FOI release

Request a copy of the clinical overview Mexiletine capsules

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 FOI2026/00579

Received 28 May 2026

Published 14 September 2026

Request

Re: Request for Mexiletine Clinical Overview and Risk Management Plan I would be grateful if you could provide a copy of the Clinical Overview and the Risk Management Plan for the authorised products: * Mexiletine Hydrochloride 100 mg Hard Capsules * Mexiletine Hydrochloride 200 mg Hard Capsules * PL 06464/3133–3134 * MAH: Waymade PLC

Response

See attached

Documents

• Clinical Overview (redacted).pdf (22.1 MB)
• FOI2026_00579 (redacted).pdf (686.0 KB)
• Risk Managament Plan (redacted).pdf (6.3 MB)

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