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仿制药参比制剂目录(第二十五批)


序号药品通用名称英文名称/商品名规格剂型持证商备注1备注2
25-1富马酸伏诺拉生片Vonoprazan Fumarate Tablets/Takecab10mg(以C17H16FN3O2S计)片剂武田薬品工業株式会社未进口原研药品日本橙皮书
25-2富马酸伏诺拉生片Vonoprazan Fumarate Tablets/Takecab20mg(以C17H16FN3O2S计)片剂武田薬品工業株式会社未进口原研药品日本橙皮书
25-3阿莫西林克拉维酸钾干混悬剂Amoxicillin and Clavulanate Potassium for Suspension/Augmentin
(力百汀)
每5ml含阿莫西林400mg,克拉维酸57mg(包装规格35、70ml)干混悬剂SmithKline Beecham Limited国内上市的原研药品原研进口
25-4阿莫西林克拉维酸钾干混悬剂Amoxicillin and Clavulanate Potassium for Suspension/
Augmentin; Augmentin Duo
每5ml含阿莫西林400mg,克拉维酸57mg(包装规格35、70、140ml)干混悬剂GlaxoSmithKline /SmithKline Beecham未进口原研药品欧盟上市
25-5别嘌醇缓释胶囊Allopurinol Sustained-release Capsules/Gichtex250mg胶囊剂(缓释胶囊)G.L.Pharma GmbH未进口原研药品欧盟上市
25-6法莫替丁注射液Famotidine Injection/Gaster Injection 10mg10mg(1ml)注射剂LTLファーマ株式会社未进口原研药品日本上市
25-7法莫替丁注射液Famotidine Injection/Gaster Injection 20mg20mg(2ml)注射剂LTLファーマ株式会社未进口原研药品日本上市
25-8富马酸卢帕他定口服溶液Rupatadine Fumarate Oral Solution/Rupafin1mg/ml(以卢帕他定计)
包装规格120ml
口服溶液剂J. Uriach & Cía.,S.A./
J. Uriach and Cía.,S.A./
J. Uriach y Compañia,S.A./VIFOR PHARMA ESPAÑA S.L.
未进口原研药品欧盟上市
25-9布立西坦口服溶液Brivaracetam Oral Solution/Briviact10mg/ml
(包装规格300ml)
口服溶液剂UCB Pharma S.A.未进口原研药品欧盟上市
25-10布立西坦注射液Brivaracetam Solution for Injection/Briviact10mg/ml
(5ml)
注射剂UCB Pharma S.A.未进口原研药品欧盟上市
25-11氟康唑干混悬剂Fluconazole for Oral Suspension/Diflucan50mg/5ml
(35ml:350mg)
干混悬剂Pfizer Chemicals Div Pfizer Inc未进口原研药品美国橙皮书
25-12氟康唑干混悬剂Fluconazole for Oral Suspension/Diflucan200mg/5ml
(35ml:1400mg)
干混悬剂Pfizer Chemicals Div Pfizer Inc未进口原研药品美国橙皮书
25-13氟康唑干混悬剂Fluconazole Oral Suspension/Diflucan10mg/ml
(35ml:350mg)
干混悬剂Pfizer Limited未进口原研药品欧盟上市
25-14氟康唑干混悬剂Fluconazole Oral Suspension/Diflucan10mg/ml
(100ml:1000mg)
干混悬剂Pfizer Limited未进口原研药品欧盟上市
25-15氟康唑干混悬剂Fluconazole Oral Suspension/Diflucan40mg/ml
(35ml:1400mg)
干混悬剂Pfizer Limited未进口原研药品欧盟上市
25-16巴曲酶注射液Batroxobin Injection10单位(1ml)注射剂日本ケミファ株式会社/東菱薬品工業株式会社未进口原研药品日本上市
25-17布地奈德福莫特罗吸入粉雾剂(Ⅰ)Budesonide and formoterol Fumarate
Powder for Inhalation(Ⅰ)/Symbicort Turbuhaler(信必可都保)
每支60吸,每吸含布地奈德80μg和富马酸福莫特罗4.5μg吸入粉雾剂AstraZeneca AB国内上市的原研药品原研进口
25-18布地奈德福莫特罗吸入粉雾剂(Ⅱ)Budesonide and formoterol Fumarate
Powder for Inhalation (Ⅱ)/Symbicort Turbuhaler(信必可都保)
每支60吸,每吸含布地奈德160μg和富马酸福莫特罗4.5μg吸入粉雾剂AstraZeneca AB国内上市的原研药品原研进口
25-19布地奈德福莫特罗吸入粉雾剂(Ⅱ)Budesonide and formoterol Fumarate
Powder for Inhalation (Ⅱ)/Symbicort Turbuhaler(信必可都保)
每支120吸,每吸含布地奈德160μg和富马酸福莫特罗4.5μg吸入粉雾剂AstraZeneca AB国内上市的原研药品原研进口
25-20布地奈德福莫特罗吸入粉雾剂(Ⅱ)Budesonide and formoterol Fumarate
Powder for Inhalation (Ⅱ)/Symbicort Turbuhaler(信必可都保)
每支60吸,每吸含布地奈德320μg和富马酸福莫特罗9.0μg吸入粉雾剂AstraZeneca AB国内上市的原研药品原研进口
25-21贝美前列素滴眼液Bimatoprost Ophthalmic Solution/Lumigan(卢美根)3ml:0.9mg眼用制剂Allergan Inc国内上市的原研药品原研进口
25-22贝美前列素滴眼液Bimatoprost Ophthalmic Solution/Lumigan(卢美根)5ml:1.5mg眼用制剂Allergan Inc国内上市的原研药品原研进口
25-23缩宫素注射液Oxytocin Injection/Pitocin10 USP Unit/ml
玻璃西林瓶装1ml
注射剂Par Sterile Products LLC未进口原研药品美国橙皮书
25-24缩宫素注射液Oxytocin Injection/Atonin-O5单位/ml
玻璃安瓿装1ml
注射剂武田薬品工業株式会社/あすか製薬株式会社
日本上市
25-25奥美沙坦酯氨氯地平片Olmesartan Medoxomil and Amlodipine Besilate
Tablets/Sevikar
20mg/5mg
(以奥美沙坦酯/氨氯地平计)
片剂Daiichi Sankyo未进口原研药品欧盟上市
25-26奥美沙坦酯氨氯地平片Olmesartan Medoxomil and Amlodipine Besilate
Tablets/Sevikar
40mg/5mg
(以奥美沙坦酯/氨氯地平计)
片剂Daiichi Sankyo未进口原研药品欧盟上市
25-27奥美沙坦酯氨氯地平片Olmesartan Medoxomil and Amlodipine Besilate
Tablets/Sevikar
40mg/10mg
(以奥美沙坦酯/氨氯地平计)
片剂Daiichi Sankyo未进口原研药品欧盟上市
25-28奥美沙坦酯氨氯地平片Amlodipine Besylate and Olmesartan Medoxomil Tablets/Azor10mg:20mg片剂Daiichi Sankyo未进口原研药品美国橙皮书
25-29注射用丹曲林钠Dantrolene Sodium for Injection/Dantrium20mg
(以丹曲林钠计)
注射剂Par Sterile Products LLC未进口原研药品美国橙皮书
25-30注射用亚胺培南西司他丁钠Imipenem and Cilastatin Sodium for Injection/Tienam(泰能)亚胺培南500mg和西司他丁500mg注射剂Merck Sharp & Dohme Corp.国内上市的原研药品原研进口
25-31琥珀酸美托洛尔非洛地平缓释片Metoprolol Succinate and Felodipine Sustained-release Tablets/Mobloc, Logimax琥珀酸美托洛尔 47.5mg,非洛地平5mg片剂(缓释片)Recordati Industria Chimica E Farmaceutica S.P.A.未进口原研药品欧盟上市
25-32甲苯磺酸艾多沙班片Edoxaban Tosilate Tablets/Lixiana(里先安)15mg(按C24H30ClN7O4S计)片剂Daiichi Sankyo Europe GmbH国内上市的原研药品原研进口
25-33甲苯磺酸艾多沙班片Edoxaban Tosilate Tablets/Lixiana(里先安)30mg(按C24H30ClN7O4S计)片剂Daiichi Sankyo Europe GmbH国内上市的原研药品原研进口
25-34甲苯磺酸艾多沙班片Edoxaban Tosilate Tablets/Lixiana(里先安)60mg(按C24H30ClN7O4S计)片剂Daiichi Sankyo Europe GmbH国内上市的原研药品原研进口
25-35酒石酸溴莫尼定滴眼液Brimonidine Tartrate Eye Drops/Alphagan(阿法根)5ml:10mg眼用制剂Allergan Pharmaceuticals Ireland国内上市的原研药品原研进口
