FOI release

Freedom of Information Request –Vortioxetine

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2026/00453

Received 24 April 2026

Published 10 June 2026

Request

Lundbeck has the above PIP approved in 2023 ( MHRA-100515-PIP01-22-M01 (update) | MHRA Please let me know if a marketing authorisation application for extending it for paed use has been submitted by Lundbeck or will be submitted and when is the tentative approval date in the UK?

Response

See attached

Documents

• FOI2026_00453 (redacted).pdf (935.3 KB)

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