Freedom of Information about current Risk Minimisation Materials for Novartis Gilenya (Fingolimod) (FOI-21-138)
Published 24 March 2021
© Crown copyright 2021
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Thank you for your email dated 03rd February 2021, where you requested:
“A copy of the latest UK educational materials associated with Gilenya® (Fingolimod) Risk Management Plan as follows:
· Patient Information Booklet titled: Important things to remember about Gilenya®
(fingolimod) treatment for patients, parents and caregivers
· Pregnancy Specific Reminder Card for patients
· Prescriber Checklist for Healthcare Professionals
Alternatively, please confirm if the Gilenya educational materials (dated March 2020) available on the Risk Minimisation Materials (RMMs) directory of the Electronic Medicines Compendium are the most recent approved versions.”
Unfortunately, the information is exempt from release under Section 21 – Information accessible by other means: the information you have requested is already in the public domain.
The educational materials currently available on the Electronic Medicines Compendium are the most up to date version and can be found at https://www.medicines.org.uk/emc/product/10357/smpc. Furthermore, the British Generics Manufacturers Association are working on a coordinated work
sharing project to produce educational materials for generic Fingolimod products. More information on this can be sourced from info@britishgenerics.co.uk.
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
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