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

teva pharma australia pty ltd - reteplase -

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

chiesi usa, inc. - reteplase (unii: dqa630rie9) (reteplase - unii:dqa630rie9) - retavase is indicated for use in acute st-elevation myocardial infarction (stemi) to reduce the risk of death and heart failure. limitation of use: the risk of stroke may outweigh the benefit produced by thrombolytic therapy in patients whose stemi puts them at low risk for death or heart failure. because thrombolytic therapy increases the risk of bleeding, retavase is contraindicated in the following situations: - active internal bleeding - recent stroke - intracranial or intraspinal surgery or serious head trauma within 3 months - intracranial conditions that increase the risk of bleeding (e.g. neoplasms, arteriovenous malformation, or aneurysms) - bleeding diathesis - current severe uncontrolled hypertension risk summary limited published data with retavase use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.  in animal reproduction studies, reteplase administered to pregnant rabbits resulted in hemorrhaging in the genital tract, leading to abortions i

Canada - English - Health Canada

ekr therapeutics inc - reteplase - powder for solution - 10.4unit - reteplase 10.4unit - thrombolytic agents

European Union - English - EMA (European Medicines Agency)

actavis group ptc ehf - reteplase - myocardial infarction - antithrombotic agents - rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent st elevation or recent left bundle branch block within 12 hours after the onset of acute-myocardial-infarction (ami) symptoms.

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

actavis australia pty ltd - reteplase -

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

actavis uk ltd - reteplase - powder and solvent for solution for injection - 10unit

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - reteplase 10 u;   - powder for injection - 10 u - active: reteplase 10 u   excipient: dibasic potassium phosphate phosphoric acid polysorbate 80 sucrose tranexamic acid water for injection - rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent st elevation or recent left bundle branch block within 12 hours after the onset of ami symptoms.

Bahrain - English - الهيئة الوطنية لتنظيم المهن والخدمات الصحية، مملكة البحرين

nasser - reteplase - powder for injection

Philippines - English - FDA (Food And Drug Administration)

ambica int'l trading corp - reteplase (recombinant tissue plasminogen activator) - lyophilized powder for injection iv - 10 units

European Union - English - EMA (European Medicines Agency)

roche registration ltd. - reteplase - myocardial infarction - antithrombotic agents - thrombolytic therapy of acute myocardial infarction