FOI release

The MHRA and CHM pertaining CHM decision to expand the NiQuitin indication (Type II variation)

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

Case reference FOI2025/00025

Received 8 January 2025

Published 28 March 2025

Request

On Wed 5, Dec 2024 Perrigo received correspondence from the MHRA to inform us that the agency and the independent experts in CHM will be reviewing the decision to expand the NiQuitin indication (Type II variation) that was approved on 17-10-2024, based on the evidence that was presented. We have been advised that this referral is necessary because it is not completely aligned with the previous decision made by the CHM some time ago. We request that all information which is held by the MHRA and CHM pertaining to this previous CHM decision is shared.

Response

see attached

Documents

• FOI2025_00025 redacted for publication.pdf (105.6 KB)

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