CHEALAC deferasirox 360 mg film-coated tablet blister pack

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)
12-01-2021

有效成分:

deferasirox, Quantity: 360 mg

可用日期:

Alembic Pharmaceuticals Australia Pty Ltd

药物剂型:

Tablet, film coated

组成:

Excipient Ingredients: crospovidone; microcrystalline cellulose; sodium starch glycollate type A; poloxamer; magnesium stearate; colloidal anhydrous silica; povidone; titanium dioxide; hypromellose; purified talc; macrogol 4000; indigo carmine aluminium lake

给药途径:

Oral

每包单位数:

30

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

The treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. CHEALAC is also indicated for the treatment of chronic iron overload in paediatric patients aged 2 to 5 years who are unable to take desferrioxamine therapy or in whom desferrioxamine has proven ineffective.,CHEALAC is also indicated for the treatment of chronic iron overload in patients with non-transfusion- dependent thalassemia syndromes aged 10 years and older.

產品總結:

Visual Identification: Dark blue, oval, biconvex, film-coated tablet with beveled edges, debossed with "L" on one side and "665" on the other side. Approximately 17 mm in length and approximately 7 mm in width.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

授权状态:

Registered

授权日期:

2020-11-16