This brand name is authorized in Austria, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Mexico, Netherlands, Poland, Romania, Singapore, United Kingdom, South Africa
The drug OMACOR contains a combination of these active pharmaceutical ingredients (APIs):
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1
Eicosapentaenoic acid
UNII AAN7QOV9EA - ICOSAPENT
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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. |
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2
Docosahexaenoic acid
UNII ZAD9OKH9JC - DOCONEXENT
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| OMACOR Capsule, soft | Health Products Regulatory Authority (IE) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| C10AX06 | Omega-3-triglycerides incl. other esters and acids | C Cardiovascular system → C10 Lipid modifying agents → C10A Lipid modifying agents, plain → C10AX Other lipid modifying agents |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | Identifier(s): 363780113 |
| Country: EE | Ravimiamet | Identifier(s): 1137372, 1137383, 1137394, 1183339, 1183351, 1680522, 1828380 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 65476 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 60511953, 61185670, 69248521 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 196188, 381570, 43346, 92600 |
| Country: HK | Department of Health Drug Office | Identifier(s): 66442 |
| Country: HR | Agencija za lijekove i medicinske proizvode | Identifier(s): HR-H-239310133 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 4924 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1019500, 1019501, 1019502, 1019503, 1019504, 1083161, 1083689, 1086025 |
| Country: MT | Medicines Authority | Identifier(s): MA517/00101 |
| Country: MX | Comisión Federal para la Protección contra Riesgos Sanitarios | Identifier(s): 065M2010 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 70580 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100162610, 100299941, 100326419, 100329116, 100341092, 100341867, 100350748, 100392209, 100428195 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W65280001, W65280002, W65280003, W65280004 |
| Country: SG | Health Sciences Authority | Identifier(s): 14504P |
| Country: ZA | Health Products Regulatory Authority | Identifier(s): A38/7.5/0729 |
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