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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):RURIOCTOCOG ALFA PEGOL.pdf
Published Date 02/11/2022