EMEA-001315-PIP02-16-M02 - paediatric investigation plan

Fevipiprant

Key facts

• Active substance:
  Fevipiprant
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0341/2019
• PIP number:
  EMEA-001315-PIP02-16-M02
• Pharmaceutical form(s):
  • Tablet
  • Chewable tablet
  • Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  Treatment of asthma
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/09/2019
• Compliance check done:
  No

Decision

P/0341/2019: EMA decision of 10 September 2019 on the acceptance of a modification of an agreed paediatric investigation plan for fevipiprant (EMEA-001315-PIP02-16-M02)

Adopted Reference Number: EMA/467449/2019