EMEA-002905-PIP01-20-M01 - paediatric investigation plan

brensocatib

Key facts

• Active substance:
  brensocatib
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  P/0359/2024
• PIP number:
  EMEA-002905-PIP01-20-M01
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of non-cystic fibrosis bronchiectasis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  25/10/2024
• Compliance check done:
  No

Decision

P/0359/2024 : EMA decisio of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for brensocatib, (EMEA- 002905-PIP01-20-M01)

Adopted Reference Number: EMA/481253/2024