MHRA-100968-PIP01-23

Key Facts

Active Substance
Active Substance:
  • dirloctocogene samoparvovec
Invented Name
Not available at present
PIP Number MHRA-100968-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of congenital haemophilia A
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
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):dirloctocogene samoparvovec.pdf
Published Date 03/10/2024