EMEA-000170-PIP01-07-M04 - paediatric investigation plan

Eltrombopag

Key facts

• Invented name:
  • Revolade
  • Revolade
• Active Substance:
  Eltrombopag
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0167/2016
• PIP number:
  EMEA-000170-PIP01-07-M04
• Pharmaceutical form(s):
  • Powder for oral suspension
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of Idiopathic Thrombocytopenia Purpura (ITP)
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Novartis Europharm Limited

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/06/2016
• Compliance procedure number:
  EMEA-C-000170-PIP01-07-M03
• Compliance opinion date:
  14/11/2014
• Compliance outcome:
  Positive

Decision

P/0167/2016: EMA decision of 15 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for eltrombopag (Revolade) (EMEA-000170-PIP01-07-M04)

AdoptedReference Number: EMA/193031/2016