EMEA-002962-PIP01-21 - paediatric investigation plan

AZD8233 sodium, PCSK9-targeted, antisense oligonucleotide (ASO)

Key facts

• Active Substance:
  AZD8233 sodium, PCSK9-targeted, antisense oligonucleotide (ASO)
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0465/2021
• PIP number:
  EMEA-002962-PIP01-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of elevated cholesterol
  • Treatment of mixed dyslipidaemia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/10/2021

Decision

P/0465/2021 : EMA decision of 29 October 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for AZD8233 sodium, PCSK9-targeted, antisense oligonucleotide (ASO) (EMEA-002962-PIP01-21)

AdoptedReference Number: EMA/509375/2021