MHRA-100198-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • RURIOCTOCOG ALFA PEGOL
Invented Name
Adynovi
PIP Number MHRA-100198-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder and solvent for solution for injection
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment and prophylaxis of bleeding in patients with haemophilia A
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
Yes
Compliance Check Decision Date
Compliance opinion date
27/10/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100198-PIP01-21-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):RURIOCTOCOG ALFA PEGOL.pdf
Published Date 14/04/2026