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1、附件仿制藥參比制劑目錄(第二十七批)廳P藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-1地局辛片Digoxin Tablets /Lanoxin0.0625mg片劑ConcordiaPharmaceuticals Inc未進口原研約品美國橙皮書27-2醋酸甲地孕酮口服混懸液Megestrol Acetate OralSuspension/Megace ES125mg/ml (包裝規(guī)格150ml)口服混懸液Endo Pharmaceuticals Inc.未進口原研約品美國橙皮書27-3二氮嗪口服混懸液Diazoxide OralSuspension/Proglycem50mg/m

2、l (包裝規(guī)格30ml)口服混懸液Teva Branded Pharmaceutical Products R and D Inc未進口原研約品美國橙皮書27-4氟比洛芬鈉滴眼液Flurbiprofen Sodium Eye Drops/Ocufen0.03% (包裝規(guī)格 0.4ml)滴眼劑Allergan Limited未進口原研約品歐盟上市27-5黃體酮陰道緩釋凝膠Progesterone Sustained-release Vagina Gel/雪諾同8%(90mg)凝膠劑Merck Serono Limited國內上市的原研藥品原研進口27-6地氯雷他定片Desloratadine T

3、ablets /Clarinex5mg片劑Merck Sharp and Dohme Corp未進口原研約品美國橙皮書廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-7地氯雷他定片Desloratadine Tablets /Azomyr;Aerius;Neoclarity5mg片劑Merck Sharp & Dohme未進口原研約品歐盟上市27-8地塞米松磷酸鈉注射液Dexamethasone Sodium Phosphate Injection/-3.8mg/ml (以地塞米松計)(1ml)注射劑Aspen Pharma Trading Limited未進口原研約品英國上市

4、27-9氯法齊明軟膠囊Clofazimine Soft Capsules /Lamprene50mg膠囊劑Novartis未進口原研約品歐盟上市27-10氯法齊明軟膠囊Clofazimine Soft Capsules /Lamprene100mg膠囊劑Novartis未進口原研約品歐盟上市27-11丙戊酸鈉口服溶液Sodium Valproate Oral Solution /Epilim Liquid200mg/5ml (包裝規(guī)格300ml)口服溶液劑Sanofi /Sanofi-Aventis /Aventis Pharma Limited未進口原研約品歐盟上市27-12丙泊酚乳狀注射液

5、Propofol Injectable Emulsion /Diprivan10mg/ml(50ml)注射劑Fresenius Kabi USA LLC未進口原研約品美國橙皮書27-13奧拉帕利膠囊Olaparib Capsules /Lynparza50mg膠囊劑AstraZenecaPharmaceuticals LP未進口原研約品美國橙皮書廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-14醋酸特利加壓素注射液Terlipressin Acetate Injection /Glycylpressin;Glypressin; Glypressine;Glipressina0

6、.1mg/ml (以特利加壓素計)(8.5ml)或0.12mg/m l(以醋酸特利加壓素計)(8.5ml)或1mg/8.5m l(以醋酸特利加壓素計)注射劑Ferring未進口原研約品歐盟上市27-15地西泮直腸凝膠Diazepam Rectal Gel /Diastat Acudial5mg/ml(20mg/4ml、10mg/2ml)凝膠劑Valeant Pharmaceuticals North America LLC. /Bausch Health US LLC未進口原研約品美國橙皮書廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-16乙酰唾胺片Acetazolamide

7、 Tablets250mg (高原病適應癥)片劑Taro PharmaceuticalIndustries Ltd國際公認的同種藥品美國橙皮書27-17阿那曲睡片Anastrozole Tablets /Arimidex1mg片劑Ani PharmaceuticalsInc未進口原研約品美國橙皮書27-18阿托伐他汀鈣片Atorvastatin Calcium Tablets/Lipitor10mg (以阿托伐他汀計)片劑Pfizer Inc.未進口原研約品美國橙皮書27-19艾司奧美拉哇鎂腸溶片Esomeprazole Magnesium Delayed-release Tablets /N

8、exium 24hr20mg(以艾司奧美拉唾計)片劑(腸溶片)AstraZeneca LP未進口原研約品美國橙皮書27-20艾司奧美拉哇鎂腸溶片Esomeprazole Magnesium Gastro-resistant Tablets /Nexium20mg(以艾司奧美拉唾計)片劑(腸溶片)AstraZeneca未進口原研約品歐盟上市27-21氨茶堿注射液Aminophylline Injection25mg/ml (以二水氨茶堿計)(10ml、20ml)注射劑Hospira Inc.國際公認的同種藥品美國橙皮書廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-22奧卡西平口

