Freedom of Information request (FOI 22/1164)
Published 17 January 2024
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FOI 22/1164
14th December 2022
Dear
Thank you for your communication, dated 2nd December 2022, in which you requested the following information:
‘if the medicinal products Tazocin 4 g/0.5 g and Tazocin 2 g/0.25 g (piperacillin and tazobactam) by Pfizer Limited has a Risk Management Plan in place?
If yes, I would be grateful if you could share the list of safety concerns presented in that RMP or summary RMP. If possible, please let me know if any of the safety concerns has:
- a specific follow-up questionnaire,
- additional PV activities or additional risk minimization measures.’
Regarding your request for the Risk Management Plan (RMP), as the Marketing Authorisation application for Tazocin 4 g/0.5 g and Tazocin 2 g/0.25 g (piperacillin and tazobactam) 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.
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FOI Team,
Safety and Surveillance