FOI release

Information on the Original Marketing Authorisation for Trihexyphenidyl Syrup 5 mg/5 mL

Some or all of the information requested was not provided because we didn't hold it.

Case reference FOI2026/00796

Received 22 July 2026

Published 9 September 2026

Request

Based on the information provided in FOI2025/0103 and FOI2026/00662, we understand that Rosemont product PL00427/0222 was approved through a Marketing Authorisation (MA) transfer from Broflex Syrup, held by Bioglan Laboratories Limited (PL 00041/0029). We also understand that Broflex Syrup held by Bioglan Laboratories Limited (PL 00041/0029) was approved as a "piggyback" abridged simple application, using Broflex Syrup held by Bio-Medical Services Limited, York (PL 04532/0001) as the reference product. We would appreciate clarification on the regulatory status of Broflex Syrup held by Bio-Medical Services Limited, York (PL 04532/0001). Specifically: 1. Was this product authorised as the original (innovator) product supported by a full dossier, including complete quality, non-clinical, and clinical data? 2. If not, was it itself authorised by reference to another medicinal product? 3. If it was authorised by reference to another product, please provide details of the original authorised product for Trihexyphenidyl Syrup 5 mg/5 mL (First approved product for Trihexyphenidyl Syrup). 4. Please also provide the regulatory authorisation history between the original authorised Trihexyphenidyl Syrup 5 mg/5 mL product and Broflex Syrup held by Bio-Medical Services Limited, York (PL 04532/0001), including any relevant changes in ownership, licensing, or marketing authorisation transfers.

Response

See attached

Documents

• FOI2026_00796 (redacted).pdf (945.6 KB)

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