OMACOR Capsule, soft Ref.[50866] Active ingredients: Docosahexaenoic acid Eicosapentaenoic acid

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: BASF AS, P.O Box 420, 1327 Lysaker, Norway

Product name and form

Omacor 1000 mg Soft Capsules.

Pharmaceutical Form

Capsule, soft

Soft, oblong, transparent gelatin capsules containing pale yellow oil.

Qualitative and quantitative composition

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
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.

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 shell:

Gelatine
Glycerol
Purified water
Medium-chain triglycerides
Lecithin (soya)

Pack sizes and marketing

White high density polyethylene (HDPE) bottle:

  • 1x20 capsules
  • 1x28 capsules
  • 1x30 capsules
  • 1x60 capsules
  • 1x100 capsules
  • 10x28 capsules

Not all pack sizes may be marketed.

Marketing authorization holder

BASF AS, P.O Box 420, 1327 Lysaker, Norway

Marketing authorization dates and numbers

PA1099/001/001

Date of first authorisation: 08 August 2003
Date of last renewal: 22 July 2006

Drugs

Drug Countries
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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