MHRA-101188-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • fosdenopterin
Invented Name
Nulibry
PIP Number MHRA-101188-PIP01-23-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for solution for injection
Therapeutic area
Therapeutic area:
  • Other: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products
Conditions / Indications
Conditions / Indications:
  • Treatment of patients with molybdenum cofactor deficiency (MoCD) Type A
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):fosdenopterin.pdf
Published Date 19/12/2023