CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED

VEGZELMA CONCENTRATE FOR SOLUTION FOR INFUSION 25 MG/ML

HSA

3.1 Therapeutic Indications Metastatic carcinoma of the colon or rectum(mCRC) Vegzelma in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum. Metastatic Breast Cancer (mBC) Vegzelma in combination with paclitaxel is indicated for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer. Vegzelma in combination with capecitabine is indicated for first-line treatment of patients with HER2-negative metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Vegzelma in combination with capecitabine. The effectiveness of Vegzelma in metastatic breast cancer (mBC) is based on an improvement in progression-free survival. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vegzelma in breast cancer. Non-Small Cell Lung Cancer (NSCLC) Vegzelma, in combination with carboplatin and paclitaxel, is indicated for first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer. Vegzelma, in combination with erlotinib, is indicated for first-line treatment of patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Advanced and/or metastatic Renal Cell Cancer (mRCC) Vegzelma in combination with interferon alfa-2a is indicated for first-line treatment of patients with advance and/or metastatic renal cell cancer. Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer Vegzelma, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of advanced (FIGO stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Vegzelma, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel is indicated for the treatment of patients with recurrent, platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other VEGF-targeted angiogenesis inhibitors. Vegzelma in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. Cervical Cancer Vegzelma in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for the treatment of persistent, recurrent, or metastatic carcinoma of the cervix.

2023-06-16

HERZUMA® 150MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

HSA

2.1 Therapeutic Indications Metastatic Breast Cancer (MBC) Herzuma® is indicated for the treatment of patients with metastatic breast cancer who have tumors that overexpress HER2: <ol class="alphaparen"> <li>as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease</li> <li>in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease</li> <li>in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer, not previously treated with trastuzumab. This indication is based on data from one Phase III trial which studied the use of Herzuma® in combination with anastrozole (see 3.1.2 Clinical/ Efficacy Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Experience with other aromatase inhibitors is limited.</li> </ol> Early Breast Cancer (EBC) Herzuma® is indicated for the treatment of patients with HER2 positive early breast cancer. <ul class="dash"> <li>following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 3.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> <li>following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.</li> <li>in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.</li> <li>in combination with neoadjuvant chemotherapy followed by adjuvant Herzuma® therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 2.4 and 3.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> </ul> Herzuma® should only be used in patients whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic Gastric Cancer (MGC) Herzuma® in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro- esophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Herzuma® should only be used in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay.

2019-10-29

REMSIMA® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/VIAL

HSA

Indications Rheumatoid Arthritis REMSIMA®, in combination with methotrexate (MTX), is indicated for: The reduction of signs and symptoms as well as the improvement in physical function in <ul class="dash"> <li>patients with active disease when the response to disease-modifying drugs, including methotrexate, has been inadequate.</li> <li>patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.</li> </ul> In these patient populations, a reduction in the rate of the progression of joint damage, as measured by x-ray, has been demonstrated (see Pharmacodynamic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Crohn’s Disease REMSIMA® is indicated for: <ul class="dash"> <li>Treatment of moderately to severely, active Crohn’s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant: or who are intolerant to or have medical contraindications for such therapies.</li> <li>Treatment of fistulising Crohn’s disease, in patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).</li> </ul> Paediatric Crohn’s Disease REMSIMA® is indicated for: Treatment of severe, active Crohn’s disease, in paediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. REMSIMA® has been studied only in combination with conventional immunosuppressive therapy. Ulcerative Colitis REMSIMA® is indicated for: Treatment of moderately to severely active ulcerative colitis in patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric Ulcerative Colitis REMSIMA® is indicated for: Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy. Ankylosing Spondylitis REMSIMA® is indicated for: Treatment of ankylosing spondylitis, in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy. Psoriatic Arthritis REMSIMA®, in combination with methotrexate, is indicated for: Treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease-modifying anti-rheumatoid drugs. Psoriasis REMSIMA® is indicated for: Treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultraviolet A (PUVA) (see Pharmacodynamic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

2016-03-28

DORIBAX™ Powder for Injection 500mg

HSA

**Therapeutic Indications** DORIBAX™ is a carbapenem antibiotic indicated as a single agent for the treatment of the following infections caused by susceptible bacteria: (See _Microbiology_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.) - Complicated intra-abdominal infections - Complicated urinary tract infections, including complicated and uncomplicated pyelonephritis and cases with concurrent bacteremia Doribax is also indicated for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia, caused by susceptible bacteria. In the nosocomial pneumonia clinical studies, adjunctive use of an aminoglycoside was permitted. Because of its broad spectrum of bactericidal activity against gram-positive and gram-negative aerobic and anaerobic bacteria, DORIBAX™ can be considered for treatment of complicated and mixed infections. Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to doripenem. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

2009-03-13

GUTRON TABLET 5 mg

HSA

**INDICATIONS** For treatment of idiopathic / neurogenic orthostatic hypotension. The Indication is based on GUTRON effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of GUTRON principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of GUTRON. After initiation of treatment, GUTRON should be continued only for patients who report significant symptomatic improvement. Because midodrine can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care including nonpharmacologic treatment (such as support stockings), plasma volume expansion and lifestyle alterations.

2001-04-28

UBRETID TABLET 5 MG

HSA

Indications Functional insufficiency of the vesical sphincteral apparatus Hypotonia of the urinary bladder Chronic hypotonic constipation and megacolon In various neurological indications (peripheral paralyses of the striated muscles, myasthenia gravis pseudoparalytica) a functional improvement can be obtained.

1989-05-22

CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED

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