EMEA-001149-PIP01-11-M04

Key facts

Invented name
  • Evarrest
  • Evicel
Active substance
  • human fibrinogen
  • human thrombin
Therapeutic area
Other
Decision number
P/0399/2017
PIP number
EMEA-001149-PIP01-11-M04
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.: +1 9082182390
Email: skluesne@its.jnj.com
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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