Freedom of Information request on a copy of of Part III.1 and Annex 4, targeted follow-up questionnaire for Provigil 100 mg tablets (FOI 22/689)
Published 27 March 2023
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FOI 22/689
8th June 2022
Dear
Thank you for your email dated 11th May 2022, in which you requested “a copy of Part III.1 and Annex 4, targeted follow-up questionnaire (RMP) for Provigil 100 mg tablets (PL 14776/0098)”.
The latest version of the RMP in question does not contain either requested section, as no routine pharmacovigilance activities have been proposed, such as a targeted follow-up questionnaire, for this product.
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