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 route
Contact for public enquiries
Sigma-Tau SpA

E-mail: Giulia.Bruno@sigma-tau.it
Phone: +39 0691393657

Decision type
W: decision granting a waiver in all age groups for all conditions or indications

Decision

Topics

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