EMA/PE/0000227908 - paediatric investigation plan

nerandomilast

Key facts

• Active substance:
  nerandomilast
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  EMA/PE/0000227908
• PIP number:
  EMA/PE/0000227908
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of fibrosing Interstitial Lung Diseases (ILD)
• Route(s) of administration:
  • Gastric use
  • Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/01/2025
• Compliance check done:
  Nie

Decision

EMA/PE/0000227908 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for nerandomilast

Adopted Reference Number: EMADOC-1700519818-1855405