FOI release

Freedom of Information request on the Risk Management Plan for Janumet (FOI 22/029)

Published 31 May 2022

FOI 22/029

8th February 2022

Dear

Thank you for your email, dated 11th January 2022, in which you requested:

‘a copy of the Risk Management Plan for:

Janumet® 50 mg/850 mg film-coated tablets – PL 53095/0035 Janumet® 50 mg/1,000 mg film-coated tablets – PL 53095/0037’

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

Information that has been redacted is exempt under Section 40 (Personal Information) of the Freedom of Information (FOI) Act and is therefore withheld. We have concluded that disclosing this information would not be appropriate because providing information subject to Section 40 would be an infringement of personal data. Furthermore, we do not believe that there is an overriding public interest in disclosing this information in this instance.

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