Freedom of Information request on the risk management plan for Rivaroxaban 2.5, 10, 15 and 20 mg film-coated tablets (FOI 22/394)
Published 31 May 2022
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FOI 22/394
14th February 2022
Dear
Thank you for your email, dated 21st January 2022, in which you requested:
“We would like to receive information under the FOI act
RIVAROXABAN ACCORD 15 MG FILM COATED TABLETS leaflet MAH GENERIC 2_PLGB 20075-1444.pdf Rivaroxaban 2.5, 10, 15 and 20 mg film-coated tablets - (PL 21562/0031-4) Please share Risk Management Plans submitted for the above MA’s”
We can confirm that the MHRA holds a copy of the requested RMPs. Please note that the first 2 RMPs you have requested are the same, and so only 1 copy has been sent. Information that has been redacted is exempt under Section 40 (Personal Information) or Section 43 (Commercial Interests) of the Freedom of Information (FOI) Act and is therefore withheld. Section 40 provides that personal information may be exempt from release where to do so would contravene data protection principles. Section 43 provides that information will be exempt from release where to do so would or would be likely to prejudice commercial interests. Furthermore, we do not believe that there is an overriding public interest in disclosing the redacted information in this instance. 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