New Drug Information
Ingredient Product Name Approval License Number/Date Indication
Sutent Capsules Sutent Capsules 024595
2007-01-02
SUTENT適用於imatinib mesylate治療期間出現疾病惡化或對該藥出現不能忍受之腸胃道間質腫瘤;治療晚期或轉移性腎細胞癌(病理上為亮細胞癌(clear cell carcinoma)
CYCLOSERINE GENGRAF CAPSULES 25MG 023327
2006-12-05
預防器官移植及骨髓移植後之移植排斥,預防移植反宿主疾病,活動性有失明危險之中部或後部非感染性葡萄膜炎,使用傳統療法無法控制者,BEHCT病一再發炎,且已侵犯視網膜者,替代性療法無效或不適用之嚴重乾癬;標準療法無效或不適用之嚴重類風濕性關節炎;以類固醇治療無效或對類固醇有依賴性的原發性腎病症候群(活體檢視「BIOPSY」主要為微小病變疾病或局部環節腎絲球硬化症),經細胞穩定(CYTOSTATIC)治療無效且腎功能指數在正常值50%以上之病人
LEVONORGESTREL Norlevo Tablet 1.5 mg  024573
2006-12-04
無事前避孕措施之緊急避孕措施
OXALIPLATIN Eloxatin 5mg/ml,concentrate for solution for infusion  024563
2006-11-13
和5-fluorouracil(5-FU)及folinic acid(FA)併用,作為-第三期結腸癌(Duke's C)原發腫瘤完全切除手術後的輔助療法。-治療轉移性結腸直腸癌
RITONAVIR Kaletra Tablets  024560
2006-11-08
治療人類免疫缺乏病毒(HIV)的感染
AMLODIPINE BESYLATE AMILO TABLETS 044687
2006-11-05
高血壓、心絞痛
Velcade for Injection Velcade for Injection 024510
2006-10-25
曾接受過至少一種治療方式且已經接受或不適宜接受骨髓移植的進展性多發性骨髓癌病人
RAMIPRIL Triapin 5mg slow-release tablets  024544
2006-09-29
治療本態性高血壓,但限於以ramipril或felodipine單方無法獲得有效控制,且已以等劑量之ramipril合併felodipine治療獲致穩定療效之病人
KETOTIFEN Zaditen 0.25 mg/ml eye-drops solution in single dose unit  024543
2006-09-28
暫時預防因過敏性結膜炎引起之眼睛癢
RISPERIDONE RISPERDAL CAPLETS 024539
2006-09-27
精神分裂症之相關症狀,雙極性疾患之躁症發作,治療失智症病人具嚴重攻擊性或精神分裂症類似症狀
LABETALOL HCL TRANDATE TABLETS 024532
2006-09-21
高血壓
THIAMINE DISULFIDE O,O-DIISOBUTYRATE Vitaminol Capsules  048230
2006-09-13
神經炎、多發性神經炎、腳氣病、維他命B1缺乏症
BUDESONIDE Obucort Swinghaler  048222
2006-09-11
支氣管氣喘
ATOMOXETINE HYDROCHLORIDE Strattera 10mg Hard Capsules 024515
2006-09-04
注意力缺損/過動症(ADHD)
DULOXETINE HYDROCHLORIDE Cymbalta Capsules 60mg "Ireland 024504
2006-08-14
重鬱症
NICOTINE Nicotinell Fruit Chewing Gum 024499
2006-08-02
戒菸輔助劑
OLMESARTAN MEDOXOMIL OLMETEC F.C. TABLETS 024497
2006-07-31
高血壓
DILTIAZEM HYDROCHLORIDE Diltelan Capsules 048127
2006-07-24
高血壓
NICOTINAMIDE Tricilest Tablets 048101
2006-07-13
維他命B群缺乏症
ESTRADIOL ETHINYL Tricilest Tablets  024485
2006-07-11
1.避孕。2.治療十五歲以上女性之中度尋常性痤瘡。該女性須為已有月經,打算避孕,對口服避孕藥治療未有已知的禁忌症,且對局部使用之抗痤瘡藥物反應不佳者
IMIPENEM Tilam for Injection 048083
2006-07-04
對Imipenem具有感受性之革蘭氏陰性菌、陽性菌感染症
ESTRADIOL Angeliq Film-coated Tablets 024466
2006-06-20
用於治療停經一年以上婦女之更年期症候群
ENZYGNOST HBE MONOCLONAL ENZYGNOST HBE MONOCLONAL  016164
2006-03-16
酵素免疫分析法測試人類血清或血漿中之B型肝炎E抗原及抗體
IBANDRONIC ACID 2.5MG BONVIVA FILM-COATED TABLETS 2.5MG 024337
2005-12-06
For treating it park through after brittle-bone disease of woman (BMD TSCORE<2.5 South Dakota),in order to reducing by vertebra fracture, (the curative effect of reducing the bone bone fracture has not been confirmed yet). It use for not preventing from not having it is the dangerous to produce osteoporosis (BMD T SCORE in- and not- among 2.5SD 1.0SD) decline, woman of BMD after not passing will be parked.
