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【第二批】仿制药参比制剂目录


【第二批】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
2-1盐酸胺碘酮片Amiodarone Hydrochloride Tablets/Ancaron0.1g片剂Sanofi K.K.日本橙皮书
2-2阿卡波糖片Acarbose Tablets/Glucobay0.1g片剂Bayer Vital GmbH原研进口
2-3头孢呋辛酯片Cefuroxime Axetil Tablets/Ceftin按头孢呋辛(C16H16N4O8S)计0.5g片剂GlaxoSmithKline美国橙皮书
2-4头孢呋辛酯干混悬剂Cefuroxime Axetil for  Suspension/Zinnat按头孢呋辛(C16H16N4O8S)计0.125g口服混悬剂(干混悬剂)GlaxoSmithKline,S.A.欧盟上市(产地:英国;上市国家:西班牙)
2-5辛伐他汀片Simvastatin Tablets/Zocor5mg片剂Merck Sharp & Dohme (Australia) Pty. Ltd.原研进口
2-6辛伐他汀片Simvastatin Tablets/Zocor40mg片剂Merck Sharp & Dohme (Australia) Pty. Ltd.原研进口
2-7盐酸氨溴索片Ambroxol Hydrochloride Tablets/Mucosolvan60mg片剂Boehringer Ingelheim Pharma GmbH & Co. KG欧盟上市(产地:法国;上市国家:德国)
2-8盐酸氨溴索缓释胶囊Ambroxol Hydrochloride Sustained-release Capsules/Mucosolvan75mg胶囊剂(缓释胶囊)Boehringer Ingelheim Pharma GmbH & Co.KG原研进口
2-9富马酸喹硫平片Quetiapine Fumarate Tablets/Seroquel0.2g片剂AstraZeneca UK Limited原研进口
2-10富马酸喹硫平片Quetiapine Fumarate Tablets/Seroquel0.3g片剂AstraZeneca UK Limited原研进口
2-11富马酸喹硫平片Quetiapine Fumarate Tablets/Seroquel50mg片剂AstraZeneca Pharmaceuticals LP美国橙皮书
2-12醋酸甲羟孕酮片Medroxyprogesterone Acetate Tablets/Provera10mg片剂Pharmacia and Upjohn Co美国橙皮书
2-13醋酸甲羟孕酮片Medroxyprogesterone Acetate Tablets/Farlutal0.5g片剂Pfizer Italia s.r.l原研进口
2-14阿莫西林克拉维酸钾干混悬剂Amoxicillin and Clavulanate Potassium for Suspension/Augmentin0.15625g(C16H19N3O5S 0.125g与C8H9NO5 0.03125g)口服混悬剂(干混悬剂)Beecham Group Plc欧盟上市(上市国家:英国;产地:英国)
2-15阿莫西林克拉维酸钾干混悬剂Amoxicillin and Clavulanate Potassium for Suspension/Augmentin0.3125g(C16H19N3O5S 0.25g与C8H9NO5 0.0625g)口服混悬剂(干混悬剂)Beecham Group Plc欧盟上市(上市国家:英国;产地:英国)
2-16阿莫西林克拉维酸钾干混悬剂Amoxicillin and Clavulanate Potassium for Suspension/Augmentin0.2285g(C16H19N3O5S 0.2g与C8H9NO5 0.0285g)口服混悬剂(干混悬剂)SmithKline Beecham Limited原研进口
2-17硫酸氢氯吡格雷片Clopidogrel Hydrogen Sulphate Tablets/Plavix300mg片剂Sanofi Clir SNC原研进口
2-18克拉霉素缓释片Clarithromycin Sustained-release Tablets/Klacid SR0.5g片剂(缓释片)ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED原研进口
2-19克拉霉素干混悬剂Clarithromycin for Suspension/Klacid0.125g口服混悬剂(干混悬剂)ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED原研进口
2-20克拉霉素干混悬剂Clarithromycin for Suspension/Klacid0.25g口服混悬剂(干混悬剂)ABBVIE INC美国橙皮书
2-21阿立哌唑片Aripiprazole Tablets/Abilify15mg片剂Otsuka Pharmaceutical Co. Ltd美国橙皮书
2-22盐酸特拉唑嗪片Terazosin Hydrochloride Tablets/Hytrin1mg(按C19H25N5O4计)片剂Amdipharm UK Limited欧盟上市(产地:英国)
2-23盐酸特拉唑嗪片Terazosin Hydrochloride Tablets/Hytrin5mg(按C19H25N5O4计)片剂Amdipharm UK Limited欧盟上市(产地:英国 )
2-24盐酸特拉唑嗪胶囊Terazosin Hydrochloride Capsule/Terazosin Hydrochloride1mg(按C19H25N5O4计)胶囊剂Sandoz Inc美国橙皮书
2-25盐酸特拉唑嗪胶囊Terazosin Hydrochloride Capsule/Terazosin Hydrochloride2mg(按C19H25N5O4计)胶囊剂Sandoz Inc美国橙皮书
2-26左甲状腺素钠片Levothyroxine Sodium Tablets/Euthyrox25μg片剂Merck Serono GmbH欧盟上市(上市国家:德国;产地:德国 )
2-27左甲状腺素钠片Levothyroxine Sodium Tablets/Euthyrox100μg片剂Merck Serono GmbH原研进口
2-28右佐匹克隆片Eszopiclone  Tablets/ Lunesta3mg片剂Sunovion Pharmaceuticals Inc美国橙皮书
2-29右佐匹克隆片Eszopiclone  Tablets/ Lunesta2mg片剂Sunovion Pharmaceuticals Inc美国橙皮书
2-30右佐匹克隆片Eszopiclone  Tablets/ Lunesta1mg片剂Sunovion Pharmaceuticals Inc美国橙皮书
2-31马来酸依那普利片Enalapril Maleate Tablets/Vasotec2.5mg片剂Valeant Pharmaceuticals North America Industries LTD美国橙皮书
2-32氯雷他定咀嚼片Loratadine Chewable Tablets/Children's Claritin5mg片剂 (咀嚼片)Bayer Healthcare LLC美国橙皮书
2-33氯雷他定口崩片Loratadine Orally Disintegrating Tablets /Claritin Reditabs10mg片剂 (口崩片)Bayer Healthcare LLC美国橙皮书国内药品通用名称为氯雷他定口腔崩解片。

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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