懷孕藥品風險分類B級的藥物
皮膚科 王修含 醫師
B級藥品:可能安全
C級藥品:避免使用(對胎兒的影響尚不清楚),除非治療上的好處大於風險
D級藥品:避免使用(已證實對胎兒有危險),除非治療上的利益大於風險
X級藥品:具有致畸胎性(Teratogenicity)
B級藥品的定義為:「動物試驗的結果顯示,並無對胎兒有害的證據,但缺乏針對懷孕婦女進行妥善設計且有對照組的研究。」(Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women.)
或
「雖然動物試驗顯示對胚胎有不良作用,但針對懷孕婦女的對照研究中,無法證明對於胎兒的危險性。」(Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus.)
新式作法:懷孕與哺乳期標示規則(Pregnancy and Lactation Labeling Rule, PLLR)
由於「懷孕分級」系統的ABCDX分類系統過於簡化,對藥物的風險評定過於簡單,且可能造成混淆,無法有效且完整涵括妊娠、生產、授乳各時期的藥物風險變化,且無法指出對於女性與男性生殖系統潛在的風險,因此美國FDA決定揚棄舊式的「懷孕分級」系統,制定出新式的「懷孕與哺乳期標示規則」(Pregnancy and Lactation Labeling Rule, PLLR),此系統於2015年6月30日正式生效。
新式標示法,請參見「懷孕與哺乳期標示規則 (Pregnancy and Lactation Labeling Rule, PLLR)」 http://www.skin168.net/2016/02/PLLR-pregnancy-drug.html
雖然美國FDA以「懷孕與哺乳期標示規則」 (PLLR)取代「懷孕分級」(Pregnancy categories),改用詳細的文字資訊取代簡略的字母代號,但已實行數十年的
「懷孕分級」系統,仍有其參考價值,故亦收錄於後,可供快速查詢之用。
新式作法:懷孕與哺乳期標示規則(Pregnancy and Lactation Labeling Rule, PLLR)
由於「懷孕分級」系統的ABCDX分類系統過於簡化,對藥物的風險評定過於簡單,且可能造成混淆,無法有效且完整涵括妊娠、生產、授乳各時期的藥物風險變化,且無法指出對於女性與男性生殖系統潛在的風險,因此美國FDA決定揚棄舊式的「懷孕分級」系統,制定出新式的「懷孕與哺乳期標示規則」(Pregnancy and Lactation Labeling Rule, PLLR),此系統於2015年6月30日正式生效。新式標示法,請參見「懷孕與哺乳期標示規則 (Pregnancy and Lactation Labeling Rule, PLLR)」 http://www.skin168.net/2016/02/PLLR-pregnancy-drug.html
雖然美國FDA以「懷孕與哺乳期標示規則」 (PLLR)取代「懷孕分級」(Pregnancy categories),改用詳細的文字資訊取代簡略的字母代號,但已實行數十年的
「懷孕分級」系統,仍有其參考價值,故亦收錄於後,可供快速查詢之用。
B級藥物列表:
一般常用藥物甚多,在此以台大醫院處方集所列的藥物為例,整理出懷孕藥品風險分類B級的安全藥物:(藥物資料來源:台大醫院藥劑部提供)
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【本站文章版權所有,歡迎非商業性「部份」轉載(請勿全文轉載),轉載請註明作者姓名標示(皮膚科王修含醫師)與出處(skin168.net/ skin168.com/ skin168.org),禁止更動內文,並提供有效的本站超連結。】
學名
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藥品中文名稱
|
商品名
| |
優泌樂-混合型50
|
Humalog Mix50, 300 IU/3 mL/pen (DC)
| ||
50% insulin lispro and 50% insulin lispro protamine
|
優泌樂筆-混合型50
|
Humalog Mix50 KwikPen, 300 IU/3 mL/pen
| |
Acarbose
|
醣祿錠
|
Glucobay Tablet 50 mg/tab
| |
Acarbose
|
醣祿錠
|
<試> Glucobay-200905056M 50 mg/tab
| |
Acetaminophen
|
力停疼錠
|
Tinten Tablet 500 mg/tab
| |
Acetylcysteine
|
希那克注射劑
|
Hidonac Injection (20%) 5 g/25 mL/btl
| |
Acetylcysteine
|
愛克痰發泡錠
|
Actein Effervescent Tablet 600 mg/tab
| |
Acetylcysteine Sodium
|
安喀寶注射液
|
Encore Injection 10%, 300 mg/3 mL/amp
| |
Acyclovir
|
熱威樂素懸液劑
|
Zovirax Suspension 40 mg/mL, 125 mL/btl
| |
Acyclovir
|
熱威樂素乳膏劑
|
Zovirax Cream 5% 2 g/tube
| |
Acyclovir
|
熱威樂素眼用軟膏
|
Zovirax Ophthalmic Ointment 3% 4.5 g/tube
| |
Acyclovir
|
力克眼用軟膏
|
Devirus Ophthalmic Ointment 3% 4.5 g/tube
| |
Acyclovir
|
疱寧錠200毫克
|
DeherpTablet 200 mg/tab
| |
Adalimumab 40 mg/syringe
|
復邁針筒裝注射劑
|
Humira 40 mg solution for injection prefilled syringe (40mg/ 0.8mL/ syringe)
| |
Agalsidase Beta
|
法布瑞酶凍晶注射劑
|
Fabrazyme for Injection 35 mg/vial
| |
Alfuzosin HCl
|
扎特持續性藥效錠
|
Xatral XL Tablet 10 mg/tab
| |
Alprostadil
|
卡維傑特注射劑
|
Caverject Sterile Powder 20 mcg/vial
| |
Amorolfine HCl
|
樂指利抗甲癬油劑
|
Loceryl Nail Lacquer 5% 3 mL/btl
| |
Amoxicillin and Clavulanate Potassium
|
安滅菌靜脈注射劑
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Augmentin for IV Injection 500 mg amoxicillin & 100 mg clavulanic acid/vial (Na 3.1 mEq, K 1 mEq/1.2 g)
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Amoxicillin and Clavulanate Potassium
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安滅菌糖漿用粉劑
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Augmentin Powder for Oral Suspension 80 mg amoxicillin /mL,
2800 mg amoxicillin & 400 mg clavulanic acid/35 mL/btl | |
Amoxicillin and Clavulanate Potassium
|
安滅菌膜衣錠1公克
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Augmentin 1 g F.C. Tablet 875 mg amoxicillin & 125 mg clavulanic acid/tab
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Amoxicillin Trihydrate
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安蒙西林膠囊
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Amoxicillin Capsule 250 mg amoxicillin/cap
| |
Amoxicillin Trihydrate
|
萬博黴素懸液用粉
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Amolin Powder for Oral Suspension 25 mg amoxicillin/mL, 60 mL/btl
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Amphotericin B
|
防治黴靜脈凍晶注射劑
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Fungizone Intravenous Injection 50 mg/vial
| |
Amphotericin B Liposomal
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脂黴素微脂粒凍晶乾粉注射劑
|
AmBisome for Injection 50 mg/vial
| |
Ampicillin Sodium
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安博黴素注射劑
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Ampolin for Injection 500 mg ampicillin/vial (Na 2.9-3.1 mEq/g potency)
| |
Ampicillin Sodium and Sulbactam Sodium
|
優耐迅肌肉/靜脈注射劑
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Unasyn 1.5 g for Injection ampicillin 1000 mg & sulbactam 500 mg/vial (Na 5.0 mEq/vial)
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Atazanavir
|
瑞塔滋膠囊
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Reyataz Capsule 150 mg/cap
| |
Atazanavir
|
瑞塔滋膠囊
|
Reyataz Capsule 200 mg/cap
| |
Azelaic Acid
|
思麗安乳膏
|
Skinoren Cream Micronized azelaic acid 20% in a cream vehicle, 30 g/tube
| |
Azithromycin Dihydrate
|
日舒錠
|
Zithromax Tablet 250 mg azithromycin/tab
| |
Azithromycin Dihydrate
|
日舒懸液用粉, 47.78毫克/公克
|
Zithromax Powder for Oral Suspension 40 mg azithromycin/mL, 15 mL/btl
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Aztreonam
|
安達菌素乾粉注射劑
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Azactam for Injection 1 g/vial
| |
Bambuterol HCl
|
幫肺克錠
|
Bambec Tablet 10 mg/tab
| |
Basiliximab
|
新睦樂凍晶注射劑
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Simulect for Injection 20 mg/vial
| |
Betahistine Mesylate
|
敏使朗錠
|
Merislon Tablet 12 mg/tab
| |
Bevacizumab
|
<試>Avastin-BO20906 400 mg/16 mL/vial
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Bevacizumab
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<試>Bevacizumab-ML25602 100 mg /4 mL/ vial
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Bevacizumab
|
<試>Bevacizumab-MO22923 400 mg /16 mL/vial
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Brimonidine Tartrate
|
艾弗目眼藥水
|
Alphagan P Ophthalmic Solution 0.15% 5 mL/btl
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Bromocriptine Mesylate
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保乳調錠
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Parlodel Tablet 2.5 mg/tab
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Budesonide
|
可滅喘都保定量粉狀吸入劑
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Pulmicort Turbuhaler 200 mcg/dose, 100 doses/btl
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Budesonide
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可滅喘懸浮吸入液1公絲/2公撮
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Pulmicort Respules Nebulising Suspension for Inhalation 1 mg/2 mL/respule
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Budesonide
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帝舒滿定量噴霧液
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Duasma Metered Dose Inhaler 200 mcg/puff, 200 puffs/btl
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Buspirone HCl
|
百事隆錠
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Busron Tablet 10 mg/tab
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Buspirone HCl
|
怡必隆錠
|
Sepirone Tablet 10 mg/tab
| |
Cabergoline
|
過乳降錠
|
Dostinex Tablet 0.5 mg/tab
| |
Carboplatin
|
<試> Paraplatin-MO22923 450 mg/45 mL/vial
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Carnitine
|
加力體能咀嚼錠
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Carnitene Chewable Tablet 1 g/tab
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Carnitine
|
加力體能注射劑
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Carnitene Injection 1 g/5 mL/amp
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Cefazolin Sodium
