EMEA-002967-PIP01-21 - paediatric investigation plan

Selatogrel

Key facts

• Active Substance:
  Selatogrel
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0263/2021
• PIP number:
  EMEA-002967-PIP01-21
• Pharmaceutical form(s):
  Solution for injection in pre-filled syringe
• Condition(s) / indication(s):
  Treatment of acute myocardial infarction
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/07/2021

Decision

P/0263/2021: EMA decision of 7 July 2021 on the granting of a product specific waiver for selatogrel (EMEA-002967-PIP01-21)

Reference Number: EMA/315326/2021