9、服混懸液Oxcarbazepine Oral Suspension60mg/ml (包裝規(guī)格100ml、250ml)混懸劑Novartis PharmaSchweiz AG國內上市的原研藥品原研進口27-23注射用鹽酸表柔比星Epirubicin Hydrochloride for Injection/法瑪新10mg (以鹽酸表柔比星計)注射劑輝瑞制藥(無錫)有限 公司經審核確定的國外原研企業(yè)在中國境內生產的藥品原研地產化27-24奧硝唾注射液Ornidazole Injection /Tiberal3ml:0.5g注射劑OrPha Swiss GmbH未進口原研約品瑞士上市27-25奧硝唾注

10、射液Ornidazole Injection /Tiberal6ml:1.0g注射劑OrPha Swiss GmbH未進口原研約品瑞士上市27-26奧硝唾注射液Ornidazole Injection /Tiberal3ml:0.5g注射劑Serb未進口原研約品歐盟上市27-27奧硝唾注射液Ornidazole Injection /Tiberal6ml:1.0g注射劑Serb未進口原研約品歐盟上市27-28苯澳馬隆片Benzbromarone Tablets /Urinorm25mg片劑?居桑品株式會社未進口原研約品日本橙皮書廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-2

11、9苯扎貝特緩釋片Bezafibrate Sustained Realease Tablets /Bezalip400mg片劑(緩釋片)Actavis Specialty Pharmaceuticals Co.未進口原研約品加拿大上市27-30葦酚薄噴霧劑2,4-DichlorbenzylAlcohol, Amylmetacresol and Menthol Spray /Neo-Angin Halsspray30ml:2,4-二氯 醇 437.4mg,戊間甲酚87.6mg,左旋溥荷腦26.1mg噴霧劑Divapharma GmbH未進口原研約品歐盟上市27-31吸入用異內托澳錢溶液Ipratr

12、opium Bromide Inhalation Solution0.02%(0.5mg/2.5ml)吸入用溶液齊The Ritedose Corp國際公認的同種藥品美國橙皮書27-32小兒法羅培南鈉顆粒Faropenem Sodium Dry Syrup/Farom for Pediatric10% (0.5g/包;50g、100g施)顆粒劑q/lz卡株式會社 (瑪路弘株式會社)未進口原研約品日本橙皮書27-33注射用兩性毒素B脂質體Amphotericin B Liposome for Injection/AmBisome50mg注射劑Astellas Pharma US Inc未進口原研

13、約品美國橙皮書6廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-34注射用兩性毒素B脂質體Amphotericin B Liposome for Injection/AmBisome50mg注射劑Gilead Sciences未進口原研約品歐盟上市27-35奧美沙坦酯口崩片Olmesartan Medoxomil Orally Disintegrating Tablets/Olmetec5mg片劑第一三共株式會社未進口原研約品日本橙皮書27-36奧美沙坦酯口崩片Olmesartan Medoxomil Orally Disintegrating Tablets/Olmetec1

14、0mg片劑第一三共株式會社未進口原研約品日本橙皮書27-37奧美沙坦酯口崩片Olmesartan Medoxomil Orally Disintegrating Tablets/Olmetec20mg片劑第一三共株式會社未進口原研約品日本橙皮書27-38奧美沙坦酯口崩片Olmesartan Medoxomil Orally Disintegrating Tablets/Olmetec40mg片劑第一三共株式會社未進口原研約品日本橙皮書27-39恩曲他濱內酚替諾福韋片(I )Emtricitabine and Tenofovir AlafenamideFumarate Tablets ( I )

15、/Descovy (達可揮)每片含200mg恩曲他濱,10mg丙酚替諾福韋片劑Gilead Sciences International Ltd.國內上市的原研藥品原研進口廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-40恩曲他濱內酚替諾福韋片(H)Emtricitabine and Tenofovir AlafenamideFumarate Tablets ( H )/Descovy (達可揮)每片含200mg恩曲他濱,25mg丙酚替諾福韋片劑Gilead Sciences International Ltd.國內上市的原研藥品原研進口27-41恩曲他濱內酚替諾福韋片Emt