|
信華注射劑
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Cefa for Injection 1 gm cefazolin/vial (Na 2.1 mEq/g potency)
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Cefazolin Sodium
|
克法妥黴素注射劑
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Kofatol for Injection 1 gm cefazolin/vial (Na 2.1 mEq/g potency)
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Cefepime HCl
|
邁菌平注射劑
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Maxipime for Injection 500 mg cefepime /vial
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Cefixime
|
速復適康(希復欣)膠囊
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Cefspan Capsule 100 mg/cap
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Cefmetazole Sodium
|
賜乎滅達榮靜脈注射劑
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Cefmetazon for Injection 500 mg cefmetazole/vial (Na 2.12 mEq/g potency) (停產)
| |
Cefmetazole Sodium
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喜達隆注射劑
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Cetazone Injection 500 mg cefmetazole/vial (Na 2.12 mEq/g potency)
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Cefotaxime Sodium
|
可活能靜脈注射劑
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Claforan for Injection 500 mg cefotaxime/vial (Na 2.1 mEq/g potency)
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Cefpirome Sulfate
|
喜活能乾粉注射劑
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Cefrom Powder for IV Injection 1 g cefpirome/vial (Na 4.7 mEq/g potency)
| |
Ceftazidime
|
祐坦賜福乾粉注射劑
|
Tatumcef Powder for Injection 500 mg with 59 mg Na2CO3/vial (Na 2.3 mEq/g potency)
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Ceftibuten
|
協復鼎膠囊
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Seftem Capsule 100 mg/cap
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Ceftriaxone Sodium
|
羅氏芬靜脈注射劑
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Rocephin for Injection 500 mg ceftriaxone/vial (Na 3.6 mEq/g potency)
| |
Cefuroxime Axetil
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欽納特錠
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Zinnat Tablet 250 mg cefuroxime/tab
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Cefuroxime Axetil
|
欽納特懸液劑
|
Zinnat Powder for Oral Suspension 125 mg cefuroxime/5 mL, 50 mL/btl
| |
Cefuroxime Sodium
|
西力欣注射劑
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Zinacef for Injection 750 mg cefuroxime/vial (Na 2.4 mEq/g potency)
| |
Cephalexin
|
信保欣膠囊
|
Cephalexin Capsule 250 mg/cap
| |
Cephalexin
|
優力黴素口服懸液用顆粒
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Ulexin for Oral Suspension 25 mg/mL, 60 mL/btl
| |
Cephradine Arginine
|
優復捷愛黴素注射劑
|
U-Save-A for Injection 0.5 g cephradine/vial (Na free)
| |
Cetirizine 2HCl
|
驅特異內服液劑
|
Zyrtec Oral Solution 1 mg/mL, 60mL/btl
| |
Chlorhexidine Gluconate
|
@ 克羅淨 濃液劑 5%
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@ Kilgerm Concentrate 5% 5 L/btl
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Chlorhexidine Gluconate
|
希必定濃液劑
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@ Hibitane Concentrate Solution 5% 5 L/btl
| |
Chlorhexidine Gluconate
|
希必潔外用液
|
Hibiscrub 4% with Detergent 5 L/btl
| |
Cholera Vaccine (Vibrio cholerae O1 & Cholera toxin B Subunit)
|
Dukoral Inactivated Vaccine 3 mL/vial
| ||
Cisatracurium
|
肌弛適注射劑
|
Nimbex Injection 10 mg/5 mL/amp
| |
Clindamycin HCl
|
利達信黴素膠囊
|
Lindacin Capsule 150 mg clindamycin/cap
| |
Clindamycin Phosphate
|
麗歐迅外用液
|
Cleocin T Topical Solution 1% 30 mL/btl
| |
Clindamycin Phosphate
|
克林達黴素注射液150公絲
|
Clindamycin injection 150mg (150mg/mL, 300 mg/amp)
| |
Clindamycin Phosphate
|
克力欣注射液150公絲/公撮
|
Clincin inj. 300 mg/2 mL/amp
| |
Clopidogrel
|
保栓通膜衣錠
|
Plavix Film-Coated Tablet 75 mg/tab
| |
Clopidogrel
|
保栓通膜衣錠
|
@ Plavix Film-Coated Tablet 300 mg/tab
| |
Clopidogrel or placebo
|
