Freedom of Information request for information: Exjade (Deferasirox) (FOI-21-011)
Published 24 March 2021
© Crown copyright 2021
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-1-february-2021/freedom-of-information-request-for-information-exjade-deferasirox-foi-21-011
Thank you for your Freedom of Information (FOI) request dated 4th January 2021, where you requested the following information:
“Annex 4: Specific adverse drug reaction follow-up forms” as per the Risk Management Plan applicable for the product (Exjade). Also, in addition to this kindly provide “Annex 6: Details of proposed additional risk minimisation activities” of the Exjade RMP
A copy of the information, which can be disclosed, is attached.
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.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division