Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: BASF AS, P.O Box 420, 1327 Lysaker, Norway
Omacor 1000 mg Soft Capsules.
Pharmaceutical Form |
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Capsule, soft Soft, oblong, transparent gelatin capsules containing pale yellow oil. |
One capsule contains: Omega-3-acid ethyl esters 90 1000 mg comprising 840 mg eicosapentaenoic acid (EPA) ethyl ester (460mg) and docosahexaenoic acid (DHA) ethyl ester (380mg), including also as antioxidant 4 mg d-alpha-tocopherol (mixed with a vegetable oil e.g. soya oil).
For a full list of excipients see section 6.1.
Active Ingredient | Description | |
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Docosahexaenoic acid |
Docosahexaenoic acid (DHA) is an omega-3 fatty acid that is a primary structural component of the human brain, cerebral cortex, skin, and retina. It can be synthesized from alpha-linolenic acid or obtained directly from maternal milk (breast milk), fish oil, or algae oil. |
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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 |
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Capsule shell: Gelatine |
White high density polyethylene (HDPE) bottle:
Not all pack sizes may be marketed.
BASF AS, P.O Box 420, 1327 Lysaker, Norway
PA1099/001/001
Date of first authorisation: 08 August 2003
Date of last renewal: 22 July 2006
Drug | Countries | |
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OMACOR | Austria, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Mexico, Netherlands, Poland, Romania, Singapore, United Kingdom, South Africa |
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