<試> Clopidogrel-H7T-MC-TABY (b) 75 mg/tab 33 tab/ btl
| ||
Clopidogrel or placebo
|
<試> Clopidogrel-H7T-MC-TABY (b) 75 mg/tab 4 tab/ btl
| ||
Clozapine
|
可致律錠
|
Clozaril Tablet 100 mg/tab
| |
Cromolyn Sodium
|
克視敏點眼液
|
Cusicrom Eye Drops 2% 10 mL/btl (停產)
| |
Cromolyn Sodium
|
克鼻敏鼻用噴液劑
|
Cusicrom Nasal Spray 4% 15 mL/btl (停產)
| |
Cromolyn Sodium
|
艾麗鼻用噴液劑
|
Allergocrom Nasal Spray Solution 2% 2.8 mg/spray, 15 mL/btl
| |
Cromolyn Sodium
|
艾麗點眼液
|
Allergocrom Eye Drops 20 mg/mL, 10 mL/btl
| |
Cyproheptadine
|
安清敏錠
|
Antisemin Tablet 4 mg/tab
| |
Cyproheptadine
|
佩你安錠
|
Pilian Tablet 4 mg/tab
| |
Cyproheptadine
|
希普利敏液
|
Cypromin Solution 0.4 mg/mL, 120 mL/btl
| |
Dalteparin Sodium
|
弗列明注射劑2500單位/公撮
|
Fragmin Injection 10000 IU/4 mL/amp (1 mg=156.25 IU)
| |
Daptomycin
|
可倍行注射劑
|
Cubicin Injection 350 mg/vial (DC)
| |
Daptomycin
|
救必辛注射劑
|
Cubicin Injection 500 mg/vial
| |
deferasirox
|
易解鐵可溶錠 125毫克/錠
|
Exjade Dispersible Tablet 125 mg/tab
| |
Desflurane
|
輸活能液態吸入劑
|
@Suprane 240 mL/btl
| |
Desmopressin Acetate
|
迷你寧注射劑
|
Minirin Injection 4 mcg/mL/amp
| |
Desmopressin Acetate
|
迷你寧鼻腔噴霧劑
|
Minirin Nasal Spray 250 mcg/25 doses/2.5 mL/btl
| |
Desmopressin Acetate
|
迷你寧錠
|
Minirin Tablet 0.1 mg/tab
| |
Dexchlorpheniramine Maleate
|
特息敏錠2公絲(右氯敏)
|
Dex-CTM Tablet 2 mg/tab
| |
Dexchlorpheniramine Maleate
|
舒敏錠
|
Somin Tablet 2 mg/tab
| |
Dicloxacillin Sodium
|
達可西林膠囊
|
Dacocilin Capsule 250 mg/cap (Na 0.6 mEq/cap)
| |
Dicyclomine HCl
|
便治爾錠
|
Bentyl Tablet 10 mg/tab
| |
Didanosine
|
惠妥滋持續性膠囊250公絲
|
Videx EC Delay-Release Capsule 250 mg/cap
| |
Didanosine
|
惠妥滋持續性藥效膠囊400公絲
|
Videx EC Delay-Release Capsule 400 mg/cap
| |
Diphenhydramine HCl
|
鹽酸二苯胺明注射液
|
Diphenhydramine HCl Injection 3%, 30 mg/1 mL/amp
| |
Diphenhydramine HCl
|
鹽酸二苯胺明注射液
|
Injectio Diphenhydramini Hydrochloridi 3%, 30 mg/1 mL/amp
| |
Dipyridamole
|
心妙健注射液
|
Shinmiochien Injection 10 mg/2 mL /amp
| |
Dobutamine HCl
|
優達命注射液
|
Utamine Injection 250 mg dobutamine/20 mL/vial
| |
Dobutamine HCL
|
得寶明塩酸塩注射劑
|
Dobutamine Hydrochloride 250 mg dobutamine/20 mL/vial
| |
Domperidone
|
胃利空懸液劑
|
Wempty Suspension 60 mg/60 mL/btl
| |
Domperidone
|
道喜錠
|
Dosin Tablet 10 mg/tab
| |
Doxepin HCl
|
普膚乳膏
|
Ichderm Cream 5% 15 g/tube
| |
Emtricitabine and tenofovir disoproxil fumarate
|
<免費>舒發泰膜衣錠
|
免費Truvada Tablet emtricitabine 200 mg & tenofovir disoproxil fumarate 300 mg/tab
| |
Emtricitabine and tenofovir disoproxil fumarate
|
舒發泰膜衣錠
|
Truvada Tablet emtricitabine 200 mg & tenofovir disoproxil fumarate 300 mg/tab
| |
Enoxaparin Sodium
|
克立生注射劑
|
Clexane Injection 60 mg (6000 anti-factor Xa IU)/0.6 mL/syringe
| |
Epoprostenol Sodium
|
服療能注射劑
|
Flolan 500 mcg/vial
| |
Epoprostenol Sodium
|
(免費)服療能注射劑
|
(Free) Flolan 500 mcg/vial
| |
Eptifibatide
|
應治凝注射液
|
Integrilin Injection 75 mg/100 mL/vial
| |
Eptifibatide or placebo
|
<試>Eptifibatide bolus-EFC6204 20 mg/10 mL/vial
| ||
Eptifibatide or placebo
|
<試>Eptifibatide infusion-EFC6204 75 mg/100 mL/vial
| ||
ertapenem sodium
|
益滿治注射劑
|
Invanz for Injection 1 g/vial
| |
Erythromycin Estolate
|
優樂黴素口服懸濁液用顆粒
|
Ulosina for Oral Suspension 25 mg/mL, 60 mL/btl
| |
Erythromycin Lactobionate
|
威黴素靜脈注射劑
|
Erythrocin Lactobionate-IV for Injection 500 mg erythromycin/vial
| |
Esomeprazole Magnesium
|
耐適恩錠
|
Nexium Tablet 40 mg (as magnesium trihydrate)/tab
| |
Esomeprazole or placebo
|
<試> D961HPC00001 20 mg/tab, 224 tab/box
| ||
Esomeprazole Sodium
|
耐適恩注射劑
|
Nexium Powder for Injection and Infusion, equivalent to 40 mg/vial
| |
Etanercept
|
恩博凍晶注射劑(DC)
|
Enbrel for Injection 25 mg/vial (DC)
| |
Etanercept
|
恩博針筒裝注射劑
|
Enbrel Solution for Injection in Pre-filled Syringe 25 mg/0.5 mL/syringe
| |
Ethambutol HCl
|
孟表多片劑
|
Myambutol Tablet 400 mg/tab
| |
Ethambutol HCl
|
醫肺妥膜衣錠
|
Ebutol F.C. Tablet 400 mg/tab
| |
Etravirine
|
英特萊錠
|
Intelence Tablets 100 mg/tab
| |
Famotidine
|
蓋舒泰D口溶錠
|
Gaster D Tablet 20 mg/tab
| |
