EMEA-001300-PIP01-12 - paediatric investigation plan

Icosapent ethyl

Key facts

• Active substance:
  Icosapent ethyl
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0217/2012
• PIP number:
  EMEA-001300-PIP01-12
• Pharmaceutical form(s):
  Capsule, soft
• Condition(s) / indication(s):
  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:
  28/09/2012
• Compliance check done:
  No

Decision

P/0217/2012: EMA decision of 28 September 2012 on the granting of a product specific waiver for icosapent ethyl (EMEA-001300-PIP01-12)

Adopted Reference Number: EMA/495588/2012