16、ricitabine and Tenofovir Alafenamide Tablets/Descovy每片含200mg恩曲他濱,25mg丙酚替諾福韋片劑Gilead Sciences Inc未進口原研約品美國橙皮書27-42卡左雙多巴緩釋片Carbidopa and Levodopa Sustained-release Tablets/Sinemet (息寧)卡比多巴50mg,左旋多巴200mg片劑(緩釋片)MSD Pharma(Singapore) Pte. Ltd.國內上市的原研藥品原研進口27-43注射用呷珠菁綠Indocyaninegreen for Injection/Diagno

17、green25mg注射劑第一三共株式會社未進口原研約品日本上市27-44多庫酯鈉片Docusate Sodium Tablets /Jamylene50mg片劑Laboratoires Tradiphar未進口原研約品歐盟上市27-45醋酸甲地孕酮片Megestrol Acetate Tablets40mg片劑Par Pharmaceutical Inc國際公認的同種藥品美國橙皮書8廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-46琥乙紅毒素顆粒ErythromycinEthylsuccinate Granules/E.E.S.; Eryped200mg/5ml顆粒劑Arbo

18、r PharmaceuticalsLLC未進口原研約品美國橙皮書27-47琥乙紅毒素顆粒ErythromycinEthylsuccinate Granules/E.E.S.; Eryped400mg/5ml顆粒劑Arbor PharmaceuticalsLLC未進口原研約品美國橙皮書27-48磺胺醋酰鈉滴眼液Sulfacetamide sodium ophthalmic solution /Bleph-1010%(5ml)滴眼劑Allergan國際公認的同種藥品美國橙皮書27-49Pentoxifylline Injection /Trental100mg/5ml注射劑Sanofi歐盟上市己酮

19、口口堿注射液未進口原研約品27-50利福毒素鈉注射液Rifamycin Sodium Injection250mg/10ml注射劑Sanofi未進口原研約品歐盟上市27-51利福毒素鈉注射液Rifamycin Sodium Injection500mg/10ml注射劑Sanofi未進口原研約品歐盟上市廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-52氫澳酸右美沙分硫酸全尼膠囊Dextromethorphan hydrobromide and quinidine sulfateCapsules/Nuedexta20mg:10mg (每粒含氫澳酸右美沙芬20mg,硫酸全尼10mg

20、)膠囊劑Avanir Pharmaceuticals Inc未進口原研約品美國橙皮書27-53匹伐他汀鈣片Pitavastatin Calcium Tablets/Livalo4mg片劑Kowa Company,Ltd.未進口原研約品日本上市27-54黃體酮軟膠囊Progesterone Soft Capsules/Utrogestan0.2g膠囊劑Besins Healthcare Benelux國內上市原研約品原研進口27-55普瑞巴林口服溶液Pregabalin Oral Solution /Lyrica20mg/ml(473ml)口服溶液劑Pfizer Europe MA EEIG/P

21、fizer Limited未進口原研約品歐盟上市27-56那他霉素滴眼液Natamycin Eye Drops /Natacyn (那特真)15ml:0.75g滴眼劑NovartisPharmaceuticals Corporation國內上市原研約品原研進口27-57富馬酸唾硫平片Quetiapine Fumarate Tablets/Seroquel25mg片劑Astrazeneca未進口原研約品歐盟上市10 廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-58富馬酸唾硫平片Quetiapine Fumarate Tablets/Seroquel100mg片劑Astraze

22、neca未進口原研約品歐盟上市27-59富馬酸唾硫平片Quetiapine Fumarate Tablets/Seroquel200mg片劑Astrazeneca未進口原研約品歐盟上市27-60富馬酸唾硫平片Quetiapine Fumarate Tablets/Seroquel300mg片劑Astrazeneca未進口原研約品歐盟上市27-61富馬酸唾硫平片Quetiapine Fumarate Tablets/Seroquel150mg片劑Astrazeneca未進口原研約品歐盟上市27-62富馬酸唾硫平片Quetiapine Fumarate Tablets/Seroquel100mg片

