化学仿制药参比制剂目录（第三十一批）（征求意见稿）

附件1化学仿制药参比制剂目录（第三十一批）（征求意见稿）序号药品通用名称英文名称/商品名规格持证商备注1备注2盐酸舍曲林片SertralineHydrochlorideTablets/Zoloft100mg（按C17H17Cl2N计）PfizerPharmaceuticalsInc未进口原研药品美国橙皮书托伐普坦片TolvaptanTablets/Samsca15mg大塚製薬株式会社未进口原研药品日本上市托伐普坦片TolvaptanTablets/Samsca30mg大塚製薬株式会社未进口原研药品日本上市盐酸右哌甲酯片DexmethylphenidateHydrochlorideTablets/Focalin2.5mgNovartisPharmaceuticalsCorporation未进口原研药品美国橙皮书盐酸右哌甲酯片DexmethylphenidateHydrochlorideTablets/Focalin5mgNovartisPharmaceuticalsCorporation未进口原研药品美国橙皮书盐酸右哌甲酯片DexmethylphenidateHydrochlorideTablets/Focalin10mgNovartisPharmaceuticalsCorporation未进口原研药品美国橙皮书奥美沙坦酯氨氯地平氢氯噻嗪片OlmesartanMedoxomilandAmlodipineandHydrochlorothiazideTablets/Tribenzor奥美沙坦酯20mg与氨氯地平5mg与氢氯噻嗪12.5mgDaiichiSankyoInc未进口原研药品美国橙皮书奥美沙坦酯氨氯地平氢氯噻嗪片OlmesartanMedoxomilandAmlodipineandHydrochlorothiazideTablets/Tribenzor奥美沙坦酯40mg与氨氯地平5mg与氢氯噻嗪12.5mgDaiichiSankyoInc未进口原研药品美国橙皮书奥美沙坦酯氨氯地平氢氯噻嗪片OlmesartanMedoxomilandAmlodipineandHydrochlorothiazideTablets/Tribenzor奥美沙坦酯40mg与氨氯地平5mg与氢氯噻嗪25mgDaiichiSankyoInc未进口原研药品美国橙皮书奥美沙坦酯氨氯地平氢氯噻嗪片OlmesartanMedoxomilandAmlodipineandHydrochlorothiazideTablets/Tribenzor奥美沙坦酯40mg与氨氯地平10mg与氢氯噻嗪12.5mgDaiichiSankyoInc未进口原研药品美国橙皮书奥美沙坦酯氨氯地平氢氯噻嗪片OlmesartanMedoxomilandAmlodipineandHydrochlorothiazideTablets/Tribenzor奥美沙坦酯40mg与氨氯地平10mg与氢氯噻嗪25mgDaiichiSankyoInc未进口原研药品美国橙皮书注射用盐酸兰地洛尔LandiololHydrochlorideforInjection/Onoact50mg（以盐酸兰地洛尔计）小野薬品工業株式会社未进口原研药品日本上市泰比培南酯细粒TebipenemPivoxilFineGranulesforPediatric/Orapenem10%（0.5g/袋）MeijiSeikaファルマ株式会社未进口原研药品日本上市布洛芬混悬滴剂IbuprofenOralSuspensionDrops/Children'sMotrin;Infants'Motrin40mg:ml（15ml、30ml）JohnsonAndJohnsonConsumerIncMcneilConsumerHealthcareDivisioon未进口原研药品美国橙皮书去氧胆酸注射液DeoxycholicAcidInjection/Kybella;Belkyra10mg:ml（2ml）AllerganPharmaceuticalsInternationalLtd未进口原研药品欧盟上市盐酸文拉法辛缓释片VenlafaxineHydrochlorideExtendedReleaseTablets150mg（按C17H27NO2计）OsmoticaPharmaceuticalCorp未进口原研药品美国橙皮书倍他米松磷酸钠注射液BetamethasoneSodiumPhosphateInjection/Celestone;Celestan;Celeston4mg:mlMSD/ScheringPlough未进口原研药品欧盟上市硝苯地平缓释片NifedipineExtended-ReleaseTablets/AdalatCC30mgAlvogenGroupHoldingsLLC未进口原研药品美国橙皮书硝苯地平缓释片NifedipineExtended-ReleaseTablets/AdalatCC60mgAlvogenGroupHoldingsLLC未进口原研药品美国橙皮书唑来膦酸注射液ZoledronicAcidInjection/Reclast100ml:5mgNovartisPharmaceuticalsCorp未进口原研药品美国橙皮书利巴韦林冻干粉吸入剂RibavirinforInhalationSolution/Virazole6gValeantPharmaceuticalsInternational未进口原研药品美国橙皮书钆特酸葡胺注射液GadotericAcidMeglumineSaltInjection/Dotarem337mg:1ml（5ml、10ml、15ml、20ml、100ml/瓶）GuerbetLLC未进口原研药品美国橙皮书托吡酯缓释胶囊TopiramateExtended-releaseCapsules/QudexyXR25mgUpsherSmithLaboratoriesLLC未进口原研药品美国橙皮书托吡酯缓释胶囊TopiramateExtended-releaseCapsules/QudexyXR50mgUpsherSmithLaboratoriesLLC未进口原研药品美国橙皮书托吡酯缓释胶囊TopiramateExtended-releaseCapsules/QudexyXR100mgUpsherSmithLaboratoriesLLC未进口原研药品美国橙皮书托吡酯缓释胶囊TopiramateExtended-releaseCapsules/QudexyXR150mgUpsherSmithLaboratoriesLLC未进口原研药品美国橙皮书托吡酯缓释胶囊TopiramateExtended-releaseCapsules/QudexyXR200mgUpsherSmithLaboratoriesLLC未进口原研药品美国橙皮书马来酸奈拉替尼片NeratinibMaleateTablets/Nerlynx40mgPumaBiotechnologyInc.未进口原研药品美国橙皮书甲磺酸伊马替尼片ImatinibMesylate

Tablets/Glivec400mgNovartisEuropharm

Limited未进口原研药品欧盟上市二甲双胍恩格列净片MetforminHydrochlorideAndEmpagliflozinTablets/Synjardy每片含盐酸二甲双胍1000mg与恩格列净5mgBoehringerIngelheim未进口原研药品欧盟上市二甲双胍恩格列净片MetforminHydrochlorideAndEmpagliflozinTablets/Synjardy每片含盐酸二甲双胍1000mg与恩格列净12.5mgBoehringerIngelheim未进口原研药品欧盟上市注射用头孢他啶CeftazidimeforInjection/Modacin0.5gグラクソ・スミスクライン株式会社未进口原研药品日本上市注射用头孢他啶CeftazidimeforInjection/Fortum1gGlaxoOperationsUkLtd.未进口原研药品英国上市注射用头孢他啶CeftazidimeforInjection/Fortum0.25gGlaxosmithklineS.P.A/GlaxosmithklineLaboratory未进口原研药品欧盟上市注射用紫杉醇（白蛋白结合型）PaclitaxelForInjection（AlbuminBound）/Abraxane100mgAbraxisBioscienceLLC未进口原研药品美国橙皮书注射用紫杉醇（白蛋白结合型）Paclitaxelpowderforsuspensionforinfusion/Abraxane100mgCelgeneEuropeB.V未进口原研药品欧盟上市过氧苯甲酰凝胶BenzoylPeroxideGel/Benzihex班赛0.5%GaldermaInternational国内上市的原研药品原研进口熊去氧胆酸口服混悬液Ursodeoxycholicacidoralsuspension/Ursofalk250mg:5mlDr.FalkPharmaGmbh未进口原研药品欧盟上市碘解磷定注射液PralidoximeIodide/パム静注500mg20ml:0.5g大日本住友製薬株式会社未进口原研药品日本上市丙酸氟替卡松吸入粉雾剂Fluticasonepropionateinhalationpowder/FloventDiskus50mcgGlaxoSmithKline未进口原研药品美国橙皮书丙酸氟替卡松吸入粉雾剂Fluticasonepropionateinhalationpowder/FloventDiskus100mcgGlaxoSmithKline未进口原研药品美国橙皮书丙酸氟替卡松吸入粉雾剂Fluticasonepropionateinhalationpowder/FloventDiskus250mcgGlaxoSmithKline未进口原研药品美国橙皮书注射用柔红霉素阿糖胞苷脂质体（DaunorubicinandCytarabine）liposomeforInjection/VYXEOS44mg:100mg（柔红霉素44mg，阿糖胞苷100mg）CelatorPharmaceuticalsInc未进口原研药品美国橙皮书恩曲他滨/利匹韦林/丙酚替诺福韦片Emtricitabine,rilpivirine,andtenofoviralafenamideTablets/ODEFSEY200mg:25mg:25mgGileadSciences,Inc.未进口原研药品美国橙皮书茚达特罗格隆溴铵吸入粉雾剂用胶囊IndacaterolMaleateandGlycopyrroniumBromidePowderforInhalation,HardCapsules/Ultibro马来酸茚达特罗110µg，格隆溴铵50μgNovartisPharmaSchweizAg国内上市的原研药品原研进口贝美前列素涂剂Bimatoprostophthalmicsolution/LATISSE3ml:0.9mgAllerganINC未进口原研药品美国橙皮书注射用甲氨蝶呤MethotrexateforInjection/注射用メソトレキセート5mg5mgファイザー株式会社未进口原研药品日本上市注射用甲氨蝶呤MethotrexateForInjection/MethotrexateParenteral50mg50mgファイザー株式会社未进口原研药品日本上市甲氨蝶呤注射液MethotrexateInjection/Methotrexat"Lederle"Lösung1ml:25mgPfizerPharmaPfeGmbH未进口原研药品欧盟上市注射用氨苄西林钠舒巴坦钠AmpicillinSodiumandSulbactamSodiumforInjection/Unasyn2g/Vial;1g/Vial（以氨苄西林;舒巴坦计）PfizerInc未进口原研药品美国橙皮书双氯芬酸二乙胺乳胶剂DiclofenacDiethylamineEmulge1%（20g:0.2g、50g:0.5g、75g:0.75g）GSKConsumerHealthcareSchweizAg国内上市的原研药品原研进口间苯三酚口服冻干片PhloroglucinolOralLyophilisates80mgTevaSante未进口原研药品欧盟上市醋丙甲泼尼龙乳膏MethylprednisoloneAceponateCream/Advantan0.1%（15g）LeoPharmaA/S未进口原研药品欧盟上市奥泽沙星乳膏OzenoxacinCream/XEPI1%（10g、30g、45g）FerrerInternacionalSa未进口原研药品美国橙皮书氯雷他定片LoratadineTablets/Claritine10mgBayerSA-NV未进口原研药品欧盟上市盐酸羟考酮片OxycodoneHydrochlorideTablet/Roxicodone15mgSpecgxLLC未进口原研药品美国橙皮书盐酸羟考酮片OxycodoneHydrochlorideTablet/Roxicodone30mgSpecgxLLC未进口原研药品美国橙皮书盐酸胍法拉辛缓释片GuanfacineHydrochlorideExtendedReleaseTablets/INTUNIV1mgShireDevelopmentInc未进口原研药品美国橙皮书盐酸胍法拉辛缓释片GuanfacineHydrochlorideExtendedReleaseTablets/INTUNIV2mgShireDevelopmentInc未进口原研药品美国橙皮书盐酸胍法拉辛缓释片GuanfacineHydrochlorideExtendedReleaseTablets/INTUNIV3mgShireDevelopmentInc未进口原研药品美国橙皮书盐酸胍法拉辛缓释片GuanfacineHydrochlorideExtendedReleaseTablets/INTUNIV4mgShireDevelopmentInc未进口原研药品美国橙皮书坎地沙坦酯氢氯噻嗪片CandesartanCilexetilandHydrochlorothiazideTablets/--坎地沙坦酯4mg，氢氯噻嗪6.25mg武田テバ薬品株式会社未进口原研药品日本上市坎