Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - macitentan - film coated tablets - macitentan 10 mg - macitentan - macitentan teva is an endothelin receptor antagonist (era) indicated for the treatment of pulmonary arterial hypertension (pah, who group i) to delay disease progression. disease progression included: death, initiation of intravenous (iv) or subcutaneous prostanoids or clinical worsening of pah (decreased 6-minute walk distance, worsened pah symptoms and need for additional pah treatment).macitentan also reduced hospitalization for pah.

United States - English - 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

Australia - English - 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.

Israel - English - Ministry of Health

j-c health care ltd - macitentan - film coated tablets - macitentan 10 mg - macitentan - opsumit ® is an endothelin receptor antagonist (era) indicated for the treatment of pulmonary arterial hypertension (pah, who group i) to delay disease progression. disease progression included: death, initiation of intravenous (iv) or subcutaneous prostanoids or clinical worsening of pah (decreased 6-minute walk distance, worsened pah symptoms and need for additional pah treatment). opsumit also reduced hospitalization for pah.

Israel - English - Ministry of Health

j-c health care ltd - macitentan - film coated tablets - macitentan 10 mg - macitentan - opsumit ® is an endothelin receptor antagonist (era) indicated for the treatment of pulmonary arterial hypertension (pah, who group i) to delay disease progression. disease progression included: death, initiation of intravenous (iv) or subcutaneous prostanoids or clinical worsening of pah (decreased 6-minute walk distance, worsened pah symptoms and need for additional pah treatment). opsumit also reduced hospitalization for pah.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - macitentan 10mg;  ;   - film coated tablet - 10 mg - active: macitentan 10mg     excipient: lactose monohydrate magnesium stearate microcrystalline cellulose opadry white oy-b-28920 amb polysorbate 80 povidone sodium starch glycolate - opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii, iii, or iv. efficacy has been shown in a pah population including idiopathic and heritable pah, pah associated with connective tissue disorders, and pah associated with corrected simple congenital heart disease.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.   - macitentan - hypertension, pulmonary - antihypertensives, - opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii to iii.efficacy has been shown in a pah population including idiopathic and heritable pah, pah associated with connective tissue disorders, and pah associated with corrected simple congenital heart disease.

Canada - English - Health Canada

janssen inc - macitentan - tablet - 10mg - macitentan 10mg - vasodilating agents

Canada - English - Health Canada

janssen inc - macitentan; tadalafil - tablet - 10mg; 40mg - macitentan 10mg; tadalafil 40mg - phosphodiesterase type 5 inhibitors

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

actelion pharmaceuticals uk ltd - macitentan - tablet - 10mg