BOSENTAN RAN bosentan (as monohydrate) 125 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bosentan monohydrate, Quantity: 129.083 mg

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

bosentan monohydrate

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

56, 60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Bosentan is indicated 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: The 125mg film-coated tablets are light peach to peach colored, oval shaped, biconvex & debossed with '125' on one side & plain on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-07-11