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

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

지금 구매하세요

Download 공공 평가 보고서 (PAR)
24-11-2017

유효 성분:

bosentan monohydrate, Quantity: 129.083 mg

제공처:

Sun Pharma ANZ Pty Ltd

INN (국제 이름):

bosentan monohydrate

약제 형태:

Tablet, film coated

구성:

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

관리 경로:

Oral

패키지 단위:

56, 60

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

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

제품 요약:

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

승인 상태:

Licence status A

승인 날짜:

2016-07-11