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<p><strong>1 INDICATIONS AND USAGE</strong></p> <p><strong>1.1 <em>RET</em> Fusion-Positive Non-Small Cell Lung Cancer</strong></p> <p>TANSTRIVE is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a <em>rearranged during transfection (RET)</em> gene fusion.</p> <p><strong>1.2 <em>RET</em>-Mutant Medullary Thyroid Cancer</strong></p> <p>TANSTRIVE is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a <em>RET</em> mutation who require systemic therapy.</p> <p><strong>1.3 <em>RET</em> Fusion-Positive Thyroid Cancer</strong></p> <p>TANSTRIVE is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a <em>RET</em> gene fusion who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).</p>
<p><strong>4.1 Therapeutic indications</strong></p> <p>Mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise</p> <ul> <li>as monotherapy when metformin is considered inappropriate due to intolerance or contraindications</li> <li>in addition to other medicinal products for the treatment of diabetes.</li> </ul> <p>For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><strong>4.1 Therapeutic indications</strong></p> <p>Mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise</p> <ul> <li>as monotherapy when metformin is considered inappropriate due to intolerance or contraindications</li> <li>in addition to other medicinal products for the treatment of diabetes.</li> </ul> <p>For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><strong>4.1 Therapeutic indications</strong></p> <p>Mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise</p> <ul> <li>as monotherapy when metformin is considered inappropriate due to intolerance or contraindications</li> <li>in addition to other medicinal products for the treatment of diabetes.</li> </ul> <p>For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
**INDICATIONS** Murest-DR tablets are indicated in combination with ciclosporin for microemulsion and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants. Murest-DR tablets are indicated for induction and maintenance treatment of adult patients with ISN/RPS Class III, IV or V lupus nephritis. The evidence for efficacy was based on surrogate endpoints in studies where the majority of patients with lupus nephritis were ISN/RPS (2003) Class IV (see Clinical Studies section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
**4.1 Therapeutic indications** Rosuvastatin is indicated for patients with primary hypercholesterolaemia and mixed dyslipidaemia (including Fredrickson Type IIa, IIb and heterozygous familial hypercholesterolaemia) as an adjunct to diet when response to diet and exercise is inadequate. Rosuvastatin is indicated to treat patients with primary dysbetalipoproteinaemia (Fredrickson Type III hyper lipoproteinaemia) as an adjunct to diet when response to diet and exercise is inadequate. Rosuvastatin reduces elevated LDL-cholesterol, total cholesterol and triglycerides and increases HDL-cholesterol, thereby enabling most patients to achieve relevant treatment guidelines. Rosuvastatin also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios and increases ApoA-I. Rosuvastatin is also indicated in patients with homozygous familial hypercholesterolaemia, either alone or as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis). Primary prevention of cardiovascular disease: Rosuvastatin is indicated in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age ≥ 50 years old in men and ≥ 60 years old in women, hsCRP ≥ 2 mg/L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease, Rosuvastatin is indicated to: - reduce the risk of stroke - reduce the risk of myocardial infarction - reduce the risk of arterial revascularization procedures Rosuvastatin is indicated in children and adolescents 10 to 17 years of age as an adjunct to diet to reduce Total-C, LDL-C and ApoB levels in adolescent boys and girls, who are at least one year postmenarche, 10–17 years of age with heterozygous familial hypercholesterolaemia if after an adequate trial of diet therapy the following findings are present: LDL-C > 190 mg/dL or > 160mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors. Paediatric studies were conducted mainly in the non-Asian population and data on Asian children/adolescents is limited.
<p><strong>4.1 Therapeutic indications</strong></p> <p>PARMODIA is indicated as adjunctive therapy to diet or other nonpharmacological treatment (e.g. exercise) to reduce TG and to increase HDL-C in patients with dyslipidemia characterised by high TG ≥150 mg/dL, particularly when there is evidence of associated risk such as hypertension and smoking.</p>
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