ASTRAZENECA SINGAPORE PTE LTD

<p><strong>4.1 Therapeutic indications</strong></p> <p>VOYDEYA is indicated as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia (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></p> <p>STRENSIQ is indicated for long-term enzyme replacement therapy in patients with pediatric-onset hypophosphatasia (HPP).</p>

<p><strong>4.1 Therapeutic indications</strong></p> <p><strong>Hepatocellular Carcinoma (HCC)</strong></p> <p>IMJUDO in combination with durvalumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC) who have not received prior systemic therapy.</p> <p><strong>Non-Small Cell Lung Cancer (NSCLC)</strong></p> <p>IMJUDO in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of patients with metastatic NSCLC with no sensitising epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumour aberrations.</p>

<p><strong>4.1 Therapeutic indications</strong></p> <p>LOKELMA is indicated for the treatment of hyperkalaemia in adult patients.</p>

<p><strong>4.1 Therapeutic indications</strong></p> <p>LOKELMA is indicated for the treatment of hyperkalaemia in adult patients.</p>

**4.1 Therapeutic indications** CALQUENCE (acalabrutinib) is indicated: - in combination with obinutuzumab or as monotherapy for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). - as monotherapy for the treatment of patients with CLL/SLL who have received at least one prior therapy. - for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

**4.1 Therapeutic indications** TAGRISSO (osimertinib) is indicated for: - the adjuvant treatment after tumour resection in patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. - the first-line treatment of patients with locally advanced or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. - the treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after EGFR TKI therapy. (See Clinical efficacy and safety section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_)

**4.1 Therapeutic indications** XIGDUO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate. For study results with respect to combination of therapies, effects on glycemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. **Limitations of Use** XIGDUO XR is not indicated for use in patients with type 1 diabetes. XIGDUO XR should not be used for the treatment of diabetic ketoacidosis.

<p><strong>4.1 Therapeutic indications</strong></p> <p>XIGDUO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.</p> <p>For study results with respect to combination of therapies, effects on glycemic 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>Limitations of Use</strong></p> <p>XIGDUO XR is not indicated for use in patients with type 1 diabetes.<br> XIGDUO XR should not be used for the treatment of diabetic ketoacidosis.</p>