EMEA-001136-PIP01-11-M03 - paediatric investigation plan

avatrombopag maleate

Key facts

• Invented name:
  Doptelet
• Active substance:
  avatrombopag maleate
• Therapeutic area:
  • Blood and lymphatic system disorders
  • Haematology-Hemostaseology
• Decision number:
  P/0137/2024
• PIP number:
  EMEA-001136-PIP01-11-M03
• Pharmaceutical form(s):
  • Film-coated tablet
  • Powder for oral suspension
• Condition(s) / indication(s):
  • Treatment of Idiopathic Thrombocytopenia Purpura (ITP)
  • Treatment of Thrombocytopenic Purpura Secondary to Liver Disease
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/05/2024
• Compliance check done:
  No

Decision

P/0137/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for avatrombopag maleate (Doptelet), (EMEA-001136-PIP01-11-M03)

Adopted Reference Number: EMA/153113/2024