中国仿制药也有自己的《橙皮书》

中国仿制药也有自己的《橙皮书》啦!CFDA近日正式公布了批仿制药参比制剂，这对国内仿制药的研发是个重大消息，很值得我们医药圈小伙伴们关注!批目录的公布，符合CFDA在2015年承诺的「分期分批公布经审核确定的参比制剂目录，建立我国仿制药参比制剂目录集」，大咪粗略看了下，此次由食药监总局公布的批目录51个制剂中，除了上年8月份中检院曾公布过4个参比制剂，还包括其他47个临床常用药品，多家外企的原研药被作为参比制剂列入中国仿制药《橙皮书》，如辉瑞、赛诺菲、勃林格、拜耳、阿斯利康、默沙东、诺华、GSK、默克、益普生、雅培、大冢、辉凌、艾健、施维雅等。总局关于发布仿制药参比制剂目录（第一批）的通告（2017年第45号）经国家食品药品监督管理总局仿制药质量与疗效一致性评价专家委员会审核确定，现发布仿制药参比制剂目录（第一批）。　　特此通告。　　附件：仿制药参比制剂目录（第一批）
食品药品监管总局2017年3月17日
序号药品通用名称英文名称/商品名规格剂型持证商备注11-1盐酸胺碘酮片AmiodaroneHydrochlorideTablets/Cordarone0.2g片剂Sanofi-AventisFrance原研进口1-2阿卡波糖片AcarboseTablets/Glucobay50mg片剂BayerVitalGmbH原研进口1-3尼莫地平片NimodipineTablets/Nimotop30mg片剂BayerVitalGmbH原研进口1-4头孢呋辛酯片CefuroximeAxetilTablets/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CefuroximeAxetilTablets/Zinacef按头孢呋辛(C16H16N4O8S)计0.25g片剂GlaxoWellcomeUKLimited原研进口1-6辛伐他汀片SimvastatinTablets/Zocor10mg片剂MerckSharp&Dohme(Australia)Pty.Ltd.原研进口1-7辛伐他汀片SimvastatinTablets/Zocor20mg片剂MerckSharp&DohmeB.V.原研进口1-8盐酸氨溴索片AmbroxolHydrochlorideTablets/Mucosolvan30mg片剂BoehringerIngelheimFrance原研进口1-9聚乙二醇4000散Macrogol4000powder/Forlax10g散剂ipsenPharma原研进口1-10醋酸去氨加压素片DesmopressinAcetateTablets/Minirin0.1mg片剂FerringAG原研进口1-11醋酸去氨加压素片DesmopressinAcetateTablets/Minirin0.2mg片剂FerringAG原研进口1-12富马酸比索洛尔片BisoprololFumarateTablets/Concor2.5mg片剂MerckSeronoGmbH原研进口1-13富马酸比索洛尔片BisoprololFumarateTablets/Concor5mg片剂MerckSeronoGmbH原研进口1-14白消安片BusulfanTablets/Myleran2mg片剂AspenPharmacareAustraliaPtyLtd原研进口1-15富马酸喹硫平片QuetiapineFumarateTablets/Seroquel25mg片剂AstraZenecaUKLimited原研进口1-16富马酸喹硫平片QuetiapineFumarateTablets/Seroquel0.1g片剂AstraZenecaUKLimited原研进口1-17醋酸甲羟孕酮片MedroxyprogesteroneAcetateTablets/Provera0.1g片剂PfizerSA/NV原研进口1-18醋酸甲羟孕酮片MedroxyprogesteroneAcetateTablets/Provera0.25g片剂PfizerItalias.r.l欧盟上市（产地：意大利）1-19阿莫西林克拉维酸钾片AmoxicillinandClavulanatePotassiumTablets/Augmentin0.375g（C16H19N3O5S0.25g与C8H9NO50.125g）片剂BeechamGroupPlc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AmoxicillinandClavulanatePotassiumTablets/Augmentin0.625g（C16H19N3O5S0.5g与C8H9NO50.125g）片剂BeechamGroupPlc原研进口1-21阿莫西林克拉维酸钾片AmoxicillinandClavulanatePotassiumTablets/Augmentin1g（C16H19N3O5S0.875g与C8H9NO50.125g）片剂BeechamGroupPlc原研进口1-22格列美脲片GlimepirideTablets/Amaryl1mg片剂Sanofi-AventisDeutschlandGmbH原研进口1-23格列美脲片GlimepirideTablets/Amaryl2mg片剂Sanofi-AventisDeutschlandGmbH原研进口1-24环孢素软胶囊CiclosporinSoftCapsules/SandimmunNeoral10mg胶囊剂（软胶囊）NovartisPharmaSchweizAG原研进口1-25环孢素软胶囊CiclosporinSoftCapsules/SandimmunNeoral25mg胶囊剂（软胶囊）NovartisPharmaSchweizAG原研进口1-26环孢素软胶囊CiclosporinSoftCapsules/SandimmunNeoral50mg胶囊剂（软胶囊）NovartisPharmaSchweizAG原研进口1-27甲巯咪唑片ThiamazoleTablets/Thyrozol5mg片剂MerckSeronoGmbH原研进口1-28硫酸氢氯吡格雷片ClopidogrelHydrogenSulphateTablets/Plavix75mg片剂SanofiClirSNC原研进口1-29硝酸甘油舌下片NitroglycerinSublingualTablets/Nitrostat0.5mg片剂（舌下片）PfizerINC原研进口1-30克拉霉素片ClarithromycinTablets/Klacid0.25g片剂ABBOTTLABORATORIESLIMITED原研进口1-31阿立哌唑片AripiprazoleTablets/Abilify5mg片剂OtsukaPharmaceuticalCo.Ltd美国橙皮书1-32阿立哌唑片AripiprazoleTablets/Abilify10mg片剂OtsukaPharmaceuticalCo.Ltd美国橙皮书1-33阿立哌唑口崩片AripiprazoleOrallyDisintegratingtablets/Abilify10mg片剂（口崩片）OtsukaPharmaceuticalEuropeLtd.欧盟上市（产地：法国）1-34盐酸环丙沙星片CiprofloxacinHydrochlorideTablets/Ciprobay0.25g(按C17H18FN3O3计)片剂BayerVitalGmbH原研进口1-35盐酸环丙沙星片CiprofloxacinHydrochlorideTablets/Ciprobay0.5g(按C17H18FN3O3计)片剂BayerVitalGmbH原研进口1-36盐酸特拉唑嗪片TerazosinHydrochlorideTablets/Hytrin2mg(按C19H25N5O4计)片剂AbbottLaboratories(Singapore)PrivateLimited原研进口1-37吲达帕胺片IndapamideTablets/Natrilix2.5mg片剂LesLaboratoiresServier原研进口1-38吲达帕胺缓释片IndapamideSustained-releaseTablets/Natrilix1.5mg片剂（缓释片）LesLaboratoiresServier原研进口1-39左甲状腺素钠片LevothyroxineSodiumTablets/Euthyrox50μg片剂MerckSeronoGmbH原研进口1-40佐匹克隆片ZopicloneTablets/Imovane7.5mg片剂Sanofi-AventisFrance原研进口1-41佐匹克隆片ZopicloneTablets/Imovane3.75mg片剂Sanofi-AventisFrance欧盟上市（产地：法国；上市国家：法国）1-42硫唑嘌呤片AzathioprineTablets/Imuran50mg片剂AspenPharmacareAustraliaPtyLtd原研进口1-43奈韦拉平片NevirapineTablets/Viramune0.2g片剂BoehringerIngelheimPharmaceuticalsINC美国橙皮书1-44米索前列醇片MisoprostolTablets/Cytotec0.2mg片剂PharmaciaLimited原研进口1-45马来酸依那普利片EnalaprilMaleateTablets/Renitec5mg片剂MerckSharp&Dohme（Australia）Pty.Ltd.原研进口1-46马来酸依那普利片EnalaprilMaleateTablets/Renitec10mg片剂MerckSharp&Dohme（Australia）Pty.Ltd.原研进口1-47拉米夫定片LamivudineTablets/Epivir(3TC)0.15g片剂ViiVHealthcareUKLimited原研进口1-48拉米夫定片LamivudineTablets/Epivir(3TC)0.3g片剂ViiVHealthcareUKLimited原研进口1-49拉米夫定片LamivudineTablets/Epivir-HBV0.1g片剂GlaxoSmithKline美国橙皮书1-50氯雷他定片LoratadineTablets/Clarityne10mg片剂BayerSA-NV原研进口1-51氯雷他定胶囊LoratadineCapsules/Claritin10mg胶囊剂BayerHealthcareLLC美国橙皮书
(生物谷Bioon.com）
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