FOI release

Freedom of Information request (FOI 22/834)

Published 17 January 2024

2nd August 2022

FOI 22/834

Dear ,

Thank you for your email.

This product was granted via a centralised procedure through the EMA on 21 June 1996.

Further information, including the Public Assessment Reports (which represent the non-clinical parts of the assessment of this product) are available through the EMA, via the below link:

https://www.ema.europa.eu/en/medicines/human/EPAR/caelyx-pegylated-liposomal

If you have a query about the information provided, please reply to this email.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

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

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Cheshire

SK9 5AF

Yours sincerely

MHRA Customer Experience Centre

Communications and engagement team

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU