ASTELLAS PHARMA SINGAPORE PTE. LTD.

<p><strong>4.1 Therapeutic indications</strong></p> <p>Xospata&reg; (gilteritinib tablets) is indicated for:</p> <ul> <li>the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (<em>FLT3</em>) mutation.</li> </ul> <p>A validated test is required to confirm the FLT3 mutation status of AML.</p>

<p><strong>4.1 Therapeutic indications</strong></p> <p>Xtandi is indicated:</p> <ul> <li><p>as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 4.4, 4.8 and 5.1 &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p></li> <li><p>for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (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></li> <li><p>for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (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></li> <li><p>for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (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></li> <li><p> for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.</p></li> </ul>

<p><strong>INDICATIONS</strong></p> <p>Mycamine is indicated for:</p> <p><u>Adults and paediatric patients 4 months and older for:</u></p> <ul> <li>treatment of invasive candidiasis</li> <li>treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate</li> <li>prophylaxis of <em>Candida</em> infection in patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count &lt; 500 cells/microlitre) for 10 or more days.</li> </ul> <p>Mycamine has not been adequately studied in patients with endocarditis, osteomyelitis and meningitis due to <em>Candida</em> infections.<br> The decision to use Mycamine should take into account a potential risk for the development of liver tumours. Mycamine should therefore only be used if other antifungals are not appropriate.</p>

<p><strong>Therapeutic Indications</strong><br> Prophylaxis of transplant rejection in adult kidney or liver allograft recipients and treatment of kidney or liver allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.</p>

**INDICATIONS** Vesicare is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

**INDICATIONS** Vesicare is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

<p><strong>INDICATIONS</strong><br> For the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).</p>

**THERAPEUTIC INDICATION** Primary immunosuppression in liver and kidney allograft recipients and liver and kidney allograft rejection resistant to conventional immunosuppressive agents.

<p><strong>THERAPEUTIC INDICATION</strong><br> Primary immunosuppression in liver and kidney allograft recipients and liver and kidney allograft rejection resistant to conventional immunosuppressive agents.</p>

<p><strong>THERAPEUTIC INDICATION</strong><br> Primary immunosuppression in liver and kidney allograft recipients and liver and kidney allograft rejection resistant to conventional immunosuppressive agents.</p>