ZYFAS PHARMA PTE. LTD.

CUBEREC 80 FILM-COATED TABLETS 80 MG

HSA

INDICATIONS Hypertension Treatment of hypertension. Heart failure Treatment of heart failure (NYHA class II–IV) in patients receiving standard therapy such as diuretics, digitalis and either angiotensin-converting enzyme (ACE) inhibitors or beta-blockers but not both; presence of all these standard therapies is not mandatory. Valsartan improves morbidity in these patients, primarily via reduction in hospitalization for heart failure. Valsartan also slows the progression of heart failure, improves NYHA functional class, ejection fraction and signs and symptoms of heart failure and improves quality of life versus placebo (see section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Post-myocardial infarction Valsartan is indicated to improve survival following recent myocardial infarction in clinically stable patients with signs, symptoms or radiological evidence of left ventricular failure and/or with left ventricular systolic dysfunction (see section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

2025-01-24

TELMISARTAN-DRLA TABLETS 80MG

HSA

4.1 Therapeutic indications <ul> <li>Treatment of essential hypertension in adults.</li> <li>Reduction of the risk of non-fatal stroke or non-fatal myocardial infarction in patients 55 years or older at high risk of developing major cardiovascular events who cannot tolerate an angiotensin coverting enzyme inhibitor (ACEI).</li> <li>High risk of cardiovascular events includes evidence of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack, or diabetes mellitus with evidence of end organ damage.</li> </ul>

2024-08-30

GLYCINORM-MR TABLETS 60 MG

HSA

INDICATIONS Gliclazide prolonged release tablets are indicated in Type 2 diabetes mellitus in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose.

2024-08-28

EVIPSYZED 25 QUETIAPINE FUMARATE TABLETS USP 25MG

HSA

4. Therapeutic indications Quetiapine is indicated for the treatment of <ul> <li>Schizophrenia</li> <li>acute manic episodes associated with bipolar I disorder.</li> <li>depressive episodes associated with bipolar disorder.</li> <li>preventing recurrence in maintenance treatment of bipolar I disorder (manic, mixed or depressive episode) as monotherapy or in combination with lithium or valproate.</li> </ul>

2024-08-23

COGNIMET FILM-COATED TABLET 10MG

HSA

4.1 Therapeutic indications Treatment of patients with moderate to severe Alzheimer’s disease.

2024-01-16

DR. REDDY'S ATORVASTATIN FILM COATED TABLET 20MG USP

HSA

4.1 Therapeutic Indications Hypercholesterolaemia Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG) in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia, heterozygous familial hypercholesterolaemia, or combined (mixed) hyperlipidaemia (Fredrickson Types IIa and IIb), elevated serum TG levels (Fredrickson Type IV), and for patients with dysbetalipoproteinemia (Fredrickson Type III) when response to diet and other nonpharmacological measures is inadequate. Atorvastatin also raises high density lipoprotein cholesterol (HDL-C) and lowers the LDL/HDL and total-C/HDL ratios. Atorvastatin is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. Prevention of cardiovascular disease Atorvastatin is indicated to reduce the risk of myocardial infarction (MI) in adult hypertensive patients without clinically evident coronary heart disease (CHD), but with at least three additional risk factors for CHD such as age ≥55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on electrocardiogram (ECG), microalbuminuria or proteinuria, ratio of plasma total-C to HDL-C ≥6, or premature family history of CHD. In adults with type 2 diabetes and without clinically evident CHD, but with multiple risk factors for CHD such as retinopathy, albuminuria, smoking or hypertension, atorvastatin is indicated to: <ul> <li>Reduce the risk of MI.</li> <li>Reduce the risk of stroke.</li> </ul> In adults with clinically evident CHD, atorvastatin is indicated to: <ul> <li>Reduce the risk of non-fatal MI.</li> <li>Reduce the risk of fatal and non-fatal stroke.</li> <li>Reduce the risk for revascularization procedures.</li> <li>Reduce the risk of hospitalization for congestive heart failure (CHF).</li> <li>Reduce the risk of angina.</li> </ul>

2023-12-26

PREGAREDI CAPSULE 150 MG

HSA

Indications Neuropathic pain Pregabalin is indicated for the treatment of neuropathic pain which includes diabetic peripheral neuropathy and post-herpetic neuralgia in adults. Epilepsy Pregabalin is indicated as adjunctive therapy of partial seizures, with or without secondary generalisation, in adults. Generalized anxiety disorder Pregabalin is indicated for the treatment of Generalized Anxiety Disorder (GAD) in adults. Fibromyalgia Pregabalin is indicated for the management of fibromyalgia.

