EMEA-001079-PIP01-10-M06 - paediatric investigation plan

fibrinogen

thrombin

aprotinin

calcium chloride

Key facts

• Active substance:
  • fibrinogen
  • thrombin
  • aprotinin
  • calcium chloride
• Therapeutic area:
  Other
• Decision number:
  P/0009/2023
• PIP number:
  EMEA-001079-PIP01-10-M06
• Pharmaceutical form(s):
  Powder and solvent for sealant
• Condition(s) / indication(s):
  • Prevention of haemorrhage resulting from a surgical 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:
  31/01/2023
• Compliance check done:
  No

Decision

P/0009/2023 : EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for fibrinogen / thrombin / aprotinin / calcium chloride (KolFib; SILKETAL), (EMEA-001079-PIP01-10-M06)

Reference Number: EMA/29421/2023