FOI release

Freedom of Information request on Copies of the BMS and Accord Lenalidomide PPP management plans and effectiveness review plans (FOI 21/1253)

Published 31 May 2022

FOI 21/1253

15th December 2021

Dear,

Thank you for your email, dated 23rd November 2021, in which you requested:

‘Copies of the BMS and Accord Lenalidomide PPP management plans and effectiveness review plans (or equivalents)?’

The Pregnancy Prevention Plan (PPP) for Bristol-Myers Squibb Pharmaceuticals limited Revlimid (Lenalidomide) is publicly available on the electronic medicines compendium (emc), the female and male documents can be viewed within the Risk Management Materials section Revlimid 10 mg Hard Capsules - Risk Management Materials

A copy of the Procedural Documents for Bristol-Myers Squibb Pharmaceuticals limited Revlimid (Lenalidomide), 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.

The requested information for Accord is exempt under Section 41 (Information provided in confidence): information provided to us in confidence, with the expectation that it will not be released, is exempt from disclosure under the FOI Act.

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