23、劑AstrazenecaPharmaceuticals LP未進口原研約品美國橙皮書27-63硫酸氫氯叱格雷片Clopidogrel Hydrogen Sulphate Tablets/Plavix75mg片劑Sanofi Aventis US LLC未進口原研約品美國橙皮書27-64硫酸氫氯叱格雷片Clopidogrel Hydrogen Sulphate Tablets/Plavix300mg片劑Sanofi Clir SNC未進口原研約品歐盟上市27-65富馬酸貝達唾咻片Bedaquiline Fumarate Tablets/斯耐瑞(Sirturo)100mg片劑Janssen-Cil

24、agInternational N.V.國內上市原研約品原研進口27-66富馬酸貝達唾咻片Bedaquiline Fumarate Tablets/Sirturo100mg片劑Janssen-CilagInternational N.V.未進口原研約品歐盟上市27-67琥珀酸曲格列汀片Trelagliptin Succinate Tablets/Zafatek50mg片劑武田槳品工H株式會 社(TakedaPharmaceutical Co., Ltd.)未進口原研約品日本橙皮書27-68氟馬西尼注射液Flumazenil Injection /Anexate10ml:1.0mg注射劑Chep

25、lapharmArzneimittel GmbH未進口原研約品歐盟上市 11廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-69氟馬西尼注射液Flumazenil Injection /Anexate5ml:0.5mg注射劑CheplapharmArzneimittel GmbH未進口原研約品歐盟上市27-70蘭索拉哇口崩片Lansoprazole Orally Disintegrating Tablets /Takepron15mg片劑武田槳品工H株式會 社(TakedaPharmaceutical Co., Ltd.)未進口原研約品日本橙皮書27-71琥珀酸曲格列汀片Tre

26、lagliptin Succinate Tablets /Zafatek100mg片劑武田槳品工H株式會 社(TakedaPharmaceutical Co., Ltd.)未進口原研約品日本橙皮書27-72氯法拉濱注射液Clofarabine Injection /Clolar20mg/20ml注射劑Genzyme Corp未進口原研約品美國橙皮書27-73富馬酸替諾福韋二叱吠酯片Tenofovir DisoproxilFumarate Tablets/Viread150mg片劑Gilead Sciences Inc未進口原研約品美國橙皮書27-74富馬酸替諾福韋二叱吠酯片Tenofovir

27、DisoproxilFumarate Tablets/Viread200mg片劑Gilead Sciences Inc未進口原研約品美國橙皮書27-75富馬酸替諾福韋二叱吠酯片Tenofovir DisoproxilFumarate Tablets/Viread300mg片劑Gilead Sciences Inc未進口原研約品美國橙皮書12 廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-76富馬酸替諾福韋二叱吠酯顆粒Tenofovir Disoproxil Fumarate Oral Powder /Viread40mg/g顆粒劑Gilead Sciences Inc未進口原

28、研約品美國橙皮書27-77枸檬酸托法哲布片Tofacitinib Citrate Tablets /Xeljanz5mg片劑Pf Prism CV未進口原研約品美國橙皮書27-78錢布醇注射液Gadobutrol Injection/Gadovist (加樂顯)7.5ml:4.5354g注射劑Bayer Vital GmbH國內上市的原研藥品原研進口27-79錢布醇注射液Gadobutrol Injection/Gadovist (加樂顯)7.5ml:4.5354g(預裝注射器)注射劑Bayer Vital GmbH國內上市的原研藥品原研進口27-80錢布醇注射液Gadobutrol Inje

29、ction/Gadovist (加樂顯)15ml:9.0708g注射劑Bayer Vital GmbH國內上市的原研藥品原研進口27-81錢布醇注射液Gadobutrol Injection/Gadovist (加樂顯)15ml:9.0708g(預裝注射器)注射劑Bayer Vital GmbH國內上市的原研藥品原研進口27-82對乙酰氨基酚注射液Acetaminophen Injection /Ofirmev1g/100ml(10mg/ml)注射劑Mallinckrodt Hosp Products Ip Ltd未進口原研約品美國橙皮書一13廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注

30、1備注227-83非諾貝酸片F(xiàn)enofibric Acid Tablets /Fibricor35mg片劑Athena Biosciences LLC未進口原研約品美國橙皮書27-84奈帕芬胺滴眼液Nepafenac Ophthalmic Suspension/Nevanac0.1%(3ml)滴眼劑NovartisPharmaceuticals Corp未進口原研約品美國橙皮書27-85奧拉帕利片Olaparib Tablets/Lynparza (利普卓)100mg片劑AstraZeneca AB國內上市的原研藥品原研進口27-86奧拉帕利片Olaparib Tablets/Lynparza

