EMEA-001169-PIP02-13 - paediatric investigation plan

alirocumab

Key facts

• Active substance:
  alirocumab
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0100/2014
• PIP number:
  EMEA-001169-PIP02-13
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of mixed dyslipidaemia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/04/2014
• Compliance check done:
  No

Decision

P/0100/2014: EMA decision of 11 April 2014 on the granting of a product-specific waiver for alirocumab (EMEA-001169-PIP02-13)

Adopted Reference Number: EMA/169085/2014