1.      Anti-dementia Drugs

1.1  Remember F.C. Tablets 8 mg

–  Indications: Treatment of mild to moderate dementia related to Alzheimer’s disease.

–  Approval Number:

DOH-PM-047265

2.      Hypnotics and Sedatives

2.1  Midazo Ampoule 5 mg/5 mL, 5 mg/mL (Midazolam)

–  Indications: Conscious sedation, ICU sedation, induction and maintenance of anesthesia, preoperative medication.

–  Approval Number:

5 mg/5 mL: DOH-PM-044436

5 mg/mL: DOH-PM-044437

2.2  Genclone 7.5 mg F.C.T. (Zopiclone)

–  Indications: Insomnia.

–  Approval Number:

DOH-PM-043460

3        Antipsychotic

3.1  Aripiprazole Tablets 10 mg, 15 mg

–  Indications: Schizophrenia in adults and adolescents (ages 13-17). Manic and mixed episodes of bipolar disorder in adults and children (ages 10-17), can be used as monotherapy or as an adjunct to lithium or valproate. Adjunctive treatment to lithium or valproate for maintenance therapy of bipolar I disorder. Adjunctive treatment for major depressive disorder. Irritability associated with autism spectrum disorder in children (ages 6-17). Tourette’s syndrome.

–  Approval Number:

10 mg: DOH-PM-057320

15 mg: DOH-PM-057364

4        Anxiolytics

4.1 Genesafe Tablets 200 mg (Mephenoxalone)

–  Indications: Relief of pain caused by spinal or muscular spasms.

–  Approval Number:

DOH-PM-042743

4.2 Gendergin Tablet 0.25 mg, 0.5 mg, SR 1 mg (Alprazolam)

–  Indications: Anxiety disorders.

–  Approval Number:

0.25 mg: DOH-PM-042948

0.5 mg: DOH-PM-042514

SR 1 mg: DOH-PM-044011

5        Antiepileptics

5.1  Neurtrol F.C. Tablets 300 mg (Oxcarbazepine)

–  Indications: Monotherapy or adjunctive therapy for partial seizures in adults; adjunctive therapy for partial seizures in children over 1 month old.

–  Approval Number:

DOH-PM-047689

1.      Cardiac Therapy

1.1  Gendobu Injection 12.5 mg/mL (Dobutamine)

–  Indications: Enhances myocardial contractility suitable for short-term treatment of organic heart disease. Cardiac compensatory dysfunction caused by myocardial contractility suppression induced by cardiac surgery.

–  Approval Number:

DOH-PM-042141

1.2  Angidil Injection 0.1% (Isosorbide Dinitrate)

–  Indications: Treatment of angina pectoris.

–  Approval Number:

DOH-PM-044974

1.3  Nicodil Tablets 5 mg (Nicorandil)

–  Indications: Angina pectoris.

–  Approval Number:

DOH-PM-049306

2.      Antihypertensives

2.1  Genzosin Tablet 2 mg, 4 mg (Doxazosin)

–   Indications: Hypertension, benign prostatic hyperplasia.

–   Instructions: Can be used as first-line treatment for hypertension, and can be used in combination with thiazide diuretics, beta-blockers, calcium channel blockers, or angiotensin-converting enzyme inhibitors. Can alleviate symptoms of urinary obstruction in patients with benign prostatic hyperplasia.

–   Approval Number:

DOH-PM-042378

DOH-PM-042874

3.      Antithrombotic Agents

3.1  Clofix F.C. Tablets 75 mg (Clopidogrel)

–  Indications: Clopidogrel is indicated for the secondary prevention of atherothrombotic events in the following situations:

● To reduce the incidence of atherothrombotic events (such as myocardial infarction, stroke, or death due to vascular disease) in patients with recent stroke, myocardial infarction, or atherosclerosis due to peripheral arterial disease

● In combination therapy with aspirin to reduce atherothrombotic events in patients with non-ST segment elevation acute coronary syndrome (including unstable angina and non-Q wave myocardial infarction), including those who have undergone percutaneous coronary intervention with stent placement.

● In combination with aspirin can be used for the internal medical treatment of acute in patients with ST-segment elevation myocardial infarction.

● For patients with atrial fibrillation who are not suitable for treatment with vitamin K antagonists and have at least one risk factor for vascular events and are at low risk of bleeding, clopidogrel can be used in combination with aspirin to prevent atherothrombotic and thromboembolic events, including stroke.

–  Approval Number:

DOH-PM-049967

4.      Lipid Modifying Agents

4.1  Rotlip Film-coated Tablets 10 mg (Rosuvastatin)

–  Indications: Hypercholesterolemia, hypertriglyceridemia.

–  Approval Number:

DOH-PM-057130

4.2  Atorin Tablets 10 mg, 20 mg (Atorvastatin)

–  Indications:

● Hypercholesterolemia, hypertriglyceridemia.

