EMEA-003451-PIP01-23 - paediatric investigation plan

derivative of azabicycloheptane-carboxamide

Key facts

• Active substance:
  derivative of azabicycloheptane-carboxamide
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  P/0252/2024
• PIP number:
  EMEA-003451-PIP01-23
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of bronchiectasis
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  19/07/2024
• Compliance check done:
  No

Decision

P/0252/2024: EMA decision of 19 July 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for derivative of azabicycloheptane-carboxamide (EMEA-003451-PIP01-23)

Adopted Reference Number: EMA/296571/2024