FOI release

​Request for information [SW-CLIENTS.FID489399]

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 FOI2026/00116

Received 4 February 2026

Published 7 October 2026

Request

The MHRA has approved the use of the product Syncrodin 3 mg film-coated tablets, for i.a. short-term treatment of jet-lag in adults, and treatment of insomnia in patients aged 6 to 17 years with ADHD or ASD (see PL 20243/0004). Accordingly, we hereby make a request, under the Freedom of Information Act, to receive copies of Module 2.5 (including any addendum documents) of the Common Technical Document (CTD) in relation to the abovementioned approval. Please do not hesitate to reach out should anything above be unclear or further information is required in order to handle the request. As the request is urgent, a swift handling would be highly appreciated. The information can be sent to us on email.

Response

See attached

Documents

• Addendum to Clinical Overview Redacted.pdf (1.4 MB)
• Clinical Overview Redacted.pdf (1.6 MB)
• FOI2026_00116 (redacted).pdf (791.2 KB)

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

You can browse our other responses or make a new FOI request.