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EPAR a stanoviska
Evropské veřejné hodnotící zprávy (EPAR) a stanoviska CHMP.
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.
SchválenoMultaq (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.
SchválenoAspaveli (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
SchválenoIclusig (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.
SchválenoQoyvolma (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 The status of this medicine is listed as Withdrawn.
SchválenoXofigo (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
SchválenoGilenya (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
SchválenoSylvant (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).
SchválenoBoey (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.
SchválenoJascayd (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.
SchválenoMayzent (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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
NovinkaHuman 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
NovinkaHuman medicines European public assessment report (EPAR): Qezzaqar, catequentinib
EMA · Qezzaqar · 24. 7. 2026
Human medicines European public assessment report (EPAR): Qezzaqar, catequentinib, Status: Opinion
NovinkaHuman 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
NovinkaHuman 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
NovinkaHuman 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
NovinkaHuman 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
NovinkaEuropean 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.
NovinkaHuman 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
SchválenoHuman 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
SchválenoHuman 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
NovinkaHuman 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
NovinkaHuman 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
NovinkaSummary of opinion: Trodelvy, 23/07/2026 Positive
EMA · 23. 7. 2026
Summary of opinion: Trodelvy, 23/07/2026 Positive Zdroj: EMA
SchválenoEuropean 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
NovinkaLumykras : 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.
SchválenoHuman 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
SchválenoOpdualag, 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.
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
NovinkaHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
NovinkaHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoVeterinary 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
NovinkaHuman 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
NovinkaHuman 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
NovinkaHuman 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
NovinkaHuman 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
NovinkaHuman 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
NovinkaHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
NovinkaVeterinary 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
SchválenoHuman 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
NovinkaVeterinary 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
NovinkaVeterinary 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
NovinkaVeterinary 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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
SchválenoHuman 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.
SchválenoEMA 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.
SchválenoHuman 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
SchválenoHuman 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
NovinkaLonquex : 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.
SchválenoSugammadex 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
SchválenoLenalidomide 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
SchválenoByannli
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
SchválenoCrysvita
EMA · Crysvita · 10. 6. 2026
Human medicines European public assessment report (EPAR): Crysvita, burosumab, Date of authorisation: 19/02/2018, Revision: 18, Status: Authorised
SchválenoOczyesa
EMA · Oczyesa · 10. 6. 2026
Human medicines European public assessment report (EPAR): Oczyesa, octreotide, Date of authorisation: 30/06/2025, Revision: 2, Status: Authorised
SchválenoVargatef
EMA · Vargatef · 10. 6. 2026
Lék Vargatef (nintedanib) je určen pro léčbu dospělých pacientů s idiopatickou plicní fibrózou.
NovinkaHuman 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
NovinkaHuman 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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