east cancer and for advanced breast cancer following anti-estrogen therapy. Femara is approved as neo-adjuvant (pre-operative) therapy for early stage breast cancer in a limited number of countries. In Japan, Femara is approved for the treatment of all hormone receptor-positive breast cancer in postmenopausal women. Jakavi (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. It is the first JAK inhibitor indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thromboycythemia myelfibrosis. Jakavi is approved in approximately 50 countries, including the member states of the EU. In three-year follow-up data from the COMFORT-I and COMFORT-II Phase III studies in myelofibrosis, Jakavi treatment reduced the risk of death and resulted in sustained reductions in spleen size—a hallmark of myelofibrosis—while also improving quality of life. Primary Care Primary Care Medicines Diovan (valsartan), together with Diovan HCT/Co-Diovan (valsartan and hydrochlorothiazide), is an anti-hypertensive medication worldwide (IMS October 2013; 59 countries audited). Diovan is the agent in its class approved to treat all of the following: high blood pressure (including children 6 to 18 years), high-risk heart attack survivors and patients with heart failure. Diovan is available in approximately 120 countries for treating high blood pressure, in approximately 90 countries for heart failure, and in approximately 70 countries for heart attack survivors. Exforge (valsartan and amlodipine besylate) is a single-pill combination of the ARB Diovan and the calcium channel blocker amlodipine besylate. Approved for the treatment of high blood pressure in Switzerland, the U.S. and EU. Exforge is available in approximately 100 countries. Galvus (vildagliptin), an oral DPP-4 inhibitor, and Eucreas, a single-pill combination of vildagliptin and metformin, are indicated for the treatment of type 2 diabetes. Galvus is approved in approximately 100 countries, including EU member states, Japan and countries in Latin America and the Asia-Pacific. Eucreas was the first single pill combining a DPP-4 inhibitor and metformin that was approved in Europe and is approved in approximately 100 countries. In 2012, Galvus received EU approval for expanded use as a second-line monotherapy for type 2 diabetes patients who cannot take metformin. In addition, in 2012, the European Commission approved the use of Galvus and Eucreas in combination with other diabetes treatments. Xolair (omalizumab) is the humanized monoclonal antibody approved for the treatment of moderate to severe persistent allergic asthma in the U.S. in adolescents (aged 12 and above) and adults. Xolair is approved in approximately 90 countries. It is approved for severe persistent allergic asthma in the EU in children (aged six and above), adolescents, and adults. A liquid formulation of Xolair in pre-filled syringes has been launched in most European countries. In Japan, Xolair was approved for the treatment of severe persistent allergic asthma in adults (aged 15 and older) and was approved in 2013 in pediatric patients aged 6 years or older for the same indication. Novartis licensed Xolair from Genentech/Roche. The company co-promotes Xolair with Genentech/Roche in the U.S. Arcapta Neohaler/Onbrez Breezhaler (indacaterol) is a once-daily long-acting beta2-adrenergic agonist (LABA) administered in a single-dose dry powder inhaler indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). In 2012, Onbrez Breezhaler 150 mcg was also approved in China. Tekturna/Rasilez (aliskiren) is a treatment for high blood pressure, and the first and only approved direct renin inhibitor. Tekturna/Rasilez was approved in the U.S. and EU in 2007, and is approved in approximately 90 countries. The product is known as Tekturna in the U.S. and Rasilez in the rest of the world. There are various Tekturna/Rasilez single-pill combination products approved in various countries, including T
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