EMEA-001196-PIP02-17 - paediatric investigation plan

Fostamatinib

Key facts

• Active substance:
  Fostamatinib
• Therapeutic area:
  Other
• Decision number:
  P/0195/2018
• PIP number:
  EMEA-001196-PIP02-17
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of idiopathic thrombocytopenic purpura as a model for immunomodulation
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Compliance check done:
  Ne

Decision

P/0195/2018: EMA decision of 17 July 2018 on the granting of a product specific-waiver for fostamatinib (EMEA-001196-PIP02-17)

Adopted Reference Number: EMA/376000/2018