CYCLOSPORIN GENGRAF ORAL SOLUTION 024082
2005-10-11
Gengraf is indicated for the prophylaxis in Organ, Bone-marrow allogeneic transplantation, graft-versus-host disease (GVHD); also indicated for the treatment of patients with active sight-threatening intermediate or posterior uveitis of non-infective aetiology in which conventional therapy has proved inefective or caused unacceptable adverse reactions, Behcet uveitis with recurrent retinal inflammation, severe cases in which alternative therapies are ineffective or inappropriate, severe cases in which standard treatments are ineffective or inappropriate, idiopathic steroid-dependent or steroid-resistant nephrotic syndrome (biopsy shows minimal-change disease or focal segmental glomerulosclerosis in most cases) which has failed to respond to conventional cytostatic therapy but only if kidney function induces are at least 50% of normal.
TIMEPIDIUM BROMIDE TIMEPIDIUM BROMIDE 024284
2005-08-08
Convulsion in the town , anodyne
EPINEPHRINE -L HCL UBISTESIN FORTE 4% 024281
2005-08-01
Narcotic for dentistry uses
METHACHOLINE CHLORIDE PROVOCHOLINE INHALATION 1280MG/VIAL 024279
2005-07-28
Auxiliary diagnosis
GALANTAMINE HYDROBROMIDE REMINYL PROLONGED RELEASE CAPSULES 8MG 024275
2005-07-27
ALZHEIMER disease, dull-witted
GALANTAMINE HYDROBROMIDE REMINYL PROLONGED RELEASE CAPSULES 24MG 024276
2005-07-27
ALZHEIMER disease, dull-witted
GALANTAMINE HYDROBROMIDE REMINYL PROLONGED RELEASE CAPSULES 16MG 024274
2005-07-27
ALZHEIMER disease, dull-witted
LANSOPRAZOLE TAKEPRON OD 15MG TABLETS 024272
2005-07-26
Gastric ulcer, duodenal ulcer, go against the feeding habits esophagitis, disease group of ZOLLINGER-ELLISON, amalgamating antibiotic to treat the digestion ulcer that correlates with pylorus spiral bacillus (HELICOBACTER PYLORI )
VINORELBINE TARTRATE NAVELBINE 20MG, SOFT CAPSULE 024269
2005-07-21
Non- little cell lung cancer
VINORELBINE TARTRATE NAVELBINE 30MG,SOFT CAPSULE 024268
2005-07-21
Non- little cell lung cancer
CIPROFLOXACIN HYDROCHLORIDE H2O CILODEX STERILE OTIC SUSPENSION 024132
2004-12-02
Cilodex Otic is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:Acute Otitis Media in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.Acute Otitis Externa in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.
ROSUVASTATIN CALCIUM CRESTOR 10MG FILM-COATED TABLETS 024131
2004-12-02
Hypercholesterolemia, hypertriglyceridemia
Rosuvastatin calcium Crestor 20mg film-coated tablets 024129
2004-12-02
Hypercholesterolaemia, Hypertirglyceridemia
BUDESONIDE MICRONIZED ENTOCORT, TABLET AND SOLUTION FOR RECTAL SUSPENSION 0.02MG/ML 024118
2004-11-24
Ulcerative colitis, involving the rectum, sigmoid and descending colon.
PEMETREXED DISODIUM HEPTAHYDRATE ALIMTA POWDER GOR CONCENTRATE FOR SOLUTION FOR INFUSION 024084
2004-10-14
Alimta in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma.
