Aplidin

Overview

By its judgment of 28 October 2020 in Case T-594/18, the General Court annulled the Commission Implementing Decision of 17 July 2018 refusing marketing authorisation for Aplidin. The judgment was subsequently appealed before the Court of Justice in Joined Cases C-6/21 P and C-16/21 P. On 22 June 2023, the Court of Justice set aside the judgment and referred the case back to the General Court (Case T-594/18 RENV).

On 28 June 2024, the European Commission revoked the Commission Implementing Decision of 17 July 2018 refusing marketing authorisation for Aplidin. Following the adoption of this decision, the Commission has requested EMA to re-assess the application for Aplidin. EMA is currently taking the appropriate steps to implement this decision.