Omega-3-acid (85% ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of 0.9-1.5), simvastatin - paediatric investigation plan

Omega-3-acid (85% ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of 0.9-1.5)

simvastatin

Key facts

• Active Substance:
  • Omega-3-acid (85% ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of 0.9-1.5)
  • simvastatin
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/120/2008
• PIP number:
  Omega-3-acid (85% ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of 0.9-1.5), simvastatin
• Pharmaceutical form(s):
  Capsule (soft)
• Condition(s) / indication(s):
  Atherosclerotic cardiovascular disease following past myocardial infarction
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2008

Decision

P/120/2008: European Medicines Agency decision of 1 December 2008 on the application for product specific waiver for omega-3-acid (85% ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio...

AdoptedReference Number: EMEA/624450/2008