Key facts

Invented name
  • Evarrest
  • Evicel
Active Substance
  • human fibrinogen
  • human thrombin
Therapeutic area
Other
Decision number
P/0397/2021
PIP number
EMEA-001149-PIP01-11-M07
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.

Email: DL-OMRilRAAllStaff@ITS.JNJ.com
Tel. +32 27463000
 

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

Decision

P/0397/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for human fibrinogen / human thrombin (Evicel, Evarrest), (EMEA-001149-PIP01-11-M07)

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