FOI release

FOI Request – Licensing, Safety, and Withdrawal Records for Astemizole

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

Case reference FOI2025/00748

Received 20 July 2025

Published 9 September 2025

Request

I am writing to make a request under the Freedom of Information Act 2000. I request access to all documentation, reports, and communications held by the MHRA (and previously, the Medicines Control Agency) regarding the antihistamine drug Astemizole (e.g., under the brand name Hismanal), including but not limited to: 1. Marketing authorisation documents, applications, and approval notices. 2. Safety reviews, risk assessments, and benefit-risk analyses conducted during its approval and marketing period. 3. Adverse event reports and pharmacovigilance data related to Astemizole use in the UK. 4. Correspondence with the marketing authorisation holder (e.g., Janssen-Cilag or Johnson & Johnson) about safety signals or regulatory action. 5. Documentation or internal reviews relating to restrictions, suspensions, or withdrawal of Astemizole from the UK market. 6. Any communications with the European Medicines Agency (EMA) or other international bodies that contributed to UK decisions on Astemizole.

Response

See attached

Documents

• FOI2025_00748 (redacted).pdf (856.4 KB)

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