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CFDA仿制药参比制剂目录(第二批)

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  • 分类:学术资料
  • 更新时间:2017-03-31
  • 大小:0.07MB
  • 语言:中文
  • 来源:CFDA
  • 内容说明:

    国家食品药品监督管理总局于2017年3月20日发布的仿制药药参比制剂目录(第二批)。

    仿制药参比制剂目录(第二批)

    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
    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。
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