FOI release

Clinical overview addendum for Oestrogel/Estrogel (PL 28397/0002), focusing on the evidenc

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 FOI2026/00913

Received 17 August 2026

Published 1 October 2026

Request

I am requesting information relating specifically to Oestrogel/Estrogel, PL 28397/0002. In response to my previous FOI request, the MHRA advised that an electronic clinical overview addendum is available for Oestrogel/Estrogel (PL 28397/0002) and suggested submitting a new request limited to this specific PL reference. Please provide a copy of that electronic clinical overview addendum. I am particularly interested in any sections relating to the authorised dosage in Section 4.2, including the evidence or rationale supporting the highest authorised dose and any discussion or assessment of higher doses, where contained within the document. If any information is exempt from disclosure, please provide the remaining non-exempt sections or relevant redacted extracts. Electronic PDF format is preferred.

Response

See attached

Documents

• Clinical Overview Addendum Csi Redacted.pdf (421.1 KB)
• FOI2026_00913 (redacted).pdf (799.2 KB)
• PLGoldFile15 Redacted.pdf (3.5 MB)

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