FOI release

Freedom of Information request on the approved Risk Management Plan for Medronate DRAXIMAGE 10 mg (FOI 22/807)

Published 4 January 2024

FOI 22/807

27th July 2022

Dear

Thank you for your email dated 4th July 2022, in which you requested “access to the approved Risk Management Plan and the latest PSUR for: Medronate DRAXIMAGE 10 mg, kit for radiopharmaceutical preparation, UK/H/7160/001”.

This product is not currently authorised in the UK so we therefore do not hold this information and are unable to provide it for you.

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Please remember to quote the reference number above in any future communications.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division