EMEA-002115-PIP01-17-M05 - paediatric investigation plan

Pretomanid

Key facts

• Invented name:
  Dovprela (previously Pretomanid FGK)
• Active Substance:
  Pretomanid
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0292/2022
• PIP number:
  EMEA-002115-PIP01-17-M05
• 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:
  11/08/2022

Decision

P/0292/2022: EMA decision of 11 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for pretomanid (Dovprela), (EMEA-002115-PIP01-17-M05)

Reference Number: EMA/630765/2022