BANSEP

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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公众评估报告 公众评估报告 (PAR)
29-11-2017

有效成分:

atorvastatin calcium, Quantity: 10.36 mg (Equivalent: atorvastatin, Qty 10 mg)

可用日期:

Sun Pharma ANZ Pty Ltd

INN(国际名称):

Atorvastatin calcium

药物剂型:

Tablet, film coated

组成:

Excipient Ingredients: sodium carbonate; butylated hydroxytoluene; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; croscarmellose sodium; lactose; hyprolose; sodium lauryl sulfate; butylated hydroxyanisole; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin

给药途径:

Oral

每包单位数:

100 tablets per pack, 28 tablets per pack, 30 tablets per pack

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

Atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia. Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated. Atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (see Clinical Trials, Prevention of Cardiovascular Disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

產品總結:

Visual Identification: White to off-white, film-coated, oval tablets debossed with "AT1" on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

授权状态:

Licence status A

授权日期:

2011-08-22

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