Famotidine
|
蓋舒泰注射液
|
Gaster Injection 20 mg/amp
| |
Fenoterol HBr
|
適喘寧液
|
Strolin Liquid 0.5 mg/mL, 60 mL/btl
| |
Ferric-Hydroxide-Sucrose Complex
|
鐵補 注射液
|
Fe-Back Injection 2% 100 mg Fe+3/ 5 mL/ vial
| |
Flavoxate HCl
|
伏順 膜衣錠
|
Foxate F.C. Tablet 200 mg/tab
| |
Fluorescein
|
服攝得點眼液2%
|
Corircusi Fluorescein Eye Drops 2% 1mL/btl (常備)
| |
Galantamine HBr
|
利憶靈持續藥效膠囊16毫克
|
Reminyl Prolonged Release Capsule 16mg/cap
| |
Galsulfase
|
(無)
|
Naglazyme Injection 5 mg/5 mL/vial
| |
Glatiramer Acetate
|
可舒鬆注射液20公絲
|
Copaxone 20mg solution for injection (Pre-filled syringe)
| |
Glucagon
|
昇糖精
|
GlucaGen for Injection 1 mg(=1 IU)/vial
| |
Glyburide
|
固利康錠
|
Gliben Tablet 5 mg/tab
| |
Glycopyrrolate
|
格比平注射劑 0.2毫克/毫升
|
Glycopyrodyn Injection 0.2mg/mL/amp
| |
Gonadorelin Acetate
|
黃體形成荷爾蒙分泌荷爾蒙注射液
|
LH-RH Injection 100 mcg/1 mL/amp
| |
Granisetron HCl
|
康您適強錠
|
Kytril Tablet 1 mg granisetron/tab
| |
Granisetron HCl
|
康您適強注射劑
|
Kytril Injection 3 mg granisetron/3 mL/amp
| |
Granisetron HCl
|
康您適強注射劑
|
<試> Kytril-MO22201 3 mg/3 mL/amp
| |
Granisetron HCl
|
(兒癌基金會) 康您適強錠
|
(兒癌基金會) Kytril Tablet 1 mg granisetron/tab
| |
Granisetron HCl
|
(兒癌基金會) 康您適強注射劑
|
(兒癌基金會) Kytril Injection 3 mg granisetron/3 mL/amp
| |
Granisetron HCl
|
(兒癌基金會) 康您適強注射劑
|
(兒癌基金會) Kytril Injection 1 mg granisetron/1 mL/amp
| |
Granisetron HCl
|
嘔速停靜脈注射劑
|
<試>Otril-T1210 1 mg /mL/vial
| |
Granisetron HCl
|
嘔速停靜脈注射劑
|
<試>Otril-T1210 3 mg /3 mL/vial
| |
Human Papillomavirus Bivalent (Types 16,18) Recombinant Vaccine
|
保蓓[二價人類乳突病毒(第16,18型)基因重組疫苗]
|
Cervarix Vaccine 0.5 mL/vial, Human Papillomavirus vaccine Type 16 and 18 (Recombinant, AS04 adjuvanted)
| |
Human Papillomavirus Recombinant Vaccine Quadrivalent (types 6, 11, 16, 18)
|
嘉喜[四價人類乳突病毒(第6,11,16,18型)基因重組疫苗]
|
Gardasil Injection 0.5 mL/syringe
| |
Human Papillomavirus Recombinant Vaccine Quadrivalent (types 6, 11, 16, 18)
|
嘉喜[四價人類乳突病毒(第6,11,16,18型)基因重組疫苗]
|
<試>Gardasil-V501-020-10 Inj 0.5 mL/ vial
| |
Imiquimod
|
樂得美乳膏
|
Aldara Cream 5% 250 mg/packet
| |
Indapamide
|
鈉催離持續性藥效錠
|
Natrilix SR Tablet 1.5 mg/tab
| |
Insulin Aspart
|
諾和瑞 諾芯管(筆型胰島素)
|
NovoRapid Penfill 300 U/3 mL/penfill
| |
Iodixanol
|
易渠派克注射劑(常備藥)
|
@Visipaque Injection 100 mL/btl, I: 320 mg/mL
| |
Iohexol
|
安你拍克注射劑
|
Omnipaque Injection 75.5% 100 mL/vial, I: 350 mg/mL
| |
Iopromide
|
優照維斯碘
|
Ultravist 370 Injection 76.9% 200 mL/btl, I: 370 mg/mL
| |
Iopromide
|
優照維斯碘
|
Ultravist 300 Injection 62.3% 100 mL/btl, I: 300 mg/mL
| |
Ioversol
|
加拿大歐得利320造影劑
|
Optiray 320 Injection 68% 200 mL/btl, I:320 mg/mL
| |
Ipratropium Bromide
|
定喘樂單一劑量吸入液
|
Atrovent Nebulizer Solution UDV 500 mcg/2 mL/vial
| |
Isophane Insulin Suspension
|
優泌林-中效型(NPH型人體胰島素)
|
Humulin N (NPH) 1000 U/10 mL/vial
| |
Isophane Insulin Suspension 70% & Insulin 30%
|
優泌林-混合型(70/30)
|
Humulin 70/30 1000 U/10 mL/vial (NPH : RI = 7:3)
| |
Lactulose
|
樂可樂舒液劑
|
Lactulose Liquid 600 mg/mL, 500mL/btl
| |
Lactulose
|
杜化液
|
Duphalac Liquid 667 mg/mL, 500 mL/btl
| |
Lactulose
|
樂可樂舒液劑
|
Lactulose Liquid 600 mg/mL, 500 mL/btl
| |
Lansoprazole
|
泰克胃通口溶錠
|
Takepron OD Tablet 30 mg/tab
| |
Laronidase
|
艾德酶靜脈注射用溶液
|
Aldurazyme concentrated solution 2.9 mg/5mL/vial
| |
Levobupivacaine hydrochloride
|
開洛凱因®注射劑
|
@ Chirocaine® 5 mg/mL, 10 mL/amp (不計價常備)
| |
Levocetirizine
|
驅異樂膜衣錠
|
Xyzal Film-coated Tablet 5 mg/tab
| |
Lidocaine
|
遠疼貼貼片
|
Lidopat Patch 5% 700 mg/patch
| |
Lidocaine and Epinephrine
|
口內寧注射液
|
@Ora Inj. Cartridge 1.8 mL/cartridge (DC)
| |
Lidocaine HCl
|
苦息樂卡因注射液
|
@Xylocaine 2% 20 mL/vial (injection for local anesthesia)
| |
Lidocaine HCl
|
苦息樂卡因凝膠
|
@Xylocaine 2% 30 g/tube (jelly for topical anesthesia)
| |
Lidocaine HCl
|
苦息樂卡因黏液 (DC)
|
@Xylocaine 2% 100 mL/btl (viscous solution for surface anesthesia) (DC)
| |
Lidocaine HCl
|
苦息樂卡因噴霧劑
|
@Xylocaine 10% 50 mL/btl (solution for spray)
| |
Lidocaine HCl
|
靜注用苦息樂卡因注射液
|
