Summary of opinion: Abecma, 25/01/2024 Positive

On 25 January 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Abecma.

Metadata
Provider: 
European Medicines AgencyEuropean Medicines Agency
URL: 
https://www.ema.europa.eu/en/medicines/human/variation/abecmahttps://www.ema.europa.eu/en/medicines/human/variation/abecma
Retrieved on: 
星期一, 一月 29, 2024
Information
Tags: 
Medication package insert, Committee, Idecabtagene vicleucel, Patient, Marketing, CHMP, Civil service commission, European Commission, EEIG, CD38, Pharmaceutical industry
Geotags: 
EUROPEAN UNION
摘要
Key Points: 
  • On 25 January 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Abecma.
  • The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.
  • The CHMP adopted an extension to the existing indication to include treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies.
  • 1New text in bold, removed in strikethrough
Copyright: 
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