EMEA-001598-PIP01-13-M03 - paediatric investigation plan

human fibrinogen

human thrombin

Key facts

• Invented name:
  VeraSeal
• Active substance:
  • human fibrinogen
  • human thrombin
• Therapeutic area:
  Other
• Decision number:
  P/0052/2021
• PIP number:
  EMEA-001598-PIP01-13-M03
• Pharmaceutical form(s):
  Solution for sealant
• Condition(s) / indication(s):
  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:
  27/01/2021
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001598-PIP01-13-M03
• Compliance opinion date:
  26/04/2023
• Compliance outcome:
  Positive

Decision

P/0052/2021: EMA decision of 27 January 2021 on the acceptance of a modification of an agreed paediatric investigation plan for human fibrinogen/ human thrombin (VeraSeal), (EMEA-001598-PIP01-13-M03)

Adopted Reference Number: EMA/3827/2021