EMEA-002996-PIP01-21 - paediatric investigation plan

ExPEC9V

Key facts

• Active substance:
  ExPEC9V
• Therapeutic area:
  Vaccines
• Decision number:
  P/0026/2022
• PIP number:
  EMEA-002996-PIP01-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of infections caused by extraintestinal pathogenic Escherichia coli (ExPEC)
• Route(s) of administration:
  Intramuscular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  04/02/2022
• Compliance check done:
  Ne

Decision

P/0026/2022: EMA decision of 4 February 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ExPEC9V (EMEA-002996-PIP01-21)

Adopted Reference Number: EMA/11870/2022