EMEA-002972-PIP02-23 - paediatric investigation plan

seralutinib

Key facts

• Active substance:
  seralutinib
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  P/0327/2024
• PIP number:
  EMEA-002972-PIP02-23
• Pharmaceutical form(s):
  • Inhalation powder
  • Capsule, hard
• Condition(s) / indication(s):
  Treatment of pulmonary arterial hypertension
• Route(s) of administration:
  Inhalation use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0327/2024 : EMA decision of 13 September 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for seralutinib (EMEA-002972-PIP02-23)

Adopted Reference Number: EMA/412945/2024