Product Dossier
OMACOR
Product Dossier for OMACOR (omega-3-acid ethyl esters 90, Arrotex Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by…
- Sponsor: Arrotex Pharmaceuticals
- Active ingredient: omega-3-acid ethyl esters 90
- Therapeutic area: Cardiology
- Same area: ATOZET
- Same area: OPSUMIT
What it is
OMACOR is a soft capsule containing omega-3-acid ethyl esters 90 at a strength of 1000 mg.
Approved indications
— Adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy such as statins, antiplatelet medicinal products, beta-blockers and ACE inhibitors. — Endogenous hypertriglyceridaemia as a supplement to diet when dietary measures alone are insufficient to produce an adequate response. — Type IV dyslipidaemia (Fredrickson classification) as monotherapy with close monitoring of LDL-C levels. — Type V dyslipidaemia (Fredrickson classification) as monotherapy with close monitoring of LDL-C levels. — Type IIb dyslipidaemia (Fredrickson classification) as add-on therapy to statins, when control of triglycerides with statins has been shown to be insufficient.
Dosing overview
OMACOR is supplied as 1000 mg soft capsules.
Regulatory history
The TGA approved OMACOR for marketing on 28 July 2010. OMACOR was first listed on the ARTG on 5 August 2010.