31、 (利普卓)150mg片劑AstraZeneca AB國內上市的原研藥品原研進口27-87二氟潑尼酯滴眼液Difluprednate Ophthalmic Emulsion/Durezol0.05%(5ml)滴眼劑NovartisPharmaceuticals Corp未進口原研約品美國橙皮書27-88來曲晚片Letrozole Tablets /Femara2.5mg片劑NovartisPharmaceuticals Corp未進口原研約品美國橙皮書27-89克拉霉素緩釋片ClarithromycinExtended-release Tablets /Clarithromycin500mg片

32、劑(緩釋片)Mayne Pharma LLC國際公認的同種藥品美國橙皮書27-90琥珀酸美托洛爾緩釋片Metoprolol Succinate Extended-release /Toprol-Xl50mg (以酒后酸美托洛爾計)片劑(緩釋片)Toprol Acquisition LLC未進口原研約品美國橙皮書14廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-91琥珀酸美托洛爾緩釋片Metoprolol Succinate Extended-release /Toprol-Xl100mg (以酒后酸美托洛爾計)片劑(緩釋片)Toprol Acquisition LLC未進口原

33、研約品美國橙皮書27-92琥珀酸美托洛爾緩釋片Metoprolol Succinate Extended-release /Toprol-Xl200mg (以酒后酸美托洛爾計)片劑(緩釋片)Toprol Acquisition LLC未進口原研約品美國橙皮書27-93磷酸奧司他韋膠囊Oseltamivir Phosphate Capsules/Tamiflu (達菲)30mg (以奧司他韋計)膠囊劑Roche Registration Ltd./Roche Pharma (Schweiz) AG國內上市的原研藥品原研進口27-94磷酸奧司他韋膠囊Oseltamivir Phosphate Ca

34、psules /Tamiflu30mg (以奧司他韋計)膠囊劑Roche Registration GmbH /Roche Registration Ltd.未進口原研約品歐盟上市27-95磷酸奧司他韋膠囊Oseltamivir Phosphate Capsules/Tamiflu (達菲)45mg (以奧司他韋計)膠囊劑Roche Registration Ltd./Roche Pharma (Schweiz) AG國內上市的原研藥品原研進口27-96磷酸奧司他韋膠囊Oseltamivir Phosphate Capsules/Tamiflu45mg (以奧司他韋計)膠囊劑Roche Reg

35、istration GmbH /Roche Registration Ltd.未進口原研約品歐盟上市一15廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-97磷酸奧司他韋膠囊Oseltamivir Phosphate Capsules/Tamiflu30mg (以奧司他韋計)膠囊劑Hoffmann La Roche Inc未進口原研約品美國橙皮書27-98磷酸奧司他韋膠囊Oseltamivir Phosphate Capsules/Tamiflu45mg (以奧司他韋計)膠囊劑Hoffmann La Roche Inc未進口原研約品美國橙皮書27-99美沙拉嗪腸溶緩釋片Mesa

36、lamineDelayed-release Tablets /Lialda1.2g片劑(腸溶緩釋片)Shire Development Inc未進口原研約品美國橙皮書27-100奈普生鈉片Naproxen Sodium Tablets /Aleve200mg(以恭普生計)片劑Bayer Healthcare LLC未進口原研約品美國橙皮書27-101拉莫三嗪分散片Lamotrigine Dispersible Tablets/Lamictal25mg片劑(分散片)The Wellcome Foundation Ltd.未進口原研約品歐盟上市27-102雙氯芬酸鈉緩釋片Diclofenac So

37、diumSustained Release Tablet!/Voltarene LPs75mg片劑(緩釋片)Novartis PharmaS.A.S.未進口原研約品歐盟上市16 廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-103腺甘注射液Adenosine Injection60mg/20ml(3mg/ml)注射劑Teva PharmaceuticalsUSA國際公認的同種藥品美國橙皮書27-104米力農注射液Milrinone Injection /Primacor 1mg/ml Solution for Injection1mg/ml注射劑Aventis Pharma