CYCLOSPORIN GENGRAF ORAL SOLUTION 024082
2004-10-11
Gengraf is indicated for the prophylaxis in Organ, Bone-marrow allogeneic transplantation, graft-versus-host disease (GVHD); also indicated for the treatment of patients with active sight-threatening intermediate or posterior uveitis of non-infective aetiology in which conventional therapy has proved inefective or caused unacceptable adverse reactions, Behcet uveitis with recurrent retinal inflammation, severe cases in which alternative therapies are ineffective or inappropriate, severe cases in which standard treatments are ineffective or inappropriate, idiopathic steroid-dependent or steroid-resistant nephrotic syndrome (biopsy shows minimal-change disease or focal segmental glomerulosclerosis in most cases) which has failed to respond to conventional cytostatic therapy but only if kidney function induces are at least 50% of normal.
Esomeprazole Sodium Nexium powder for injection and infusion 40mg 024079
2004-10-05
Nexium is indicated for gastroesophageal reflux disease in patients with esophagitis and/or severe symptoms of reflux as an alternative to oral therapy when oral intake is not appropriate.
CIPROFLOXACIN (HCL) CILOXAN EAR DROPS 024075
2004-09-29
Ciloxan ear drops is indicated for acute otitis externa due to susceptible strains of bacterial species.
VALGANCICLOVIR HYDROCHLORIDE VALCYTE FILM-COATED TABLETS 450MG 024071
2004-09-24
1. Valcyte tablets are indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) 2. Valcyte is indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive. Recipient/CMV seronegative [(D+/R-)]。Valcyte is not indicated for use in liver transplant patients.The safety and efficacy of Valcyte for the prevention of CMV disease in other solid organ transplant patients such as lung transplant patients have not been established.
POLYETHYLENE GLYCOL 400 SYSTANE LUBRICANT EYE DROPS 024065
2004-09-08
For the temporary relief of burning and irritation due to dryness of the eye.
EZETIMIBE EZETROL TABLETS 10MG 024058
2004-09-01
Primary Hypercholesterolemia, Homozygous Familial Hypercholesterolemia (HoFH), Homozygous Sitosterolemia (Phytosterolemia).
OSELTAMIVIR PHOSPHATE TAMIFLU POWDER FOR ORAL SUSPENSION 024056
2004-08-27
Tamiflu is indicated for the treatment of influenza in adults and children 1 year of age and older.
ARIPIPRAZOLE OTSUKA ABILIFY TABLETS 10MG 024047
2004-08-12
Schizophrenia
ARIPIPRAZOLE OTSUKA ABILIFY TABLETS 5MG 024046
2004-08-12
Schizophrenia
ARIPIPRAZOLE OTSUKA ABILIFY TABLETS 30MG 024050
2004-08-12
Schizophrenia
ARIPIPRAZOLE OTSUKA ABILIFY TABLETS 20MG 024049
2004-08-12
Schizophrenia
ARIPIPRAZOLE OTSUKA ABILIFY TABLETS 15MG 024048
2004-08-12
Schizophrenia
ACETYLSALICYLIC ACID ASPIRIN PROTECT 100 024025
2004-06-28
Prevention of myocardial infarction. Prevention of thromboembolism. Transient ischemic attacks in male.
RALOXIFENE HYDROCHLORIDE EVISTA 60MG FILM COATED TABLETS 024023
2004-06-28
Evista is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
MIRTAZAPINE REMERON SOLTAB 30MG 024009
2004-06-09
Episode of major depression
DEXMEDETOMIDINE HYDROCHLORIDE PRECEDEX INJECTION 100MCG/ML 024002
2004-06-02
Dexmedetomidine hydrochloride is indicated for use in an intensive care setting and not more than 24 hours.
Losartan potassium Cozzar F.C. Tablets 100mg 023655
2003-02-13
Hypertension, Nephropathy in Type 2 Diabetic Patients
Efavirenz Stocrit Tablets 600mg 023607
2002-12-11
STOCRIT is indicated in antiviral combination treatment of HIV-1 infected adults, adolescents and children.
Didanosine Videx EC Delayed-Release Capsules 125mg 023577
2002-10-30
Videx EC (didanosine) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in adults.
Didanosine Videx EC Delayed-Release Capsules 200mg 023578
2002-10-30
Videx EC (didanosine) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in adults.
Didanosine Videx EC Delayed-Release Capsules 250mg 023579
2002-10-30
Videx EC (didanosine) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in adults.
Didanosine Videx EC Delayed-Release Capsules 400mg 023579
2002-10-30
Videx EC (didanosine) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in adults.
