EMEA-001149-PIP01-11-M07 - paediatric investigation plan

human fibrinogen

human thrombin

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
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/09/2021
• Compliance check done:
  Non

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)

Adopted Reference Number: EMA/471932/2021