EMEA-000170-PIP02-10-M03 - paediatric investigation plan

Eltrombopag

Key facts

• Invented name:
  • Revolade
  • Revolade
• Active Substance:
  Eltrombopag
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0070/2019
• PIP number:
  EMEA-000170-PIP02-10-M03
• Pharmaceutical form(s):
  • Powder for oral suspension
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of secondary thrombocytopenia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  22/03/2019

Decision

P/0070/2019: EMA decision of 22 March 2019 on the acceptance of a modification of an agreed paediatric investigation plan for eltrombopag (Revolade), (EMEA-000170-PIP02-10-M03)

AdoptedReference Number: EMA/107435/2019