EMA/PE/0000238807 - paediatric investigation plan

derivative of azabicycloheptane-carboxamide

Key facts

• Active substance:
  derivative of azabicycloheptane-carboxamide
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  EMA/PE/0000238807
• PIP number:
  EMA/PE/0000238807
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of bronchiectasis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/05/2025
• Compliance check done:
  Nie

Decision

EMA/PE/0000238807 : EMA decision of 16 May 2025 on the acceptance of a modification of an agreed paediatric investigation plan for derivative of azabicycloheptane-carboxamide (BI 1291583)

Adopted Reference Number: EMADOC-1700519818-2107010