FOI release

Evidence supporting the highest licensed doses of Estradot, Evorel and Oestrogel.

Some or all of the information requested was not provided because we determined that the cost to do so would exceed the appropriate limit.

Case reference FOI2026/00832

Received 28 July 2026

Published 8 September 2026

Request

Please provide the recorded clinical and regulatory basis for the highest authorised doses of: Estradot 100 micrograms/24 hours — PL 04416/1723 Evorel 100 — PL 49105/0008 Oestrogel Pump-Pack — PL 28397/0002 For each product, please provide the relevant redacted clinical assessment/expert report, the studies supporting the current Section 4.2 dosage, any recorded rationale for selecting the highest dose, and whether higher doses were submitted or assessed. If complete documents cannot be disclosed, please provide relevant non-exempt extracts and study identifiers. Electronic PDF format is preferred.

Response

See attached

Documents

• FOI2026_00832 (redacted).pdf (653.5 KB)

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