FOI release

Clinical Overview for PL 25258/0402

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 FOI2026/00257

Received 5 March 2026

Published 7 May 2026

Request

Our client would like to request a redacted clinical overview for the product Melatonin 1 mg/ml oral solution from Glenmark Pharmaceuticals Europe Ltd (PL 25258/0402).

Response

See attached

Documents

• Clinical-overview (redacted).pdf (47.4 MB)
• FOI2026_00257 (redacted).pdf (648.9 KB)

This is Medicines and Healthcare products Regulatory Agency's response to a freedom of information (FOI) or environmental information regulations (EIR) request.

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