EMA/PE/0000221485 - paediatric investigation plan

cangrelor (tetrasodium)

Key facts

• Invented name:
  Kengrexal
• Active substance:
  cangrelor (tetrasodium)
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  EMA/PE/0000221485
• PIP number:
  EMA/PE/0000221485
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Prevention of non-site-specific embolism and thrombosis
• Route(s) of administration:
  Intravenous use
• Decision type:
  RPM: decision refers to a refusal on the application for modification of an agreed PIP
• Decision date:
  06/12/2024
• Compliance check done:
  No

Decision

EMA/PE/0000221485 : EMA decision of 6 December 2024 on the refusal of a modification of an agreed paediatric investigation plan for cangrelor tetrasodium (Kengrexal)

Adopted Reference Number: EMADOC-1700519818-1792970