Committee for Medicinal Products for Human Use (CHMP)
WEBThe Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines. It plays a vital role in the authorisation of medicines in the European Union.
Committee for Medicinal Products for Human Use - Wikipedia
WEBThe Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding medicinal products for human use.
CHMP members - European Medicines Agency (EMA)
WEBThe CHMP consists of: a chair, elected by serving CHMP members; one member and an alternate appointed by each of the EU Member States after consulting EMA's Management Board; one member and an alternate appointed by each of the EEA-EFTA States;
Meeting highlights from the - European Medicines Agency (EMA)
WEBJun 27, 2024 · EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its June 2024 meeting. The committee recommended granting a marketing authorisation for Balversa (erdafitinib), for the treatment of adult patients with unresectable or metastatic urothelial carcinoma, a cancer of the bladder and urinary system.
Merck Receives Positive EU CHMP Opinions for KEYTRUDA® …
WEB1 day ago · RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending approval of KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, for two indications in gynecologic cancers.
Apellis Says CHMP Confirms Negative Opinion For Pegcetacoplan …
WEB1 day ago · (RTTNews) - Apellis Pharmaceuticals, Inc. (APLS) announced on Friday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has upheld its negative ...
CHMP Committee for Medicinal Products for Human Use - BfArM
WEBThe CHMP's scientific assessment report forms the basis for the European Commission's decision to grant or refuse a central marketing authorization for a medicinal product for human use. The CHMP is composed of scientists from all member states of the European Economic Area (EEA).
Pfizer Receives Positive CHMP Opinion for its Novel Antibiotic ...
WEBNEW YORK, March 22, 2024 – Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for EMBLAVEO® (aztreonam-avibactam) in the treatment of adult patients with complicated ...
EMA's Committee for Medicinal Products for Human Use (CHMP)
WEBJul 14, 2022 · The latest meeting saw EMA’s human medicines committee (CHMP) recommend the approval of nine new medicines, refuse two biosimilar medications and recommend extensions of therapeutic indication for six medicines.
EMA's CHMP meeting highlights from September 2020 - PMC
WEBOct 3, 2020 · Seven new medicines (including two vaccines) were recommended for approval at the recent September meeting of the CHMP, 1 according to the EMA. In its recent news item about the highlights from this meeting, the following medicines were recommended approval (or issued a positive opinion) by the CHMP, including: bupivacaine (Exparel) for the ...