Regulatory PathRegulatory requirements compared

Active substance

Idecabtagene vicleucel

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EMA European Union — centrally authorised medicines

Abecma Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 18 Aug 2021 · ATC L01

Therapeutic indication (EMA)

Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti CD38 antibody and have demonstrated disease progression on the last therapy.

Safety signals and safety-related labeling changes

All safety entries for idecabtagene vicleucel →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.