2023-04-18

HCQS HYDROXYCHLOROQUINE TABLET BP 200 MG

HSA

4.1 Therapeutic indications Treatment of rheumatoid arthritis, juvenile chronic arthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused or aggravated by sunlight.

2022-10-28

ROZAT 10 FILM COATED TABLET 10 MG

HSA

INDICATIONS Rosuvastatin is indicated for patients with primary hypercholesterolaemia and mixed dyslipidaemia (including Fredrickson Type IIa, IIb; and heterozygous familial hypercholesterolaemia) as an adjunct to diet when response to diet and exercise is inadequate. Rosuvastatin is indicated to treat patients with primary dysbetalipoproteinaemia (Fredrickson Type III hyper lipoproteinaemia) as an adjunct to diet when response to diet and exercise is inadequate. Rosuvastatin reduces elevated LDL-cholesterol, total cholesterol and triglycerides and increases HDL-cholesterol, thereby enabling most patients to achieve relevant treatment guidelines. Rosuvastatin also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios and increases ApoA-I. Rosuvastatin is also indicated in patients with homozygous familial hypercholesterolaemia, either alone or as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis). Primary Prevention of cardiovascular disease: Rosuvastatin is indicated in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age ≥ 50 years old in men and ≥ 60 years old in women, hsCRP ≥ 2 mg/L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease, Rosuvastatin is indicated to: <ul> <li>reduce the risk of stroke</li> <li>reduce the risk of myocardial infarction</li> <li>reduce the risk of arterial revascularization procedures</li> </ul> Rosuvastatin is indicated in children and adolescents 10 to 17 years of age as an adjunct to diet to reduce Total-C, LDL-C and ApoB levels in adolescent boys and girls, who are at least one year post-menarche, 10–17 years of age with heterozygous familial hypercholesterolaemia if after an adequate trial of diet therapy the following findings are present: LDL-C > 190 mg/dL or > 160 mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors. Paediatric studies were conducted mainly in the non-Asian population and data on Asian children/adolescents is limited.

2022-07-14

ROZAT 20 FILM COATED TABLET 20 MG

HSA

INDICATIONS Rosuvastatin is indicated for patients with primary hypercholesterolaemia and mixed dyslipidaemia (including Fredrickson Type IIa, IIb; and heterozygous familial hypercholesterolaemia) as an adjunct to diet when response to diet and exercise is inadequate. Rosuvastatin is indicated to treat patients with primary dysbetalipoproteinaemia (Fredrickson Type III hyper lipoproteinaemia) as an adjunct to diet when response to diet and exercise is inadequate. Rosuvastatin reduces elevated LDL-cholesterol, total cholesterol and triglycerides and increases HDL-cholesterol, thereby enabling most patients to achieve relevant treatment guidelines. Rosuvastatin also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios and increases ApoA-I. Rosuvastatin is also indicated in patients with homozygous familial hypercholesterolaemia, either alone or as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis). Primary Prevention of cardiovascular disease: Rosuvastatin is indicated in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age ≥ 50 years old in men and ≥ 60 years old in women, hsCRP ≥ 2 mg/L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease, Rosuvastatin is indicated to: <ul> <li>reduce the risk of stroke</li> <li>reduce the risk of myocardial infarction</li> <li>reduce the risk of arterial revascularization procedures</li> </ul> Rosuvastatin is indicated in children and adolescents 10 to 17 years of age as an adjunct to diet to reduce Total-C, LDL-C and ApoB levels in adolescent boys and girls, who are at least one year post-menarche, 10–17 years of age with heterozygous familial hypercholesterolaemia if after an adequate trial of diet therapy the following findings are present: LDL-C > 190 mg/dL or > 160 mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors. Paediatric studies were conducted mainly in the non-Asian population and data on Asian children/adolescents is limited.

2022-07-13

ZYFAS PHARMA PTE. LTD.

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