ATORVATOR atorvastatin (as calcium trihydrate) 20 mg tablets blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
28-11-2017

有効成分:

atorvastatin calcium trihydrate, Quantity: 21.69 mg (Equivalent: atorvastatin, Qty 20 mg)

から入手可能:

Sun Pharma ANZ Pty Ltd

INN(国際名):

atorvastatin calcium trihydrate

医薬品形態:

Tablet, film coated

構図:

Excipient Ingredients: croscarmellose sodium; calcium carbonate; polysorbate 80; hyprolose; microcrystalline cellulose; lactose monohydrate; Euphorbia antisyphilitica; magnesium stearate; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; PEG-4 stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc

投与経路:

Oral

パッケージ内のユニット:

30, 6

処方タイプ:

(S4) Prescription Only Medicine

適応症:

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.,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.

製品概要:

Visual Identification: White to off-white, elliptical, film-coated tablets debossed with "AS20" on one side and plain on the other side..; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius

認証ステータス:

Licence status A

承認日:

2011-09-23