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【第十三批】仿制药参比制剂目录


【第十三批】仿制药参比制剂目录


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
13-1苯磺贝他斯汀片Bepotastine Besilate Tablets/TALION10mg片剂Mitsubishi Tanabe Pharma Corporation原研进口
13-2卡格列净片Canagliflozin Tablets/INVOKANA100mg片剂Janssen-Cilag International NV原研进口
13-3卡格列净片Canagliflozin Tablets/INVOKANA300mg片剂Janssen-Cilag International NV原研进口
13-4安立生坦片Ambrisentan Tablets /VOLIBRIS5mg片剂GLAXOSMITHKLINE INC.原研进口
13-5安立生坦片Ambrisentan Tablets /VOLIBRIS10mg片剂GLAXOSMITHKLINE INC.原研进口
13-6门冬氨酸钾镁片Potassium Aspartate and Magnesium Aspartate Tablets/Panangin门冬氨酸镁0.140g和门冬氨酸钾0.158g片剂Gedeon Richter Plc.原研进口
13-7琥珀酸普芦卡必利片Prucalopride Succinate Tablets / Resolor1mg片剂Janssen Inc.原研进口
13-8琥珀酸普芦卡必利片Prucalopride Succinate Tablets / Resolor2mg片剂Janssen Inc.原研进口
13-9替格瑞洛片Ticagrelor Tablets / BRILINTA60mg片剂AstraZeneca AB原研进口
13-10马来酸阿法替尼片Afatinib Dimaleate Tablets/GIOTRIF20mg片剂Boehringer Ingelheim International GmbH原研进口
13-11马来酸阿法替尼片Afatinib Dimaleate Tablets/GIOTRIF30mg片剂Boehringer Ingelheim International GmbH原研进口
13-12马来酸阿法替尼片Afatinib Dimaleate Tablets/GIOTRIF40mg片剂Boehringer Ingelheim International GmbH原研进口
13-13马来酸阿法替尼片Afatinib Dimaleate Tablets/GIOTRIF50mg片剂Boehringer Ingelheim International GmbH原研进口
13-14盐酸倍他司汀片Betahistine Dihydrochloride Tablets/SERC8mg片剂MYLAN MEDICAL SAS欧盟上市(产地:法国)
13-15枸橼酸氢钾钠颗粒Potassium Sodium Hydrogen Citrate Granules/Uralyt-U97.1g/100g颗粒剂Madaus GmbH原研进口
13-16加巴喷丁胶囊Gabapentin Capsules/Neurontin100mg胶囊剂Pfizer Pharma Pfe GmbH欧盟上市(产地:德国)
13-17加巴喷丁胶囊Gabapentin Capsules/Neurontin300mg 胶囊剂Pfizer Pharma Pfe GmbH欧盟上市(产地:德国)
13-18加巴喷丁胶囊Gabapentin Capsules/Neurontin400mg 胶囊剂Pfizer Pharma Pfe GmbH欧盟上市(产地:德国)
13-19盐酸莫西沙星片Moxifloxacin Hydrochloride Tablets/Avelox400mg片剂Bayer Vital GmbH原研进口
13-20贝前列素钠片Beraprost Sodium Tablets/Dorner20μg片剂Toray Industries, Inc.原研进口
13-21吡拉西坦颗粒Piracetam Granules/Nootropil2400mg颗粒剂UCB Magyarország Kft.欧盟上市(产地:比利时)
13-22氨苄西林胶囊Ampicillin Capsules/AMPICILLIN TRIHYDRATE250mg(以C16H19N3O4S计)胶囊剂DAVA Pharmaceuticals INC美国橙皮书
13-23瑞格列奈二甲双胍片Repaglinide and Metformin Hydrochloride Tablets/--1mg/500mg片剂LUPIN LTD美国橙皮书
13-24瑞格列奈二甲双胍片Repaglinide and Metformin Hydrochloride Tablets/--2mg/500mg片剂LUPIN LTD美国橙皮书
13-25复方甘草酸苷片Compound Glycyrrhizin Tablets/Stronger Neo-Minophagen C(美能)甘草酸单铵盐35mg(甘草酸苷25mg)、甘氨酸25mg、DL-蛋氨酸25mg片剂Minophagen Pharmaceutical Co., Ltd.原研进口
13-26盐酸羟考酮缓释片Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN5mg片剂NAPP PHARMACEUTICALS LIMITED原研进口
13-27盐酸羟考酮缓释片Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN10mg片剂NAPP PHARMACEUTICALS LIMITED原研进口
