EMEA-002358-PIP03-19 - paediatric investigation plan

avapritinib

Key facts

• Active substance:
  avapritinib
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0083/2020
• PIP number:
  EMEA-002358-PIP03-19
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of mastocytosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  18/03/2020
• Compliance check done:
  Nej

Decision

P/0083/2020: EMA decision of 18 March 2020 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for avapritinib (EMEA-002358-PIP03-19)

Adopted Reference Number: EMA/76608/2020