Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2025
Four new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended four medicines for approval at its February 2025 meeting.The committee recommended…, Positive recommendations on new medicines , Deqsiga International non-proprietary name (INN) human normal immunoglobulin…, Lynozyfic INN linvoseltamab Marketing-authorisation applicant…, Vyjuvek INN beremagene geperpavec Marketing-authorisation applicant…, Positive recommendation on new generic medicine , Trabectedin Accord INN trabectedin Marketing-authorisation applicant…, Positive recommendations on extensions of therapeutic indications , Abrysvo INN respiratory syncytial virus vaccine (bivalent, recombinant) …, Calquence INN acalabrutinib Marketing-authorisation holder…, Columvi INN glofitamab Marketing-authorisation holder…, Darzalex INN daratumumab Marketing-authorisation holder…, Enhertu INN trastuzumab deruxtecan Marketing-authorisation holder…, Fabhalta INN iptacopan Marketing-authorisation holder…, Imfinzi INN durvalumab Marketing-authorisation holder…, Ixchiq Common name Chikungunya vaccine (live) Marketing-authorisation holder…, Jaypirca INN pirtobrutinib Marketing-authorisation holder…, Kaftrio INN ivacaftor / tezacaftor / elexacaftor Marketing-authorisation…, Kalydeco INN ivacaftor Marketing-authorisation holder…, Prevymis INN letermovir Marketing-authorisation holder…, Rinvoq INN upadacitinib Marketing-authorisation holder…, Stelara INN ustekinumab Marketing-authorisation holder…, Supemtek Tetra INN influenza quadrivalent vaccine (rDNA) Marketing-…, Tremfya INN guselkumab Marketing-authorisation holder…, Outcome of re-examination procedures , Keytruda INN pembrolizumab Marketing-authorisation holder…, Kizfizo INN temozolomide Marketing-authorisation holder…, Leqembi INN lecanemab Marketing-authorisation holder…, Withdrawal of initial marketing authorisation applications , Pelgraz Paediatric INN pegfilgrastim Marketing-authorisation applicant…, Rilonacept FGK Representative Service GmbH INN rilonacept Marketing-…, Withdrawal of application to change the marketing authorisation , Bimervax Common name COVID-19 Vaccine (recombinant, adjuvanted) / selvacovatein / damlecovatein…, Dupixent INN dupilumab Marketing-authorisation holder…
Four new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended four medicines for approval at its February 2025 meeting.The committee recommended…, Positive recommendations on new medicines , Deqsiga International non-proprietary name (INN) human normal immunoglobulin…, Lynozyfic INN linvoseltamab Marketing-authorisation applicant…, Vyjuvek INN beremagene geperpavec Marketing-authorisation applicant…, Positive recommendation on new generic medicine , Trabectedin Accord INN trabectedin Marketing-authorisation applicant…, Positive recommendations on extensions of therapeutic indications , Abrysvo INN respiratory syncytial virus vaccine (bivalent, recombinant) …, Calquence INN acalabrutinib Marketing-authorisation holder…, Columvi INN glofitamab Marketing-authorisation holder…, Darzalex INN daratumumab Marketing-authorisation holder…, Enhertu INN trastuzumab deruxtecan Marketing-authorisation holder…, Fabhalta INN iptacopan Marketing-authorisation holder…, Imfinzi INN durvalumab Marketing-authorisation holder…, Ixchiq Common name Chikungunya vaccine (live) Marketing-authorisation holder…, Jaypirca INN pirtobrutinib Marketing-authorisation holder…, Kaftrio INN ivacaftor / tezacaftor / elexacaftor Marketing-authorisation…, Kalydeco INN ivacaftor Marketing-authorisation holder…, Prevymis INN letermovir Marketing-authorisation holder…, Rinvoq INN upadacitinib Marketing-authorisation holder…, Stelara INN ustekinumab Marketing-authorisation holder…, Supemtek Tetra INN influenza quadrivalent vaccine (rDNA) Marketing-…, Tremfya INN guselkumab Marketing-authorisation holder…, Outcome of re-examination procedures , Keytruda INN pembrolizumab Marketing-authorisation holder…, Kizfizo INN temozolomide Marketing-authorisation holder…, Leqembi INN lecanemab Marketing-authorisation holder…, Withdrawal of initial marketing authorisation applications , Pelgraz Paediatric INN pegfilgrastim Marketing-authorisation applicant…, Rilonacept FGK Representative Service GmbH INN rilonacept Marketing-…, Withdrawal of application to change the marketing authorisation , Bimervax Common name COVID-19 Vaccine (recombinant, adjuvanted) / selvacovatein / damlecovatein…, Dupixent INN dupilumab Marketing-authorisation holder…
