FOI release

Freedom of Information request (FOI 22/963)

Published 17 January 2024

FOI 22/963

16th September 2022

Dear

Thank you for your email.

The Summary of Product Characteristics (SmPC) for Imbruvica (ibrutinib) 140 mg hard capsules, dated 15 February 2018, was approved as the RSI in July 2018. A copy is attached.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

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Yours sincerely

MHRA Customer Experience Centre