FOI release

Request for information _ FOI

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 FOI2026/00377

Received 7 April 2026

Published 2 June 2026

Request

I would like to request for Module 2.4, Module 2.5, Module 2.6 and Module 2.7 submitted for Melatonin 1 mg/ml oral solution, MAH: Glenmark Pharmaceuticals Europe Ltd, (PL 25258/0402).

Response

See attached

Documents

• Clinical-overview_Redacted.pdf (6.2 MB)
• FOI2026_00377 (redacted).pdf (688.6 KB)
• Non-Clinical overview_Redacted.pdf (2.6 MB)

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