Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - riociguat, quantity: 1 mg - tablet, film coated - excipient ingredients: hypromellose; crospovidone; lactose monohydrate; hyprolose; sodium lauryl sulfate; microcrystalline cellulose; magnesium stearate; propylene glycol; titanium dioxide; iron oxide yellow - pulmonary arterial hypertension:,adempas, as monotherapy or in combination with approved pah treatments (endothelin receptor antagonists or inhaled or subcutaneous prostanoids), is indicated for the treatment of:,? idiopathic pulmonary arterial hypertension,? heritable pulmonary arterial hypertension,? pulmonary arterial hypertension associated with connective tissue diseases or,? pulmonary arterial hypertension associated with congenital heart disease in adult patients with who functional class ii, lll or iv symptoms,chronic thromboembolic pulmonary hypertension:,adempas is indicated for the treatment of:,persistent or recurrent chronic thromboembolic pulmonary hypertension (cteph) after surgical treatment or,inoperable cteph in adult patients with who functional class ii, lll or iv symptoms

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

merck sharp & dohme ltd - riociguat - tablet - 1mg

Israel - English - Ministry of Health

bayer israel ltd - riociguat - film coated tablets - riociguat 1 mg - riociguat - chronic thromboembolic pulmonary hypertension (cteph) adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii with • inoperable cteph, • persistent or recurrent cteph after surgical treatment, to improve exercise capacity. pulmonary arterial hypertension (pah)adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity.efficacy has been shown in a pah population including aetiologies of idiopathic or heritable pah or pah associated with connective tissue disease.

Israel - English - Ministry of Health

bayer israel ltd - riociguat - film coated tablets - riociguat 1 mg - riociguat - chronic thromboembolic pulmonary hypertension (cteph) adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii with • inoperable cteph, • persistent or recurrent cteph after surgical treatment, to improve exercise capacity. pulmonary arterial hypertension (pah)adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity.efficacy has been shown in a pah population including aetiologies of idiopathic or heritable pah or pah associated with connective tissue disease.

United States - English - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - riociguat (unii: ru3fe2y4xi) (riociguat - unii:ru3fe2y4xi) - riociguat .5 mg - adempas is indicated for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (cteph), (who group 4) after surgical treatment, or inoperable cteph, to improve exercise capacity and who functional class [see clinical studies (14.1)]. adempas is indicated for the treatment of adults with pulmonary arterial hypertension (pah), (who group 1), to improve exercise capacity, who functional class and to delay clinical worsening. efficacy was shown in patients on adempas monotherapy or in combination with endothelin receptor antagonists or prostanoids. studies establishing effectiveness included predominately patients with who functional class ii–iii and etiologies of idiopathic or heritable pah (61%) or pah associated with connective tissue diseases (25%) [see clinical studies (14.2)] . based on data from animal reproduction studies, adempas may cause fetal harm when administered to a pregnant woman and is contraindicated in females who are pregnant. adempas was consistently

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - riociguat, quantity: 2 mg - tablet, film coated - excipient ingredients: titanium dioxide; hypromellose; sodium lauryl sulfate; hyprolose; magnesium stearate; lactose monohydrate; iron oxide red; iron oxide yellow; microcrystalline cellulose; propylene glycol; crospovidone - pulmonary arterial hypertension:,adempas, as monotherapy or in combination with approved pah treatments (endothelin receptor antagonists or inhaled or subcutaneous prostanoids), is indicated for the treatment of:,? idiopathic pulmonary arterial hypertension,? heritable pulmonary arterial hypertension,? pulmonary arterial hypertension associated with connective tissue diseases or,? pulmonary arterial hypertension associated with congenital heart disease in adult patients with who functional class ii, lll or iv symptoms,chronic thromboembolic pulmonary hypertension:,adempas is indicated for the treatment of:,persistent or recurrent chronic thromboembolic pulmonary hypertension (cteph) after surgical treatment or,inoperable cteph in adult patients with who functional class ii, lll or iv symptoms

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - riociguat, quantity: 1.5 mg - tablet, film coated - excipient ingredients: sodium lauryl sulfate; lactose monohydrate; propylene glycol; microcrystalline cellulose; hypromellose; magnesium stearate; titanium dioxide; crospovidone; hyprolose; iron oxide yellow - pulmonary arterial hypertension:,adempas, as monotherapy or in combination with approved pah treatments (endothelin receptor antagonists or inhaled or subcutaneous prostanoids), is indicated for the treatment of:,? idiopathic pulmonary arterial hypertension,? heritable pulmonary arterial hypertension,? pulmonary arterial hypertension associated with connective tissue diseases or,? pulmonary arterial hypertension associated with congenital heart disease in adult patients with who functional class ii, lll or iv symptoms,chronic thromboembolic pulmonary hypertension:,adempas is indicated for the treatment of:,persistent or recurrent chronic thromboembolic pulmonary hypertension (cteph) after surgical treatment or,inoperable cteph in adult patients with who functional class ii, lll or iv symptoms

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - riociguat, quantity: 2.5 mg - tablet, film coated - excipient ingredients: magnesium stearate; sodium lauryl sulfate; hypromellose; titanium dioxide; crospovidone; propylene glycol; lactose monohydrate; iron oxide red; microcrystalline cellulose; iron oxide yellow; hyprolose - pulmonary arterial hypertension:,adempas, as monotherapy or in combination with approved pah treatments (endothelin receptor antagonists or inhaled or subcutaneous prostanoids), is indicated for the treatment of:,? idiopathic pulmonary arterial hypertension,? heritable pulmonary arterial hypertension,? pulmonary arterial hypertension associated with connective tissue diseases or,? pulmonary arterial hypertension associated with congenital heart disease in adult patients with who functional class ii, lll or iv symptoms,chronic thromboembolic pulmonary hypertension:,adempas is indicated for the treatment of:,persistent or recurrent chronic thromboembolic pulmonary hypertension (cteph) after surgical treatment or,inoperable cteph in adult patients with who functional class ii, lll or iv symptoms

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - riociguat, quantity: 0.5 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; hypromellose; magnesium stearate; propylene glycol; crospovidone; titanium dioxide; hyprolose; lactose monohydrate; sodium lauryl sulfate - pulmonary arterial hypertension:,adempas, as monotherapy or in combination with approved pah treatments (endothelin receptor antagonists or inhaled or subcutaneous prostanoids), is indicated for the treatment of:,? idiopathic pulmonary arterial hypertension,? heritable pulmonary arterial hypertension,? pulmonary arterial hypertension associated with connective tissue diseases or,? pulmonary arterial hypertension associated with congenital heart disease in adult patients with who functional class ii, lll or iv symptoms,chronic thromboembolic pulmonary hypertension:,adempas is indicated for the treatment of:,persistent or recurrent chronic thromboembolic pulmonary hypertension (cteph) after surgical treatment or,inoperable cteph in adult patients with who functional class ii, lll or iv symptoms

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - riociguat 1mg - film coated tablet - 1 mg - active: riociguat 1mg excipient: crospovidone hyprolose hypromellose   iron oxide yellow lactose monohydrate magnesium stearate microcrystalline cellulose propylene glycol purified water sodium laurilsulfate titanium dioxide - pulmonary arterial hypertension adempas, as monotherapy or in combination with approved pah treatments (endothelin receptor agonists or inhaled or subcutaneous prostanoids ), is indicated for the treatment of: - idiopathic pulmonary arterial hypertension - heritable pulmonary arterial hypertension - pulmonary arterial hypertension associated with connective tissue diseases - pulmonary arterial hypertension associated with congenital heart disease in adult patients with who functional class ii, iii or iv symptoms.