Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025
Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight medicines for approval at its January 2025 meeting.The CHMP recommended…, Positive recommendations on new medicines , Capvaxive Common name pneumococcal polysaccharide conjugate vaccine (21-valent)…, Datroway INN datopotamab deruxtecan Marketing authorisation applicant…, Tivdak INN tisotumab vedotin Marketing authorisation applicant…, Vimkunya INN Chikungunya vaccine (recombinant, adsorbed) Marketing authorisation…, Positive recommendations on new biosimilar medicines , Dyrupeg INN pegfilgrastim Marketing authorisation applicant…, Pavblu INN aflibercept Marketing authorisation applicant…, Skojoy INN aflibercept Marketing authorisation applicant…, Positive recommendation on new generic medicine , Eltrombopag Accord INN eltrombopag Marketing authorisation holder…, Positive recommendations on new therapeutic indications , Breyanzi INN lisocabtagene maraleucel / lisocabtagene maraleucel Marketing…, Imfinzi INN durvalumab Marketing authorisation holder…, Opdivo INN nivolumab Marketing authorisation holder…, Ronapreve INN casirivimab / imdevimab Marketing authorisation holder…, Rxulti INN brexpiprazole Marketing authorisation holder…, Sivextro INN tedizolid phosphate Marketing authorisation holder…, Slenyto INN melatonin Marketing authorisation holder…, Yervoy INN ipilimumab Marketing authorisation holder…, Positive opinions for medicines intended for use outside the EU , Ivermectin / Albendazole INN ivermectin / albendazole Marketing…, Withdrawal of initial marketing authorisation application , Datopotamab deruxtecan Daiichi Sankyo INN datopotamab Marketing authorisation…, Nugalviq INN Govorestat Marketing authorisation applicant…
Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight medicines for approval at its January 2025 meeting.The CHMP recommended…, Positive recommendations on new medicines , Capvaxive Common name pneumococcal polysaccharide conjugate vaccine (21-valent)…, Datroway INN datopotamab deruxtecan Marketing authorisation applicant…, Tivdak INN tisotumab vedotin Marketing authorisation applicant…, Vimkunya INN Chikungunya vaccine (recombinant, adsorbed) Marketing authorisation…, Positive recommendations on new biosimilar medicines , Dyrupeg INN pegfilgrastim Marketing authorisation applicant…, Pavblu INN aflibercept Marketing authorisation applicant…, Skojoy INN aflibercept Marketing authorisation applicant…, Positive recommendation on new generic medicine , Eltrombopag Accord INN eltrombopag Marketing authorisation holder…, Positive recommendations on new therapeutic indications , Breyanzi INN lisocabtagene maraleucel / lisocabtagene maraleucel Marketing…, Imfinzi INN durvalumab Marketing authorisation holder…, Opdivo INN nivolumab Marketing authorisation holder…, Ronapreve INN casirivimab / imdevimab Marketing authorisation holder…, Rxulti INN brexpiprazole Marketing authorisation holder…, Sivextro INN tedizolid phosphate Marketing authorisation holder…, Slenyto INN melatonin Marketing authorisation holder…, Yervoy INN ipilimumab Marketing authorisation holder…, Positive opinions for medicines intended for use outside the EU , Ivermectin / Albendazole INN ivermectin / albendazole Marketing…, Withdrawal of initial marketing authorisation application , Datopotamab deruxtecan Daiichi Sankyo INN datopotamab Marketing authorisation…, Nugalviq INN Govorestat Marketing authorisation applicant…