Xylocaine 2% for IV Injection 100 mg/5 mL/amp
| |
Lidocaine HCl
|
苦息樂卡因液1%
|
@Xylocaine 1% 5 mL/amp (solution for topical anesthesia)
| |
Loperamide HCl
|
優腹寧錠
|
Ufunin Tablet 2 mg/tab
| |
Loperamide HCl
|
易必寧膠囊
|
Lopedin Capsule 2 mg/cap
| |
Loratadine and Pseudoephedrine Sulfate
|
康瑞斯持續性藥效錠
|
Clarinase Repetabs Tablet, loratadine 5 mg and pseudoephedrine sulfate 120 mg/tab
| |
memantine HCL
|
憶必佳膜衣錠10公絲
|
Ebixa Film-coated Tablet 10mg/tab
| |
memantine HCL
|
滅擾膜衣錠10毫克
|
Manotin F.C. Tablets 10mg/tab
| |
Meropenem Trihydrate
|
美平乾粉注射劑
|
Mepem for Injection 500 mg meropenem/vial
| |
Mesalamine
|
阿腸克錠
|
Asacol Tablet 400 mg/tab
| |
Mesalamine
|
安腸克栓劑
|
Asacol Suppository 500 mg/supp
| |
Mesalamine
|
頗得斯安持續性藥效錠
|
Pentasa SR Tablet 500 mg/tab
| |
Mesalamine
|
阿腸克浣腸劑
|
Colasa Enema 2 g/100 mL/btl
| |
Mesalamine
|
頗得斯安栓劑
|
Pentasa Suppository 500 mg/pill
| |
Mesna
|
優路保注射液
|
Uromitexan Injection 400 mg/4 mL/amp
| |
Metformin HCl
|
泌樂寬膜衣錠
|
Glibudon F.C. Tablet 500 mg/tab
| |
Metformin HCl
|
庫魯化錠850公絲
|
Glucophage Tablet 850 mg/tab
| |
Metformin HCl
|
<試> Glucophage-200905056M 500 mg/tab
| ||
Metformin HCl
|
<試>Metformin-1245.24 500 mg/tab 420 tab/box
| ||
Metoclopramide HCl
|
安適胃寧液
|
Aswell Solution 60 mg/60 mL/btl (0.767 mg metoclopramide/mL)
| |
Metoclopramide HCl
|
胃斯妥持效膠囊
|
Gastro-Timelets SR Capsule 30 mg/cap (25.37 mg metoclopramide/cap)
| |
Metoclopramide HCl
|
胃明朗膜衣錠
|
Promeran Tablet 5 mg/tab (3.84 mg metoclopramide/tab)
| |
Metoclopramide HCl
|
腹寧朗注射液
|
Primperan Injection 10 mg/2 mL/amp (7.67 mg metoclopramide/amp)
| |
Metoclopramide HCl
|
補樂美淨糖衣錠
|
Prometin Tablet 5 mg/tab (3.84 mg metoclopramide/tab)
| |
Metronidazole
|
愛汝清注射液
|
Anegyn Injection 500 mg/100 mL/bag (Na 28 mEq/g)
| |
Metronidazole
|
服立治兒錠
|
Flagyl Oral Tablet 250 mg/tab
| |
Metronidazole
|
柔潔凝膠
|
Metrogel 0.75% 15 g/tube
| |
Montelukast Sodium
|
欣流咀嚼錠
|
Singulair Chewable Tablet 5 mg montelukast /tab
| |
Montelukast Sodium
|
欣流膜衣錠
|
Singulair Film Coated Tablet 10 mg montelukast /tab
| |
Montelukast Sodium
|
欣流咀嚼錠
|
Singulair Chewable Tablet 4 mg montelukast /tab
| |
Mupirocin
|
百多邦黴素軟膏
|
Bactroban Ointment, Mupirocin 2% in a polyethylene glycol base, 15 g/tube
| |
Nalbuphine HCl
|
芯奔靜脈注射液
|
Bain Injection 10 mg/1 mL/amp
| |
Nevirapine
|
衛滋錠
|
Viramune Tablet 200 mg/tab
| |
Nevirapine
|
衛滋內服懸液
|
(CDC 母子垂直感染) Viramune Oral Susp 10 mg/1mL. 240 mL/ btl
| |
Nicorandil
|
喜革脈錠
|
Sigmart Tablet 5 mg/tab
| |
Octreotide Acetate
|
善得定注射液
|
Sandostatin Injection 0.1 mg octreotide/1 mL/amp
| |
Octreotide Acetate
|
善得定長效緩釋注射劑
|
Sandostatin LAR for Injection 20 mg octreotide in microspheres/vial
| |
Omalizumab
|
樂無喘凍晶注射劑
|
Xolair Powder and Solvent for Solution for Injection 150 mg/vial
| |
Ondansetron HCl
|
卓弗蘭注射劑
|
Zofran Injection 8 mg ondansetron/4 mL/amp
| |
Ondansetron HCl
|
卓弗蘭膜衣錠
|
Zofran Tablet 8 mg ondansetron/tab
| |
Ondansetron HCl
|
(兒癌基金會) 卓弗蘭膜衣錠
|
(兒癌基金會) Zofran Tablet 8 mg ondansetron/tab
| |
Ondansetron HCl
|
(兒癌基金會) 卓弗蘭注射劑
|
(兒癌基金會) Zofran Injection 8 mg ondansetron/4 mL/amp
| |
Ondansetron HCl
|
(兒癌基金會) 卓弗蘭注射劑
|
(兒癌基金會) Zofran Injection 4 mg ondansetron/2 mL/amp
| |
Orlistat
|
羅氏鮮膠囊
|
Xenical Capsule 120 mg/cap
| |
Oxacillin Sodium
|
撲萄黴素注射劑
|
Prostaphlin for Injection 500 mg oxacillin/vial (Na 2.8 mEq/g potency)
| |
Oxybutynin Choride (eq to Oxibutinina Hcl 5 mg)
|
歐舒緩釋錠 5 毫克
|
Oxbu Extended-release Tablets 5 mg/tab
| |
Paclitaxel
|
<試>Taxol-MO22923 30 mg /1 vial / box
| ||
Palonosetron HCl
|
嘔立舒注射劑
|
Aloxi Solution for Injection 0.25 mg palonosetron/5 mL/vial
| |
Pantoprazole Sodium
|
保衛康治潰樂凍晶注射劑
|
Pantoloc i.v. Injection 40 mg pantoprazole/vial
| |
Pantoprazole Sodium
|
保衛康治潰樂腸溶膜衣錠40毫克
|
Pantoloc Gastro-Resistant Tablet 40 mg/tab
| |
Penicillin G Benzathine
|
利達平注射劑
|
Retarpen for Injection 2.4 MU penicillin G/vial (1.8 g/vial)
| |
Penicillin G Sodium
|
基青黴素鈉注射液用粉
|
Penicillin G Sodium for Injection 3MU base/vial (Na 2.0 mEq/MU)
