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

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

bosentan monohydrate, Quantity: 129.082 mg

Доступно од:

Amneal Pharma Australia Pty Ltd

INN (Међународно име):

bosentan monohydrate

Фармацеутски облик:

Tablet, film coated

Састав:

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

Пут администрације:

Oral

Јединице у пакету:

60

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

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

Резиме производа:

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

Статус ауторизације:

Licence status A

Датум одобрења:

2017-08-22