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【第七批】仿制药参比制剂目录


【第七批】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
7-1阿普唑仑片Alprazolam Tablets/Solanax0.4mg片剂Pfizer Japan Inc.日本橙皮书
7-2阿昔洛韦胶囊Aciclovir Capsules/Zovirax0.2g胶囊剂Mylan Pharmaceuticals Inc美国橙皮书美国橙皮书收载名称:Acyclovir Capsules
7-3阿昔洛韦片Aciclovir Tablets/Zovirax0.2g片剂Glaxo Smithkline K.K.日本橙皮书
7-4氨苯砜片Dapsone Tablets  /--0.1g片剂Jacobus Pharmaceutical CO美国橙皮书
7-5奥美拉唑肠溶胶囊Omeprazole Enteric Capsules/Losec20mg胶囊剂AstraZeneca UK Limited欧盟上市(上市国家:英国)英国上市名称:Omeprazole hard gastro-resistant capsules
7-6奥美拉唑肠溶胶囊Omeprazole Enteric Capsules/Losec10mg胶囊剂AstraZeneca UK Limited欧盟上市(上市国家:英国)英国上市名称:Omeprazole hard gastro-resistant capsules
7-7奥美拉唑肠溶片Omeprazole Enteric-coated Tablets/Omepral20mg片剂(肠溶片)AstraZeneca K.K.日本橙皮书
7-8奥美拉唑肠溶片Omeprazole Enteric-coated Tablets/Omepral10mg片剂(肠溶片)AstraZeneca K.K.日本橙皮书
7-9苯巴比妥片Phenobarbital Tablets/Luminaletten15mg片剂DESITIN Arzneimittel GmbH欧盟上市(上市国家:德国;产地:德国)
7-10苯巴比妥片Phenobarbital Tablets/Phenobal30mg片剂Fujinaga pharm Co.,Ltd.日本橙皮书
7-11苯巴比妥片Phenobarbital Tablets/Luminal0.1g片剂DESITIN Arzneimittel GmbH欧盟上市(上市国家:德国;产地:德国)
7-12苯妥英钠片Phenytoin Sodium Tablets50mg片剂Aurobindo Pharma - Milpharm Ltd.欧盟上市(上市国家:英国;产地:英国)
7-13苯妥英钠片Phenytoin Sodium Tablets0.1g片剂Aurobindo Pharma - Milpharm Ltd.欧盟上市(上市国家:英国;产地:英国)
7-14别嘌醇片Allopurinol Tablets/Zyloprim0.1g片剂SEBELA IRELAND LTD美国橙皮书持证商为PROMETHEUS LABORATORIES INC.的产品亦可
7-15丙戊酸钠片Sodium Valproate Tablets/Depakene0.1g片剂Kyowa Hakko Kirn Co., Ltd.日本橙皮书
7-16丙戊酸钠片Sodium Valproate Tablets/Depakene0.2g片剂Kyowa Hakko Kirn Co., Ltd.日本橙皮书
7-17茶碱缓释片Theophylline Sustained-release Tablets/Theolong0.1g(按C7H8N4O2计)片剂(缓释片)Eisai Co., Ltd.日本橙皮书日本橙皮书收载名称:Theophylline Extended-release Tablets
7-18茶碱缓释片Theophylline Sustained-release Tablets/THEODUR0.1g(按C7H8N4O2计)片剂(缓释片)Mitsubishi Tanabe Pharma Corporation日本橙皮书日本橙皮书收载名称:Theophylline Extended-release Tablets
7-19茶碱缓释片Theophylline Sustained-release Tablets/UNICON0.1g(按C7H8N4O2计)片剂(缓释片)Nichi-Iko Pharmaceutical Co.,Ltd日本橙皮书日本橙皮书收载名称:Theophylline Extended-release Tablets
7-20茶碱缓释片Theophylline Sustained-release Tablets/THEOPHYLLINE0.1g(按C7H8N4O2计)片剂(缓释片)PLIVA INC美国橙皮书美国橙皮书收载名称:Theophylline Extended-release Tablets
7-21地红霉素肠溶片Dirithromycin Enteric Coated Tablets/Dynabac0.25g片剂(肠溶片)Abdi İbrahim İlaç上市国家:土耳其;产地:土耳其
7-22地塞米松片Dexamethasone Tablets/DEXAMETHASONE0.75mg片剂WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD美国橙皮书
