EMEA-001573-PIP02-17 - paediatric investigation plan

pemafibrate

Key facts

• Active substance:
  pemafibrate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0073/2018
• PIP number:
  EMEA-001573-PIP02-17
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Prevention of cardiovascular events in patients with elevated triglycerides levels
  • Treatment of hypertriglyceridaemia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/03/2018
• Compliance check done:
  No

Decision

P/0073/2018: EMA decision of 16 March 2018 on the granting of a product-specific waiver for pemafibrate (EMEA-001573-PIP02-17)

Adopted Reference Number: EMA/87925/2018