EMEA-002347-PIP01-18 - paediatric investigation plan

Asciminib

Key facts

• Active Substance:
  Asciminib
• Therapeutic area:
  Oncology
• Decision number:
  P/0052/2020
• PIP number:
  EMEA-002347-PIP01-18
• Pharmaceutical form(s):
  • Age-appropriate oral solid dosage form
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of chronic myeloid leukaemia
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/01/2020

Decision

P/0052/2020: EMA decision of 29 January 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for asciminib (EMEA-002347-PIP01-18)

AdoptedReference Number: EMA/23718/2020