EMEA-001915-PIP01-15-M03 - paediatric investigation plan

volanesorsen

Key facts

• Invented name:
  Waylivra
• Active substance:
  volanesorsen
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0131/2021
• PIP number:
  EMEA-001915-PIP01-15-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of familial chylomicronemia syndrome
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2021
• Compliance check done:
  Nein

Decision

P/0131/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for volanesorsen (Waylivra), (EMEA-001915-PIP01-15-M03)

Adopted Reference Number: EMA/150641/2021