BANSEP

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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공공 평가 보고서 공공 평가 보고서 (PAR)
29-11-2017

유효 성분:

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

제공처:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Atorvastatin calcium

약제 형태:

Tablet, film coated

구성:

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

관리 경로:

Oral

패키지 단위:

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

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

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.

제품 요약:

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

승인 상태:

Licence status A

승인 날짜:

2011-08-22

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