25-36酒石酸溴莫尼定滴眼液Brimonidine Tartrate Eye Drops/Alphagan P(阿法舒)0.15%(5ml:7.5mg)眼用制剂Allergan Inc.国内上市的原研药品原研进口
25-37酒石酸溴莫尼定滴眼液Brimonidine Tartrate Eye Drops/Alphagan P(阿法舒)0.15%(10ml:15mg)眼用制剂Allergan Inc.国内上市的原研药品原研进口
25-38卡前列素氨丁三醇注射液Carboprost Tromethamine Injection/Hemabate(欣母沛)1ml:250μg注射剂Pharmacia and Upjohn Company国内上市的原研药品原研进口
25-39咪达那新片Imidafenacin Tablets/Uritos0.1mg片剂Kyorin Pharmaceutical Co.,Ltd./杏林製薬株式会社未进口原研药品日本橙皮书
25-40富马酸丙酚替诺福韦片Tenofovir Alafenamide Tablets/Vemlidy25mg片剂Gilead Sciences Inc未进口原研药品美国橙皮书
25-41琥珀酸去甲文拉法辛缓释片Desvenlafaxine Extended-release Tablets/Pristiq25mg片剂(缓释片)PF Prism CV未进口原研药品美国橙皮书
25-42琥珀酸去甲文拉法辛缓释片Desvenlafaxine Extended-release Tablets/Pristiq50mg片剂(缓释片)PF Prism CV未进口原研药品美国橙皮书
25-43琥珀酸去甲文拉法辛缓释片Desvenlafaxine Extended-release Tablets/Pristiq100mg片剂(缓释片)PF Prism CV未进口原研药品美国橙皮书
25-44硫酸镁注射液Magnesium Sulfate Injection5g/10ml (500mg/ml)注射剂Fresenius Kabi USA LLC未进口原研药品美国橙皮书
25-45硫酸镁注射液Magnesium Sulfate Injection10g/20ml (500mg/ml)注射剂Fresenius Kabi USA LLC未进口原研药品美国橙皮书
25-46注射用氟氯西林钠Flucloxacillin Sodium for Injection/Floxapen250mg(以C19H17ClFN3O5S计)注射剂Accord Healthcare Limited/Teva Pharmaceutical Industries Ltd./Actavis(Allergan plc)/Aurobindo Pharma B.V.未进口原研药品欧盟上市
25-47布瑞哌唑片Brexpiprazole Tablets/Rexulti0.25mg片剂Otsuka Pharmaceutical
Co Ltd
未进口原研药品美国橙皮书
25-48布瑞哌唑片Brexpiprazole Tablets/Rexulti0.5mg片剂Otsuka Pharmaceutical
Co Ltd
未进口原研药品美国橙皮书
25-49布瑞哌唑片Brexpiprazole Tablets/Rexulti1mg片剂Otsuka Pharmaceutical
Co Ltd
未进口原研药品美国橙皮书
25-50布瑞哌唑片Brexpiprazole Tablets/Rexulti2mg片剂Otsuka Pharmaceutical
Co Ltd
未进口原研药品美国橙皮书
25-51布瑞哌唑片Brexpiprazole Tablets/Rexulti3mg片剂Otsuka Pharmaceutical
Co Ltd
未进口原研药品美国橙皮书
25-52布瑞哌唑片Brexpiprazole Tablets/Rexulti4mg片剂Otsuka Pharmaceutical
Co Ltd
未进口原研药品美国橙皮书
25-53依托咪酯乳状注射液Etomidate Injectable Emulsion/Etomidate-Lipuro(宜妥利)10ml:20mg注射剂B.Braun Melsungen AG国内上市的原研药品原研进口
25-54盐酸坦索罗辛胶囊Tamsulosin Hydrochloride Capsules/Flomax0.4mg胶囊剂Boehringer Ingelheim Pharmaceuticals,Inc./Sanofi Aventis US LLC未进口原研药品美国橙皮书
25-55卢立康唑乳膏Luliconazole Cream/Luzu1%(60g)乳膏剂Medicis Pharmaceutical Corp未进口原研药品美国橙皮书
25-56马来酸氟伏沙明片Fluvoxamine Maleate Tablets/Luvox(兰释)50mg片剂Abbott Laboratories (Singapore) Private Limited国内上市的原研药品原研进口
25-57马来酸氟伏沙明片Fluvoxamine Maleate Tablets/Luvox(兰释)100mg片剂Abbott Laboratories (Singapore) Private Limited国内上市的原研药品原研进口