7-23地西泮片Diazepam Tablets/VALIUM5mg片剂HOFFMANN LA ROCHE INC美国橙皮书
7-24对乙酰氨基酚片Paracetamol Tablets/Panadol Original Tablets0.5g片剂GlaxoSmithKline Consumer Healthcare欧盟上市(上市国家:英国;产地:爱尔兰)
7-25对乙酰氨基酚片Paracetamol Tablets/Panadol Advance Tablets0.5g片剂GlaxoSmithKline Consumer Healthcare欧盟上市(上市国家:英国;产地:德国)
7-26法莫替丁片Famotidine Tablets/Gaster20mg片剂AstellasPharma Inc.日本橙皮书
7-27呋塞米片Furosemide Tablets/LASIX20mg片剂US PHARMACEUTICAL HOLDINGS II LLC美国橙皮书
7-28氟哌啶醇片Haloperidol Tablets/HALOPERIDOL2mg片剂SANDOZ INC美国橙皮书
7-29复方磺胺甲噁唑片Compound Sulfamethoxazole Tablets/BACTRIM磺胺甲噁唑 0.4g,甲氧苄啶 80mg片剂Sun Pharmaceutical Industries Inc美国橙皮书
7-30复方左炔诺孕酮片Compound Levonorgestrel Tablets/Microgynon 30左炔诺孕酮0.15mg,炔雌醇0.03mg片剂Bayer plc欧盟上市(上市国家:英国)英国上市名称:Levonorgestrel and Ethinylestradiol Tablets
7-31磺胺嘧啶片Sulfadiazine Tablets0.5g片剂SANDOZ INC美国橙皮书
7-32甲氨蝶呤片Methotrexate Tablets/METHOTREXATE2.5mg片剂Pfizer Japan Inc.日本橙皮书
7-33甲硝唑片Metronidazole Tablets/FLAGYL0.2g片剂Winthrop Pharmaceuticals UK Limited欧盟上市(上市国家:英国;产地:西班牙)
7-34酒石酸美托洛尔片Metoprolol Tartrate Tablets/Seloken50mg片剂AstraZeneca AB欧盟上市(上市国家:瑞典;产地:中国)
7-35劳拉西泮片Lorazepam Tablets/Ativan1mg片剂VALEANT INTERNATIONAL BARBADOS SRL美国橙皮书
7-36劳拉西泮片Lorazepam Tablets/Ativan0.5mg片剂VALEANT INTERNATIONAL BARBADOS SRL美国橙皮书
7-37利福平胶囊Rifampicin Capsules/RIFADIN0.3g胶囊剂SANOFI AVENTIS US LLC美国橙皮书
7-38利福平胶囊Rifampicin Capsules/RIFADIN0.15g胶囊剂SANOFI AVENTIS US LLC美国橙皮书
7-39硫酸吗啡缓释片Morphine Sulphate Sustained-release Tablets/--10mg片剂(缓释片)NAPP PHARMA CEUTICALS LIM ITED原研进口
7-40硫酸吗啡缓释片Morphine Sulphate Sustained-release Tablets/--30mg片剂(缓释片)NAPP PHARMA CEUTICALS LIM ITED原研进口
7-41硫酸吗啡缓释片Morphine Sulphate Sustained-release Tablets/--60mg片剂(缓释片)NAPP PHARMA CEUTICALS LIM ITED原研进口
7-42氯氮平片Clozapine Tablets/Clozaril25mg片剂HERITAGE LIFE SCIENCES BARBADOS INC美国橙皮书
7-43氯氮平片Clozapine Tablets/Leponex50mg片剂Mylan Healthcare GmbH欧盟上市(上市国家:德国;产地:德国)
7-44氯化钾颗粒Potassium Chloride Granules/Potassium Chloride20MEQ(相当于1.5g氯化钾)颗粒剂PHARMA RES SOFTWARE SOLUTION LLC美国橙皮书美国橙皮书收载名称:Potassium Chloride for oral solution
7-45氯硝西泮片Clonazepam Tablets/Klonopin2mg片剂HOFFMANN LA ROCHE INC美国橙皮书
7-46氯硝西泮片Clonazepam Tablets/Klonopin0.5mg片剂HOFFMANN LA ROCHE INC美国橙皮书
7-47马来酸氯苯那敏片Chlorphenamine Maleate Tablets/Chlor-Tripolon4mg片剂BAYER INC CONSUMER CARE上市国家:加拿大;产地:加拿大加拿大上市名称:Chlorpheniramine Maleate Tablets
7-48尼群地平片Nitrendipine Tablets/Bayotensin mite10mg片剂Bayer Vital GmbH欧盟上市(上市国家:德国)
7-49齐多夫定胶囊Zidovudine Capsules/Retrovir0.1g胶囊剂VIIV HEALTHCARE UK LIMITED原研进口
