EMEA-002932-PIP02-21 - paediatric investigation plan

vorasidenib hemicitrate hemihydrate

Key facts

• Active substance:
  vorasidenib hemicitrate hemihydrate
• Therapeutic area:
  Oncology
• Decision number:
  P/0007/2022
• PIP number:
  EMEA-002932-PIP02-21
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of low grade glioma
• 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:
  31/01/2022
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-002932-PIP02-21
• Compliance opinion date:
  15/12/2023
• Compliance outcome:
  Positive

Decision

P/0007/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for vorasidenib (as hemicitrate, hemihydrate salt) (EMEA-002932-PIP02-21)

Reference Number: EMA/12217/2022