EMEA-000170-PIP03-13-M04 - paediatric investigation plan

Eltrombopag

Key facts

• Invented name:
  • Revolade
  • Revolade
• Active Substance:
  Eltrombopag
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0516/2020
• PIP number:
  EMEA-000170-PIP03-13-M04
• Pharmaceutical form(s):
  • Film-coated tablet
  • Powder for oral suspension
• Condition(s) / indication(s):
  Treatment of aplastic anaemia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Novartis Europharm Limited

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  22/12/2020

Decision

P/0516/2020 : EMA decision of 22 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for eltrombopag (Revolade) (EMEA-000170-PIP03-13-M04)

AdoptedReference Number: EMA/633039/2020