EMEA-001196-PIP03-21 - paediatric investigation plan

Fostamatinib

Key facts

• Invented name:
  Tavlesse
• Active substance:
  Fostamatinib
• Therapeutic area:
  • Haematology-Hemostaseology
  • Immunology-Rheumatology-Transplantation
• Decision number:
  P/0027/2022
• PIP number:
  EMEA-001196-PIP03-21
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of autoimmune haemolytic anaemia
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2022
• Compliance check done:
  Nej

Decision

P/0027/2022: EMA of of 31 January 2022 on the granting of a product specific waiver for fostamatinib (Tavlesse), (EMEA-001196-PIP03-21)

Adopted Reference Number: EMA/12352/2022