FOI release

Freedom of Information request (FOI 22/1111)

Published 17 January 2024

1st December 2022

FOI 22/1111

Dear ,

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

“a copy of the Risk Management Plan for Xyzal (Levocetirizine dihydrochloride) 5 mg Film-coated Tablets”

We can confirm that the MHRA holds a copy of the requested RMP.

We hope the information provided is helpful, but 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,

Safety & Surveillance Group

Medicines and Healthcare Products Regulatory Agency