.jpg)
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 March 2025
Five new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2025 meeting.The committee recommended…, Positive recommendation on new medicine , Xoanacyl International non-proprietary name (INN) Ferric citrate coordination complex…, Positive recommendation on new biosimilar medicines , Jubereq INN denosumab Marketing-authorisation applicant…, Qoyvolma INN ustekinumab Marketing-authorisation applicant…, Osvyrti INN denosumab Marketing-authorisation applicant…, Positive recommendation on new hybrid medicine , Ryjunea INN atropine sulfate Marketing-authorisation applicant…, Positive recommendations on extensions of therapeutic indications , Bosulif INN bosutinib Marketing-authorisation holder…, Calquence INN acalabrutinib Marketing-authorisation holder…, Flucelvax Common name influenza vaccine (surface antigen, inactivated, prepared in cell cultures…, Opdivo INN nivolumab Marketing-authorisation holder…, Tevimbra INN tislelizumab Marketing-authorisation holder…, Tremfya INN guselkumab Marketing-authorisation holder…, Xydalba INN dalbavancin Marketing-authorisation holder…, Negative recommendation on new medicine , Kisunla INN donanemab Marketing-authorisation applicant…, Negative recommendation on extension of therapeutic indication , Pemazyre INN pemigatinib Marketing-authorisation holder…, Conclusion of referral , Mysimba INN naltrexone / bupropion Marketing-authorisation holder…, Withdrawal of initial marketing authorisation applications , Insulin Human Rechon INN insulin human Marketing-authorisation applicant…, Cinainu INN liquid ethanolic extract of Allium cepa (onion) fresh bulb and Citrus limon (lemon) fresh fruit / dry…, Withdrawal of application to change the marketing authorisation , Amyvid INN florbetapir (18F) Marketing-authorisation holder…, Other updates Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 24-27 March 2025AdoptedReference Number: EMA/96923/2025…
Five new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2025 meeting.The committee recommended…, Positive recommendation on new medicine , Xoanacyl International non-proprietary name (INN) Ferric citrate coordination complex…, Positive recommendation on new biosimilar medicines , Jubereq INN denosumab Marketing-authorisation applicant…, Qoyvolma INN ustekinumab Marketing-authorisation applicant…, Osvyrti INN denosumab Marketing-authorisation applicant…, Positive recommendation on new hybrid medicine , Ryjunea INN atropine sulfate Marketing-authorisation applicant…, Positive recommendations on extensions of therapeutic indications , Bosulif INN bosutinib Marketing-authorisation holder…, Calquence INN acalabrutinib Marketing-authorisation holder…, Flucelvax Common name influenza vaccine (surface antigen, inactivated, prepared in cell cultures…, Opdivo INN nivolumab Marketing-authorisation holder…, Tevimbra INN tislelizumab Marketing-authorisation holder…, Tremfya INN guselkumab Marketing-authorisation holder…, Xydalba INN dalbavancin Marketing-authorisation holder…, Negative recommendation on new medicine , Kisunla INN donanemab Marketing-authorisation applicant…, Negative recommendation on extension of therapeutic indication , Pemazyre INN pemigatinib Marketing-authorisation holder…, Conclusion of referral , Mysimba INN naltrexone / bupropion Marketing-authorisation holder…, Withdrawal of initial marketing authorisation applications , Insulin Human Rechon INN insulin human Marketing-authorisation applicant…, Cinainu INN liquid ethanolic extract of Allium cepa (onion) fresh bulb and Citrus limon (lemon) fresh fruit / dry…, Withdrawal of application to change the marketing authorisation , Amyvid INN florbetapir (18F) Marketing-authorisation holder…, Other updates Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 24-27 March 2025AdoptedReference Number: EMA/96923/2025…
