EMEA-001196-PIP01-11 - paediatric investigation plan

Fostamatinib

Key facts

• Active Substance:
  Fostamatinib
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0242/2012
• PIP number:
  EMEA-001196-PIP01-11
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  22/10/2012

Decision

P/0242/2012: EMA decision of 22 October 2012 on the granting of a product specific waiver for fostamatinib (EMEA-001196-PIP01-11)

AdoptedReference Number: EMA/624726/2012