European Union - English - EMA (European Medicines Agency)

viatris limited - clopidogrel besilate - peripheral vascular diseases; stroke; myocardial infarction - antithrombotic agents - secondary prevention of atherothrombotic events clopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.adult patients suffering from acute coronary syndrome.non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa).st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy.in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic stroke (is) clopidogrel in combination with asa is indicated in:adult patients with moderate to high-risk tia (abcd2 score ≥4) or minor is (nihss ≤3) within 24 hours of either the tia or is event.prevention of atherothrombotic and thromboembolic events in atrial fibrillation:in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke.for further information please refer to section 5.1.

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

takeda pharmaceuticals australia pty ltd - c1 esterase inhibitor, quantity: 500 u - injection, solution - excipient ingredients: water for injections - treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with c1 inhibitor deficiency. routine prevention of angioedema attacks in adults and adolescents with frequent attacks of hereditary angioedema (hae), who are intolerant to or insufficiently protected by oral therapy.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - docetaxel - carcinoma, non-small-cell lung; breast neoplasms; prostatic neoplasms - antineoplastic agents - breast cancerdocetaxel teva pharma monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. previous chemotherapy should have included an anthracycline or an alkylating agent.non-small-cell lung cancerdocetaxel teva pharma is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.docetaxel teva pharma in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.prostate cancerdocetaxel teva pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

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

juno pharmaceuticals pty ltd - hexaminolevulinate hydrochloride -

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

csl behring australia pty ltd - factor viii, quantity: 1000 iu; von willebrand factor, quantity: 2400 iu - injection, diluent for - excipient ingredients: - the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated. the prophylaxis and treatment of non-surgical and surgical bleeding associated with factor viii deficiency due to haemophilia a.

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

csl behring australia pty ltd - von willebrand factor, quantity: 1200 iu; factor viii, quantity: 500 iu - injection, diluent for - excipient ingredients: - the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated. the prophylaxis and treatment of non-surgical and surgical bleeding associated with factor viii deficiency due to haemophilia a.

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

csl behring australia pty ltd - factor viii, quantity: 500 iu; von willebrand factor, quantity: 1200 iu - injection, diluent for - excipient ingredients: - the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated. the prophylaxis and treatment of non-surgical and surgical bleeding associated with factor viii deficiency due to haemophilia a.

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

csl behring australia pty ltd - factor viii, quantity: 250 iu; von willebrand factor, quantity: 600 iu - injection, diluent for - excipient ingredients: - the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated. the prophylaxis and treatment of non-surgical and surgical bleeding associated with factor viii deficiency due to haemophilia a.

European Union - English - EMA (European Medicines Agency)

viatris limited - pirfenidone - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - immunosuppressants - pirfenidone viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

European Union - English - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drugs used in diabetes - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance.- in addition to other medicinal products for the treatment of type 2 diabetes.for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.