Freedom of Information request (FOI 22/840)
Published 17 January 2024
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15th August 2022
FOI 22/840
Dear
Thank you for your email, dated 22nd July 2022, in which you requested:
“a copy of the Risk Management Plan for Eliquis 2.5 mg film-coated tablets and Eliquis 5 mg film-coated tablets PL Numbers PLGB 54213/0001 and PLGB 54213/0002, along with any risk minimisation measures and a copy of the approved Distribution Plan for risk materials”
We can confirm that the MHRA holds a copy of the requested RMP, attached above.
Risk minimisation measures for Eliquis are available publicly available on the eMC, which can be accessed here:
2.5 mg film-coated tablets - https://www.medicines.org.uk/emc/product/4756/smpc
5 mg film-coated tablets - https://www.medicines.org.uk/emc/product/2878/smpc
For all DOACs including apixaban innovator and generics, the MHRA distribution requirement is for copies of the aRMMs to be made available on the eMC or other appropriate website, with hard copies available to provide on request. Ideally, a copy of the patient alert card should be provided in the pack with the tablets for all DOACs including generics.
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.
Kind regards,
FOI Team
Safety and Surveillance Division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU