EMEA-001136-PIP02-19-M01 - paediatric investigation plan

avatrombopag

Key facts

• Invented name:
  Doptelet
• Active Substance:
  avatrombopag
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0482/2020
• PIP number:
  EMEA-001136-PIP02-19-M01
• Pharmaceutical form(s):
  • Film-coated tablet
  • Powder for oral suspension
• Condition(s) / indication(s):
  Treatment of chemotherapy-induced thrombocytopenia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/12/2020

Decision

P/0482/2020 : EMA decision of 9 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for avatrombopag (Doptelet) (EMEA-001136-PIP02-19-M01)

AdoptedReference Number: EMA/631901/2020