MHRA-100083-PIP01-21-M01 (update)

Key Facts

Active Substance
  • Human Fibrinogen (INN) / Human Thrombin (INN)
  • HUMAN THROMBIN
  • HUMAN FIBRINOGEN
Invented Name
  • EVICEL, Solution for sealant
  • EVARREST, Sealant matrix (withdrawn EU MAA)
  • EVICEL
  • EVICEL
  • EVICEL
PIP Number MHRA-100083-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Solution for sealant
  • Sealant matrix
Therapeutic area
Therapeutic area:
  • Other: blood-derived topical haemostats
Conditions / Indications
  • Treatment of: haemorrhage from a surgical procedure
  • CSF leakage from a neurosurgical procedure
Route(s) of administration
Route(s) of administration:
  • Epilesional 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):Human Fibrinogen (INN) / Human Thrombin (INN) ;HUMAN THROMBIN;HUMAN FIBRINOGEN.pdf
Published Date 15/11/2021