EMEA-003066-PIP01-21 - paediatric investigation plan

Bordetella pertussis antigen: Filamentous Haemagglutinin

Bordetella pertussis antigen: Pertactin

Bordetella pertussis antigen: Pertussis toxoid

Inactivated Type 1 Poliovirus (Mahoney)

Inactivated Type 2 Poliovirus (MEF-1)

Inactivated Type 3 Poliovirus (Saukett)

tetanus toxoid

Key facts

• Active substance:
  • Bordetella pertussis antigen: Filamentous Haemagglutinin
  • Bordetella pertussis antigen: Pertactin
  • Bordetella pertussis antigen: Pertussis toxoid
  • Inactivated Type 1 Poliovirus (Mahoney)
  • Inactivated Type 2 Poliovirus (MEF-1)
  • Inactivated Type 3 Poliovirus (Saukett)
  • tetanus toxoid
• Therapeutic area:
  • Infectious diseases
  • Vaccines
• Decision number:
  P/0489/2021
• PIP number:
  EMEA-003066-PIP01-21
• Pharmaceutical form(s):
  Solution for injection in pre-filled syringe
• Condition(s) / indication(s):
  Prevention of infectious diseases caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, Poliovirus types 1, 2 and 3
• Route(s) of administration:
  Intramuscular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/12/2021
• Compliance check done:
  No

Decision

P/0489/2021 : EMA decision of 3 December 2021 on the granting of a product specific waiver for diphtheria toxoid, tetanus toxoid, bordetella pertussis antigen: pertussis toxoid, bordetella pertussis antigen... (EMEA-003066-PIP01-21)

Adopted Reference Number: EMA/632050/2021