MHRA-100465-PIP01-22-M02 (update)

Key Facts

Active Substance
Active Substance:
  • efanesoctocog alfa
Invented Name
Not yet available
PIP Number MHRA-100465-PIP01-22-M02 (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 of congenital haemophilia A
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
  • Swedish Orphan Biovitrum AB
  • Country Sweden
  • Tel +4686972000
  • Email info@sobi.com
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 Check Procedure Number
Compliance procedure number
MHRA-100465-PIP01-22-M02-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):efanesoctocog alfa.pdf
Published Date 19/12/2023