European Medicines Agency: Committee for Medicinal Products for Human Use (CHMP) 18-21 February 2013
Meeting highlights

Positive recommendations on new medicines
Hexacima
– Sanofi Pasteur S.A.
– diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type B conjugate vaccine (adsorbed)
– Primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type B (Hib).
– Summary of opinion for Hexacima

Hexyon
– Sanofi Pasteur MSD, SNC
-diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type B conjugate vaccine (adsorbed)
– Primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type B (Hib).
– Summary of opinion for Hexyon

Positive recommendations on extensions of therapeutic indications
Cervarix
– GlaxoSmithKline Biologicals
– human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, absored)
– Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic human papillomavirus (HPV) types. See section 5.1 for important information on the data that support this indication.
– Summary of opinion for Cervarix