FOI release

FOI request: fluoxetine SmPC documents - 2011/2019

Case reference FOI2026/00387

Received 12 April 2026

Published 2 June 2026

Request

Please treat this as a formal request under the Freedom of Information Act 2000. Please provide copies of SmPC documents for fluoxetine held by the MHRA between 1 January 2011 and 31 December 2019. Please include all versions, including historical versions. This request does not seek any information that could expose patient identity. Where information is exempt, I request that related, non-exempt material be disclosed.

Response

See attached

Documents

• FOI2026_00387 (redacted).pdf (592.3 KB)
• FOI2026_00387_Annex A.docx (36.2 KB)
• SmPCs-PL 00006_0195.zip (1.5 MB)
• SmPCs_PL 00006_0272.zip (1.5 MB)

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