EMEA-003134-PIP01-21 - paediatric investigation plan

nifurtimox

Key facts

• Active substance:
  nifurtimox
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0081/2022
• PIP number:
  EMEA-003134-PIP01-21
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of Chagas disease
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/03/2022
• Compliance check done:
  Da
• Compliance procedure number:
  EMEA-C-003134-PIP01-21
• Compliance opinion date:
  09/09/2022
• Compliance outcome:
  Positive

Decision

P/0081/2022 : EMA decision of 11 March 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for nifurtimox (EMEA-003134-PIP01-21)

Adopted Reference Number: EMA/100581/2022