7-50齐多夫定片Zidovudine Tablets/--0.3g片剂HETERO LABS LTD UNIT III美国橙皮书
7-51氢氯噻嗪片Hydrochlorothiazide Tablets/Esidrix25mg片剂Laboratoires Juvise Pharmaceuticals欧盟上市(上市国家:德国;产地:德国)
7-52秋水仙碱片Colchicine Tablets/Colchicine0.5mg片剂TAKATA SEIYAKU Co.,Ltd.日本橙皮书
7-53巯嘌呤片Mercaptopurine Tablets/Purinethol50mg片剂Stason Pharmaceuticals INC美国橙皮书
7-54双氯芬酸钠肠溶片Diclofenac Sodium Enteric-coated Tablets/Voltaren25mg片剂(肠溶片)Novartis Pharma GmbH欧盟上市(上市国家:德国;产地:德国)
7-55双氯芬酸钠缓释胶囊Diclofenac Sodium Sustained Release Capsules/Diclofenac-Actavis 100 mg Retardkapseln0.1g胶囊剂(缓释胶囊)PUREN Pharma GmbH & Co. KG欧盟上市(上市国家:德国;产地:德国)
7-56双氯芬酸钠缓释胶囊Diclofenac Sodium Sustained Release Capsules/Diclomax Retard0.1g胶囊剂(缓释胶囊)Galen Limited欧盟上市(上市国家:英国;产地:英国)
7-57双氯芬酸钠缓释片Diclofenac Sodium Sustained Release Tablets/Voltaren0.1g片剂(缓释片)Novartis Pharma Schweiz AG上市国家:瑞士;产地:瑞士
7-58双氯芬酸钠缓释片Diclofenac Sodium Sustained Release Tablets/Voltarene LP0.1g片剂(缓释片)NOVARTIS PHARMA SAS欧盟上市(上市国家:法国;产地:意大利)
7-59双氯芬酸钠缓释片Diclofenac Sodium Sustained Release Tablets/--0.1g片剂(缓释片)ACTAVIS ELIZABETH LLC美国橙皮书美国橙皮书收载名称:Diclofenac Sodium Extended Release Tablets
7-60双嘧达莫片Dipyridamole Tablets/Persantin25mg片剂Nippon Boehringer Ingelheim Co., Ltd.日本橙皮书
7-61司他夫定胶囊Stavudine Capsules/Zerit15mg胶囊剂BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE美国橙皮书
7-62司他夫定胶囊Stavudine Capsules/Zerit20mg胶囊剂BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE美国橙皮书
7-63司他夫定胶囊Stavudine Capsules/Zerit40mg胶囊剂BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE美国橙皮书
7-64碳酸锂片Lithium Carbonate Tablets/TERALITHE0.25g片剂SANOFI-AVENTIS France欧盟上市(上市国家:法国;产地:法国)
7-65头孢氨苄胶囊Cefalexin Capsules / Keflex0.25g(按C16H17N3O4S计)胶囊剂PRAGMA PHARMACEUTICALS LLC美国橙皮书美国橙皮书收载名称:Cephalexin Capsules
7-66头孢氨苄胶囊Cefalexin Capsules / Sencephalin0.125g(按C16H17N3O4S计)胶囊剂Takeda Pharmaceutical Co., Ltd.日本橙皮书
7-67头孢氨苄片Cefalexin Tablets / Keflex0.25g(按C16H17N3O4S计)片剂Flynn Pharma Ltd欧盟上市(上市国家:英国;产地:意大利)
7-68硝苯地平缓释片Nifedipine Sustained-release Tablets/Adalat retard20mg片剂(缓释片)Bayer Vital GmbH欧盟上市(产地:德国)
7-69硝苯地平缓释片Nifedipine Sustained-release Tablets/Adalat-L20mg片剂(缓释片)Bayer日本橙皮书
7-70缬沙坦胶囊Valsartan Capsules/DIOVAN80mg胶囊剂Novartis Pharmaceuticals UK Limited欧盟上市(上市国家:英国;产地:中国)
7-71熊去氧胆酸片Ursodeoxycholic Acid Tablets/URSO50mg片剂Mitsubishi Tanabe Pharma Corporation日本橙皮书
7-72溴吡斯的明片Pyridostigmine Bromide Tablets/Mestinon60mg片剂Valeant Pharmaceuticals North America LLC美国橙皮书
