Regulatory PathRegulatory requirements compared

Active substance

Aumolertinib

Open in the medicines table

EMA European Union — centrally authorised medicines

Aumseqa SFL Pharmaceuticals Deutschland GmbH · Revoked · authorised 12 Feb 2026 · ATC L01EB

Therapeutic indication (EMA)

Aumseqa as monotherapy is indicated for:- the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC)whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (forbiomarker-based patient selection, see section 4.2).- the treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC (forbiomarker-based patient selection, see section 4.2)

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
AUMSEQA 55 MG FILM-COATED TABLETSPLGB 54280/0002SFL PHARMACEUTICALS DEUTSCHLAND GMBHPOM

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.