化学仿制药参比制剂目录(第三十二批)

1、 PAGE PAGE 12化学仿制药参比制剂目录（第三十二批）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2BictegravirSodium,比克替拉韦钠（以比克替Emtricitabineand拉韦计）50mg，恩曲他滨比克恩丙诺片Tenofovir200mgGileadSciencesIreland国内上市的原研原研进口AlafenamideUC药品Fumarate Tablets/ Biktarvy（必妥维Abiraterone Acetate Tablets/ ZytigaLercanidipine福韦（以丙酚替诺福韦计）25mg250mgJanssenBiotechInc未

2、进口原研药品美国橙皮书盐酸乐卡地平片Hydrochloride Tablets/Zanidip（再宁 平 ） Famotidine，Calcium Carbonate and20mgRecordatiS.P.A.Johnson AndJohnson国内上市的原研药品原研进口法莫替丁钙镁咀Magnesium法莫替丁10mg，碳酸钙Consumer Inc未进口原研药品美国橙皮书嚼片HydroxideChewable800mg，氢氧化镁165mgConsumerHealthcareTablets/Pepcid CompleteDivision序号药品通用名英文名称/商品名规格持证商Compound

3、 Sodium Valproate and备注1备注2丙戊酸钠缓释片Valproic Acid Sustained Release Tablets/ Depakine Chrono500mg （以丙戊酸钠计） Sanofi Aventis France未进口原研药品欧盟上市地高辛注射液Digoxin2mL:0.5mgAspen PharmaTrading未进口原研药品欧盟上市Injection/LanoxinLimited依非韦伦片Efavirenz600mgBristol-Myers 未进口原研药品美国橙皮书Tablets/SustivaPharmaCompay奥氮平片Olanzapine2

4、.5mgEli LillyNederland未进口原研药品欧盟上市Tablets/Zyprexa黄体酮注射液Progesterone1.112ml:25mgIBSA Farmaceutici未进口原研药品欧盟上市Injection/LubionItaliaSrl阿普司特片阿普司特片来迪派韦索磷布Apremilast Apremilast Ledipasvirand10mg 30mg90mg 来迪派韦,400mg 索Celgene Europe Celgene Europe Gilead Sciences国内上市的原研欧盟上市欧盟上市韦片Sofosbuvir Tablets/Harvoni（夏帆

5、宁）磷布韦InternationalLtd.药品原研进口利福平胶囊Rifampicin Capsules/RIFADIN150mgSanofi未进口原研药品欧盟上市序号药品通用名英文名称/商品名规格Betamethasone4mg/ml持证商备注1MSD Belgium BVBA/SPRL/MSD备注 2倍他米松磷酸钠phosphate sodium（以倍他米松计）Sharp &Dohme未进口原研药品欧盟上市注射液（1ml）GMBH/Merck Sharp &Dohme BV/MSD Polska Sp. z o.o.CalcipotriolScalp国内上市的原研Solution/Daiv

6、onex（达力士）0.005%（30ml:1.50mg）LEOPharmaA/S药品原研进口盐酸阿罗洛尔片Arotinolol5mg大日本住友製薬株式未进口原研药品日本上市HydrochlorideTablets会社Beclometasone丙酸倍氯米松吸Dipropionate200 揿，每揿含丙酸TevaUKLimited未进口原研药品欧盟上市入气雾剂InhalationAerosol50g/QvarBeclometasone丙酸倍氯米松吸Dipropionate200 揿，每揿含丙酸TevaUKLimited未进口原研药品日本上市入气雾剂InhalationAerosol/QvarBec

7、lometasoneChiesi Limited/丙酸倍氯米松吸入气雾剂Dipropionate Inhalation /ClenilModuliteAripiprazole Orally200 倍氯米松 250gChiesi Farmaceutici S.p.A.OtsukaPharmaceutical未进口原研药品欧盟上市阿立哌唑口崩片Disintegratingtablets/Abilify10mgCo. Ltd未进口原研药品美国橙皮书序号药品通用名称复方磺胺甲噁唑英文名称/商品名规格持证商AripiprazoleOrallyOtsukaPharmaceutical Disintegra

8、ting15mgCo. Ltd tablets/AbilifyCompound磺胺甲噁唑800g，甲氧苄SunPharmaceutical备注 1未进口原研药品备注 2美国橙皮书Sulfamethoxazole片Tablets/Bactrim啶 160mgIndustries Inc未进口原研药品美国橙皮书苯磺顺阿曲库铵注射液伏立康唑片 射液CisatracuriumAspen PharmaTrading Besylate2.5ml:5mgLimitedInjection/Nimbex50mgPF Prism CV Tablets/VfendFasudilAsahi KaseiPharmaHy

