FOI release

Clinical overview and BE study report for a registered product in UK

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

Case reference FOI2025/01127

Received 27 October 2025

Published 7 October 2026

Request

Under the Freedom of Information Act, I would like to request the clinical overview and the bioequivalence study report for: Ferrous fumarate 210 mg tablets PL 51463/0129 approved on 13 September 2024 submitted under Regulation 51B of The Human Medicines Regulation 2012, as amended (previously Article 10(1) of Directive 2001/83/EC. I understand that commercially confidential and personal data within any documents provided may be redacted and this is considered acceptable.

Response

See attached

Documents

• FOI2025_01127 (redacted).pdf (884.7 KB)

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