GENRX BOSENTAN bosentan (as monohydrate) 62.5mg tablets bottle

Active ingredient:

bosentan monohydrate, Quantity: 64.542 mg (Equivalent: bosentan, Qty 62.5 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

bosentan monohydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: silicon dioxide; methylcellulose; crospovidone; poloxamer; macrogol 8000; titanium dioxide; iron oxide red; hyprolose; hypromellose; magnesium stearate; iron oxide yellow

Administration route:

Oral

Units in package:

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: Orange-white coloured, round shaped, biconvex film coated tablet, engraved "APO" on one side and "62.5" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-02-25