Freedom of Information request (FOI 22/1121)
Published 17 January 2024
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22nd November 2022
FOI 22/1121
Dear ,
Thank you for your request dated 18th November 2022 where you requested the educational materials for Jinarc and Samsca.
Please note that the additional risk minimisation measures apply for the ADPKD indication only so if you are submitting a licence application for adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH) the aRMMs are not required.
We can confirm that there are no educational materials in place for Samsca and those for Jinarc can be accessed on EMC using the link below:
https://www.medicines.org.uk/emc/product/6849/rmms
Kind regards,
FOI Team
Safety & Surveillance Group
Medicines and Healthcare Products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU