Posted by Michael Wonder on 02 Apr 2019
Heron announces European Medicines Agency validation of marketing authorisation application for HTX-011 for post-operative pain management
1 April 2019 - Heron Therapeutics today announced that the marketing authorisation application for its investigational agent, HTX-011, for post-operative pain, was validated by the EMA.
Validation of the application confirms that the submission is complete and starts the EMA's Centralised Procedure. The EMA granted eligibility to the Centralised Procedure for HTX-011 based on it meeting the criteria of a medicinal product constituting a significant scientific innovation.
The Centralised Procedure allows applicants to receive a marketing authorisation that is valid throughout the European Union. With the validation of the MAA, an opinion from the EMA CHMP would be anticipated in the first half of 2020.
