EMEA-001491-PIP01-13-M02 - paediatric investigation plan

fosdenopterin (ORGN001)

Key facts

• Invented name:
  Nulibry
• Active substance:
  fosdenopterin (ORGN001)
• Therapeutic area:
  Other
• Decision number:
  P/0132/2022
• PIP number:
  EMEA-001491-PIP01-13-M02
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of molybdenum cofactor deficiency type A
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/04/2022
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-001491-PIP01-13-M01
• Compliance opinion date:
  15/10/2021
• Compliance outcome:
  Positive

Decision

P/0132/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for fosdenopterin (ORGN001), (EMEA-001491-PIP01-13-M02)

Adopted Reference Number: EMA/193794/2022