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Contact Us 第三十一批

【第三十一批】仿制药参比制剂目录


【第三十一批】仿制药参比制剂目录


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
31-1过氧苯甲酰凝胶Benzoyl Peroxide Ge lBenzihex（班赛）0.05Galderma International国内上市的原研药品原研进口
31-2茚达特罗格隆溴铵吸入粉雾剂用胶囊Indacaterol Maleate and Glycopyrronium Bromide Powder For Inhalation, Hard CapsulesUltibro马来酸茚达特罗110µg，格隆溴铵50μgNovartis Pharma Schweiz Ag国内上市的原研药品原研进口
31-3多替拉韦钠片Dolutegravir Sodium Tablets特威凯50mg（以多替拉韦计）Viiv Healthcare B.V.国内上市的原研药品原研进口
31-4他克莫司滴眼液Tacrolimus Eye Drops
0.1%（5ml:5mg，以他克莫司计）Senju Pharmaceutical Co.,Ltd.国内上市的原研药品原研进口
31-5曲伏噻吗滴眼液Travoprost and Timolol Maleate Eye DropsDuotrav（苏力坦）2.5ml:曲伏前列素0.1mg和马来酸噻吗洛尔12.5mg（以噻吗洛尔计）Novartis Europharm Limited国内上市的原研药品原研进口
31-6布林佐胺噻吗洛尔滴眼液Brinzolamide and Timolol Maleate Eye DropsAzarga5ml:布林佐胺50mg和马来酸噻吗洛尔25mg（以噻吗洛尔计）Novartis Europharm Limited国内上市原研药品原研进口
31-7布林佐胺滴眼液Brinzolamide Eye DropsAzopt5ml:50mg（1%）Novartis Europharm Limited国内上市原研药品原研进口
31-8盐酸右哌甲酯片Dexmethylphenidate Hydrochloride Tablets Focalin2.5mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
31-9盐酸右哌甲酯片Dexmethylphenidate Hydrochloride Tablets Focalin5mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
31-10盐酸右哌甲酯片Dexmethylphenidate Hydrochloride Tablets Focalin10mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
31-11奥美沙坦酯氨氯地平氢氯噻嗪片Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsTribenzor奥美沙坦酯20mg与氨氯地平5mg与氢氯噻嗪12.5mgDaiichi Sankyo Inc未进口原研药品美国橙皮书
31-12奥美沙坦酯氨氯地平氢氯噻嗪片Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsTribenzor奥美沙坦酯40mg与氨氯地平5mg与氢氯噻嗪12.5mgDaiichi Sankyo Inc未进口原研药品美国橙皮书
31-13奥美沙坦酯氨氯地平氢氯噻嗪片Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsTribenzor奥美沙坦酯40mg与氨氯地平5mg与氢氯噻嗪25mgDaiichi Sankyo Inc未进口原研药品美国橙皮书
31-14奥美沙坦酯氨氯地平氢氯噻嗪片Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsTribenzor奥美沙坦酯40mg与氨氯地平10mg与氢氯噻嗪12.5mgDaiichi Sankyo Inc未进口原研药品美国橙皮书
31-15奥美沙坦酯氨氯地平氢氯噻嗪片Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsTribenzor奥美沙坦酯40mg与氨氯地平10mg与氢氯噻嗪25mgDaiichi Sankyo Inc未进口原研药品美国橙皮书
31-16布洛芬混悬滴剂Ibuprofen Oral Suspension DropsChildren's Motrin; Infants' Motrin40mg:ml（15ml、30ml）Johnson And Johnson Consumer Inc Mcneil Consumer Healthcare Divisioon未进口原研药品美国橙皮书
31-17利巴韦林冻干粉吸入剂Ribavirin For Inhalation SolutionVirazole6gValeant Pharmaceuticals International未进口原研药品美国橙皮书
31-18马来酸奈拉替尼片Neratinib Maleate TabletsNerlynx40mgPuma Biotechnology Inc.未进口原研药品美国橙皮书
31-19丙酸氟替卡松吸入粉雾剂Fluticasone propionate inhalation powderFlovent Diskus50mcgGlaxo Smith Kline未进口原研药品美国橙皮书
31-20丙酸氟替卡松吸入粉雾剂Fluticasone propionate inhalation powderFlovent Diskus100mcgGlaxo Smith Kline未进口原研药品美国橙皮书
31-21丙酸氟替卡松吸入粉雾剂Fluticasone propionate inhalation powderFlovent Diskus250mcgGlaxo Smith Kline未进口原研药品美国橙皮书
31-22注射用柔红霉素阿糖胞苷脂质体Daunorubicin and Cytarabine liposome For InjectionVyxeos44mg:100mg（柔红霉素44mg，阿糖胞苷100mg）Celator Pharmaceuticals Inc未进口原研药品美国橙皮书
31-23恩曲他滨利匹韦林丙酚替诺福韦片Emtricitabine, Rilpivirine, and Tenofovir Alafenamide TabletsOdefsey200mg:25mg:25mgGilead Sciences, Inc.未进口原研药品美国橙皮书
31-24贝美前列素涂剂Bimatoprost ophthalmic solutionLatisse3ml:0.9mgAllergan INC未进口原研药品美国橙皮书
31-25奥泽沙星乳膏Ozenoxacin CreamXepi1%（10g、30g、45g）Ferrer Internacional SA未进口原研药品美国橙皮书
31-26盐酸羟考酮片Oxycodone Hydrochloride TabletRoxicodone15mgSpecgx LLC未进口原研药品美国橙皮书
31-27盐酸羟考酮片Oxycodone Hydrochloride TabletRoxicodone30mgSpecgx LLC未进口原研药品美国橙皮书
31-28盐酸胍法辛缓释片Guanfacine Hydrochloride Extended Release TabletsIntuniv1mgShire Development Inc未进口原研药品美国橙皮书
31-29盐酸胍法辛缓释片Guanfacine Hydrochloride Extended Release Tablets Intuniv2mgShire Development Inc未进口原研药品美国橙皮书
31-30盐酸胍法辛缓释片Guanfacine Hydrochloride Extended Release Tablets Intuniv3mgShire Development Inc未进口原研药品美国橙皮书
31-31盐酸胍法辛缓释片Guanfacine Hydrochloride Extended Release Tablets Intuniv4mgShire Development Inc未进口原研药品美国橙皮书
31-32利多卡因丁卡因乳膏Lidocaine and Tetracaine CreamPliaglis每g含利多卡因70mg与丁卡因70mg（30g）Taro Pharms未进口原研药品美国橙皮书
31-33非诺贝特胆碱缓释胶囊Fenofibric Acid Delayed Release CapsulesTriliPix45mgAbbvie Inc.未进口原研药品美国橙皮书
31-34非诺贝特胆碱缓释胶囊Fenofibric Acid Delayed Release CapsulesTriliPix135mgAbbvie Inc.未进口原研药品美国橙皮书
31-35更昔洛韦眼用凝胶Ganciclovir Ophthalmic GelZirgan0.15%（5g/支）Bausch＆Lomb Incorporated未进口原研药品美国橙皮书
31-36美沙拉秦缓释胶囊Mesalamine extended release capsulesApriso375mgValeant Pharmaceuticals International未进口原研药品美国橙皮书
31-37盐酸环苯扎林缓释胶囊Cyclobenzaprine hydrochloride extended-release capsulesAmrix15mgTeva Pharmaceuticals International GmbH未进口原研药品美国橙皮书
31-38盐酸环苯扎林缓释胶囊Cyclobenzaprine hydrochloride extended-release capsulesAmrix30mgTeva Pharmaceuticals International GmbH未进口原研药品美国橙皮书
31-39依非韦伦拉米夫定替诺福韦片Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate TabletsSymfilo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Mylan Pharmaceuticals Inc未进口原研药品美国橙皮书
