Posted by Michael Wonder on 17 Sep 2018
EMA validates marketing authorisation application for Trogarzo
14 September 2018 - Theratechnologies is pleased to announce that the EMA has confirmed the validity of the marketing authorization application for Trogarzo (ibalizumab) filed on August 28, 2018.
The validation confirms the submission is complete, and begins the EMA’s centralised review process. As a result, the start of procedure date has been set to 13 September 2018.
The EMA will review the application for Trogarzo under the accelerated assessment procedure.
