MHRA-101071-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • pegzilarginase
Invented Name
Loargys
PIP Number MHRA-101071-PIP01-23-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection/ infusion
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of hyperargininaemia
Route(s) of administration
  • Intravenous use
  • SUBCUTANEOUS USE
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
20/01/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-101071-PIP01-23-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):pegzilarginase.pdf
Published Date 16/07/2026