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【第一批】仿制药参比制剂目录


【第一批】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
1-1盐酸胺碘酮片Amiodarone Hydrochloride Tablets/Cordarone0.2g片剂Sanofi-Aventis France原研进口
1-2阿卡波糖片Acarbose Tablets/Glucobay50mg片剂Bayer Vital GmbH原研进口
1-3尼莫地平片Nimodipine Tablets/Nimotop30mg片剂Bayer Vital GmbH原研进口
1-4头孢呋辛酯片Cefuroxime Axetil Tablets/Ceftin按头孢呋辛(C16H16N4O8S)计0.125g片剂GlaxoSmithKline美国橙皮书
1-5头孢呋辛酯片Cefuroxime Axetil Tablets/Zinacef按头孢呋辛(C16H16N4O8S)计0.25g片剂Glaxo Wellcome UK Limited原研进口
1-6辛伐他汀片Simvastatin Tablets/Zocor10mg片剂Merck Sharp & Dohme (Australia) Pty. Ltd.原研进口
1-7辛伐他汀片Simvastatin Tablets/Zocor20mg片剂Merck Sharp & Dohme B.V.原研进口
1-8盐酸氨溴索片Ambroxol Hydrochloride Tablets/Mucosolvan30mg片剂Boehringer Ingelheim France原研进口
1-9聚乙二醇4000散Macrogol 4000 powder/Forlax10g散剂Ipsen Pharma原研进口
1-10醋酸去氨加压素片Desmopressin Acetate Tablets/Minirin0.1mg片剂Ferring AG原研进口
1-11醋酸去氨加压素片Desmopressin Acetate Tablets/Minirin0.2mg片剂Ferring AG原研进口
1-12富马酸比索洛尔片Bisoprolol Fumarate Tablets/ Concor2.5mg片剂Merck Serono GmbH原研进口
1-13富马酸比索洛尔片Bisoprolol Fumarate Tablets/ Concor5mg片剂Merck Serono GmbH原研进口
1-14白消安片Busulfan Tablets/Myleran2mg片剂Aspen Pharmacare Australia Pty Ltd原研进口
1-15富马酸喹硫平片Quetiapine Fumarate Tablets/Seroquel25mg片剂AstraZeneca UK Limited原研进口
1-16富马酸喹硫平片Quetiapine Fumarate Tablets/Seroquel0.1g片剂AstraZeneca UK Limited原研进口
1-17醋酸甲羟孕酮片Medroxyprogesterone Acetate Tablets/Provera0.1g片剂Pfizer SA/NV原研进口
1-18醋酸甲羟孕酮片Medroxyprogesterone Acetate Tablets/Provera0.25g片剂Pfizer Italia s.r.l欧盟上市(产地:意大利)
1-19阿莫西林克拉维酸钾片Amoxicillin and Clavulanate Potassium Tablets/Augmentin0.375g(C16H19N3O5S 0.25g与C8H9NO5 0.125g)片剂Beecham Group Plc欧盟上市(产地:英国;上市国家:英国)
1-20阿莫西林克拉维酸钾片Amoxicillin and Clavulanate Potassium Tablets/Augmentin0.625g(C16H19N3O5S 0.5g与C8H9NO5 0.125g)片剂Beecham Group Plc原研进口
1-21阿莫西林克拉维酸钾片Amoxicillin and Clavulanate Potassium Tablets/Augmentin1g(C16H19N3O5S 0.875g与C8H9NO5 0.125g)片剂Beecham Group Plc原研进口
1-22格列美脲片Glimepiride Tablets/Amaryl1mg片剂Sanofi-Aventis Deutschland GmbH原研进口
1-23格列美脲片Glimepiride Tablets/Amaryl2mg片剂Sanofi-Aventis Deutschland GmbH原研进口
1-24环孢素软胶囊Ciclosporin Soft Capsules/Sandimmun Neoral10mg胶囊剂(软胶囊)Novartis Pharma Schweiz AG原研进口
1-25环孢素软胶囊Ciclosporin Soft Capsules/Sandimmun Neoral25mg胶囊剂(软胶囊)Novartis Pharma Schweiz AG原研进口
