EMEA-001070-PIP01-10-M02 - paediatric investigation plan

2-iminobiotin

Key facts

• Active substance:
  2-iminobiotin
• Therapeutic area:
  Neonatology-Paediatric Intensive Care
• Decision number:
  P/0192/2020
• PIP number:
  EMEA-001070-PIP01-10-M02
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of perinatal asphyxia
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/05/2020
• Compliance check done:
  No

Decision

P/0192/2020: EMA decision of 15 May 2020 on the acceptance of a modification of an agreed paediatric investigation plan for 2-iminobiotin (EMEA- 001070-PIP01-10-M02)

Adopted Reference Number: EMA/233140/2020