9、drochloride2ml:30mgCorporatioInjection/ErilManganeseChloride250mL/36mg 氯未进口原研药品未进口原研药品未进口原研药品欧盟上市 日本上市氯化锰口服溶液OralSolution/化锰四水合物（Meiji Seika 未进口原研药品日本上市Bothdel OralSolution10株式会社利多卡因凝胶贴膏LidocaineTeikoku PharmaUsaCataplasms/5%IncLidoderm未进口原研药品美国橙皮书Loxoprofensodium1%hydrate gel未进口原研药品日本上市Delafloxacin

10、 for300mgMelinta Subsidiary未进口原研药品美国橙皮书盐酸氯米帕明注射液Injection/BaxdelaCorpClomipramineAlfasigmaFrance/Hydrochloride25mg/2mlAlfasigmaS.p.A.Injection / Anafranil未进口原研药品欧盟上市药品通用名称盐酸托莫西汀口服溶液英文名称/商品名Atomoxetine Hydrochloride Oral Solution /Strattera规格100ml0.4g持证商日本株式会社备注 1未进口原研药品备注 2日本上市艾曲泊帕乙醇胺 Eltrombopag Ol

11、amine片Tablets/PromactaFerrous Sulfate25mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书Extended-release Tablets/Fero- Gradumet105mg（以铁元素计）EPD 合同会 未进口原研药品社日本上市克霉唑乳膏Clotrimazole Cream/Canesten1%BayerInc未进口原研药品加拿大上市曲安奈德乳膏Triamcinolone Acetonide CreamInjection/VfendSevelamerCarbonate Tablets /RenvelaI

12、midapril0.1%200mg 800mgFougera Pharmaceuticals IncPF Prism CV Sanofi Genzyme田辺三菱製薬株式会国际公认的同种药品未进口原研药品未进口原研药品美国橙皮书美国橙皮书美国橙皮书盐酸咪达普利片HydrochlorideTablets/ TanatrilAmoxicillin Sodium2.5mg社未进口原研药品日本上市注射用阿莫西林andClavulanate550mg（500/50）GlaxoSmithKlineAG未进口原研药品瑞士上市钠克拉维酸钾Potassium forinjection（10:1）药品通用名称钠克拉

13、维酸钾钠克拉维酸钾硝呋太尔片英文名称/商品名Amoxicillin Sodium and Clavulanate Potassium for injection（10:1） Amoxicillin Sodium and Clavulanate Potassium for injection（10:1） Nifuratel Tablets/ Macmiror规格1.1g（1000/100）2.2g（2000/200）200mg持证商GlaxoSmithKlineAGGlaxoSmithKlineAGPolichem S.R.L./ Polichem SA备注 1未进口原研药品备注 2瑞士上市马尿

14、酸乌洛托品Mesalazine Enemas/ Rowasa Methenamine4g/60mlMylan SpecialtyLP未进口原研药品美国橙皮书HippurateTablets/1g片HippexMylan ProductsLtd未进口原研药品欧盟上市注射用磷酸特地 Tedizolid Phosphate唑胺ForInjection/Sivextro200mgCubist PharmaceuticalsLLC/Merck&未进口原研药品CO.,INC美国橙皮书Fluorouracil Injection/Fluorouracil1g/20mlFreseniusKabiUSA国际公认

15、的同种LLC药品美国橙皮书Fluorouracil Injection/Fluorouracil Tigecycline forInjection/Tygacil1g/20ml 50mgAccord HealthcareINC PF PrismCV国际公认的同种药品未进口原研药品美国橙皮书美国橙皮书他克莫司胶囊TacrolimusCapsules/Prograf5mgAstellas PharmaUS Inc未进口原研药品美国橙皮书序号药品通用名英文名称/商品名规格持证商备注1备注 2Tacrolimus Capsules/1mgAstellas PharmaUS未进口原研药品美国橙皮书Pro

16、grafIncTacrolimus Capsules/0.5mgAstellas PharmaUS未进口原研药品美国橙皮书咀嚼片PrografIncSucroferricViforFreseniusoxyhydroxide500mgMedicalCareRenal未进口原研药品ChewableTablet/PharmaFranceVelphoro美国橙皮书溴夫定片Brivudine Tablets/125mgBerlin-ChemieAG国内上市的原研原研进口Zostex（左代）药品Azelastine盐酸氮卓斯汀丙hydrochloride120 MEDA Pharma GmbHSpray/