1-26环孢素软胶囊Ciclosporin Soft Capsules/Sandimmun Neoral50mg胶囊剂(软胶囊)Novartis Pharma Schweiz AG原研进口
1-27甲巯咪唑片Thiamazole Tablets/Thyrozol5mg片剂Merck Serono GmbH原研进口
1-28硫酸氢氯吡格雷片Clopidogrel Hydrogen Sulphate Tablets/Plavix75mg片剂Sanofi Clir SNC原研进口
1-29硝酸甘油舌下片Nitroglycerin Sublingual Tablets/ Nitrostat0.6mg片剂(舌下片)Pfizer INC原研进口适用于硝酸甘油舌下片和舌下含服的硝酸甘油片
1-30克拉霉素片Clarithromycin Tablets/Klacid0.25g片剂ABBOTT LABORATORIES LIMITED原研进口
1-31阿立哌唑片Aripiprazole Tablets/Abilify5mg片剂Otsuka Pharmaceutical Co. Ltd美国橙皮书
1-32阿立哌唑片Aripiprazole Tablets/Abilify10mg片剂Otsuka Pharmaceutical Co. Ltd美国橙皮书
1-33阿立哌唑口崩片Aripiprazole Orally Disintegrating tablets/Abilify10mg片剂(口崩片)Otsuka Pharmaceutical Europe Ltd.欧盟上市(产地:法国)
1-34盐酸环丙沙星片Ciprofloxacin  Hydrochloride Tablets/Ciprobay0.25g(按C17H18FN3O3计)片剂Bayer Vital GmbH原研进口进口产品现名为环丙沙星片。
1-35盐酸环丙沙星片Ciprofloxacin  Hydrochloride Tablets/Ciprobay0.5g(按C17H18FN3O3计)片剂Bayer Vital GmbH原研进口进口产品现名为环丙沙星片。
1-36盐酸特拉唑嗪片Terazosin Hydrochloride Tablets/Hytrin2mg(按C19H25N5O4计)片剂Abbott Laboratories (Singapore) Private Limited原研进口
1-37吲达帕胺片Indapamide Tablets/Natrilix2.5mg片剂Les Laboratoires Servier原研进口
1-38吲达帕胺缓释片Indapamide Sustained-release Tablets/Natrilix1.5mg片剂(缓释片)Les Laboratoires Servier原研进口
1-39左甲状腺素钠片Levothyroxine Sodium Tablets/Euthyrox50μg片剂Merck Serono GmbH原研进口
1-40佐匹克隆片Zopiclone Tablets/Imovane7.5mg片剂Sanofi-Aventis France原研进口
1-41佐匹克隆片Zopiclone Tablets/Imovane3.75mg片剂Sanofi-Aventis France欧盟上市(产地:法国 ;上市国家:法国)
1-42硫唑嘌呤片Azathioprine Tablets/Imuran50mg片剂Aspen Pharmacare Australia Pty Ltd原研进口
1-43奈韦拉平片Nevirapine Tablets/Viramune0.2g片剂Boehringer Ingelheim Pharmaceuticals INC美国橙皮书
1-44米索前列醇片Misoprostol Tablets/Cytotec0.2mg片剂Pharmacia Limited原研进口
1-45马来酸依那普利片Enalapril Maleate Tablets/Renitec5mg片剂Merck Sharp & Dohme(Australia) Pty. Ltd.原研进口
1-46马来酸依那普利片Enalapril Maleate Tablets/Renitec10mg片剂Merck Sharp & Dohme(Australia) Pty. Ltd.原研进口
1-47拉米夫定片Lamivudine Tablets/Epivir(3TC)0.15g片剂ViiV Healthcare Pty. Ltd.原研进口
1-48拉米夫定片Lamivudine Tablets/Epivir(3TC)0.3g片剂ViiV Healthcare UK Limited原研进口
1-49拉米夫定片Lamivudine Tablets/Epivir-HBV0.1g片剂GlaxoSmithKline美国橙皮书
1-50氯雷他定片Loratadine Tablets/Clarityne10mg片剂Bayer SA-NV原研进口
1-51氯雷他定胶囊Loratadine Capsules/Claritin10mg胶囊剂Bayer Healthcare LLC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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