FOI release

Freedom of Information request on copies of the adverse event follow-up questionnaires approved as part of the risk management plan for Forxiga (FOI 21-573)

Published 13 August 2021

23rd June 2021 FOI 21/573

Dear

Thank you for your information request, dated 25th May 2021, where you asked for copies of the specific adverse event follow-up questionnaires approved as part of the risk management plan for the reference product Forxiga.

I am pleased to provide you with the information requested, see attached.

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.

Yours sincerely,

FOI Team, Vigilance and Risk Management of Medicines Division