25-58米格列醇口崩片Miglitol Orally Disintegrating Tablets/Seibule Od Tab.25mg片剂(口崩片)Sanwa Kagaku Kenkyusho Co.,Ltd.(株式会社三和化学研究所)未进口原研药品日本橙皮书
25-59米格列醇口崩片Miglitol Orally Disintegrating Tablets/Seibule Od Tab.50mg片剂(口崩片)Sanwa Kagaku Kenkyusho Co.,Ltd.(株式会社三和化学研究所)未进口原研药品日本橙皮书
25-60特利加压素注射液Terlipressin Injection/Glypressin/Glycylpressin8.5ml:1mg注射剂Ferring Pharmaceuticals Ltd./Ferring GmbH未进口原研药品欧盟上市
25-61溴莫尼定噻吗洛尔滴眼液Brimonidine Tartrate and Timolol Maleate
Eye Drops
5ml:酒石酸溴莫尼定10.0mg和马来酸噻吗洛尔25.0mg(以噻吗洛尔计)滴眼剂Allergan Pharmaceuticals Ireland国内上市的原研药品原研进口
25-62氢溴酸替格列汀片Teneligliptin Hydrobromide Hydrate Tablets/Tenelia20mg(以替格列汀计)片剂田辺三菱製薬株式会社未进口原研药品日本橙皮书
25-63氢溴酸替格列汀片Teneligliptin Hydrobromide Hydrate Tablets/Tenelia40mg(以替格列汀计)片剂田辺三菱製薬株式会社未进口原研药品日本橙皮书
25-64碳酸镧颗粒Lanthanum Carbonate Hydrate Granules/
Fosrenol
250mg颗粒剂バイエル薬品株式会社未进口原研药品日本橙皮书
25-65碳酸镧颗粒Lanthanum Carbonate Hydrate Granules/
Fosrenol
500mg颗粒剂バイエル薬品株式会社未进口原研药品日本橙皮书
25-66泼尼松片Prednisone Tablets/Prednisone1mg片剂West-Ward Pharmaceuticals International Ltd国际公认的同种药品美国橙皮书
25-67泼尼松片Prednisone Tablets/Prednisone2.5mg片剂West-Ward Pharmaceuticals International Ltd国际公认的同种药品美国橙皮书
25-68泼尼松片Prednisone Tablets/Prednisone5mg片剂West-Ward Pharmaceuticals International Ltd国际公认的同种药品美国橙皮书
25-69泼尼松片Prednisone Tablets/Prednisone10mg片剂West-Ward Pharmaceuticals International Ltd国际公认的同种药品美国橙皮书
25-70泼尼松片Prednisone Tablets/Prednisone20mg片剂West-Ward Pharmaceuticals International Ltd国际公认的同种药品美国橙皮书
25-71泼尼松片Prednisone Tablets/Prednisone50mg片剂West-Ward Pharmaceuticals International Ltd国际公认的同种药品美国橙皮书
25-72重酒石酸去甲肾上腺素注射液Norepinephrine Bitartrate Injection/Levophed1mg/ml(4ml)注射剂Hospira,Inc未进口原研药品美国橙皮书
25-73盐酸多奈哌齐口腔崩解片Donepezil Hydrochloride Orally Disintegrating Tablets/Aricept D3mg片剂エーザイ株式会社未进口原研药品日本橙皮书
25-74盐酸多奈哌齐口腔崩解片Donepezil Hydrochloride Orally Disintegrating Tablets/Aricept D10mg片剂エーザイ株式会社未进口原研药品日本橙皮书
25-75硝酸甘油注射液Nitroglycerin Injection/Nitroglycerin5mg/ml
(50mg/10ml)
注射剂Luitpold Pharmaceuticals
Inc/American Regent Inc
国际公认的同种药品美国橙皮书
25-76硝酸甘油注射液Nitroglycerin Injection/Glyceryl Trinitrate Sterile Concentrate50mg/10ml注射剂Hospira UK Limited国际公认的同种药品英国上市
25-77硝酸甘油注射液Nitroglycerin Injection/Glyceryl Trinitrate Sterile Concentrate25mg/5ml注射剂Hospira UK Limited国际公认的同种药品英国上市
