FOI release

FOI Request – Marketing Authorisation Certificate for Butamirate Syrup (PL 30306/0497)

Case reference FOI2025/01069

Received 4 October 2025

Published 5 November 2025

Request

I am writing under the Freedom of Information Act 2000 to request information regarding the product Butamirate Syrup, reportedly associated with the following marketing authorisation number: * Product: Butamirate Syrup 7.5mg/5ml * PL Number: 30306/0497 * MA Holder: Actavis Group PTC ehf I kindly request confirmation of whether this product currently holds (or previously held) a valid UK Marketing Authorisation (MA). If available, I would appreciate a copy of the MHRA-issued approval certificate or public details related to the licensing status, including any dates of authorisation, renewal, withdrawal, or cancellation.

Response

See attached

Documents

• FOI2025_01069 (redacted).pdf (514.6 KB)
• leafletMAHGENERIC PL 30306_0497.pdf (171.6 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.