Canada - English - Health Canada

accord healthcare inc - bosentan (bosentan monohydrate) - tablet - 125mg - bosentan (bosentan monohydrate) 125mg - vasodilating agents

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

zentiva pharma uk ltd - bosentan monohydrate - oral tablet - 125mg

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - bosentan monohydrate 125mg;   - film coated tablet - 125 mg - active: bosentan monohydrate 125mg   excipient: magnesium stearate opadry orange 03k93638 povidone pregelatinised maize starch sodium starch glycolate - 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 class iii or iv symptoms.

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - bosentan monohydrate 62.5mg;   - film coated tablet - 62.5 mg - active: bosentan monohydrate 62.5mg   excipient: magnesium stearate opadry orange 03k93638 povidone pregelatinised maize starch sodium starch glycolate - 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 class iii or iv symptoms.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

zentiva pharma uk ltd - bosentan monohydrate - oral tablet - 62.5mg

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - bosentan monohydrate, quantity: 129.08 mg (equivalent: bosentan, qty 125 mg) - tablet, film coated - excipient ingredients: magnesium stearate; ethylcellulose; purified talc; pregelatinised maize starch; iron oxide red; iron oxide yellow; glyceryl behenate; triacetin; maize starch; titanium dioxide; sodium starch glycollate; hypromellose; povidone - tracleer 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - bosentan monohydrate, quantity: 64.54 mg (equivalent: bosentan, qty 62.5 mg) - tablet, film coated - excipient ingredients: maize starch; iron oxide yellow; glyceryl behenate; triacetin; iron oxide red; purified talc; magnesium stearate; titanium dioxide; hypromellose; povidone; sodium starch glycollate; ethylcellulose; pregelatinised maize starch - tracleer 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

dr reddy's new zealand limited - bosentan monohydrate 129.082mg equivalent to bosentan 125 mg - film coated tablet - 125 mg - active: bosentan monohydrate 129.082mg equivalent to bosentan 125 mg excipient: ethylcellulose glycerol magnesium stearate maize starch opadry yellow 03k82318 povidone sodium starch glycolate starch - the medicine 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 class iii or iv symptoms.

New Zealand - English - Medsafe (Medicines Safety Authority)

dr reddy's new zealand limited - bosentan monohydrate 64.541mg equivalent to bosentan 62.5 mg - film coated tablet - 62.5 mg - active: bosentan monohydrate 64.541mg equivalent to bosentan 62.5 mg excipient: ethylcellulose glycerol magnesium stearate maize starch opadry yellow 03k82318 povidone sodium starch glycolate starch - the medicine 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 class iii or iv symptoms.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

viatris uk healthcare ltd - bosentan monohydrate - oral tablet - 125mg