FOI release

Product: Ethosuximide 250 mg/5 ml Oral Solution

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 FOI2026/01374

Received 7 October 2026

Published 6 November 2026

Request

I am writing to submit a Freedom of Information request under the Freedom of Information Act 2000 concerning the following medicinal product: • Product: Ethosuximide 250 mg/5 ml Oral Solution • PL Number: PL 34424/0087 • Marketing Authorisation Holder: Key Pharmaceuticals Having reviewed the MHRA Public Assessment Report (PAR) for this product, I understand that the marketing authorisation application was submitted under the applicable Regulation 10.1 procedure I would therefore be grateful if the MHRA could provide copies of the clinical and non-clinical overviews submitted in support of the marketing authorisation application for PL 34424/0087.

Response

See attached

Documents

• clinical-overview MHRA redacted.pdf (669.6 KB)
• FOI2026_01374 (redacted).pdf (771.8 KB)
• nonclinical-overview redacted.pdf (582.3 KB)

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