17、 Dymista32-55Spray/ Dymista32-55盐酸格拉司琼片Granisetron Hydrochloride1mgTablets/Kytril32-56硝酸甘油片Nitroglycerin Sublingual Tablets/0.6mgNitrostatFluticasonePropionateNasal137g 50g& Co. KGAtnahs Pharma Netherlands PfizerPharmaceuticals LTD未进口原研药品欧盟上市欧盟上市 32-57拉莫三嗪片Lamotrigine100mgThe Wellcome国内上市的原研原研进口Tabl

18、ets/LAMICTALFoundationLtd药品32-58Mirabegron Sustained-release 25mgAstellas PharmaGlobal DevelopmentInc未进口原研药品美国橙皮书32-5932-6032-61药品通用名称射液射液剂英文名称/商品名Irinotecan Hydrochloride Injection/Camptosar Irinotecan Hydrochloride Injection/Camptosar Cefdinirfor Suspension规格5ml:0.1g2ml:40mg250mg/5ml持证商PfizerIncPf

19、izerIncSandoz Inc备注 1未进口原研药品未进口原研药品国际公认的同种药品备注 2美国橙皮书32-6232-63液用粉末素注射液盐酸去氧肾上腺Mitomycin for PhenylephrineHydrochlorideInjection/ Phenylephrine0.2mg5ml:0.5mgMobiusTherapeutics未进口原研药品LLCEtonPharmaceuticals未进口原研药品West Ward美国橙皮书美国橙皮书32-64素注射液Hydrochloride InjectionTedizolid Phosphate1mL:10mgPharmaceutic

20、alCorpMSD PHARMA未进口原研药品美国橙皮书32-65磷酸特地唑胺片Tablets/Sivextro200mg（SINGAPORE）PTE. LTD.未进口原研药品新加坡上市32-66注射用二丁酰环 Bucladesine Sodium300mg 未进口原研药品日本上市磷腺苷钠Injection/Ciclosporin Eye株式会社32-67环孢素眼用乳剂DropsEmulsion/Verkazia0.10%SantenOy未进口原研药品欧盟上市32-68药品通用名称英文名称/商品名规格持证商备注1马来酸阿伐曲泊Avatrombopag20mgAkaRx,Inc未进口原研药品备注

21、 2美国橙皮书帕片Tablets/DOPTELET32-69马来酸米达唑仑 Midazolam Maleate7.5mg（以咪达唑仑计）CPS Cito Pharma未进口原研药品瑞士上市片Tablets/DormicumServices32-70醋酸去氨加压素 DesmopressinAcetate1ml:4g（按去氨加压素FerringAG未进口原研药品瑞士上市注射液Injection/Minirin计 3.56g）32-71醋酸去氨加压素 DesmopressinAcetate1ml:15g（按去氨加压素FerringAG未进口原研药品瑞士上市注射液Injection/OctostimD

22、rotaverine计 13.4g）32-72盐酸屈他维林片Hydrochloride40mgSanofi-Aventis未进口原研药品Tablets/ NO-SPA欧盟上市32-73米库氯铵注射液Mivacurium Chloride10ml:20mgAspen PharmaTrading未进口原研药品英国上市Injection/MivacronLimited32-7432-75射液射液RopivacaineHydrochlorideInjection/NaropinRopivacaineHydrochlorideInjection/NaropinAspen PharmaTrading Li

23、mitedAspen PharmaTrading Limited未进口原研药品未进口原研药品欧盟上市欧盟上市32-76马来酸阿法替尼 Afatinib Dimaleate50mgBoehringerIngelheim未进口原研药品欧盟上市片Tablets/GiotrifInternationalGmbH32-77萘普生钠片Naproxen Sodium275mgAtnahs Pharma未进口原研药品法国上市Tablets/ApranaxNetherlands32-7832-79替米沙坦片替米沙坦片Telmisartan Telmisartan 40mgBoehringerIngelheim未

24、进口原研药品80mgBoehringerIngelheim未进口原研药品美国橙皮书美国橙皮书序号序号药品通用名称英文名称/商品名规格持证商110-66卡维地洛片Carvedilol6.25mgRoche PharmaAG/Cheplapharm Arzneimittel Gmbh欧盟上市10-68卡维地洛片Carvedilol12.5mgRoche PharmaAG/Cheplapharm Arzneimittel Gmbh欧盟上市备注 2持证商发生变 Cheplapharm Arzneimittel Gmbh持证商发生变 Cheplapharm Arzneimittel Gmbh1.2015 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。备注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。未通过审议品种目录序号序号称英文名称/商品名规格持证商12遴选情况说明32-80氨氯地平阿托伐他汀钙AMLODIPINEBESYLATE; ET经一致性评价专家委员会专家审议，5mg/80mgPfizer Inc研药品美国橙皮书80mg 规格的阿托伐他汀对于中国人群的有效未通过。序号药品通用名称英文名称/商品名规格持