FOI release

Freedom of Information request about a copy of a submitted RMP-Levetiracetam concentrate for solution for infusion (FOI 21/264)

Published 7 May 2021

Thank you for your email, dated 08thMarch 2021, in which you requested:

a copy of a submitted RMP-Levetiracetam concentrate for solution for infusion

“I should be grateful if you could provide us with a copy of a Risk Management Plan (RMP) for the following authorised medicinal product:”

-Levetiracetam 100 mg/ml concentrate for solution for injectionPL 17509/0088’

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

The MHRA information supplied in response to your request is subject to Crown copyright. The FOIA only entitles you to access to MHRA information. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information

If you have a query about this email, please contact us. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involve in your request. If you wish to pursue that option please write to the Communication Directorate, 4-T, Medicines and Healthcare products Regulatory Agency, (via this email address). After that, if you remain dissatisfied, you may ask the Information Commissioner at:

The Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF

Copyright notice The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, re sell or otherwise use any information provided without prior agreement from the copyright holder.