EMEA-001490-PIP01-13-M04 - paediatric investigation plan

Cholera vaccine, live attenuated, oral (strain CVD 103-HgR)

Key facts

• Invented name:
  Vaxchora
• Active substance:
  Cholera vaccine, live attenuated, oral (strain CVD 103-HgR)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0189/2023
• PIP number:
  EMEA-001490-PIP01-13-M04
• Pharmaceutical form(s):
  • Powder for oral suspension
  • Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  Prevention of cholera
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/05/2023
• Compliance check done:
  No

Decision

P/0189/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for cholera vaccine, live attenuated, oral (strain CVD 103-HgR) (Vaxchora), (EMEA-001490-PIP01-13-M04)

Adopted Reference Number: EMA/201813/2023