| |
Pentosan Polysulfate Sodium
|
愛泌羅膠囊 (DC)
|
Elmiron Capsule 100 mg/cap (DC)
| |
Pergolide Mesylate
|
協良行錠
|
Celance Tablet 0.05 mg/tab
| |
Pergolide Mesylate
|
協良行錠
|
Celance Tablet 0.25 mg/tab
| |
Phenazopyridine HCl
|
順路寧糖衣錠
|
Sronin S.C. Tablet 50 mg/tab
| |
Piperacillin Sodium and Tazobactam Sodium
|
達梭黴素涷晶注射劑
|
Tazocin Lyo-Injection 2 g piperacillin & 0.25 g tazobactam/vial (Na+ 2.79 mEq/g potency)
| |
Prasugrel or placebo
|
<試> Prasugrel-H7T-MC-TABY (b) 10 mg/tab 34 tab/btl
| ||
Prasugrel or placebo
|
<試> Prasugrel-H7T-MC-TABY (b) 10 mg/tab 34 tab/btl
| ||
Prasugrel or placebo
|
<試> Prasugrel-H7T-MC-TABY (b) 10 mg/tab 3 tab/btl
| ||
Prasugrel or placebo
|
<試> Prasugrel-H7T-MC-TABY (b) 5 mg/tab 34 tab/btl
| ||
Praziquantel
|
凱光錠 (帕多奎)
|
Kaicide Tablet 600 mg/tab
| |
progesterone
|
快孕隆8%陰道凝膠
|
Crinone 8% vaginal gel, 90 mg/tube
| |
Progesterone, Micronized
|
優潔通軟膠囊
|
Utrogestan Soft Capsule 100 mg/cap
| |
Propofol
|
飛可復注射劑 (2%)
|
@Fresofol Injection 1000 mg/50 mL/vial
| |
Propofol
|
普洛福靜脈注射液
|
@ Propofol-Lipuro 200 mg/ 20 mL/amp
| |
Propofol
|
雷可孚注射劑10公絲/公撮
|
@ Recofol Injection 200mg/ 20 mL/amp
| |
Propofol
|
飛可復1%注射劑
|
@Fresofol Injection 200 mg/ 20 mL/amp
| |
Psyllium Hydrophilic Mucilloid
|
康賜爾散劑
|
Konsyl 1 g/g, 6 g/pack
| |
Rabeprazole Sodium
|
百抑潰膜衣錠
|
Pariet Tablet 20 mg/tab
| |
Ranitidine HCl
|
善胃得注射液 (DC)
|
Zantac Injection 50 mg ranitidine/2 mL/amp (DC)
| |
Regular Insulin Inj
|
優泌林-常規型(常規型人體胰島素)
|
Humulin R 1000 IU/10 m/vial
| |
Rifabutin
|
淨核膠囊
|
Mycobutin Capsule 150 mg/cap
| |
Ritodrine HCl
|
妳得寶注射劑
|
Yutopar Injection 50 mg/5 mL/amp
| |
Ritodrine HCl
|
妳得寶錠
|
Yutopar Tablet 10 mg/tab
| |
Ritonavir
|
諾億亞軟膠囊
|
Norvir Capsule 100 mg/cap
| |
Rivastigmine
|
憶思能穿皮貼片5
|
Exelon Patch 9 mg/5 cm2, 4.6 mg/24 hr/pce
| |
Rivastigmine Hydrogen Tartrate
|
憶思能膠囊
|
Exelon Capsule 1.5 mg/cap
| |
Rivastigmine Hydrogen Tartrate
|
憶思能膠囊
|
Exelon Capsule 4.5 mg/cap
| |
Rivastigmine Hydrogen Tartrate
|
憶思能膠囊 (釋出處方)
|
Exelon Capsule 3 mg/cap (釋出處方)
| |
Saxagliptin
|
昂格莎膜衣錠
|
Onglyza Film-coated Tablet 5 mg/tab
| |
Saxagliptin or Placebo
|
<試> Saxagliptin-D1680C00003 2.5 mg/tab, 105 tab/btl
| ||
Saxagliptin or Placebo
|
<試> Saxagliptin-D1680C00003 5 mg/tab, 105 tab/btl
| ||
Sevoflurane
|
西福銳吸入用液劑
|
@Ultane 250 mL/btl
| |
Sildenafil Citrate
|
威而鋼膜衣錠
|
Viagra Film-coated Tablet 100 mg/tab
| |
Sildenafil citrate
|
瑞肺得膜衣錠20毫克
|
Revatio Film-Coated Tablet 20mg/tab
| |
Sildenafil Citrate
|
威而鋼小兒分包
|
粉Viagra 2 mg/pack (1/50 tab)
| |
Sildenafil Citrate
|
威而鋼小兒分包
|
粉Viagra 5 mg/pack (1/20 tab)
| |
Sildenafil citrate
|
<試>Revatio A1481156 10 mg /1 tab 90 tab/ btl
| ||
Sildenafil citrate
|
<試>Revatio A1481156 20 mg /1 tab 90 tab/ btl
| ||
Sildenafil citrate
|
<試>Revatio A1481156 40 mg /1 tab 90 tab/ btl
| ||
Sildenafil citrate
|
<試>Revatio A1481156 80 mg /1 tab 90 tab/ btl
| ||
Silodosin
|
優列扶膠囊4毫克
|
Urief Capsule 4 mg/cap
| |
Silver Sulfadiazine
|
膚美淨軟膏
|
Flamazine Cream 1% 500 g/box
| |
Silver Sulfadiazine
|
灼膚星乳膏
|
Sulfasil Cream 1% 50 g/tube
| |
Sitagliptin or placebo
|
佳糖維100 毫克 膜衣錠
|
<試>Sitagliptin-200904052M 100 mg/tab 35 tab/btl
| |
Sitagliptin or placebo
|
<試> Sitagliptin-082-00 100 mg/tab 200 tab/btl
| ||
Sitagliptin or placebo
|
<試> Sitagliptin-082-00 25 mg/tab 200 tab/btl
| ||
Sitagliptin Phosphate
|
佳糖維100 毫克 膜衣錠
|
Januvia FC Tablet , equivalent to sitagliptin 100 mg/tab
| |
Somatostatin Acetate
|
速妥善注射劑
|
Somatosan for Injection 3 mg somatostatin/amp
| |
Somatostatin Acetate
|
施他寧注射劑
|
Stilamin for Injection 3 mg somatostatin/amp
| |
Sotalol HCl
|
心得治錠160公絲
|
Cardol Tablet 160 mg/tab
| |
Sterculia and Frangula
|
樂瑪可顆粒劑
|
Normacol Plus Granules 7 g/sachet
| |
Sucralfate
|
舒胃泰懸浮液
|
Sucrate Gel Suspension 1 g/5 mL/sachet
| |
Sulfasalazine
|
撒樂腸溶錠500公絲
|
Salazine Enteric-coated Tablet 500 mg/tab
| |
Tadalafil
|
犀利士膜衣錠
|
Cialis Film-coated Tablet 5 mg/tab
