EMEA-000912-PIP01-10-M06 - paediatric investigation plan

bedaquiline fumarate

Key facts

• Invented name:
  • Sirturo
  • Sirturo
• Active substance:
  bedaquiline fumarate
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0470/2022
• PIP number:
  EMEA-000912-PIP01-10-M06
• Pharmaceutical form(s):
  • Tablet
  • Granules
• 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:
  16/11/2022
• Compliance check done:
  No

Decision

P/0470/2022 : EMA decision of of 16 November 2022 on the acceptance of a modification of an agreed paediatric investigation plan for bedaquiline (fumarate) (Sirturo), (EMEA-000912-PIP01-10-M06)

Adopted Reference Number: EMA/884378/2022