Posted by Michael Wonder on 22 Jan 2019
Sanofi UK marketing authorisation granted for Sanofi Pasteur’s trivalent influenza vaccine (split virion, inactivated) high dose (TIV high dose)
21 January 2019 - UK is the only European country where TIV high dose is approved.
UK marketing authorisation has been granted for Sanofi Pasteur’s trivalent influenza vaccine (split virion, inactivated) high dose (TIV high dose), which is indicated for active immunisation of people 65 years of age and older against influenza disease.
The UK approval of TIV high dose followed a national procedure, with Sanofi Pasteur working in collaboration with the UK regulator in an agile and flexible way to gain accelerated assessment of the dossier. The process took just seven months, compared with a standard review time of 12 months for national approvals. This way of working could provide opportunities for faster product approvals after the UK leaves the European Union.