| |
Tamsulosin HCl
|
活路利淨D口溶錠
|
Harnalidge D Tablet 0.2 mg/tab
| |
Telbivudine
|
喜必福膜衣錠600毫克
|
Sebivo Film-coated Tablet 600 mg/tab
| |
Telbivudine
|
喜必福膜衣錠600毫克 for CDC
|
Sebivo Film-coated Tablet 600 mg/tab for CDC
| |
Telbivudine
|
喜必福膜衣錠600毫克 for 移植
|
Sebivo Film-coated Tablet 600 mg/tab for 移植
| |
Tenofovir Disoproxil Fumarate
|
<試> Viread-PP22512 300 mg/tab 30 tab/btl
| ||
Tenofovir Disoproxil Fumarate
|
惠立妥膜衣錠
|
(後天免疫專用) Viread 300 mg/tab
| |
Tenofovir Disoproxil Fumarate
|
惠立妥膜衣錠
|
(Cash) Viread Tablet 300 mg/tab
| |
Tenofovir Disoproxil Fumarate
|
惠立妥膜衣錠 (for CDC approval)
|
Viread Tablet (for CDC approval) 300 mg/tab
| |
Tenofovir Disoproxil Fumarate
|
惠立妥膜衣錠
|
(器官移植專用) Viread Tablet 300 mg/tab
| |
Tenofovir Disoproxil Fumarate
|
<試> Viread- 201010078M 300 mg/tab
| ||
Terbinafine HCl
|
療黴舒錠
|
Lamisil Tablet 250 mg terbinafine/tab
| |
Terbutaline Sulfate
|
撲咳喘吸入液
|
Bricanyl Solution for Nebulizing 5 mg/2 mL/single dose plastic unit
| |
Ticarcillin Disodium and Clavulanate Potassium
|
特泯菌靜脈注射劑
|
Timentin for Injection 1.5 g ticarcillin & 100 mg clavulanic acid/vial (Na 8mEq, K 0.5mEq/vial)
| |
Ticlopidine HCl
|
利血達膜衣錠
|
Licodin F.C. Tablet 250 mg/tab
| |
Tirofiban
|
雅瑞濃縮輸注液
|
Aggrastat Concentrate for Infusion 12.5 mg/50 mL/vial
| |
Tranexamic Acid
|
斷血炎注射液 10%
|
Transamin Injection 10%, 1000 mg/10 mL/amp
| |
Tranexamic Acid
|
斷血炎膠囊
|
Transamin Capsule 250 mg/cap
| |
Trastuzumab
|
<試>Herceptin-BO20906 150 mg/vial
| ||
Trastuzumab
|
賀癌平凍晶注射劑
|
Herceptin for Injection 440 mg/vial
| |
Trastuzumab
|
賀癌平凍晶注射劑
|
<試>Herceptin-ML19200 440 mg/vial
| |
Tropisetron HCl
|
耐嘔伴靜脈注射液
|
Navoban Injection 5 mg tropisetron/5 mL/amp (DC)
| |
Urokinase
|
血栓溶素
|
Urokinase for Injection 60000 IU/vial
| |
Urokinase or placebo
|
血栓溶素
|
<試> Urokinase-200908047M 60000 IU / vial
| |
Ursodiol
|
吾立甦錠小兒分包 25 mg/pack
|
Urso 25 mg/pack for pediatric use only
| |
Ursodiol
|
吾立甦錠小兒分包 20 mg/pack
|
Urso 20 mg/pack for pediatric use only
| |
Ursodiol
|
吾立甦錠小兒分包 16.7 mg/pack
|
Urso 16.7 mg/pack for pediatric use only
| |
Ursodiol
|
吾立甦錠
|
Urso Tablet 100 mg/tab
| |
Ursodiol
|
吾立甦錠小兒分包33.3 mg/pack
|
Urso 33.3 mg/pack for pediatric use only
| |
Ustekinumab
|
(無)
|
<專>免費 Stelara Injection 45 mg /0.5mL/syringe
| |
Ustekinumab
|
(無)
|
<專> (自費) Stelara Injection 45 mg /0.5mL/syringe
| |
Valacyclovir HCL
|
祛疹易錠
|
Valtrex Tablet 500 mg valacyclovir/tab
| |
Vardenafil
|
樂威壯膜衣錠
|
Levitra Film-coated Tablet 20 mg/tab
|
級別
Category
|
定義/描述
Definition/Description
|
A
|
針對懷孕婦女妥善設計,且有對照組的研究中,無法證明使用此藥會增高胎兒異常的危險。
Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities.
|
B
|
動物試驗的結果顯示,並無對胎兒有害的證據,但缺乏針對懷孕婦女進行妥善設計且有對照組的研究。(Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women.)
或(or)
雖然動物試驗顯示對胚胎有不良作用,但針對懷孕婦女的對照研究中,無法證明對於胎兒的危險性。(Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus.)
|
C
|
動物試驗顯示對胚胎有不良作用,但缺乏針對人類懷孕婦女妥善設計且有對照組的研究。(Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women.)
或(or)
針對動物或人類懷孕婦女,目前缺乏妥善設計且有對照組的研究,可證明此藥物的危險性。(No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.)
|
D
|
針對孕婦的控制實驗或觀察研究中,已證實此藥對胎兒有危險性。但在考量利弊得失下,此藥對於治療的利益可能大於潛在的危險性。
Studies, adequate well-controlled or observational, in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk.
|
X
|
針對動物或孕婦的控制實驗或觀察研究中,已顯示此藥會造成胚胎異常,而且禁用於已經或可能懷孕的婦女。(註:藥物導致的傷害大於可能的利益)
Studies, adequate well-controlled or observational, in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. The use of the product is contraindicated in women who are or may become pregnant.
|
註:本表原文引用自美國FDA網站
http://www.fda.gov/fdac/features/2001/301_preg.html
延伸閱讀:
懷孕藥品風險分類A級的安全藥物 http://www.skin168.net/2012/03/drugs-pregnancy-category.html
懷孕藥品風險分類B級的安全藥物 http://www.skin168.net/2012/03/drugs-pregnancy-category-b.html
懷孕藥物分類(US FDA Pregnancy category definitions) http://skin168.pixnet.net/blog/post/102299041
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