38、Limited /Sanofi-Aventis /Sanofi未進口原研約品歐盟上市27-105西格列汀二甲雙胴片Sitagliptin Phosphate/Metformin Hydrochloride Tablets /Efficib;Janumet;Velmetia ;Ristfor50mg/850mg片劑Merck Sharp & Dohme B.V.未進口原研約品歐盟上市27-106西格列汀二甲雙胴片Sitagliptin Phosphate/Metformin Hydrochloride Tablets /Efficib;Janumet;Velmetia ;Ristfor50mg/

39、1000mg片劑Merck Sharp & Dohme B.V.未進口原研約品歐盟上市27-107雙氯芬酸鈉腸溶緩釋膠囊Diclofenac Sodium Enteric-Coated Sustained Release Capsules/Difene75mg膠囊劑(腸溶緩釋膠囊)Glenwood GmbH Pharmazeutische Erzeugnisse未進口原研約品歐盟上市一17廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-108雙氯芬酸鈉腸溶緩釋膠囊Diclofenac Sodium Enteric-Coated Sustained Release Capsule

40、s/Difene100mg膠囊劑(腸溶緩釋膠囊)Glenwood GmbH Pharmazeutische Erzeugnisse未進口原研約品歐盟上市27-109碳酸鋰緩釋片Lithium Carbonate Extended Release Tablets /Lithobidi300mg片劑(緩釋片)Ani PharmaceuticalsInc未進口原研約品美國橙皮書27-110酮康唾泡沫劑Ketoconazole Foam /Extina2% (50g施、100g卿)氣霧劑Mylan Pharmaceuticals Inc未進口原研約品美國橙皮書27-111美索巴莫片Methocarba

41、mol Tablets500mg片劑Granules India Ltd國際公認的同種藥品美國橙皮書27-112馬來酸阿法替尼片Afatinib Dimaleate Film-CoatedTablets/Giotrif30mg片劑Boehringer Ingelheim International GmbH未進口原研約品歐盟上市27-113馬來酸阿法替尼片Afatinib Dimaleate Film-Coated Tablets/Giotrif40mg片劑Boehringer Ingelheim International GmbH未進口原研約品歐盟上市18 廳p藥品通用名稱英義名稱/冏品名

42、規(guī)格劑型持證商備注1備注227-114馬來酸阿法替尼片Afatinib Dimaleate Film-Coated Tablets/Giotrif20mg片劑Nippon Boehringer Ingelheim Co., Ltd.未進口原研約品日本橙皮書27-115馬來酸阿法替尼片Afatinib Dimaleate Film-Coated Tablets/Giotrif30mg片劑Nippon Boehringer Ingelheim Co., Ltd.未進口原研約品日本橙皮書27-116馬來酸阿法替尼片Afatinib Dimaleate Film-Coated Tablets/Giot

43、rif40mg片劑Nippon Boehringer Ingelheim Co., Ltd.未進口原研約品日本橙皮書27-117馬來酸阿法替尼片Afatinib Dimaleate Film-Coated Tablets/Giotrif50mg片劑Nippon Boehringer Ingelheim Co., Ltd.未進口原研約品日本橙皮書27-118替米沙坦片Telmisartan Tablets /Micardis40mg片劑Boehringer Ingelheim International GmbH未進口原研約品歐盟上市27-119妥布毒素眼膏Tobramycin Eye Oint

44、ment/Tobrex (托百士)0.3%(3.5g:10.5mg)眼膏劑Novartis Pharma NV國內上市的原研藥品原研進口27-120安布毒余地塞米松滴眼液Tobramycin and Dexamethasone Eye Drops/Tobradex (典必殊)5ml:安布毒素15mg和地塞米松5mg滴眼劑Novartis Pharma NV國內上市的原研藥品原研進口一19廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-121安布毒余地塞米松眼膏Tobramycin and Dexamethasone Eye Ointment/Tobradex (典必殊)3.5g

45、 (安布毒素10.5mg,地塞米松 3.5mg)眼膏劑Novartis Pharma NV國內上市的原研藥品原研進口27-122鹽酸奈康唾乳膏Neticonazole Hydrochloride Cream /Atolant1%(10g:0.1g)乳膏劑久光裂蕖株式會未進口原研約品日本上市27-123亞葉酸鈣注射液Calcium Folinate Injection10ml:0.1g注射劑Hospira UK Ltd未進口原研約品歐盟上市27-124亞葉酸鈣注射液Calcium Folinate Injection30ml:0.3g注射劑Hospira UK Ltd未進口原研約品歐盟上市27-

