NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

<p><strong>4.1 Therapeutic indications</strong><br> Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).<br> NovoEight&reg; does not contain Willebrand factor and is not indicated in von Willebrand disease.</p> <p>NovoEight&reg; can be used for all age groups.</p>

**4.1 Therapeutic indications** Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of - ≥30 kg/m2 (obesity), or - ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.

<p><strong>4.1 Therapeutic indications</strong></p> <p>Rybelsus&reg; is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control 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 combination with other medicinal products for the treatment of diabetes.</li> </ul> <p>For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1 &ndash; <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><br> Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).<br> NovoEight&reg; does not contain Willebrand factor and is not indicated in von Willebrand disease.</p> <p>NovoEight&reg; can be used for all age groups.</p>

<p><strong>Therapeutic indications</strong><br> Treatment of diabetes mellitus in adults and adolescents from the age of 12&ndash;17 years.</p>

<p><strong>Therapeutic indications:</strong> Treatment of patients with diabetes mellitus requiring insulin.</p>

<p><strong>4.1 Therapeutic indications</strong><br> <u>Adults</u><br> Saxenda&reg; is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:</p> <ul> <li>&ge; 30 kg/m² (obesity), or</li> <li>&ge; 27 kg/m² to &lt; 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.</li> </ul> <p>Treatment with Saxenda&reg; should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight.</p> <p><u>Adolescents (&ge; 12 years)</u><br> Saxenda&reg; can be used as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with:</p> <ul> <li>an inadequate response to reduced calorie diet and increased physical activity alone, and</li> <li>obesity (BMI corresponding to &ge; 30 kg/m² for adults by international cut-off points)* and</li> <li>body weight above 60 kg.</li> </ul> <p>Limitations of Use: The safety and effectiveness of Saxenda&reg; in pediatric patients with type 2 diabetes have not been established.<br> Treatment with Saxenda&reg; should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose.</p> <p>*IOTF BMI cut-off points for obesity by sex between 12&ndash;18 years (see table 1):</p> <img src="/TGIF/Saxenda-Table1_210525.png" alt="Saxenda Indications Table 1" /><br><br>

<p><strong>Therapeutic indications</strong><br> Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.</p>

<p><strong>4.1 Therapeutic indications</strong><br> <u>Children:</u><br> Growth failure due to growth hormone insufficiency, growth failure in girls due to gonadal dysgenesis (Turner syndrome), growth retardation in prepubertal children due to chronic renal disease and short children born small for gestational age (SGA).</p> <p>Growth disturbance (current height standard deviation score (SDS) &lt;‐2.5 and parental adjusted height SDS &lt;‐1) in short children born small for gestational age (SGA), with a birth weight and/or length below ‐2 standard deviation SD, who failed to show catch‐up growth (height velocity standard deviation score (HV SDS) &lt;0 during the last year) by 4 years of age or later.</p> <p><u>Adults:</u><br> Pronounced growth hormone deficiency in known hypothalamic-pituitary disease (one other deficient axis, other than prolactin), demonstrated by one provocative test after institution of adequate replacement therapy for any other deficient axis.<br> Childhood onset growth hormone insufficiency, reconfirmed by two provocative tests.</p> <p>In adults, the insulin tolerance test is the provocative test of choice. When the insulin tolerance test is contraindicated, alternative provocative tests must be used. The combined arginine-growth hormone releasing hormone is recommended. An arginine or glucagon test may also be considered; however, these tests have less established diagnostic value than the insulin tolerance test.</p>