地沙坦酯氢氯噻嗪片CandesartanCilexetilandHydrochlorothiazideTablets/--坎地沙坦酯8mg，氢氯噻嗪6.25mg武田テバ薬品株式会社未进口原研药品日本上市盐酸非索非那定片FexofenadineHydrochlorideTablets/Telfast180mgSanofi未进口原研药品英国上市盐酸吡格列酮片PioglitazoneHydrochlorideTablets/ACTOS15mgTakedaPharmaceuticalsUsaInc未进口原研药品美国橙皮书盐酸吡格列酮片PioglitazoneHydrochlorideTablets/ACTOS30mgTakedaPharmaceuticalsUsaInc未进口原研药品美国橙皮书盐酸吡格列酮片PioglitazoneHydrochlorideTablets/ACTOS15mg武⽥テバ薬品株式会社未进口原研药品日本上市托格列净片TofogliflozinTablets/Deberza20mg兴和株式会社未进口原研药品日本上市多替拉韦钠片DolutegravirSodiumTablets

/特威凯50mg（以多替拉韦计）ViivHealthcareB.V.国内上市的原研药品原研进口利多卡因丁卡因乳膏LidocaineandTetracaineCream/Pliaglis每g含利多卡因70mg与丁卡因70mg（30g）TaroPharms未进口原研药品美国橙皮书利多卡因丁卡因乳膏LidocaineandTetracaineCream/Pliaglis每g含利多卡因70mg与丁卡因70mg（15g，30g）DifaCooperSpa/GaldermaLaboratoriumGmbh未进口原研药品欧盟上市美沙拉秦肠溶缓释颗粒Salofalk500mggastro-resistantprolonged-releasegranules0.5gDr.FalkPharmaGmbh未进口原研药品欧盟上市美沙拉秦肠溶缓释颗粒Salofalk1.5ggastro-resistantprolonged-releasegranules1.5gDr.FalkPharmaGmbh未进口原研药品欧盟上市硫酸艾莎康唑胶囊IsavuconazoniumSulfateCapsules/Cresemba100mg（按艾沙康唑计）BasileaPharmaceuticaDeutschlandGmbh未进口原研药品欧盟上市注射用硫酸艾莎康唑IsavuconazoniumSulfateforInjection/Cresemba200mg（按艾沙康唑计）BasileaPharmaceuticaDeutschlandGmbh未进口原研药品欧盟上市ω-3鱼油中长链脂肪乳/氨基酸（16）/葡萄糖（36%）注射液ω-3FishOilMediumandLongChainFatEmulsion/AminoAcids（16）/Glucose（36%）Injection625mlB.BraunMelsungenAg未进口原研药品欧盟上市芦曲泊帕片LusutrombopagTablets3mg日本塩野義製薬株式会社未进口原研药品日本上市甲磺酸卡莫司他片CamostatMesilateTablets/FOIPAN100mg小野药品工业株式会社未进口原研药品日本上市非诺贝特胆碱缓释胶囊FenofibricAcidDelayedReleaseCapsules/TriliPix45mgAbbvieInc.未进口原研药品美国橙皮书非诺贝特胆碱缓释胶囊FenofibricAcidDelayedReleaseCapsules/TriliPix135mgAbbvieInc.未进口原研药品美国橙皮书联苯苄唑溶液BifonazoleSolution/Mycospor1%（10ml）バイエル薬品株式会社未进口原研药品日本上市更昔洛韦眼用凝胶GanciclovirOphthalmicGel/Zirgan0.15%（5g/支）Bausch＆LombIncorporated未进口原研药品美国橙皮书他克莫司滴眼液TacrolimusEyeDrops0.1%（5ml:5mg，以他克莫司计）SenjuPharmaceuticalCo.,Ltd.