BOSENTAN AMNEAL bosentan (as monohydrate) 125 mg film-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bosentan monohydrate, Quantity: 129.082 mg

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

bosentan monohydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: sodium starch glycollate type A; povidone; pregelatinised maize starch; maize starch; glycerol dibehenate; magnesium stearate; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red; ethylcellulose

Administration route:

Oral

Units in package:

60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

for the treatment of,? idiopathic pulmonary arterial hypertension,? familial pulmonary arterial hypertension,? pulmonary arterial hypertension associated with scleroderma or,? pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger?s physiology,in patients with WHO functional Class II, III or IV symptoms

Product summary:

Visual Identification: Orange, oval, biconvex, film coated tablets, debossed with AN on one side and 874 on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2017-08-22