Regulatory PathRegulatory requirements compared

Active substance

Obecabtagene autoleucel

Open in the medicines table

EMA European Union — centrally authorised medicines

Aucatzyl Autolus GmbH · Authorised · authorised 17 Jul 2025 · ATC L01XL

Therapeutic indication (EMA)

Aucatzyl is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B cell precursor acute lymphoblastic leukaemia (B ALL).

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
AUCATZYL 410 X 10^6 CELLS DISPERSION FOR INFUSIONPLGB 46113/0001AUTOLUS LIMITEDPOM

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.