MHRA-100982-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • pegunigalsidase alfa
Invented Name
Elfabrio
PIP Number MHRA-100982-PIP01-23-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for infusion
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of Fabry disease
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
  • Chiesi Ltd
  • Country United Kingdom
  • Tel +390521279917
  • Email info@chiesi.com
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):pegunigalsidase alfa.pdf
Published Date 19/12/2023