EMEA-002934-PIP01-20 - paediatric investigation plan

crisantaspase

Key facts

• Active substance:
  crisantaspase
• Therapeutic area:
  Oncology
• Decision number:
  P/0453/2021
• PIP number:
  EMEA-002934-PIP01-20
• Pharmaceutical form(s):
  • Solution for injection
  • Solution for infusion
• Condition(s) / indication(s):
  • Treatment of acute lymphoblastic leukaemia
  • Treatment of lymphoblastic lymphoma
• Route(s) of administration:
  • Intramuscular use
  • Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/10/2021
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-002934-PIP01-20
• Compliance opinion date:
  26/05/2023
• Compliance outcome:
  Positive

Decision

P/0453/2021 : EMA decision of 29 October 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for crisantaspase (EMEA-002934-PIP01-20)

Adopted Reference Number: EMA/535417/2021