Source: European Medicines Agency (EU) Revision Year: 2022 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 |
Eicosapentaenoic acid (EPA; also icosapentaenoic acid) is an omega-3 fatty acid. It also has the trivial name timnodonic acid. Eicosapentaenoic acid is a polyunsaturated fatty acid (PUFA) that acts as a precursor for prostaglandin-3 (which inhibits platelet aggregation), thromboxane-3, and leukotriene-5 eicosanoids. Eicosapentaenoic acid is both a precursor and the hydrolytic breakdown product of eicosapentaenoyl ethanolamide (EPEA: C22H35NO2; 20:5,n-3). |
| 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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