EMEA-001905-PIP01-15 - paediatric investigation plan

Lusutrombopag

Key facts

• Active Substance:
  Lusutrombopag
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0224/2016
• PIP number:
  EMEA-001905-PIP01-15
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of thrombocytopenia secondary to liver disease
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Shionogi Limited

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/08/2016

Decision

P/0224/2016: EMA decision of 12 August 2016 on the granting of a product specific waiver for lusutrombopag (EMEA-001905-PIP01-15)

AdoptedReference Number: EMA/441060/2016