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.
If you have a query about the information provided, please reply to this email.
Please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Experience Centre