仿制药参比制剂目录第六批.docx

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1、仿制药参比制剂目录（第六批）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26-1草酸艾司西酰普兰片EscitalopramOxalateTabletsZLexapro5mg（按C2oH2FN20计）片剂H.LundbeckA/S原研进口6-2草酸艾司西猷普兰片EscitalopramOxalateTabletsZLexaproIomg（按C2oH2iFN20计）片剂H.LundbeckA/S原研进口6-3草酸艾司西瞅普兰片EscitalopramOxalateTabletsZLexapro20mg（按C20H2IFN2O计）片剂H.LundbeckA/S原研进口6-4多潘立酮口崩片

2、DomperidoneOrallyDisintegratingTabletsZMotiliumIOmg片剂Janssen-CilagAG-Switzerland欧盟上市（上市国家：瑞士；产地：英国）瑞士上市名称：DomperidoneOrodispersibleTablets6-5恩替卡韦片EntecavirTablets/BARACLUDE0.5mg片剂BristolmyersSQUIBB美国橙皮书6-6恩替卡韦片EntecavirTablets/BARACLUDEImg片剂BristolmyersSQUIBB美国橙皮书6-7红霉素肠溶片ErythromycinEnteric-coatedT

3、ablets/ERY-TAB0.5g（50万单位）片剂ArborPharmaceuticals1.LC美国橙皮书美国上市名称：Erythromycindelayed-releasetablets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26-8甲磺酸倍他司汀片BetahistineMesilateTabletsZMerislon6mg片剂EisaiCo.,Ltd.日本橙皮书6-9利培酮片RisperidoneTabletsZRisperdal3mg片剂JanssenPharmaceuticalsInc美国橙皮书6-10磷酸奥司他韦胶囊OseltamivirPhosphateCap

4、sules/Tamiflu75mg（按C6H28N2O4计）胶囊剂RocheRegistrationLtd.原研进口6-11硫酸氨基葡萄糖胶囊GlucosamineSulfateCapsules/Viartril-S0.25g（以硫酸氨基葡萄糖计）胶囊剂ROTTAPHARMS.P.A原研进口适用于：含氯化钠的硫酸氨基葡萄糖混合物6-12硫酸羟氯喳片HydroxychloroquineSulfateTabletsZPlaquenil0.2g片剂AventisPharmaLimited原研进口6-13匹伐他汀钙片PitavastatinCalciumTablets/LivaloKowaImg片剂K

5、owaCompany,Ltd.原研进口6-14匹伐他汀钙片PitavastatinCalciumTablets/LivaloKowa2mg片剂KowaCompany,Ltd.原研进口6-15氢混酸西欧普兰片CitalopramHydrobromideTabletsZCipramiI20mg（按C20H2IFN2O计）片剂H.LundbeckA/S原研进口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26-16头丸地尼胶囊CefdinirCapsulesZCefzon0.1g胶囊剂AstellasPharmaInc.原研进口6-17缴沙坦胶囊ValsartanCapsulesZDlOV

6、AN40mg胶囊剂NovartisPharmaceuticalsUKLimited欧盟上市（上市国家：英国；产地：瑞土）6-18缴沙坦胶囊ValsartanCapsulesZDIOVAN0.16g胶囊剂NovartisPharmaceuticalsUKLimited欧盟上市（上市国家：英国；产地：瑞土）6-19缴沙坦片ValsartanTabletsZDIOVAN0.16g片剂NOVARTISPHARMACeuticalscorp美国橙皮书6-20缴沙坦片ValsartanTabletsZDIOVAN80mg片剂NOVARTISPHARMACeuticalscorp美国橙皮书6-21缴沙坦片V

7、alsartanTabletsZDIOVAN40mg片剂NOVARTISPHARMACeuticalscorp美国橙皮书6-22盐酸乙胺丁醇片EthambutolHydrochlorideTabletsZMyambutol0.4g片剂STIPharmaLLC美国橙皮书6-23盐酸地尔硫草片DiltiazemHydrochlorideTablets/HERBESSER60mg片剂MitsubishiTanabePharmaCorporation日本橙皮书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26-24盐酸二甲双服缓释片MetforminHydrochlorideSustaine

8、d-releaseTabletsZGLUCOPHAGEXR.5g片剂（缓释片）BRISTOLMYERSSQUIBBCO美国橙皮书6-25盐酸二甲双胭片MetforminHydrochlorideTabletsZGlucophage0.85g片剂MerckSanteS.A.S欧盟上市（上市国家：法国；产地：法国）6-26盐酸雷尼替丁片RanitidineHydrochlorideTablets/Zantac75mg（按C13H22N43S计）片剂GlaxoSmithKIineK.K日本橙皮书6-27盐酸美西律胶囊MexiletineHydrochlorideCapsulesZMexitil50m

9、g胶囊剂NipponBoehringerIngelheimCo.,Ltd.日本橙皮书6-28盐酸美西律胶囊MexiletineHydrochlorideCapsules/Mexitil0.1g胶囊剂NipponBoehringerIngelheimCo.,Ltd.日本橙皮书6-29盐酸特比蔡芬片TerbinafineHydrochlorideTabletsZLamisil0.125g（按C21H25Ni+）片剂SunPharmaceuticalIndustriesLimited日本橙皮书6-30盐酸特比蔡芬片TerbinafineHydrochlorideTabIetsZLamisil0.25

10、g（按C21H25N计）片剂NOVARTISPHARMACEUTICALSCORP美国橙皮书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26-31盐酸西替利嗪口崩片CetirizineHydrochlorideOrallyDisintegratingTablets/ZyrtecAllergyIOmg片剂（口崩片）JohnsonandJohnsonConsumerIncMcneilConsumerHealthcareDivision美国橙皮书6-32盐酸西替利嗪片CetirizineHydrochlorideTablets/ZyrtecIOmg片剂UCB-PharmaAG原研进口6-33盐酸左西替利嗪片LevocetirizineHydrochlorideTabletsZXyzal5mg片剂UCBPharmaAG原研进口6-34硬脂酸红霉素片ErythromycinStearateTabletsZERYTHROCINSTEARATE0.25g（按C37H67NO13计，25万单位）片剂ArborPharmaceuticals1.LC美国橙皮书6-35阿司匹林肠溶胶囊AspirinEntericCapsulesZAstrix0.1g胶囊剂（肠溶胶囊）MaynePharmaInternationalPtyLtd上市国家：澳大利亚