MHRA-102467-PIP01-26-M01 (update)

Key Facts

Active Substance
Active Substance:
  • HUMAN FIBRINOGEN
Invented Name
  • Fesilty 1 g Powder and solvent for solution for injection/infusion
  • Fesilty
PIP Number MHRA-102467-PIP01-26-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for solution for injection or infusion
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of congenital fibrinogen deficiency
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
21/04/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-102467-PIP01-26-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):HUMAN FIBRINOGEN.pdf
Published Date 06/07/2026