国内上市的原研药品原研进口曲伏噻吗滴眼液TravoprostandTimololMaleateEyeDrops/Duotrav（苏力坦）2.5ml:曲伏前列素0.1mg和马来酸噻吗洛尔12.5mgNovartisEuropharmLimited国内上市的原研药品原研进口布林佐胺噻吗洛尔滴眼液BrinzolamideandTimololMaleateEyeDrops/Azarga5ml:布林佐胺50mg和马来酸噻吗洛尔25mg（以噻吗洛尔计）NovartisEuropharmLimited国内上市原研药品原研进口布林佐胺滴眼液BrinzolamideEyeDrops/Azopt5ml:50mg（1%）NovartisEuropharmLimited国内上市原研药品原研进口盐酸伐昔洛韦颗粒ValaciclovirHydrochlorideGranules/Valtrex500mgグラクソ・スミスクライン株式会社未进口原研药品日本上市富马酸氯马斯汀注射液ClemastineFumarateInjection2ml:2mg（按氯马斯汀计）GlaxosmithklineConsumerHealthcareGmbh&Co.KG未进口原研药品欧盟上市头孢呋辛酯干混悬剂CefuroximeAxetilforSuspension/Zinnat按头孢呋辛（C16H16N4O8S）计0.125gGlaxoWeLLComeUkLimited未进口原研药品英国上市美沙拉秦缓释胶囊Mesalamineextendedreleasecapsules/Apriso375mgValeantPharmaceuticalsInternational未进口原研药品美国橙皮书盐酸环苯扎林缓释胶囊Cyclobenzaprinehydrochlorideextended-releasecapsules/AMRIX15mgTevaPharmaceuticalsInternationalGmbh未进口原研药品美国橙皮书盐酸环苯扎林缓释胶囊Cyclobenzaprinehydrochlorideextended-releasecapsules/AMRIX30mgTevaPharmaceuticalsInternationalGmbh未进口原研药品美国橙皮书扎那米韦吸入粉雾剂ZanamivirPowderforInhalation/RELENZA5mgGlaxosmithklineAustraliaPtyLtd未进口原研药品澳大利亚上市依非韦伦拉米夫定替诺福韦片Efavirenz,LamivudineAndTenofovirDisoproxilFumarateTablets/SYMFILO每片含0.4g依非韦伦，0.3g拉米夫定和0.3g富马酸替诺福韦二吡呋酯MylanPharmaceuticalsInc未进口原研药品美国橙皮书环酯红霉素干混悬剂ErythromycinCyclocarbonateforSuspension/Davercin150mg:5mlTarchominPharmaceuticalWorks“Polfa”S.A.未进口原研药品欧盟上市沙格列汀片SaxagliptinTablets/Onglyza2.5mgAstrazenecaAb未进口原研药品美国橙皮书阿莫西林细粒剂AmoxicillinFineGranules/Sawacillin10%（按C16H19N3O5S计）Ltlファーマ株式会社未进口原研药品日本上市依巴斯汀口服溶液EbastineOralSolution/Ebastel1mg:mlAlmirallS.A.未进口原研药品欧盟上市醋酸艾替班特注射液IcatibantAcetateInjection/Firazyr30mg/3ml（以艾替班特计）ShireOrphanTherapiesLLC未进口原研药品美国橙皮书达比加群酯胶囊DabigatranEtexilateCapsules/Pradaxa110mg（以达比加群酯计）BoehringerIngelheimPharmaceuticalsInc未进口原研药品美国橙皮书达比加群酯胶囊DabigatranEtexilateCapsules/Pradaxa150mg（以达比加群酯计）BoehringerIngelheimPharmaceuticalsInc未进口原研药品美国橙皮书他克莫司缓释胶囊TacrolimusExtended-releaseCapsules/ASTAGRAFXL0.5mgAstellasPharmaUSInc未进口原研药品美国橙皮书他克莫司缓释胶囊TacrolimusExtended-releaseCapsules/ASTAGRAFXL1mgAstellasPharmaUSInc未进口原研药品美国橙皮书他克莫司缓释胶囊TacrolimusExtended-releaseCapsules/ASTAGRAFXL5mgAstellasPharmaUSInc未进口原研药品美国橙皮书氨酚咖妥胶囊Butalbital,Acetaminophen,andCaffeineCapsules乙酰氨基酚；布他比妥；咖啡因，300mg;50mg;40mgNexgenPharma,Inc国际公认的同种药品美国橙皮书注射用维库溴铵VecuroniumBromideForInjection10mgSunPharmaceuticalIndustries.Ltd.