● To reduce the risk of myocardial infarction and stroke in type 2 diabetes patients without coronary heart disease but with at least one other coronary heart disease risk factor including hypertension, retinopathy, albuminuria, or smoking.

● To lower the incidence of cardiovascular events in individuals at high risk for coronary heart disease.

● For hypertensive patients without coronary heart disease but with at least three other coronary heart disease risk factors including type 2 diabetes, age ≥ 55 years, microalbuminuria or proteinuria, smoking, or a first-degree relative who had coronary heart disease at age ≤ 55 (male) or ≤ 60 (female), Atorvastatin is indicated to reduce the risk of myocardial infarction, stroke, and revascularization procedures and angina.

–  Instructions:

Atorvastatin can lower total cholesterol, LDL-C, apo B, and triglycerides in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial hypercholesterolemia) and mixed hyperlipidemia (Fredrickson types IIa and IIb). It also increases HDL-C and treats elevated serum triglyceride levels in patients with hypertriglyceridemia (Fredrickson type IV) and primary β-lipoproteinemia (Fredrickson type III) when dietary therapy is insufficient. For homozygous familial hypercholesterolemia patients, atorvastatin reduces total cholesterol and LDL-C when dietary and other therapies are insufficient.

–          Dosage and Administration:

The dosage range is 10 to 80 mg once daily. Atorin can be administered as a single dose at any time of the day, with or without food.

Heterozygous familial hypercholesterolemia in pediatric patients (10-17 years of age): The recommended starting dose is 10 mg/day; the maximum recommended dose is 20 mg/day. Adjustments should be made at intervals of 4 weeks or more.

–  Contraindications: Patients with active liver disease or unexplained persistent elevations in hepatic transaminase levels. Patients allergic to any component of this medication.

–          Mechanism of Action:

Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Cholesterol and triglycerides circulate in the bloodstream as part of lipoprotein complexes. A variety of clinical studies have demonstrated that elevated levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apo B (a membrane complex for LDL-C) promote atherosclerosis in humans, which is a risk factor for cardiovascular diseases. Increased levels of high-density lipoprotein cholesterol HDL-C are associated with a reduced risk of cardiovascular diseases.

–  Approval Numbers:

10 mg: DOH-PM-049543

20 mg: DOH-PM-052530

5.      Agents Acting on the Renin-Angiotensin System

5.1  Bestan Tablets 150, 300 mg (Irbesartan)

–   Indications: Essential hypertension. Treatment of hypertension and diabetic nephropathy in patients with hypertension and type 2 diabetes.

–   Approval Number:

MOHW-OM-058235

1.      Anti-acne Preparations

1.1  Acure Gel 0.1% (Adapalene)

–  Indication: Treatment of acne vulgaris.

–  Approval Number:

DOH-PM-044573

1.      Anti-inflammatory and Antirheumatic Products

1.1  Asaid Film-coated Tablets 100 mg

–  Indications: Treatment of pain and inflammation caused by osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

–  Approval Number:

MOHW-OM-058604

2.      Muscle Relaxants

2.1  Carisoma Tablets 250 mg (Carisoprodol)

–  Indications: Anxiety tension, frequent tension, myositis, intercostal neuralgia, sciatica, neck pain, rheumatoid arthritis, osteoarthritis, muscle stiffness, muscle pain.

–  Approval Number:

DOH-PM-055961

2.2  Genso Injection 25 mg/2.5 mL (Atracurium)

–  Indications: Atracurium is a highly selective and competitive non-depolarizing neuromuscular blocking agent. It is used as an adjunct for general anesthesia in surgery or sedation in ICUs, to relax skeletal muscles, assist in endotracheal intubation, and coordinate mechanical ventilation.

Use standard doses for elderly and high-risk patients.

–  Approval Number:

DOH-PM-042879

2.3  Rocuron Injection 10 mg/mL (Rocuronium)

–  Indications: Adjunct to general anesthesia to facilitate endotracheal intubation, provide skeletal muscle relaxation during rapid sequence induction of anesthesia in surgery, and for use in ICUs for intubation and mechanical ventilation.

–  Approval Number:

MOHW-OM-058097

3. Topical Products for Joint and Muscular Pain

3.1  Toplax Film-coated Tablets 50 mg (Tolperisone)

–  Indications: Recurrent painful muscle spasms and abnormal increase in muscle tone caused by cerebrovascular diseases.

–  Approval Number:

DOH-PM-056735

1.      Antimalarials

1.1  Geniquin FC Tablet 200 mg (Hydroxychloroquine)

–  Indications: Discoid and systemic lupus erythematosus, chronic polymorphous light eruption, chronic rheumatoid arthritis, malaria caused by Plasmodium vivax and Plasmodium malariae.

–  Approval Number:

DOH-PM-042899

1.    Antineoplastic Agents

1.1  Doce Injection 20 mg/mL, 1 mL/vial (Docetaxel)

–  Indications: Breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, head and neck cancer.

