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 |
|
| 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
|
| Contact for public enquiries |
Sigma-Tau SpA
E-mail: Giulia.Bruno@sigma-tau.it |
| Decision type |
W: decision granting a waiver in all age groups for all conditions or indications
|