7-73盐酸阿米替林片Amitriptyline Hydrochloride Tablets/--25mg片剂Sandoz Inc美国橙皮书
7-74盐酸昂丹司琼片Ondansetron Hydrochloride Tablets/Zofran4mg(按C18H19N3O计)片剂Novartis Pharmaceuticals Corp美国橙皮书
7-75盐酸昂丹司琼片Ondansetron Hydrochloride Tablets/Zofran8mg(按C18H19N3O计)片剂Novartis Pharmaceuticals Corp美国橙皮书
7-76盐酸苯海拉明片Diphenhydramine Hydrochloride Tablets/ Benadryl25mg片剂Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division美国上市
7-77盐酸地芬尼多片Difenidol Hydrochloride Tablets/Cephadol25mg片剂NIPPON SHINYAKU CO.,LTD.日本橙皮书
7-78盐酸多塞平片Doxepin Hydrochloride Tablets/SINEQUAN25mg(按C19H21NO计)片剂Pfizer Hellas A.E.欧盟上市(上市国家:希腊;产地:希腊)
7-79盐酸多西环素片Doxycycline Hyclate Tablets/Vibramycin0.1g(按 C22H24N2O8计)片剂Pfizer Japan Inc.日本橙皮书
7-80盐酸多西环素片Doxycycline Hyclate Tablets/Vibramycin50mg(按 C22H24N2O8计)片剂Pfizer Japan Inc.日本橙皮书
7-81盐酸氟桂利嗪片Flunarizine Hydrochloride Tablets/Sibelium5mg(按C26H26F2N2计)片剂Janssen-Cilag S.p.A欧盟上市(产地:意大利)
7-82盐酸金刚烷胺片Amantadine Hydrochloride Tablets/AMANTADINE HYDROCHLORIDE0.1g片剂USL PHARMA INC美国橙皮书
7-83盐酸氯丙嗪片Chlorpromazine Hydrochloride Tablets/Largactil25mg片剂sanofi-aventis australia pty ltd上市国家:澳大利亚;产地:西班牙
7-84盐酸氯米帕明片Clomipramine Hydrochloride Tablets/Anafranil10mg片剂Novarti Pharma Schweiz AG上市国家:瑞士
7-85盐酸氯米帕明片Clomipramine Hydrochloride Tablets/Anafranil25mg片剂Novarti Pharma Schweiz AG上市国家:瑞士
7-86盐酸普罗帕酮片Propafenone Hydrochloride Tablets/Pronon100mg片剂TOA EIYO LTD.日本橙皮书
7-87盐酸维拉帕米片Verapamil Hydrochloride Tablets/Isoptin mite40mg片剂Mylan Healthcare GmbH欧盟上市(上市国家:德国)持证商为Abbott Arzneimittel GmbH 的产品亦可
7-88盐酸溴己新片Bromhexine Hydrochloride Tablets/Bisolvon8mg片剂Boehringer Ingelheim Pharma GmbH & Co. KG欧盟上市(上市国家:德国;产地:法国)
7-89盐酸异丙嗪片Promethazine Hydrochloride Tablets/Phenergan25mg片剂Sanofi欧盟上市(上市国家:英国;产地:西班牙)
7-90叶酸片Folic Acid Tablets/SPECIAFOLDINE5mg片剂MERUS LABS LUXCO  S.à R.L.欧盟上市(上市国家:法国,产地:法国)
7-91依非韦伦片Efavirenz Tablets/ Stocrin50mg片剂Merk Sharp & Dohme Limited欧盟上市(上市国家:英国;产地:中国)
7-92依非韦伦片Efavirenz Tablets/ Stocrin0.2g片剂MSD.K.K日本橙皮书
7-93依非韦伦片Efavirenz Tablets/ Stocrin0.6g片剂MSD.K.K日本橙皮书
7-94乙酰唑胺片Acetazolamide Tablets/Diamox0.25g片剂Sanwa Kagaku Kenkyusho Co., Ltd.日本橙皮书
7-95盐酸苯海索片Trihexyphenidyl Hydrochloride Tablets/Trihexyphenidyl Hydrochloride2mg片剂WATSON LABORATORIES INC美国橙皮书
7-96卡托普利片Captopril Tablets/Capoten25mg片剂E. R. Squibb & Sons Limited欧盟上市(产地:意大利)
7-97阿奇霉素片Azithromycin Tablets/Zithromax0.25g片剂PFIZER INC美国橙皮书

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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