EMEA-002766-PIP02-21 - paediatric investigation plan

Bentracimab

Key facts

• Active Substance:
  Bentracimab
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0290/2021
• PIP number:
  EMEA-002766-PIP02-21
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  • Prevention of ticagrelor associated haemorrhage
  • Treatment of ticagrelor associated haemorrhage
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/08/2021

Decision

P/0290/2021 : EMA decision of 11 August 2021 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for bentracimab (EMEA-002766-PIP02-21)

AdoptedReference Number: EMA/434009/2021