46、125小兒復方氨基酸注射液(19AA-I ) /小 兒復方氨基酸注射液(18AA- R )6% Amino Acid Injection /Trophamine6% (500ml)注射劑B Braun Medical Inc未進口原研約品美國橙皮書27-126維生素K1注射液Vitamin K1 Injection0.5ml:1mg注射劑International Medication Systems, Ltd國際公認的同種 藥品美國橙皮書27-127環(huán)叱酮胺搽劑Ciclopirox Olamine Solution/Mycoster1%(30ml、45ml)搽劑Pierre Fabre De

47、rmatologie未進口原研約品歐盟上市27-128我雷他aE糖漿Loratadine Syrup/開瑞坦1mg:1ml(60ml、100ml)糖漿劑Bayer Sa-NV國內上市的原研 藥品原研進口20 廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-129西洛他口坐片Cilostazol Tablets /Pletal50mg片劑Otsuka Pharmaceuticals Europe Ltd.未進口原研約品歐盟上市27-130西洛他口坐片Cilostazol Tablets /Pletal100mg片劑OtsukaPharmaceuticals Europe Ltd.

48、未進口原研約品歐盟上市27-131羅氟司特片Roflumilast Tablets /Daliresp500mg片劑AstrazenecaPharmaceuticals LP未進口原研約品美國橙皮書27-132羅氟司特片Roflumilast Tablets /Daliresp500mg片劑Takeda GmbH未進口原研約品歐盟上市27-133普拉洛芬滴眼液Pranoprofen Eye Drops/普南撲靈0.1%(5ml:5mg)滴眼液Senju Pharmaceutical Co.,Ltd.國內上市的原研藥品原研進口27-134西洛他口坐口腔崩解片Cilostazol Orally D

49、isintegrating Tablets /Pletaal Od Tablets50mg片劑大土家ffiig株式會社未進口原研約品日本橙皮書27-135西洛他口坐口腔崩解片Cilostazol Orally Disintegrating Tablets /Pletaal Od Tablets100mg片劑大土家ffiig株式會社未進口原研約品日本橙皮書一21廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-136煙酸緩釋片Niacin Extended-release Tablet/Niaspan500mg片劑(緩釋片)ABbvie Inc未進口原研約品美國橙皮書27-137煙

50、酸緩釋片Niacin Extended-release Tablet/Niaspan750mg片劑(緩釋片)ABbvie Inc未進口原研約品美國橙皮書27-138煙酸緩釋片Niacin Extended-release Tablet/Niaspan1000mg片劑(緩釋片)ABbvie Inc未進口原研約品美國橙皮書27-139鹽酸二甲雙月瓜口服溶液Metformin Hydrochloride Oral Solution/Riomet500mg/5ml口服溶液Sun Pharmaceutical Industries Ltd未進口原研約品美國橙皮書27-140亞甲藍注射液Methylthi

51、onine Chloride Injection /Methylthioninium Chloride Proveblue50mg/10ml(5mg/ml)注射劑Provepharm SAS未進口原研約品歐盟上市27-141批降鈣素注射液Calcitonin SalmonInjection /Miacalcic1ml:100IU注射劑Essential Pharma未進口原研約品歐盟上市22 廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-142艾曲泊帕乙醇胺片Eltrombopag Olamine Tablets/Rev01ade (瑞弗蘭)25mg片劑Novartis Ph

52、armaSchweiz AG國內上市的原研藥品原研進口27-143氟伐他汀鈉緩釋片F(xiàn)luvastatin Sodium Extended Release Tablets/Lescol Xl80mg片劑(緩釋片)NovartisPharmaceuticals Corp未進口原研約品美國橙皮書27-144馬來酸嚷嗎洛爾滴眼液Timolol Maleate Eye Drops /Timoptic In Ocudose0.25%(0.3ml)滴眼劑ValeantPharmaceuticals International未進口原研約品美國橙皮書27-145馬來酸嚷嗎洛爾滴眼液Timolol Maleat

53、e Eye Drops /Timoptic In Ocudose0.5%(0.3ml)滴眼劑ValeantPharmaceuticalsInternational未進口原研約品美國橙皮書27-146尼洛替尼膠囊Nilotinib Capsules/Tasigna (達侏納)150mg膠囊劑Novartis PharmaSchweiz AG國內上市的原研藥品原研進口27-147尼洛替尼膠囊Nilotinib Capsules/Tasigna (達侏納)200mg膠囊劑Novartis PharmaSchweiz AG國內上市的原研藥品原研進口一23廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備

