The new vaccine will be marketed as Hexyon by Sanofi Pasteur MSD in western Europe and as Hexacima by Sanofi Pasteur in eastern Europe.
It confers protection against pertussis (whooping cough), hepatitis B, diphtheria, poliomyelitis, tetanus and the HIB bacterium.
GSK’s Infanrix Hexa is currently the only six-in-one child vaccine on the market, with global revenues of £775m last year.
The EMA’s approval of Sanofi’s previous vaccine, Hexavac, was withdrawn after its effectiveness in protecting against hepatitis B was questioned.
According to Sanofi Pasteur, Hexyon has “a similar high immunogenicity profile for all antigens” to Infanrix Hexa, while its liquid formulation makes it more convenient for injection.
It will be used for primary and booster vaccination of infants aged six weeks to 24 months.
Jean-Paul Kress, President of Sanofi Pasteur MSD, said the recommendation “validates the clinical data supporting the vaccine’s effective and safe use for infants. Furthermore, its unique ready-to-use formulation will provide healthcare professionals with a simpler, more convenient vaccination process."
Olivier Charmeil, the head of Sanofi Pasteur, predicted the new vaccine would be a “key growth driver” for the company in 2013.