FOI release

Nevanac Approval Information and Public Assessment Report

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 FOI2026/00417

Received 17 April 2026

Published 3 June 2026

Request

We would like to request information regarding the product Nevanac. From what our research has shown, Nevanac was originally approved on 11th December 2007, and the initial marketing authorisation holder was Alcon Laboratories (UK) Ltd. This was later transferred to Novartis Europharm Limited in 2018. Following this, the product was grandfathered in the UK post-brexit with the licence number PLGB 00101/1110-1111. Therefore, we would like to request the following: * Confirmation of Original Date of Approval in UK * Legal Basis of Original Application in UK * Public Assessment Reports for the Original Approval in UK

Response

See attached

Documents

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