54、注1備注227-148硫酸沙丁胺醇吸入氣霧劑Salbutamol Sulfate Inhalation Aerosol/Ventolin (萬托林)100 n gt(以沙丁胺醇計)氣霧劑Glaxo Wellcome S.A. /Glaxosmithkline Australia Pty Ltd.國內上市的原研藥品原研進口27-149鹽酸利多卡因凝膠Lidocaine Hydrochloride Gel/Xylocaine2%(鋁管裝5ml、30ml)凝膠劑(Jelly)Oak Pharmaceuticals Inc未進口原研約品美國橙皮書27-150鹽酸利多卡因凝膠Lidocaine Hydr

55、ochloride Gel/Xylocaine2%(鋁管裝30ml)凝膠劑(Jelly)式會社未進口原研約品日本上市27-151鹽酸利多卡因凝膠Lidocaine Hydrochloride Gel/Xylocaine;Xylocain2%或 20mg/g(鋁管裝30ml或 30g)凝膠劑(Gel)Aspen Pharma Trading Limited未進口原研約品歐盟上市24 廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-152鹽酸利多卡因凝膠Lidocaine Hydrochloride Gel /Xylocaine;Xylocain2%或 20mg/g(預填充注射器裝

56、10g)凝膠劑(Gel)Aspen Pharma Trading Limited未進口原研約品歐盟上市27-153鹽酸曲恩汀膠囊Trientine Hydrochloride Capsules/Syprine250mg (以C6H18N4 2HCl計)膠囊劑Aton Pharma Inc /Bausch Health Americas Inc未進口原研約品美國橙皮書27-154鹽酸達拉他韋片Daclatasvir Hydrochloride Tablets/Daklinza30mg (以C40H 50N8O6 計)片劑Bristol-Myers Squibb Pharma Eeig未進口原研約

57、品歐盟上市27-155鹽酸達拉他韋片Daclatasvir Hydrochloride Tablets/Daklinza (百立澤)60mg (以C40H 50N8O6 計)片劑Bristol-Myers Squibb (Singapore)PTE.Ltd.國內上市的原研藥原研進口27-156鹽酸哌甲酯緩釋片Methylphenidate Hydrochloride Prolonged-release Tablets/Concertci (專注達)18mg (以C14H19NO2 HCl計)片劑(緩釋片)JanssenPharmaceuticals Inc國內上市的原研藥原研進口一25廳p藥品

58、通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-157鹽酸哌甲酯緩釋片Methylphenidate Hydrochloride Prolonged-release Tablets/Concertci (專注達)36mg (以C14H19NO2 HCl計)片劑(緩釋片)JanssenPharmaceuticals Inc國內上市的原研藥原研進口27-158司來帕格片Selexipag Tablets/Uptravi (優(yōu)拓比)0.8mg片劑ActelionPharmaceuticals Ltd國內上市的原研藥原研進口27-159普伐他汀鈉片Pravastatin Sodium Tabl

59、ets/Pravachol20mg (以C23H35NaO7 計)片劑Bristol Myers Squibb未進口原研約品美國橙皮書27-160普伐他汀鈉片Pravastatin Sodium Tablets/Pravachol40mg (以C23H35NaO7 計)片劑Bristol Myers Squibb未進口原研約品美國橙皮書27-161葉酸片F(xiàn)olic Acid Tablets1mg片劑AmnealPharmaceutical國際公認的同種藥品美國橙皮書27-162伊班瞬酸鈉注射液Sodium Ibandronate Injection/Bondronat2ml:2mg (以伊班瞬

60、酸計)注射劑Atnahs Pharma/Roche Registration Limited未進口原研約品歐盟上市26 廳p藥品通用名稱英義名稱/冏品名規(guī)格劑型持證商備注1備注227-163鹽酸劃、內沙星片Ciprofloxacin Hydrochloride Tablets/Cipro250mg (以C17H18FN3O3計)片劑Bayer HealthcarePharmaceuticals Inc未進口原研約品美國橙皮書27-164鹽酸劃、內沙星片Ciprofloxacin Hydrochloride Tablets /Ciprobay;Ciflox; Ciproxin;Ciproxine

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