31-40他克莫司缓释胶囊Tacrolimus Extended-release Capsules Astagraf XL0.5mgAstellas Pharma US Inc未进口原研药品美国橙皮书
31-41他克莫司缓释胶囊Tacrolimus Extended-release Capsules  Astagraf XL1mgAstellas Pharma US Inc未进口原研药品美国橙皮书
31-42他克莫司缓释胶囊Tacrolimus Extended-release Capsules  Astagraf XL5mgAstellas Pharma US Inc未进口原研药品美国橙皮书
31-43氨酚咖妥胶囊Butalbital, Acetaminophen, and Caffeine Capsules
乙酰氨基酚；布他比妥；咖啡因，300mg;50mg;40mgNexgen Pharma, Inc国际公认的同种药品美国橙皮书
31-44注射用维库溴铵Vecuronium Bromide For Injection
10mgSun Pharmaceutical Industries. Ltd.国际公认的同种药品美国橙皮书
31-45去氧胆酸注射液Deoxycholic Acid InjectionKybella; Belkyra10mg:ml（2ml）Allergan Pharmaceuticals International Ltd未进口原研药品欧盟上市
31-46倍他米松磷酸钠注射液Betamethasone Sodium Phosphate InjectionCelestone; Celestan; Celeston4mg/ml（以倍他米松计）MSD/Schering Plough未进口原研药品欧盟上市
31-47熊去氧胆酸口服混悬液Ursodeoxycholic acid oral suspensionUrsofalk250mg:5mlDr. Falk Pharma GmbH未进口原研药品欧盟上市
31-48间苯三酚口服冻干片Phloroglucinol Oral Lyophilisates
80mgTeva Sante未进口原研药品欧盟上市
31-49醋丙甲泼尼龙乳膏Methylprednisolone Aceponate CreamAdvantan0.1%（15g）Leo Pharma A/S未进口原研药品欧盟上市
31-50利多卡因丁卡因乳膏Lidocaine and Tetracaine CreamPliaglis每g含利多卡因70mg与丁卡因70mg（15g，30g）Difa Cooper SPA/Galderma Laboratorium GmbH未进口原研药品欧盟上市
31-51美沙拉秦肠溶缓释颗粒Mesalazine gastro-resistant prolonged-release granules Salofalk0.5gDr. Falk Pharma GmbH未进口原研药品欧盟上市
31-52美沙拉秦肠溶缓释颗粒Mesalazine gastro-resistant prolonged-release granules Salofalk1.5gDr. Falk Pharma GmbH未进口原研药品欧盟上市
31-53硫酸艾莎康唑胶囊Isavuconazonium Sulfate CapsulesCresemba100mg（以艾沙康唑计）Basilea Pharmaceutica Deutschland GmbH未进口原研药品欧盟上市
31-54注射用硫酸艾莎康唑Isavuconazonium Sulfate For InjectionCresemba200mg（以艾沙康唑计）Basilea Pharmaceutica Deutschland GmbH未进口原研药品欧盟上市
31-55富马酸氯马斯汀注射液Clemastine Fumarate Injection
2ml:2mg（以氯马斯汀计）Glaxosmithkline Consumer Healthcare GmbH & Co. KG未进口原研药品欧盟上市
31-56依巴斯汀口服溶液Ebastine Oral SolutionEbastel1mg:mlAlmirall S.A.未进口原研药品欧盟上市
31-57注射用盐酸兰地洛尔Landiolol Hydrochloride For InjectionOnoact50mg（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
31-58泰比培南酯细粒Tebipenem Pivoxil Fine Granules For PediatricOrapenem10%（0.5g/袋）Meiji Seika ファルマ株式会社未进口原研药品日本上市
31-59碘解磷定注射液Pralidoxime Iodide
20ml:0.5g大日本住友製薬株式会社未进口原研药品日本上市
31-60注射用甲氨蝶呤Methotrexate For Injection
5mgファイザー株式会社未进口原研药品日本上市
31-61注射用甲氨蝶呤Methotrexate For Injection
50mgファイザー株式会社未进口原研药品日本上市
