OMACOR

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

Active ingredients

The drug OMACOR contains a combination of these active pharmaceutical ingredients (APIs):

1 Eicosapentaenoic acid UNII AAN7QOV9EA - ICOSAPENT

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). Read about Eicosapentaenoic acid

2 Docosahexaenoic acid UNII ZAD9OKH9JC - DOCONEXENT

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. Read about Docosahexaenoic acid

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
OMACOR Capsule, soft	Health Products Regulatory Authority (IE)	MPI, EU: SmPC

Medicine classification

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
Discover more medicines within C10AX06

Authorization and marketing

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: 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