CHEALAC deferasirox 360 mg film-coated tablet blister pack

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

deferasirox, Quantity: 360 mg

MAH:

Alembic Pharmaceuticals Australia Pty Ltd

pharmaceutical_form:

Tablet, film coated

composition:

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

administration_route:

Oral

units_in_package:

30

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

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.

leaflet_short:

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

authorization_status:

Registered

authorization_date:

2020-11-16