FOI release

Freedom of Information request on the follow up questionnaire documents for Gilenya 0.5mg hard capsules from Novartis Europharm Limited (FOI 22/779)

Published 21 December 2023

FOI 22/779

24th June 2022

Dear

Thank you for your email, dated 23rd June 2022, in which you requested:

‘the Follow up-Questionnaire documents’ for Gilenya 0.5mg hard capsules from Novartis Europharm Limited.

A copy of the information, which can be disclosed, is attached.

As per the instruction of the MAH, no information has been redacted from the attached file.

I hope the information provided is helpful; however, 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