Tirofiban Aggrastat Injection Premixed 023539
2002-08-29
AGGRASTAT, in combination with heparin, is indicated for patients with unstable angina or non-Q-wave myocardial infarction to prevent cardiac ischemic events and is also indicated for patients with coronary ischemic syndromes undergoing coronary angioplasty or atherectomy to prevent cardiac ischemic complications related to abrupt closure of the treated coronary artery.
Latanoprost &Timolo XalcomEye Drop 023537
2002-08-28
For the treatment of patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers
Reboxetine Edronax Tablets 4m 023519
2002-08-19
Depression
Simvastatin Zocor 40mg F.C. Tablets 023506
2002-07-29
Treatment of patients with hyperlipidemia, hypertriglyceridemia
Rofecoxib Vioxx Tablet 50mg 023490
2002-07-15
VIOXX is indicated:For relief of the signs and symptoms of osteoarthritis. For relief of the signs and symptoms of rheumatoid arthritis in adults.For the management of acute pain in adults.For the treatment of primary dysmenorrhea.
Amisulpride Solian Tab.200mg 023492
2002-07-15
Schizophrenia
Amisulpride Solian Tab. 50mg 023493
2002-07-15
Schizophrenia
Rofecoxib Vioxx 50mg 023490
2002-07-15
Treatment of acute and chronicarthritis symptoms. Pain relief and treatment of pain caused by period.
Caspofungin acetate Cancidas injection 70mg 023483
2002-07-01
Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies.
Caspofungin acetate Cancidas injection 50mg 023485
2002-07-01
Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies.
Caspofungin acetate Cancidas 10/ 50mg 023485
2002-07-01
Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies.
Etanercept 25mg Enbrel 000713
2002-04-30
ENBREL is indicated for reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.
Ethinylestradiol 15mcg Minesse 023163
2002-04-10
Prevention of pregnancy.
Raltitrexed Tomudex 2mg Lyophilised Powder for I.V. Infusion 023401
2002-03-25
late stage, metastatic colorectal cancer patients who have grade IV neutropenia and grade IV severe diarrhea when treated with 5-fluorouracil.
Montelukast sodium Singulair Chewable Tablet 4mg 023398
2002-03-11
Indicated in adult and pediatric patients for the prophylaxis and chronic treatment of asthma, including the prevention of day-and nighttime symptoms, and the prevention of exercise-induced bronchoconstriction
Montelukast sodium Singulair 4mg 023398
2002-03-11
Indicated in adult and pediatric patients for the prophylaxis and chronic treatment of asthma, including the prevention of day-and nighttime symptoms, the treatment of aspirin-sensitive asthmatic patients, and the prevention of exercise-induced bronchoconstriction.
Losartan potassium Hyzaar Forte F.C. Tablets 100/25mg 023395
2002-03-08
Hypertension
Losartan potassium Hyzaar 100/25mg 023395
2002-03-08
Hypertension
Nedocromil Tilade CFC-free Inhaler 023376
2002-02-04
Treatment of mild-persistent asthma
Sirolimus 1mg Tab Rapamune 023363
2002-01-21
Rapamune is indicated for the prophylaxis of organ rejection in patients receiving renal transplants. It is recommended that Rapamune be used in a regimen with cyclosporine and corticosteroids.
Indinavir sulfate Crixivan Capsules 100mg 023354
2002-01-14
CRIXIVAN is indicated for the treatment of adult and pediatric patients with HIV-1 infection.
Sibutramine Reductil Capsules 15mg 023356
2002-01-14
For supportive treatment within a weight management program of:
‧Patients with alimentary obesity and a BMI of 30 kg/m2 or abovel
‧Patients with alimentary excess weight and a BMI of 27 kg/m2 or above who have obesity-related risk factors like type II diabetes or dyslipidaemia.
Sibutramine Reductil Capsules 10mg 023355
2002-01-14
For supportive treatment within a weight management program of:
‧Patients with alimentary obesity and a BMI of 30 kg/m2 or abovel
‧Patients with alimentary excess weight and a BMI of 27 kg/m2 or above who have obesity-related risk factors like type II diabetes or dyslipidaemia.
Timolol maleate; Dorzolamide hydrochloride Cosopt Ophthalmic Solution 023337
2001-12-24
COSOPT is indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension, open-angle glaucoma, pseudoexfoliative glaucoma or other secondary open-angle glaucomas when concomitant therapy is appropriate.
