FOI release

FOI request:Androfeme

Case reference FOI2025/00996

Received 15 September 2025

Published 24 October 2025

Request

I am writing to request information under the Freedom of Information Act regarding the product AndroFeme (testosterone 1% cream), specifically in relation to its marketing authorisation and regulatory assessment in the UK. Could you please provide the following information: 1. EPAR Availability * Is there a European Public Assessment Report (EPAR) or equivalent public assessment document available for AndroFeme? * If so, please provide a copy or link. If not, please explain why one is not available. 1. Legal Basis of the Submission * What was the legal basis of the application for marketing authorisation (e.g. full application under Article 8(3), hybrid application under Article 10(3), generic under 10(1), etc.)? 1. Regulatory Exclusivity * Has AndroFeme been granted any form of regulatory data exclusivity or market protection in the UK? * If yes, please indicate the exclusivity period and its basis. 1. Reference Products * Were any reference medicinal products (RMPs) used in support of the application for AndroFeme? * If so, please identify them, including name, MA holder, and authorising Member State (if applicable). I would appreciate receiving this information in electronic form. If any of this information is exempt from disclosure, please provide an explanation citing the applicable exemption(s).

Response

See attached

Documents

• FOI2025_00996 (redacted).pdf (750.0 KB)

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