Australien - Englisch - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - selexipag, quantity: 1400 microgram - tablet, film coated - excipient ingredients: mannitol; maize starch; hyprolose; hypromellose; propylene glycol; magnesium stearate; titanium dioxide; carnauba wax; iron oxide yellow - 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

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - selexipag, quantity: 400 microgram - tablet, film coated - excipient ingredients: hyprolose; hypromellose; carnauba wax; magnesium stearate; mannitol; maize starch; propylene glycol; titanium dioxide; iron oxide red - 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

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

actelion pharmaceuticals us, inc. - selexipag (unii: 5exc0e384l) (selexipag - unii:5exc0e384l) - selexipag 200 ug - uptravi is indicated for the treatment of pulmonary arterial hypertension (pah, who group i) to delay disease progression and reduce the risk of hospitalization for pah. effectiveness of uptravi tablets was established in a long-term study in pah patients with who functional class ii–iii symptoms. patients had idiopathic and heritable pah (58%), pah associated with connective tissue disease (29%), pah associated with congenital heart disease with repaired shunts (10%) [see clinical studies (14.1)] . hypersensitivity to the active substance or to any of the excipients. concomitant use of strong inhibitors of cyp2c8 (e.g., gemfibrozil) [see drug interactions (7.1) and clinical pharmacology (12.3)] . risk summary there are no adequate and well-controlled studies with uptravi in pregnant women. animal reproduction studies performed with selexipag showed no clinically relevant effects on embryofetal developmen

Israel - Englisch - Ministry of Health

j-c health care ltd - selexipag - film coated tablets - selexipag 400 mcg - selexipag - 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

Israel - Englisch - Ministry of Health

j-c health care ltd - selexipag - film coated tablets - selexipag 1400 mcg - selexipag - 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

Neuseeland - Englisch - 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.

Jordanien - Englisch - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع ادوية شاوي و رشيدات و مسنات - shawi & rushedat drug store - selexipag 400 mcg/1 tab - 400 mcg/1 tab

Kanada - Englisch - Health Canada

janssen inc - selexipag - tablet - 400mcg - selexipag 400mcg - vasodilating agents

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - selexipag, quantity: 800 microgram - tablet, film coated - excipient ingredients: hyprolose; iron oxide black; carnauba wax; titanium dioxide; maize starch; hypromellose; mannitol; propylene glycol; magnesium stearate; iron oxide yellow - 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

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - selexipag, quantity: 1600 microgram - tablet, film coated - excipient ingredients: hypromellose; titanium dioxide; magnesium stearate; mannitol; iron oxide yellow; carnauba wax; hyprolose; maize starch; propylene glycol; iron oxide black; iron oxide red - 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