NOVEM PHARMA PRIVATE LIMITED

<p><strong>4.1 Therapeutic indications</strong></p> <p><u>Schizophrenia</u></p> <p>Aripiprazole is indicated for the treatment of schizophrenia. The efficacy of Aripiprazole in the treatment of schizophrenia was established in four short-term (4- and 6-week) controlled trials in adults and one 6-week trial in paediatrics (13 to 17 years). Maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to paediatrics (see section 5.1 &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). The physician who elects to use Aripiprazole for extended periods should periodically re-evaluate the long- term usefulness of the drug for the individual patient (see section 4.2).</p> <p><u>Bipolar I Disorder</u></p> <p>Aripiprazole is indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder and for maintaining stability or preventing recurrence, as monotherapy in adults and in adolescents aged 13 years and older, and as an adjunct to lithium or valproate in adults.<br> The efficacy of Aripiprazole as monotherapy was established in four 3-week monotherapy trials in adults and one 4-week monotherapy trial in paediatric patients. Efficacy as adjunctive therapy was established in one 6-week adjunctive trial in adults (see section 5.1 &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).<br> Maintenance efficacy was demonstrated in one monotherapy maintenance trial and in one adjunctive maintenance trial in adults (see section 5.1 &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Physicians who elect to use Aripiprazole for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see section 4.2).</p> <p><u>Adjunctive Treatment of Major Depressive Disorder</u></p> <p>Aripiprazole is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD).<br> Efficacy was established in three 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode (see section 5.1 &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p> <p><u>Irritability Associated with Autistic Disorder</u></p> <p>Aripiprazole is indicated for the treatment of irritability associated with autistic disorder. Efficacy was established in two 8-week trials in paediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods) (see section 5.1 &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). The efficacy of Aripiprazole for the maintenance treatment of irritability associated with autistic disorder was not established.</p> <p><u>Tourette&rsquo;s Disorder</u></p> <p>Aripiprazole is indicated for the treatment of Tourette&rsquo;s disorder. Efficacy was established in one 8-week (aged 7 to 17 years) and one 10-week (aged 6 to 18 years) placebo-controlled trial in paediatric patients with Tourette&rsquo;s disorder (see section 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> ROZEVON is indicated as adjunct to diet for treatment of primary hypercholesterolemia as substitution therapy in adult patients adequately controlled with the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products.</p>

<p><strong>4.1 Therapeutic indications</strong><br> ROZEVON is indicated as adjunct to diet for treatment of primary hypercholesterolemia as substitution therapy in adult patients adequately controlled with the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products.</p>

<p><strong>4.1 Therapeutic indications</strong></p> <p>Tolterodine is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.</p>

<p><strong>4.1 Therapeutic indications</strong></p> <p>Tolterodine is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.</p>

<p><strong>4.1 Therapeutic indications</strong></p> <p>Repaglinide is indicated in adults with type 2 diabetes mellitus whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in adults with type 2 diabetes mellitus who are not satisfactorily controlled on metformin alone.</p> <p>Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.</p>

<p><strong>4.1 Therapeutic indications</strong></p> <p><u><em>Neuropathic pain</em></u><br> Pregabalin is indicated for the treatment of neuropathic pain, which includes diabetic peripheral neuropathy and post-herpetic neuralgia, in adults.</p> <p><u><em>Epilepsy</em></u><br> Pregabalin is indicated as adjunctive therapy of partial seizures, with or without secondary generalisation, in adults.</p> <p><u><em>Generalised anxiety disorder</em></u><br> Pregabalin is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.</p> <p><u><em>Fibromyalgia</em></u><br> Pregabalin is indicated for the management of fibromyalgia.</p>