MHRA-100695-PIP01-22-M04 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • Etranacogene dezaparvovec
Invented Name
  • Hemgenix
  • Hemgenix
  • Hemgenix
  • Hemgenix
PIP Number MHRA-100695-PIP01-22-M04 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of haemophilia B
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
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ETRANACOGENE DEZAPARVOVEC.pdf
Published Date 30/04/2024