25-78单硝酸异山梨酯缓释胶囊(IV)Isosorbide Mononitrate Sustained-release Capsules(IV)/异乐定50mg胶囊剂(缓释胶囊)优时比(珠海)制药有限公司经审核确定的国外原研企业在中国境内生产的药品原研地产化
25-79盐酸米那普仑胶囊Milnacipran Hydrochloride Capsules/Ixel25mg(按C15H22N2O•HCl计)胶囊剂Pierre Fabre Medicament未进口原研药品欧盟上市
25-80盐酸米那普仑胶囊Milnacipran Hydrochloride Capsules/Ixel50mg(按C15H22N2O•HCl计)胶囊剂Pierre Fabre Medicament未进口原研药品欧盟上市
25-81异烟肼注射液Isoniazid Injection/Iscotin100mg/2ml注射剂アルフレッサ ファーマ株式会社/第一三共株式会社
日本上市
25-82重酒石酸间羟胺注射液Metaraminol Tartrate Injection/Aramine10mg/1ml注射剂Phebra Pty Ltd
澳大利亚上市
25-83盐酸左布比卡因注射液Levobupivacaine Hydrochloride Injection/Chirocaine10ml:50mg注射剂AbbVie AG未进口原研药品瑞士上市
25-84盐酸左布比卡因注射液Levobupivacaine Hydrochloride Injection/Chirocaine10ml:75mg注射剂AbbVie AG未进口原研药品瑞士上市
25-85奥卡西平片Oxcarbazepine Tablets/Trileptal600mg片剂Novartis未进口原研药品欧盟上市
25-86奥卡西平片Oxcarbazepine tablets/Trileptal600mg片剂Novartis Pharmaceuticals Corp未进口原研药品美国橙皮书
25-87克拉霉素缓释片Clarithromycin sustained-release tablets/Klaricid XL500mg片剂(缓释片)Mylan Products Ltd未进口原研药品英国上市
25-88阿昔洛韦片Acyclovir tablets /zovirax800mg片剂Mylan Pharmaceuticals Inc未进口原研药品美国橙皮书
25-89阿仑膦酸钠片Alendronate Sodium Tablets/Fosamax70mg(按            C4H13NO7P2计)片剂MSD PHARMA(SINGAPORE) PTE. LTD./Merck Sharp & Dohme B.V.原研进口持证商发生变更,增加新持证商:Merck Sharp & Dohme B.V.
25-90盐酸莫西沙星氯化钠注射液Moxifloxacin Hydrochloride And Sodium Chloride Injection/ Avelox(拜复乐)250ml:莫西沙星0.4g与氯化钠2.0g注射液Bayer Vital GmbH国内上市的原研药品原研进口(勘误持证商)
23-63醋酸去氨加压素口服溶液Desmopressin Acetate Oral Solution360μg/ml口服溶液剂Gp-Pharm, S.A.未进口原研药品欧盟上市
(勘误单位为
μg/ml,
不限定商品名)
23-164利匹韦林片Rilpivirine Tablets/Edurant(恩临)25mg(以C22H18N6计)片剂Janssen-Cilag International N.V.国内上市的原研药品原研进口
(勘误通用名为:利匹韦林片)
23-323盐酸左西替利嗪口服溶液Levocetirizine dihydrochloride Oral Solution0.05%(75ml、150ml、200ml)口服溶液剂UCB Pharma GmbH/ UCB Pharma Limited未进口原研药品欧盟上市
(勘误装量规格,不限定商品名)
23-324盐酸左西替利嗪口服溶液Levocetirizine dihydrochloride Oral Solution0.5mg/ml(148ml)口服溶液剂Sanofi Aventis US LLC未进口原研药品美国橙皮书(勘误不限定商品名)
23-334丙戊酸钠注射液Sodium Valproate For Intravenous Injection/Orfiril3ml:300mg注射液Desitin Arzneimittel GmbH
欧盟上市
(勘误持证商,将英文修订为德文)
23-335丙戊酸钠注射液Sodium Valproate For Intravenous Injection/Orfiril10ml:1g注射液Desitin Arzneimittel GmbH
欧盟上市
(勘误持证商,将英文修订为德文)



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