New Zealand - English - Medsafe (Medicines Safety Authority)

clinect nz pty limited - iloprost 0.1 mg/ml equivalent to iloprost trometamol 0.134 mg/ml;   - concentrate for infusion - 0.05 mg/0.5ml - active: iloprost 0.1 mg/ml equivalent to iloprost trometamol 0.134 mg/ml   excipient: ethanol as 96% v/v hydrochloric acid as 1m hcl nitrogen sodium chloride trometamol water for injection - treatment of patients with severe peripheral arterial occlusive disease (poad), particularly those at risk of amputation and in whom surgery or angioplasty is not possible. treatment of advanced thromboangitis obliterans (buerger's disease) with critical limb ischaemia in cases where revascularisation is not indicated. treatment of patients with severe disabling raynaud's phenomenon unresponsive to other therapies. treatment of moderate or severe primary and secondary pulmonary hypertension such as new york heart association functional classes iii and iv.

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

actelion pharmaceuticals us, inc. - iloprost (unii: jed5k35ygl) (iloprost - unii:jed5k35ygl) - iloprost 0.01 mg in 1 ml - ventavis is indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1) to improve a composite endpoint consisting of exercise tolerance, symptoms (nyha class), and lack of deterioration. studies establishing effectiveness included predominately patients with nyha functional class iii–iv symptoms and etiologies of idiopathic or heritable pah (65%) or pah associated with connective tissue diseases (23%) [see clinical studies (14)] . none. risk summary limited published data from case series and case reports with ventavis in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with pulmonary arterial hypertension (see clinical considerations) . in animal reproductive studies, administration of continuous intravenous iloprost to pregnant han-wistar rats during organogenesis at doses 2-times the recommended human dose on a mg/m2 basis resulted in adverse develo

Singapore - English - HSA (Health Sciences Authority)

bayer (south east asia) pte ltd - iloprost trometamol 0.013 mg/ml eqv iloprost - solution - 0.010 mg/ml - iloprost trometamol 0.013 mg/ml eqv iloprost 0.010 mg/ml

Israel - English - Ministry of Health

bayer israel ltd - iloprost - concentrate for solution for infusion - iloprost 0.1 mg/ml - iloprost - iloprost - peripheral arterial occlusive disease (stage 3 and 4 of fontaine's classification) in advanced arteriosclerosis, in whom surgery or angioplasty therapy is not possible.thromboangitis obliterans (buerger's disease) with critical limb ischemia in cases where revascularisation is not indicated and severe disabling raynaud's phenomenon .

Malta - English - Medicines Authority

pharmamentum jægersborg alle 164, 2860 gentofte, denmark - iloprost - concentrate for solution for infusion - iloprost 100 µg/ml - antithrombotic agents

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

bayer australia ltd - iloprost, quantity: 10 microgram/ml - inhalation, conventional - excipient ingredients: trometamol; hydrochloric acid; ethanol; sodium chloride; water for injections - treatment of patients with primary pulmonary hypertension or secondary pulmonary hypertension due to connective tissue disease or drug-induced, in moderate or severe stages of the disease. in addition, treatment of moderate or severe secondary pulmonary hypertension due to chronic pulmonary thromboembolism, where surgery is not possible.

European Union - English - EMA (European Medicines Agency)

bayer ag - iloprost - hypertension, pulmonary - antithrombotic agents - treatment of patients with primary pulmonary hypertension, classified as new york heart association functional class iii, to improve exercise capacity and symptoms.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

bayer co. (malaysia) sdn. bhd. - iloprost; iloprost -

Israel - English - Ministry of Health

bayer israel ltd - iloprost - solution for inhalation - iloprost 0.01 mg/ml - iloprost - treatment of patients with primary pulmonary hypertension (pph) or secondary pulmonary hypertension (sph) . due to connective tissue disease or drug - induced, in moderate or severe stages of the disease. in addition, treatment of moderate or severe secondary pulmonary hypertension due to chronic pulmonary thromboembolism, where surgery is not possible.

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

bayer plc - iloprost trometamol - solution for infusion - 100microgram/1ml