Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Amarin Pharmaceuticals Ireland Limited, 88 Harcourt Street, Dublin 2, D02DK18, Ireland
Vazkepa 998 mg soft capsules.
| Pharmaceutical Form |
|---|
|
Soft capsule (capsule). Oblong soft capsule, 25 × 10 mm, printed with “IPE” in white ink, with a light yellow to amber shell containing a colourless to pale yellow liquid. |
Each capsule contains 998 mg of icosapent ethyl.
Excipients with known effect: Each capsule contains 30 mg maltitol (E965 ii), 83 mg sorbitol (E420 ii) and soya lecithin.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Eicosapentaenoic acid |
Icosapent ethyl is a stable ethyl ester of the omega-3 fatty acid, eicosapentaenoic acid (EPA). The mechanisms of action contributing to reduction of cardiovascular events with icosapent ethyl are not completely understood. The mechanisms are likely multi-factorial including improved lipoprotein profile with reduction of triglyceride-rich lipoproteins, anti-inflammatory, and antioxidant effects, reduction of macrophage accumulation, improved endothelial function, increased fibrous cap thickness/stability, and antiplatelet effects. Each of these mechanisms can beneficially alter the development, progression, and stabilisation of atherosclerotic plaque, as well as the implications of plaque rupture, and preclinical and clinical studies support such benefits with EPA. |
| List of Excipients |
|---|
|
Capsule fill: all-rac-alpha-tocopherol Capsule shell: Gelatin Printing ink: Titanium dioxide |
High density polyethylene (HDPE) bottles with a child-resistant polypropylene heat induction sealed closure containing 120 soft capsules.
Pack size of one bottle or three bottles per carton.
PVC/PCTFE/Al perforated unit dose blisters containing 4x2 soft capsules.
Not all pack sizes may be marketed.
Amarin Pharmaceuticals Ireland Limited, 88 Harcourt Street, Dublin 2, D02DK18, Ireland
EU/1/20/1524/001
EU/1/20/1524/002
EU/1/20/1524/003
Date of first authorisation: 26 March 2021
| Drug | Countries | |
|---|---|---|
| VAZKEPA | Austria, Estonia, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom |
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