Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

ph10.5) for solution for infusion vials (sandoz ltd - epoprostenol sodium - powder and solvent for solution for infusion - 500microgram

Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

ph10.5) for solution for infusion vials (sandoz ltd - epoprostenol sodium - powder and solvent for solution for infusion - 1.5mg

Canada - anglais - Health Canada

janssen inc - epoprostenol (epoprostenol sodium) - powder for solution - 0.5mg - epoprostenol (epoprostenol sodium) 0.5mg - vasodilating agents

Canada - anglais - Health Canada

janssen inc - epoprostenol (epoprostenol sodium) - powder for solution - 1.5mg - epoprostenol (epoprostenol sodium) 1.5mg - vasodilating agents

Irlande - anglais - HPRA (Health Products Regulatory Authority)

drehm pharma gmbh - epoprostenol - pdr+solv for soln for inf - 500 microgram

Irlande - anglais - HPRA (Health Products Regulatory Authority)

drehm pharma gmbh - epoprostenol - pdr+solv for soln for inf - 1.5 milligram

Canada - anglais - Health Canada

glaxosmithkline inc - epoprostenol (epoprostenol sodium) - powder for solution - 0.5mg - epoprostenol (epoprostenol sodium) 0.5mg - vasodilating agents

Canada - anglais - Health Canada

glaxosmithkline inc - epoprostenol (epoprostenol sodium) - powder for solution - 1.5mg - epoprostenol (epoprostenol sodium) 1.5mg - vasodilating agents

États-Unis - anglais - NLM (National Library of Medicine)

glaxosmithkline llc - epoprostenol sodium (unii: 4k04iq1of4) (epoprostenol - unii:dcr9z582x0) - epoprostenol 0.5 mg - flolan is indicated for the treatment of pulmonary arterial hypertension (pah) (who group i) to improve exercise capacity. trials establishing effectiveness included predominantly (97%) patients with new york heart association (nyha) functional class iii-iv symptoms and etiologies of idiopathic or heritable pah (49%) or pah associated with connective tissue diseases (51%). flolan is contraindicated in patients with heart failure caused by reduced left ventricular ejection fraction [see clinical studies (14.3)] . flolan is contraindicated in patients with a hypersensitivity to the drug or any of its ingredients. risk summary limited published data from case series and case reports have not established an association with flolan and major birth defects, miscarriage or adverse maternal or fetal outcomes when flolan is used during pregnancy. there are risks to the mother and fetus from untreated pulmonary arterial hypertension (see clinical considerations) . in animal reproduction studies, pregnant rats and rabbi

Israël - anglais - Ministry of Health

salomon,levin & elstein ltd - epoprostenol as sodium 1.5 mg - powder and solvent for solution for infusion - epoprostenol - epoprostenol teva is indicated for the long-term intravenous treatment of primary arterial pulmonary hypertension and arterial pulmonary hypertension associated with the scleroderma spectrum of disease in nyha class iii and class iv patients who do not respond to conventional therapy.