Freedom of Information request for information: Exjade (Deferasirox) (FOI-21-011)
Published 24 March 2021
Thank you for your Freedom of Information (FOI) request dated 4th January 2021, where you requested the following information:
鈥淎nnex 4: Specific adverse drug reaction follow-up forms鈥� as per the Risk Management Plan applicable for the product (Exjade). Also, in addition to this kindly provide 鈥淎nnex 6: Details of proposed additional risk minimisation activities鈥� 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