EMEA-001865-PIP02-16 - paediatric investigation plan

omega-3-carboxylic acids

Key facts

• Active substance:
  omega-3-carboxylic acids
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0377/2017
• PIP number:
  EMEA-001865-PIP02-16
• Pharmaceutical form(s):
  • Capsule, soft
  • Age appropriate dosage form, other
• Condition(s) / indication(s):
  Treatment of dyslipidaemia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2017
• Compliance check done:
  No

Decision

P/0377/2017: EMA decision of 1 December 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for omega-3-carboxylic acids (EMEA-001865-PIP02-16)

Adopted Reference Number: EMA/704196/2017