MHRA-100451-PIP01-22-M03 (update)

Key Facts

Active Substance
Active Substance:
  • fidanacogene elaparvovec
Invented Name
Not yet available
PIP Number MHRA-100451-PIP01-22-M03 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of congenital factor IX deficiency (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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):fidanacogene elaparvovec .pdf
Published Date 28/10/2024