Posted by Michael Wonder on 11 Jun 2019
Evolus provides update of Nuceiva marketing authorisation application in Europe
10 June 2019 - Evolus today provided an update on the marketing authorisation application for Nuceiva in Europe that may result in the European Commission extending its final decision on approval beyond the 90 days previously stated by the company.
On April 26, the EMA Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the application for Nuceiva. Following a positive opinion from the CHMP, the EC undergoes an administrative decision-making process before issuing a final decision on an MAA.
Evolus was informed by the EMA that the EC has requested supplementary information from the EMA/CHMP as part of their review of the Nuceiva application. The EC has the ability to delay its standard timeline if additional information is requested of the EMA/CHMP during its decision-making process.
