EMEA-002343-PIP01-18 - paediatric investigation plan

Diphtheria toxoid

tetanus toxoid

pertussis toxoid

pertussis filamentous haemagglutinin

pertactin

Key facts

• Active substance:
  • Diphtheria toxoid
  • tetanus toxoid
  • pertussis toxoid
  • pertussis filamentous haemagglutinin
  • pertactin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0231/2019
• PIP number:
  EMEA-002343-PIP01-18
• Condition(s) / indication(s):
  Prevention of infectious diseases caused by Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis
• Route(s) of administration:
  Intramuscular use
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  16/07/2019
• Compliance check done:
  No

Decision

P/0231/2019: EMA decision of 16 July 2019 on the refusal of a paediatric investigation plan and on the granting of a waiver for diphtheria toxoid / tetanus toxoid / pertussis toxoid / pertussis filamentous haemagglutinin / pertactin (EMEA-002343-PIP01-18)

Adopted Reference Number: EMA/385570/2019