Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 May 2025
Ten new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended ten medicines for approval at its May 2025 meeting.The committee recommended granting…, Positive recommendations on new medicines , Aucatzyl International non-proprietary name (INN) obecabtagene autoleucel…, Blenrep INN belantamab mafodotin Marketing-authorisation applicant…, Ezmekly INN mirdametinib Marketing-authorisation applicant…, Itovebi INN inavolisib Marketing-authorisation applicant…, Maapliv INN amino acids Marketing-authorisation applicant…, Positive recommendations on new biosimilar medicines , Bomyntra INN denosumab Marketing-authorisation applicant…, Conexxence INN denosumab Marketing-authorisation applicant…, Rolcya INN denosumab Marketing-authorisation applicant…, Positive recommendation on new hybrid medicine , Riulvy INN tegomil fumarate Marketing-authorisation applicant…, Positive recommendation on new generic medicine , Emtricitabine/Tenofovir alafenamide Viatris INN emtricitabine / tenofovir alafenamide…, Withdrawal of initial marketing authorisation application , Teriparatide Ascend INN teriparatide Marketing-authorisation applicant…, Negative opinion of initial marketing authorisation application , Atropine sulfate FGK INN atropine Marketing-authorisation applicant…, Kinselby INN resminostat mesilate Marketing-authorisation applicant…, Positive recommendations on extensions of therapeutic indications , Imfinzi INN durvalumab Marketing-authorisation holder…, Rezolsta INN darunavir / cobicistat Marketing-authorisation holder…, Saxenda INN liraglutide Marketing-authorisation holder…, Tevimbra INN tislelizumab Marketing-authorisation holder…, Withdrawal of extension of indication , Lutathera INN lutetium Marketing-authorisation applicant…, Re-examination of recommendations , Aplidin INN plitidepsin More information…, Winlevi INN clascoterone More information Winlevi…, Start of referral procedure , Ipidacrine INN ipidacrine More information EMA…, Outcome of referral procedure , Azithromycin containing medicinal products for systemic use INN various More…, Other updates , Start of Union reviews adopted during the CHMP meeting of 19-22 May 2025AdoptedReference Number: EMA/170235/2025 English (EN…
Ten new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended ten medicines for approval at its May 2025 meeting.The committee recommended granting…, Positive recommendations on new medicines , Aucatzyl International non-proprietary name (INN) obecabtagene autoleucel…, Blenrep INN belantamab mafodotin Marketing-authorisation applicant…, Ezmekly INN mirdametinib Marketing-authorisation applicant…, Itovebi INN inavolisib Marketing-authorisation applicant…, Maapliv INN amino acids Marketing-authorisation applicant…, Positive recommendations on new biosimilar medicines , Bomyntra INN denosumab Marketing-authorisation applicant…, Conexxence INN denosumab Marketing-authorisation applicant…, Rolcya INN denosumab Marketing-authorisation applicant…, Positive recommendation on new hybrid medicine , Riulvy INN tegomil fumarate Marketing-authorisation applicant…, Positive recommendation on new generic medicine , Emtricitabine/Tenofovir alafenamide Viatris INN emtricitabine / tenofovir alafenamide…, Withdrawal of initial marketing authorisation application , Teriparatide Ascend INN teriparatide Marketing-authorisation applicant…, Negative opinion of initial marketing authorisation application , Atropine sulfate FGK INN atropine Marketing-authorisation applicant…, Kinselby INN resminostat mesilate Marketing-authorisation applicant…, Positive recommendations on extensions of therapeutic indications , Imfinzi INN durvalumab Marketing-authorisation holder…, Rezolsta INN darunavir / cobicistat Marketing-authorisation holder…, Saxenda INN liraglutide Marketing-authorisation holder…, Tevimbra INN tislelizumab Marketing-authorisation holder…, Withdrawal of extension of indication , Lutathera INN lutetium Marketing-authorisation applicant…, Re-examination of recommendations , Aplidin INN plitidepsin More information…, Winlevi INN clascoterone More information Winlevi…, Start of referral procedure , Ipidacrine INN ipidacrine More information EMA…, Outcome of referral procedure , Azithromycin containing medicinal products for systemic use INN various More…, Other updates , Start of Union reviews adopted during the CHMP meeting of 19-22 May 2025AdoptedReference Number: EMA/170235/2025 English (EN…
