Freedom of information request on Risk Management Plan (RMP) for Zeposia (Ozanimod) MAH Bristol-Myers Squibb in the recent indication extension to Ulcerative Colitis (UC)(FOI 22/430)
Published 31 May 2022
© Crown copyright 2022
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-31-january-2022/freedom-of-information-request-on-risk-management-plan-rmp-for-zeposia-ozanimod-mah-bristol-myers-squibb-in-the-recent-indication-extension-to-ulc
FOI 22/430
1st February 2022
Dear
Thank you for your email, dated 13th December 2021, in which you requested:
“The current:
• Risk Management Plan (RMP) for Zeposia (Ozanimod) MAH Bristol-Myers Squibb in the recent indication extension to Ulcerative Colitis (UC)“
A copy of the information, which can be disclosed, is attached.
Information that has been redacted is exempt under Section 40 (Personal Information) of the Freedom of Information (FOI) Act and is therefore withheld. We have concluded that disclosing this information would not be appropriate because providing information subject to Section 40 would be an infringement of personal data. Furthermore, we do not believe that there is an overriding public interest in disclosing this information in this instance.
I hope the information provided is helpful; however, 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 DivisionFOI 22/430
1st February 2022
Dear
Thank you for your email, dated 13th December 2021, in which you requested:
“The current:
• Risk Management Plan (RMP) for Zeposia (Ozanimod) MAH Bristol-Myers Squibb in the recent indication extension to Ulcerative Colitis (UC)“
A copy of the information, which can be disclosed, is attached.
Information that has been redacted is exempt under Section 40 (Personal Information) of the Freedom of Information (FOI) Act and is therefore withheld. We have concluded that disclosing this information would not be appropriate because providing information subject to Section 40 would be an infringement of personal data. Furthermore, we do not believe that there is an overriding public interest in disclosing this information in this instance.
I hope the information provided is helpful; however, 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