17/11/2025, Revision: 1, Status: Authorised

EMA · Lynkuet · 23. 6. 2026

Human medicines European public assessment report (EPAR): Lynkuet, elinzanetant, Date of authorisation: 17/11/2025, Revision: 1, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Balversa, erdafitinib, Date of authorisation: 22/08/2024, Revision: 4, Status: Authorised

EMA · Balversa · 23. 6. 2026

Human medicines European public assessment report (EPAR): Balversa, erdafitinib, Date of authorisation: 22/08/2024, Revision: 4, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Date of authorisation: 19/06/2015, Revision: 75, Status: Authorised

EMA · Opdivo · 23. 6. 2026

Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Date of authorisation: 19/06/2015, Revision: 75, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Qalsody, tofersen, Date of authorisation: 29/05/2024, Revision: 3, Status: Authorised

EMA · Qalsody · 23. 6. 2026

Human medicines European public assessment report (EPAR): Qalsody, tofersen, Date of authorisation: 29/05/2024, Revision: 3, Status: Authorised Zdroj: EMA

Schváleno

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

EMA · Evfraxy · 23. 6. 2026

Human medicines European public assessment report (EPAR): Evfraxy, denosumab, Date of authorisation: 30/06/2025, Revision: 2, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Hemangiol, propranolol, Date of authorisation: 23/04/2014, Revision: 8, Status: Authorised

EMA · Hemangiol · 23. 6. 2026

Human medicines European public assessment report (EPAR): Hemangiol, propranolol, Date of authorisation: 23/04/2014, Revision: 8, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Hexacima, diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed), Date of authorisation: 17/04/2013, Date of refusal: 22/02/2013, Revision: 35, Status: Authorised

EMA · Hexacima · 22. 6. 2026

Human medicines European public assessment report (EPAR): Hexacima, diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed), Date of authorisation: 17/04/2013, Date of refusal: 22/02/2013, Revision: 35, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Rinvoq, upadacitinib, Date of authorisation: 16/12/2019, Revision: 32, Status: Authorised

EMA · Rinvoq · 22. 6. 2026

Human medicines European public assessment report (EPAR): Rinvoq, upadacitinib, Date of authorisation: 16/12/2019, Revision: 32, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Tecentriq, atezolizumab, Date of authorisation: 20/09/2017, Revision: 38, Status: Authorised

EMA · Tecentriq · 22. 6. 2026

Human medicines European public assessment report (EPAR): Tecentriq, atezolizumab, Date of authorisation: 20/09/2017, Revision: 38, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Kuvan, sapropterin, Date of authorisation: 02/12/2008, Revision: 23, Status: Authorised

EMA · Kuvan · 22. 6. 2026

Human medicines European public assessment report (EPAR): Kuvan, sapropterin, Date of authorisation: 02/12/2008, Revision: 23, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Hexyon, diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed), Date of authorisation: 17/04/2013, Date of refusal: 22/02/2013, Revision: 36, Status: Authorised

EMA · Hexyon · 22. 6. 2026

Human medicines European public assessment report (EPAR): Hexyon, diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed), Date of authorisation: 17/04/2013, Date of refusal: 22/02/2013, Revision: 36, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Bimervax, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 30/03/2023, Revision: 14, Status: Authorised

EMA · 22. 6. 2026

Human medicines European public assessment report (EPAR): Bimervax, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 30/03/2023, Revision: 14, Status: Authorised Zdroj: EMA

Novinka

Veterinary medicines European public assessment report (EPAR): Nobivac NXT FeLV, feline leukemia (RNA particle) vaccine, Status: Opinion

EMA · 19. 6. 2026

Veterinary medicines European public assessment report (EPAR): Nobivac NXT FeLV, feline leukemia (RNA particle) vaccine, Status: Opinion Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Semglee, insulin glargine, Date of authorisation: 23/03/2018, Revision: 12, Status: Authorised

EMA · Semglee · 19. 6. 2026

Human medicines European public assessment report (EPAR): Semglee, insulin glargine, Date of authorisation: 23/03/2018, Revision: 12, Status: Authorised Zdroj: EMA

Novinka

Veterinary medicines European public assessment report (EPAR): Nobivac NXT HCPChFeLV, feline calicivirosis, feline rhinotracheitis, feline panleucopenia, feline chlamydiosis (live) and feline leukemia (RNA replicon particle) vaccine, Status: Opinion

EMA · 19. 6. 2026

Veterinary medicines European public assessment report (EPAR): Nobivac NXT HCPChFeLV, feline calicivirosis, feline rhinotracheitis, feline panleucopenia, feline chlamydiosis (live) and feline leukemia (RNA replicon particle) vaccine, Status: Opinion Zdroj: EMA

Novinka

Veterinary medicines European public assessment report (EPAR): Nobivac NXT HCPFeLV, feline calicivirosis, feline rhinotracheitis, feline panleucopenia (live) and feline leukemia (RNA replicon particle) vaccine, Status: Opinion

EMA · 19. 6. 2026

Veterinary medicines European public assessment report (EPAR): Nobivac NXT HCPFeLV, feline calicivirosis, feline rhinotracheitis, feline panleucopenia (live) and feline leukemia (RNA replicon particle) vaccine, Status: Opinion Zdroj: EMA

Novinka

Veterinary medicines European public assessment report (EPAR): Scovella, velagliflozin, Status: Opinion

EMA · Scovella · 19. 6. 2026

Veterinary medicines European public assessment report (EPAR): Scovella, velagliflozin, Status: Opinion Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Leqembi, lecanemab, Date of authorisation: 15/04/2025, Revision: 4, Status: Authorised

EMA · Leqembi · 19. 6. 2026

Human medicines European public assessment report (EPAR): Leqembi, lecanemab, Date of authorisation: 15/04/2025, Revision: 4, Status: Authorised Zdroj: EMA

Schváleno

Human medicines European public assessment report (EPAR): Eydenzelt, aflibercept

EMA · Eydenzelt · 16. 6. 2026

Human medicines European public assessment report (EPAR): Eydenzelt, aflibercept, Date of authorisation: 12/02/2025, Revision: 4, Status: Authorised

Schváleno

Human medicines European public assessment report (EPAR): Kefdensis

EMA · Kefdensis · 16. 6. 2026

Human medicines European public assessment report (EPAR): Kefdensis, denosumab, Date of authorisation: 17/11/2025, Revision: 2, Status: Authorised

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

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): 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

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

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

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

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

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

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.

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

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.

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