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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 recommendations on new medicines , Xoanacyl INN Ferric citrate coordination complex Marketing-authorisation…, 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 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 guselkumab 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 rilonacept Marketing-authorisation applicant…, Withdrawal of application to change the marketing authorisation , Amyvid INN florbetapir (18F) Marketing-authorisation holder…
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 recommendations on new medicines , Xoanacyl INN Ferric citrate coordination complex Marketing-authorisation…, 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 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 guselkumab 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 rilonacept Marketing-authorisation applicant…, Withdrawal of application to change the marketing authorisation , Amyvid INN florbetapir (18F) Marketing-authorisation holder…
