EMEA-003442-PIP01-23 - paediatric investigation plan

genetically detoxified pertussis toxin (PTgen)

pertussis filamentous haemagglutinin (FHA)

Key facts

• Active substance:
  • genetically detoxified pertussis toxin (PTgen)
  • pertussis filamentous haemagglutinin (FHA)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0406/2023
• PIP number:
  EMEA-003442-PIP01-23
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of Pertussis disease
• Route(s) of administration:
  Intramuscular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/10/2023
• Compliance check done:
  No

Decision

P/0406/2023 : EMA decision of 27 October 2023 on the granting of a product specific waiver for genetically detoxified pertussis toxin (PTgen) / pertussis filamentous haemagglutinin (FHA) (EMEA-003442-PIP01-23)

Adopted Reference Number: EMA/429431/2023