오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - macitentan, quantity: 10 mg - tablet, film coated - excipient ingredients: sodium starch glycollate type a; magnesium stearate; microcrystalline cellulose; polysorbate 80; povidone; lactose monohydrate; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - opsumit, as monotherapy or in combination with approved pah treatments (phosphodiesterase-5 inhibitors or inhaled prostanoids), is indicated for the treatment of: ?idiopathic pulmonary arterial hypertension ?heritable pulmonary arterial hypertension ?pulmonary arterial hypertension associated with connective tissue disease ?pulmonary arterial hypertension associated with congenital heart disease with repaired shunts in patients with who functional class ii, iii or iv symptoms.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - miglustat, quantity: 100 mg - capsule, hard - excipient ingredients: magnesium stearate; povidone; sodium starch glycollate; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid; potassium hydroxide; industrial methylated spirit; ammonia; sorbitan monolaurate; gelatin; sodium lauryl sulfate - zavesca is indicated for the oral treatment of patients with mild to moderate type 1 gaucher disease, for whom enzyme replacement therapy is not a therapeutic option. zavesca is indicated for the treatment of the progressive neurological manifestations in adult and paediatric patients with niemann-pick type c disease.

오스트레일리아 - 영어 - 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.

오스트레일리아 - 영어 - 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.

이스라엘 - 영어 - 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

이스라엘 - 영어 - 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.

이스라엘 - 영어 - 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

미국 - 영어 - NLM (National Library of Medicine)

actelion pharmaceuticals us, inc. - macitentan (unii: z9k9y9wmvl) (macitentan - unii:z9k9y9wmvl) - macitentan 10 mg - opsumit is an endothelin receptor antagonist (era) indicated for the treatment of pulmonary arterial hypertension (pah, who group i) to reduce the risks of disease progression and hospitalization for pah. effectiveness was established in a long-term study in pah patients with predominantly who functional class ii–iii symptoms treated for an average of 2 years. patients had idiopathic and heritable pah (57%), pah caused by connective tissue disorders (31%), and pah caused by congenital heart disease with repaired shunts (8%) [see clinical studies (14.1)] . opsumit may cause fetal harm when administered to a pregnant woman. opsumit is contraindicated in females who are pregnant. opsumit was consistently shown to have teratogenic effects when administered to animals. if opsumit is used during pregnancy, advise the patient of the potential risk to a fetus [see warnings and precautions (5.1) and use in specific popul

뉴질랜드 - 영어 - 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.

뉴질랜드 - 영어 - 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.