Posted by Michael Wonder on 26 Mar 2021
Takeda begins regulatory submissions for dengue vaccine candidate in EU and Dengue-endemic countries
26 March 2021 - EMA to conduct first-ever parallel assessment of a medicinal product, Takeda’s dengue vaccine candidate (TAK-003), for use in the EU; countries outside of the EU through the EU-M4all (Previously Article 58) procedure.
Takeda today announced that the EMA has accepted the Company’s filing packages for its dengue vaccine candidate (TAK-003) which is being investigated for the prevention of dengue due to any dengue virus serotype in individuals ages four to 60.
Takeda intends to submit regulatory filings in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka and Thailand during 2021.
