EMEA-001391-PIP01-12 - paediatric investigation plan

glucarpidase

Key facts

• Active substance:
  glucarpidase
• Therapeutic area:
  Oncology
• Decision number:
  P/0176/2013
• PIP number:
  EMEA-001391-PIP01-12
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of methotrexate toxicity
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  30/07/2013
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-001391-PIP01-12
• Compliance opinion date:
  24/07/2020
• Compliance outcome:
  Positive

Decision

P/0176/2013: EMA decision of 30 July 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for glucarpidase (EMEA-001391-PIP01-12)

Adopted Reference Number: EMA/375098/2013