–  Approval Number:

MOHW-OM-058065

1.2  Genetaxyl Crem Less Injection 6 mg/mL (Paclitaxel)

–  Indications: Advanced ovarian cancer, breast cancer with axillary lymph node metastasis, as adjuvant chemotherapy sequent to doxorubicin, metastatic breast cancer after failure of combination chemotherapy (prior therapy should have included an anthracycline unless contraindicated), non-small cell lung cancer, AIDS-related Kaposi’s sarcoma as second-line treatment; used in combination with cisplatin as a first-line therapy for advanced ovarian cancer. When combined with gemcitabine, it is indicated for patients with locally recurrent, unresectable, or metastatic breast cancer who have previously received anthracycline therapy. When used with Herceptin, it is indicated for the treatment of metastatic HER2 over-expressed breast cancer in patients who have not received prior chemotherapy.

–  Approval Number:

DOH-PM-045331

2.      Immunosuppressants

2.1  Mycocep Capsules 250 mg

–  Indications:

● Used in combination with cyclosporin and steroids for the prophylaxis and remission of acute organ rejection in kidney transplantation, and for the prophylaxis of acute organ rejection in heart and liver transplantation.

● Used in combination with corticosteroids, Mycocep is indicated for induction and maintenance therapy in adults with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III, IV, or V lupus nephritis.

–  Approval Number:

DOH-PM-050866

1.     Antimycotics for Systemic Use

1.1  Genazole IV Injection 100 mg/50 mL (Fluconazole)

–  Indications: Antifungal agent

–  Approval Number:

DOH-PM-043000

2.      Antivirals for Systemic Use

2.1  Livepro F.C. Tablets 0.5 mg, 1 mg

–  Indications: Treatment of chronic hepatitis B virus (HBV) infection with evidence of active HBV replication in adults and children aged 2 years and older.

–  Approval Number:

MOHW-OM-058091 (0.5 mg)

MOHW-OM-059253 (1 mg)

1. Antihistamines for Systemic Use

1.1  Desdin Film-coated Tablet 5 mg (Desloratadine)

–  Indications: Symptoms associated with perennial allergic rhinitis and seasonal allergic rhinitis, relief of chronic idiopathic urticaria symptoms in adults and children aged 12 years and older.

–  Approval Number:

DOH-PM-049099

1.2  Genadine Tablet 10 mg (Loratadine)

–  Indications: Relief of symptoms associated with allergic rhinitis such as runny nose, nasal congestion, itching, and itchy/burning eyes. Relief of symptoms caused by chronic urticaria and allergic skin diseases.

–  Approval Number:

DOH-PM-042860

2.      Throat Preparations

2.1  Loxol SR Tablets 75 mg (Ambroxol)

–  Indications: Expectorant.

–  Approval Number:

DOH-PM-046386

1.      Drugs for Urinary Frequency and Incontinence

1.1  Spalex Tablets 10 mg (Trospium)

–  Indications: Relief of smooth muscle spasms and pain.

–  Approval Number:

MOHW-OM-058618

1.2  Urotrol Tablet 15 mg (Propiverine)

–  Indications: 1. Urinary incontinence. 2. Urgency, and frequent urination associated with unstable bladder conditions.

The factors causing the above conditions include Idiopathic bladder instability and Neurogenic bladder detrusor hyperreflexia, originating from spinal cord injury (e.g., patients with paralysis of both lower limbs due to spinal cord transection injury).

–  Approval Number:

DOH-PM-045700

1.      Drugs Used in Diabetes

1.1  Glusafe Tablets 2 mg (Glimepiride)

–  Indications: Non-insulin-dependent (type 2) diabetes mellitus.

–  Approval Number:

DOH-PM-046074

1.2  Safemat 2/500 mg (Glimepiride, Metformin)

–          Indications: Treatment of type 2 diabetes patients when monotherapy with glimepiride or metformin does not result in adequate glycemic control, as an adjunct to diet and exercise. Not suitable for first-line therapy.

–  Approval Number:

MOHW-OM-059300

1.3  Precose Tablets 50 mg (Acarbose)

–  Indications: Treatment of non-insulin-dependent diabetes mellitus.

–  Approval Number:

DOH-PM-049579

2.      Drugs for Functional Gastrointestinal Disorders

2.1  Comfortine F.C.T. 50 mg

–  Indications: Gastric ulcer, duodenal ulcer, allergic colitis, colitis, and biliary dyskinesia.

–  Approval Number:

DOH-PM-057818

3.      Bile and Liver Therapy

3.1 Genurso Tablets 100 mg (Ursodeoxycholic Acid)

–  Indications: Dissolution of cholesterol gallstones, improvement of liver function associated with primary biliary cirrhosis.

–  Approval Number:

DOH-PM-042210

4.      Antibiotics

4.1  Mycostatin for oral suspension 100,000 units/mL (Nystatin)

 – Indications: Prophylaxis and treatment of oral, skin, and intestinal infections caused by Candida albicans

–  Approval Number:

DOH-PM-034904