Decision regarding the Brinzolamide objection

The Medicines Evaluation Board (MEB) has made a decision regarding an objection by Alcon Laboratories (UK) Ltd.

Alcon objected to the marketing authorisation granted by the MEB to Teva Nederland B.V. for Brinzolamide Teva 10 mg/mL, eye drops, suspension (RVG 112007). The MEB declares that the objections raised by Alcon are unfounded and upholds the contested decision from 24 February 2015. This means that the marketing authorisation as granted to Teva remains valid.

On 31 March 2015, Alcon objected to the decision by the MEB on 24 February 2015 to award a marketing authorisation to Teva Nederland B.V. On 19 June 2015, the objections committee of the MEB heard Alcon as part of the objection proceedings, after which the MEB took the aforementioned decision related to the objection on 15 July 2015. Alcon was informed of the decision on the objection on 15 July 2015.