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