FOI release

FOI Request: Aumseqa

This request was refused in full, so we didn't provide the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2026/00959

Received 26 August 2026

Published 29 October 2026

Request

I would like to request access to the following documents in relation to the authorisation of Aumseqa (aumolertinib) 55 mg film-coated tablets, PLGB 54280/0002, granted to SFL Pharmaceuticals Deutschland GmbH: * The following questions from the List of Questions or List of Outstanding Issues from the MHRA to the applicant during the assessment of aumolertinib and the Responses to these questions from the applicant: Questions/Issue number #5, #23, #24, #27, #49, #50-68, #69-77, #78-80, #81-82, #83-86 * Post Assessment report for Aumseqa dated Dec 2024 for the listed Objections * OHEAG meting minutes from 12 December 2024, which refers to Aumseqa and Annex 3 to these minutes * CHM meeting minutes from 19 Dec 2024 that discuss the listed Objections for Aumseqa * Documents explaining the assessment by MHRA that aumolertinib is a new active substance, as noted in section IV.1 of the PAR. * Request for scientific advice by the applicant in relation to the development and authorization of Aumseqa, and the MHRA's response to any such requests, sought on 1 September 2022.

Response

See attached

Documents

• FOI2026_01013 & FOI2026_00959.pdf (814.3 KB)

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