Bicalutamide Tomudex 2mg Lyophilised Powder for I.V. Infusion 023320
2001-11-28
Treatment of advanced prostate cancer in combination with LHRH analogue therapy or surgical castration
Budesonide Pulmicort Nasal Aqua 64ug/dose 023310
2001-11-06
Seasonal and perennial allergic rhinitis, vasomotor rhinitis, nasal polyps
Budesonide Pulmicort Nasal Aqua 32ug/dose 023309
2001-11-06
Seasonal and perennial allergic rhinitis, vasomotor rhinitis, nasal polyps
Polyribosylribitolphosphate; Outer membrane protein complex; Hepatitis B surface antigen Comvax s. 000695
2001-10-23
COMVAX is indicated for vaccination against invasive disease caused by Haemophilus influenzae type b and against infection caused by all known subtypes of hepatitis B virus in infants 6 weeks to 15 months of age born of HBsAg negative mother
Budesonide , formoterol fumarate dihydrate Symbicort Turbuhaler 160/4.5ug/dose 023265
2001-08-20
Bronchial asthma where use of combination (inhaled corticosteroid and long acting beta-agonist) is appropriate
Budesonide , formoterol fumarate dihydrate Symbicort Turbuhaler 80/4.5ug/dose 023262
2001-08-20
Bronchial asthma where use of combination (inhaled corticosteroid and long acting beta-agonist) is appropriate
Esomeprazole Nexium Tablets 40mg 023221
2001-07-04
GERD- treatment of erosive reflux esophagitis, symptomatic treatment of GERD; in combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori and healing of Helicobacter pylori associated duodenal ulcer.
Esomeprazole Nexium Tablets 20mg 023225
2001-07-04
GERD- treatment of erosive reflux esophagitis, symptomatic treatment of GERD; in combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori and healing of Helicobacter pylori associated duodenal ulcer.
Alendronate sodium Fosamax Tablets 70mg 023167
2001-04-24
In postmenopausal women with osteoporosis FOSAMAX is indicated for the treatment of osteoporosis. FOSAMAX is indicated for the treatment of osteoporosis in men.
Simvastatin Zocor 80mg F.C. Tablets 023144
2001-03-20
Treatment of patients with hyperlipidemia, hypertriglyceridemia
Nefazodone HCl Serzone Tablets 250mg 023140
2001-03-19
Serzone (nefazodone hydrochloride) is indicated for the treatment of depression.
Nefazodone HCl Serzone Tablets 200mg 023142
2001-03-19
Serzone (nefazodone hydrochloride) is indicated for the treatment of depression.
Nefazodone HCl Serzone Tablets 100mg 023143
2001-03-19
Serzone (nefazodone hydrochloride) is indicated for the treatment of depression.
Nefazodone HCl Serzone Tablets 50mg 023141
2001-03-19
Serzone (nefazodone hydrochloride) is indicated for the treatment of depression
Hydroxycarbamide Hydrea Capsules 500mg 023135
2001-03-09
Didanosine Videx Chewable Buffered Tablets 200mg 023122
2001-02-19
Videx (didanosine) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection.
Rofecoxib Vioxx Oral Suspension 12.5mg/5ml 023112
2001-02-05
VIOXX is indicated:For relief of the signs and symptoms of osteoarthritis. For the management of acute pain in adults.For the treatment of primary dysmenorrhea.
Rofecoxib Vioxx Oral Suspension 25mg/5ml 023111
2001-02-05
VIOXX is indicated:For relief of the signs and symptoms of osteoarthritis. For the management of acute pain in adults.For the treatment of primary dysmenorrhea.
Rofecoxib Vioxx Tablet 25mg . 023113
2001-02-05
VIOXX is indicated:For relief of the signs and symptoms of osteoarthritis. For relief of the signs and symptoms of rheumatoid arthritis in adults.For the management of acute pain in adults.For the treatment of primary dysmenorrhea
Rofecoxib Vioxx Tablet 12.5mg . 023114
2001-02-05
VIOXX is indicated:For relief of the signs and symptoms of osteoarthritis. For relief of the signs and symptoms of rheumatoid arthritis in adults.For the management of acute pain in adults.For the treatment of primary dysmenorrhea
Aztreonam Azactam for Injection 023105
2001-01-29
Azactam (aztreonam) for injection is selectively and specifically indicated in severe bacterial infections which are known or believed to be caused by "difficult" gram negative microorganisms. In particular, the product is indicated in debilitated and/or immunodepressed patients suffering from the aforementioned infections; Surgical Prophylaxis.

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