FOI release

Request for Module 2 and Module 5 Documents

Some or all of the information requested may not have been provided because we determined that the request was vexatious.

Case reference FOI2026/00423

Received 20 April 2026

Published 11 May 2026

Request

We are writing to request copies of Module 2.4 (Nonclinical Overview), Module 2.5 (Clinical Overview), and Module 5 (Clinical Study Reports) for Sertraline 50 mg and 100 mg film-coated tablets (PL 20416/0214-0215), which are currently held by Crescent Pharma Limited. The licence was transferred following a change of ownership from Rx Pharma (previous Licence No. PL 18869/0022). Upon review of our records, we note that we do not hold these documents as approved by the MHRA. To ensure our records remain complete and compliant with the approved dossier, we kindly request copies of the authorised Module 2.4, Module 2.5, and Module 5 (Clinical Study Reports) for this product.

Response

See attached

Documents

• FOI2026_00423 (redacted).pdf (766.3 KB)

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