Key facts

Invented name
Hexacima and associated names
Active Substance
  • Purified Tetanus Toxoid
  • Inactivated Type 1 Poliovirus (Mahoney)
  • Inactivated Type 2 Poliovirus (MEF-1)
  • Inactivated Type 3 Poliovirus (Saukett)
  • Haemophilus influenzae type b polysaccharide conjugated to tetanus protein
  • Hepatitis B Surface Antigen, recombinant
  • Purified Diphtheria Toxoid (DTaP-IPV-HepB-PRP-T)
  • Purified Filamentous Haemagglutinin
  • purified pertussis toxoid
Therapeutic area
Vaccines
Decision number
P/0229/2013
PIP number
EMEA-001201-PIP01-11-M02
Pharmaceutical form(s)
Suspension for injection
Condition(s) / indication(s)
Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus types 1, 2 and 3, Haemophilus influenzae type b and Hepatitis B virus
Route(s) of administration
Intramuscular use
Contact for public enquiries

Sanofi pasteur

Email: piplan@sanofipasteur.com
Tel. +33 4373 75038

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-001201-PIP01-11-M02
Compliance opinion date
Compliance outcome
Positive

Decision

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