EMEA-001149-PIP01-11-M05

Key facts

Invented name
  • Evarrest
  • Evicel
Active substance
  • human fibrinogen
  • human thrombin
Therapeutic area
Other
Decision number
P/0339/2019
PIP number
EMEA-001149-PIP01-11-M05
Pharmaceutical form(s)
  • Solution for sealant
  • Sealant matrix
Condition(s) / indication(s)
  • Treatment of cerebrospinal fluid leakage resulting from a neurosurgical procedure
  • Treatment of haemorrhage resulting from a surgical procedure
Route(s) of administration
Epilesional use
Contact for public enquiries
Omrix Biopharmaceuticals N.V.

Tel. +32 27463000
E-mail: omrix-regaffairs@its.jnj.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

How useful was this page?

Add your rating