EMEA-002910-PIP01-20 - paediatric investigation plan

Olpasiran

Key facts

• Active substance:
  Olpasiran
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0081/2021
• PIP number:
  EMEA-002910-PIP01-20
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of cardiovascular events
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  17/03/2021
• Compliance check done:
  Ne

Decision

P/0081/2021 : EMA decision of 17 March 2021 on the granting of a product specific waiver for olpasiran (EMEA-002910-PIP01-20)

Adopted Reference Number: EMA/97658/2021