EMEA-002115-PIP01-17-M06 - paediatric investigation plan

pretomanid

Key facts

• Invented name:
  Dovprela (previously Pretomanid FGK)
• Active substance:
  pretomanid
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0295/2024
• PIP number:
  EMEA-002115-PIP01-17-M06
• Pharmaceutical form(s):
  • Dispersible tablet
  • Tablet
• Condition(s) / indication(s):
  Treatment of multi-drug-resistant tuberculosis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  20/08/2024
• Compliance check done:
  Non

Decision

P/0295/2024: EMA decision of 20 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for pretomanid (Dovprela), (EMEA-002115-PIP01-17-M06)

Adopted Reference Number: EMA/364156/2024