13-28盐酸羟考酮缓释片Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN15mg片剂NAPP PHARMACEUTICALS LIMITED原研进口
13-29盐酸羟考酮缓释片Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN20mg片剂NAPP PHARMACEUTICALS LIMITED原研进口
13-30盐酸羟考酮缓释片Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN30mg片剂NAPP PHARMACEUTICALS LIMITED原研进口
13-31盐酸羟考酮缓释片Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN40mg片剂NAPP PHARMACEUTICALS LIMITED原研进口
13-32盐酸羟考酮缓释片Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN60mg片剂NAPP PHARMACEUTICALS LIMITED原研进口
13-33盐酸羟考酮缓释片Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN80mg片剂NAPP PHARMACEUTICALS LIMITED原研进口
13-34盐酸羟考酮缓释片Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN120mg片剂NAPP PHARMACEUTICALS LIMITED原研进口
13-35盐酸丙卡特罗颗粒Procaterol Hydrochloride Granules/Meptin0.01% 1g (1g:100μg)颗粒剂OTSUKA PHARMACEUTICAL Co.,Ltd.日本橙皮书
13-36缬沙坦胶囊Valsartan Capsules80mg胶囊北京诺华制药有限公司原研地产化品种
13-37缬沙坦胶囊Valsartan Capsules160mg胶囊北京诺华制药有限公司原研地产化品种
13-38氟伐他汀钠缓释片Fluvastatin Sodium extended release tablets80mg片剂北京诺华制药有限公司原研地产化品种
13-39替比夫定片Telbivudine Tablets600mg片剂北京诺华制药有限公司原研地产化品种
13-40赛洛多辛胶囊Silodosin Capsules4mg胶囊第一三共制药(北京)有限公司原研地产化品种
13-41硫酸特布他林片Terbutaline Sulphate Tablets2.5mg片剂阿斯利康制药有限公司原研地产化品种
13-42单硝酸异山梨酯缓释片Isosorbide Mononitrate Sustained Release Tablets30mg片剂阿斯利康制药有限公司原研地产化品种
13-43单硝酸异山梨酯缓释片Isosorbide Mononitrate Sustained Release Tablets60mg片剂阿斯利康制药有限公司原研地产化品种
13-44兰索拉唑肠溶胶囊Lansoprazole Enteric-coated Capsules30mg胶囊天津武田药品有限公司原研地产化品种
13-45托吡酯片Topiramate Tablets25mg片剂西安杨森制药有限公司原研地产化品种
13-46托吡酯片Topiramate Tablets100mg片剂西安杨森制药有限公司原研地产化品种
13-47伊曲康唑胶囊Itraconazole Capsules0.1g胶囊西安杨森制药有限公司原研地产化品种
13-48氟哌噻吨美利曲辛片Flupentixol and Melitracen Tablets/Deanxit氟哌噻吨0.5mg,美利曲辛10mg薄膜衣片H.Lundbeck N.V.欧盟上市(上市国:比利时,产地:丹麦)增补
13-49乙酰半胱氨酸颗粒Acetylcysteine  Granules/Fluimucil0.2g颗粒剂ZAMBON ITALIA S.R.L上市国家:意大利,产地:意大利增补
13-50格列喹酮片Gliquidone Tablets/Glurenorm30mg片剂Astellas Pharma GmbH/Glenwood GmbH Pharmazeutische Erzeugnisse欧盟上市(上市国家:德国;产地:希腊)增补
10-214氨氯地平阿托伐他汀钙片Amlodipine Besylate and Atorvastatin Calcium Tablets/--氨氯地平5mg,阿托伐他汀10mg片剂Pfizer Prism CV原研进口持证商由“Pfizer Prism CV”更正为“PF Prism CV”
10-215氨氯地平阿托伐他汀钙片Amlodipine Besylate and Atorvastatin Calcium Tablets/--氨氯地平5mg,阿托伐他汀20mg片剂Pfizer Prism CV原研进口持证商由“Pfizer Prism CV”更正为“PF Prism CV”
10-216氨氯地平阿托伐他汀钙片Amlodipine Besylate and Atorvastatin Calcium Tablets/--氨氯地平5mg,阿托伐他汀40mg片剂Pfizer Prism CV原研进口持证商由“Pfizer Prism CV”更正为“PF Prism CV”

1、参比制剂选择原则:有原研进口的应选择原研进口药作为参比制剂首选。
2、本网站所有仿制药参比制剂目录数据源自国家药品监督管理局官方网站,如有纰漏请以国家官网为准。

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