Freedom of Information request (FOI 22/1148)
Published 17 January 2024
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FOI 22/1148
5th December 2022
Dear
Thank you for your email, dated 28th November 2022, in which you requested:
“a summary of RMP available for Primacor 1 mg/ml solution for injection”
We can confirm that we do not hold the information that you have requested. As the original Marketing Authorisation application for Primacor was made prior to the 2012 amendment in pharmacovigilance legislation, which requires an RMP for all new applications, the MHRA does not hold an RMP for this product.
However you may be interested to know that the CMDh publishes safety concerns captured in the EU RMP, including details of safety concerns captured in some RMPs for products containing milrinone, which can be found here: https://www.hma.eu/human-medicines/cmdh/pharmacovigilance/rmp.html
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,
Vigilance and Risk Management of Medicines Division