FOI release

PAR PLGB 41042/0088 • PLGB 41042/0089

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 FOI2026/00496

Received 6 May 2026

Published 11 June 2026

Request

I am writing to make a request under the Freedom of Information Act 2000. Please provide copies of any assessment reports, scientific evaluation reports, or other internal decision documents prepared by the MHRA in connection with the granting of the following UK marketing authorisations: • PLGB 41042/0088 • PLGB 41042/0089 In particular, I kindly request disclosure of any documents relating to: 1. The scientific or regulatory assessment undertaken by MHRA when granting these marketing authorisations, including any available assessment reports or summaries, whether full or abbreviated. 2. The assessment and approval of any extensions or variations to these marketing authorisations relating to the extension of therapeutic indications. 3. Any consideration given by MHRA, in connection with the above authorisations or subsequent indication extensions, to the applicability of an extension of the market protection period to eleven years under the Human Medicines Regulations 2012 (as amended). If any of the requested information is held in multiple documents, please provide all documents that fall within the scope of this request. If any information cannot be disclosed, I would be grateful if you could specify the relevant exemption under the Freedom of Information Act and provide any non‑confidential portions that can be released.

Response

See attached

Documents

• FOI2026_00496 (redacted).pdf (838.8 KB)

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