Aumseqa
Revoked
This medicine's authorisation has been revoked
Aumolertinib
MedicineHumanRevoked
Hungarian is available via eTranslation, the European Commission's machine translation service.
Translate to Hungarian | Important information about machine translation
Overview
On 25 September 2026, the European Commission revoked the marketing authorisation for Aumseqa (aumolertinib) in the European Union (EU). The marketing authorisation holder for the medicine was SFL Pharmaceuticals Deutschland GmbH.
The revocation of the marketing authorisation followed a review by EMA, and a final decision by the European Commission, which concluded that the marketing authorisation application for Aumseqa relied in part on data from another medicine, which at the time of submission of the application were under regulatory data protection.
Further information in relation to the revocation of the marketing authorisation for Aumseqa can be found in the Commission Implementing Decision C(2026) 6955 final revoking the marketing authorisation, which is available on the Union Register of medicinal products for human use. Aumseqa was granted marketing authorisation in the EU on 12 February 2026 for the treatment of non-small cell lung cancer.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Aumseqa
- Active substance
- Aumolertinib mesilate
- International non-proprietary name (INN) or common name
- Aumolertinib
- Therapeutic area (MeSH)
- Carcinoma, Non-Small-Cell Lung
- Anatomical therapeutic chemical (ATC) code
- L01EB
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
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 (for
biomarker-based patient selection, see section 4.2).
- the treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC (for
biomarker-based patient selection, see section 4.2)
Assessment history
News on Aumseqa
This page was last updated on