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.

Israel - English - Ministry of Health

j-c health care ltd - bosentan - film coated tablets - bosentan 62.5 mg - bosentan - bosentan - treatment of pulmonary arterial hypertension (pah) in patients of who functional class ii-iv.reduction in the number of new digital ulcers in patients with systemic sclerosis with active digital ulcer disease

Israel - English - Ministry of Health

j-c health care ltd - bosentan as monohydrate - film coated tablets - bosentan as monohydrate 62.5 mg - bosentan - bosentan - treatment of pulmonary arterial hypertension (pah) in patients of who functional class ii-iv.reduction in the number of new digital ulcers in patients with systemic sclerosis with active digital ulcer disease.

Israel - English - Ministry of Health

j-c health care ltd - bosentan as monohydrate - film coated tablets - bosentan as monohydrate 125 mg - bosentan - bosentan - treatment of pulmonary arterial hypertension (pah) in patients of who functional class ii-iv.reduction in the number of new digital ulcers in patients with systemic sclerosis with active digital ulcer disease

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - bosentan 125mg;   - film coated tablet - 125 mg - active: bosentan 125mg   excipient: ethylcellulose glyceryl behenate hypromellose iron oxide red iron oxide yellow magnesium stearate maize starch povidone purified talc sodium starch glycolate starch titanium dioxide triacetin - 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 class iii or iv symptoms.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - bosentan 62.5mg (as monohydrate);   - film coated tablet - 62.5 mg - active: bosentan 62.5mg (as monohydrate)   excipient: ethylcellulose glyceryl behenate hypromellose iron oxide red iron oxide yellow magnesium stearate maize starch povidone purified talc sodium starch glycolate starch titanium dioxide triacetin - 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 class iii or iv symptoms.

Philippines - English - FDA (Food And Drug Administration)

actelion pharmaceuticals ltd.; importer: johnson & johnson (phils.), inc.; distributor: johnson & johnson (phils.), inc. - bosentan (monohydrate) - tablet - 125 mg

Philippines - English - FDA (Food And Drug Administration)

actelion pharmaceuticals ltd.; importer: johnson & johnson (phils.) inc.; distributor: zuellig pharma corporation - macitentan - film-coated tablet - 10 mg

Philippines - English - FDA (Food And Drug Administration)

actelion pharmaceuticals ltd.; importer: johnson & johnson (philippines), inc. - selexipag - film-coated tablet - 200 mcg