European Union - English - EMA (European Medicines Agency)

alexion europe sas - sebelipase alfa - lipid metabolism, inborn errors - other alimentary tract and metabolism products, - kanuma is indicated for long-term enzyme replacement therapy (ert) in patients of all ages with lysosomal acid lipase (lal) deficiency.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - selexipag 1000ug - film coated tablet - 1000 mcg - active: selexipag 1000ug excipient: carnauba wax hyprolose hypromellose disintergrant/low substituted hydroxypropyl cellulose iron oxide red iron oxide yellow magnesium stearate maize starch mannitol propylene glycol titanium dioxide - uptravi, 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 · pulmonary arterial hypertension associated with drugs and toxins in patients with who functional class ii, iii or iv symptoms. uptravi is effective in combination with an endothelin receptor antagonist (era) or a phosphodiesterase-5 (pde-5) inhibitor, or in triple combination with an era and a pde-5 inhibitor, or as monotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - selexipag 1200ug - film coated tablet - 1200 mcg - active: selexipag 1200ug excipient: carnauba wax hyprolose hypromellose disintergrant/low substituted hydroxypropyl cellulose iron oxide black iron oxide red magnesium stearate maize starch mannitol propylene glycol titanium dioxide - uptravi, 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 · pulmonary arterial hypertension associated with drugs and toxins in patients with who functional class ii, iii or iv symptoms. uptravi is effective in combination with an endothelin receptor antagonist (era) or a phosphodiesterase-5 (pde-5) inhibitor, or in triple combination with an era and a pde-5 inhibitor, or as monotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - selexipag 1400ug - film coated tablet - 1400 mcg - active: selexipag 1400ug excipient: carnauba wax hyprolose hypromellose disintergrant/low substituted hydroxypropyl cellulose iron oxide yellow magnesium stearate maize starch mannitol propylene glycol titanium dioxide - uptravi, 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 · pulmonary arterial hypertension associated with drugs and toxins in patients with who functional class ii, iii or iv symptoms. uptravi is effective in combination with an endothelin receptor antagonist (era) or a phosphodiesterase-5 (pde-5) inhibitor, or in triple combination with an era and a pde-5 inhibitor, or as monotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - selexipag 1600ug - film coated tablet - 1600 mcg - active: selexipag 1600ug excipient: carnauba wax hyprolose hypromellose disintergrant/low substituted hydroxypropyl cellulose iron oxide black iron oxide red iron oxide yellow magnesium stearate maize starch mannitol propylene glycol titanium dioxide - uptravi, 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 · pulmonary arterial hypertension associated with drugs and toxins in patients with who functional class ii, iii or iv symptoms. uptravi is effective in combination with an endothelin receptor antagonist (era) or a phosphodiesterase-5 (pde-5) inhibitor, or in triple combination with an era and a pde-5 inhibitor, or as monotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - selexipag 200ug - film coated tablet - 200 mcg - active: selexipag 200ug excipient: carnauba wax hyprolose hypromellose disintergrant/low substituted hydroxypropyl cellulose iron oxide yellow magnesium stearate maize starch mannitol propylene glycol titanium dioxide - uptravi, 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 · pulmonary arterial hypertension associated with drugs and toxins in patients with who functional class ii, iii or iv symptoms. uptravi is effective in combination with an endothelin receptor antagonist (era) or a phosphodiesterase-5 (pde-5) inhibitor, or in triple combination with an era and a pde-5 inhibitor, or as monotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - selexipag 400ug - film coated tablet - 400 mcg - active: selexipag 400ug excipient: carnauba wax hyprolose hypromellose disintergrant/low substituted hydroxypropyl cellulose iron oxide red magnesium stearate maize starch mannitol propylene glycol titanium dioxide - uptravi, 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 · pulmonary arterial hypertension associated with drugs and toxins in patients with who functional class ii, iii or iv symptoms. uptravi is effective in combination with an endothelin receptor antagonist (era) or a phosphodiesterase-5 (pde-5) inhibitor, or in triple combination with an era and a pde-5 inhibitor, or as monotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - selexipag 600ug - film coated tablet - 600 mcg - active: selexipag 600ug excipient: carnauba wax hyprolose hypromellose disintergrant/low substituted hydroxypropyl cellulose iron oxide black iron oxide red magnesium stearate maize starch mannitol propylene glycol titanium dioxide - uptravi, 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 · pulmonary arterial hypertension associated with drugs and toxins in patients with who functional class ii, iii or iv symptoms. uptravi is effective in combination with an endothelin receptor antagonist (era) or a phosphodiesterase-5 (pde-5) inhibitor, or in triple combination with an era and a pde-5 inhibitor, or as monotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - selexipag 800ug - film coated tablet - 800 mcg - active: selexipag 800ug excipient: carnauba wax hyprolose hypromellose disintergrant/low substituted hydroxypropyl cellulose iron oxide black iron oxide yellow magnesium stearate maize starch mannitol propylene glycol titanium dioxide - uptravi, 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 · pulmonary arterial hypertension associated with drugs and toxins in patients with who functional class ii, iii or iv symptoms. uptravi is effective in combination with an endothelin receptor antagonist (era) or a phosphodiesterase-5 (pde-5) inhibitor, or in triple combination with an era and a pde-5 inhibitor, or as monotherapy.

European Union - English - EMA (European Medicines Agency)

janssen cilag international nv - selexipag - hypertension, pulmonary - antithrombotic agents - uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (pah) in adult patients with who functional class (fc) ii–iii, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (era) and/or a phosphodiesterase type 5 (pde-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies. 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.,