BioCentury
ARTICLE | Clinical News

Hexyon/Hexacima regulatory update

February 25, 2013 8:00 AM UTC

EMA's CHMP issued a positive opinion recommending approval of an MAA for Hexyon/Hexacima from Sanofi for primary and booster vaccination against diphtheria, tetanus, pertussis, Hepatitis B, polio and Haemophilus influenzae type b (Hib) in infants and toddlers ages 6 weeks to 24 months. Sanofi Pasteur MSD, a JV between Sanofi's Sanofi Pasteur S.A. vaccines unit and Merck, is developing the combination vaccine. Sanofi Pasteur MSD will market the vaccine as Hexyon in Western European countries, including France, Germany and the U.K., while Sanofi Pasteur S.A. will market the vaccine in Eastern European countries as Hexacima. ...