EMEA-001201-PIP01-11-M02 - paediatric investigation plan

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

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: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  23/09/2013
• Compliance procedure number:
  EMEA-001201-PIP01-11-M02
• Compliance opinion date:
  27/01/2017
• Compliance outcome:
  Positive

Decision

P/0229/2013: EMA decision of 23 September 2013 on the acceptance of a modification of an agreed PIP for Purified Tetanus Toxoid / Inactivated Type 1, 2 and 3 Poliovirus / Purified Pertussis Toxoid / Haemophilus influenza...

AdoptedReference Number: EMA/492665/2013