FOI release

Freedom of Information request on a copy of questionnaire for cardiac AEs (associated with PR interval prolongation) as described in the RMP v 15.1 (12-May 2020) for the originator product Vimpat (lacosamide) UCB Pharma ( FOI 21/1145)

Published 26 May 2022

FOI 21/1145

3rd November 2021

Dear,

Thank you for your Freedom of Information (FOI) request dated 18th October 2021, where you requested the following information:

‘A copy of questionnaire for cardiac AEs (associated with PR interval prolongation) as described in the RMP v 15.1 (12-May 2020) for the originator product Vimpat (lacosamide) UCB Pharma ?’

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

We hope the information provided is helpful, but 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