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

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

bosentan monohydrate, Quantity: 129.082 mg

Tilgængelig fra:

Amneal Pharma Australia Pty Ltd

INN (International Name):

bosentan monohydrate

Lægemiddelform:

Tablet, film coated

Sammensætning:

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

Indgivelsesvej:

Oral

Enheder i pakken:

60

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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

Produkt oversigt:

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

Autorisation status:

Licence status A

Autorisation dato:

2017-08-22