The EC decision follows the European Medicines Agency recommendation supported by the results of Phase III clinical studies that demonstrated the safety and immune response of Hexyon/Hexacima against all six targeted diseases.
The vaccine will protect infants against diphtheria, tetanus, pertussis, Hepatitis B, poliomyelitis, and Haemophilus influenzae type b.
The company will market the new vaccine in Eastern European countries under the brand name Hexacima.
Sanofi Pasteur president and CEO Olivier Charmeil said that the Hexyon 6-in-1 pediatric vaccine would reduce the number of vaccination visits for infants and protect children against six major childhood diseases.
The new 6-in-1 vaccine will be available in international markets under the trade name Hexaxim.