国际公认的同种药品美国橙皮书盐酸环喷托酯滴眼液CyclopentolateHydrochlorideEyeDrops/Cyclogyl（赛飞杰）1ml:10mgAlconNV国际公认的同种药品国际公认进口注射用氨苄西林钠AmpicillinSodiumForInjection0.5gSandozInc国际公认的同种药品美国橙皮书司来帕格片SelexipagTablets/Uptravi（优拓比）0.2mgActelionPharmaceuticalsLtd国内上市的原研药品原研进口司来帕格片SelexipagTablets/Uptravi0.4mgActelionPharmaceuticalsLtd未进口原研药品美国橙皮书盐酸美金刚片MemantineHydrochlorideTablets/易倍申10mgH.LundbeckA/S国内上市的原研药品原研进口托吡司特片TopiroxostatTablets/Topiloric60mg株式会社富士薬品未进口原研药品日本上市5-15琥珀酸亚铁片FerrousSuccinateTablets/INOFER0.1gLaboratoireDeL’Inofer/LaboratoireX.O欧盟上市持证商发生变更，增加持证商LaboratoireX.O备注1.未在国内上市品种，需参照原总局2015年第230号公告等的相关要求开展研究，通用名、剂型等经药典委核准后为准。2.参比制剂目录公示后，未正式发布的品种将进行专题研究，根据研究结果另行发布。3.欧盟上市的参比制剂包括其在英国上市的同一药品。

附件2未通过审议品种目录序号药品通用名称英文名称/商品名规格持证商备注1备注2遴选情况说明丙戊酸口服溶液ValproicAcidOralSolution250mg:5mlPharmaceuticalAssociates,Inc.国际公认的同种药品美国橙皮书经一致性评价专家委员会审议，丙戊酸口服溶液的活性成份为丙戊酸钠。已发布赛诺菲原研药丙戊酸钠口服溶液,规格200mg/ml和200mg/5ml作为参比制剂，本品的规格、用法用量与已发布参比制剂不同。审议未通过。硫酸阿托品注射液AtropineSulfateInjection/AtropineSulfateLifeshieldAbbojectSyringe5ml:0.5mgHospiraInc未进口原研药品美国橙皮书经一致性评价专家委员会审议，已发布田辺三菱在日本上市的1ml:0.5mg规格为参比制剂，本品规格、适应症、用法用量与已发布参比制剂及国内上市品有差异。未提供完整和充分的安全性、有效性数据。审议未通过。复方聚桂醇软膏Cose-Anal5.0%/10.0%（20g）WillPharmaSA（BE）未进口原研产品欧盟上市经一致性评价专家委员会审议，未提供完整和充分的安全性、有效性数据。审议未通过。复方聚桂醇乳膏OptidermCream3.0%/5.0%（50g、100g、200g和500g）AlmirallHermalGmbH未进口原研产品欧盟上市经一致性评价专家委员会审议，未提供完整和充分的安全性、有效性数据。审议未通过。赖诺普利氨氯地平片LisinoprilandAmlodipineTablets/Lisonorm赖诺普利10mg；氨氯地平5mgGedeonRichterPlc.未进口原研药品欧盟上市经一致性评价专家委员会审议，未提供完整和充分的安全性、有效性数据。审议未通过。福司氟康唑注射液Fosfluconazol

/Prodif1.25ml:0.1g辉瑞株式会社未进口原研药品日本上市经一致性评价专家委员会审议，原研曾申请进口，因与已上市的氟康唑注射剂比，本品质量控制方面存在问题，未被批准。审议未通过。福司氟康唑注射液Fosfluconazol

/Prodif2.5ml:0.2g辉瑞株式会社未进口原研药品日本上市福司氟康唑注射液Fosfluconazol

/Prodif5ml:0.4g辉瑞株式会社未进口原研药品日本上市复方α-酮酸片Compoundα-KetoacidTablets/Ketosteil0.63gFreseniusKabiDeutschlandGmbH未进口原研药品欧盟上市经一致性评价专家委员会审议，未提供完整和充分的安全性、有效性数据。审议未通过。曲美布汀干混悬剂Trimebutineforsuspension/Debridat、DebridatEnfant4g:74.4mg；152.5g:1.2g；76.25g:0.6gPfizerHoldingFrance未进口原研药品欧盟上市经一致性评价专家委员会审议，未提供完整和充分的安全性、有效性数据。审议未通过。烟酸注射液NicotinicAcidInjection/Nyclin1