31-62托格列净片Tofogliflozin TabletsDeberza20mg兴和株式会社未进口原研药品日本上市
31-63芦曲泊帕片Lusutrombopag Tablets
3mg日本塩野義製薬株式会社未进口原研药品日本上市
31-64甲磺酸卡莫司他片Camostat Mesilate TabletsFoipan100mg小野药品工业株式会社未进口原研药品日本上市
31-65联苯苄唑溶液Bifonazole SolutionMycospor1%（10ml）バイエル薬品株式会社未进口原研药品日本上市
31-66盐酸伐昔洛韦颗粒Valaciclovir Hydrochloride GranulesValtrex500mg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
31-67阿莫西林细粒剂Amoxicillin Fine GranulesSawacillin0.1（以C16H19N3O5S计）Ltlファーマ株式会社未进口原研药品日本上市
31-68扎那米韦吸入粉雾剂Zanamivir Powder For InhalationRelenza5mgGlaxosmithkline Australia Pty Ltd未进口原研药品澳大利亚上市
31-69盐酸环喷托酯滴眼液Cyclopentolate Hydrochloride Eye DropsCyclogyl（赛飞杰）1ml:10mgAlcon NV国际公认的同种药品国际公认进口
31-70盐酸美金刚片Memantine Hydrochloride Tablets易倍申10mgH. Lundbeck A/S国内上市的原研药品原研进口
31-71司来帕格片Selexipag TabletsUptravi（优拓比）0.2mgActelion Pharmaceuticals Ltd国内上市的原研药品原研进口
31-72司来帕格片Selexipag Tablets Uptravi0.4mgActelion Pharmaceuticals Ltd未进口原研药品美国橙皮书
31-73盐酸舍曲林片Sertraline Hydrochloride TabletsZoloft100mg（以C17H17Cl2N计）Pfizer Pharmaceuticals Inc未进口原研药品美国橙皮书
31-74复方氨基酸（15AA-II）/葡萄糖（10%）电解质注射液Compound Amino Acids（15AA-II），Glucose（10%）And Electrolyte InjectionClinimix E 2.75/51000mlBaxter Healthcare Corp未进口原研药品美国橙皮书
31-75醋酸艾替班特注射液Icatibant Acetate InjectionFirazyr30mg/3ml（以艾替班特计）Shire Orphan Therapies LLC未进口原研药品美国橙皮书
31-76达比加群酯胶囊Dabigatran Etexilate CapsulesPradaxa110mg（以达比加群酯计）Boehringer Ingelheim Pharmaceuticals Inc未进口原研药品美国橙皮书
31-77达比加群酯胶囊Dabigatran Etexilate CapsulesPradaxa150mg（以达比加群酯计）Boehringer Ingelheim Pharmaceuticals Inc未进口原研药品美国橙皮书
31-78盐酸文拉法辛缓释片Venlafaxine Hydrochloride Extended Release Tablets
150mg（以C17H27NO2计）Osmotica Pharmaceutical Corp未进口原研药品美国橙皮书
31-79硝苯地平缓释片Nifedipine Extended-Release TabletsAdalat CC30mgAlvogen Group Holdings LLC未进口原研药品美国橙皮书
31-80硝苯地平缓释片Nifedipine Extended-Release TabletsAdalat CC60mgAlvogen Group Holdings LLC未进口原研药品美国橙皮书
31-81唑来膦酸注射液Zoledronic Acid InjectionReclast100ml:5mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书
31-82钆特酸葡胺注射液Gadoteric Acid Meglumine Salt InjectionDotarem337mg:1ml（5ml、10ml、15ml、20ml、100ml/瓶）Guerbet LLC未进口原研药品美国橙皮书
31-83托吡酯缓释胶囊Topiramate Extended-release CapsulesQudexy XR25mgUpsher Smith Laboratories LLC未进口原研药品美国橙皮书
31-84托吡酯缓释胶囊Topiramate Extended-release CapsulesQudexy XR50mgUpsher Smith Laboratories LLC未进口原研药品美国橙皮书
31-85托吡酯缓释胶囊Topiramate Extended-release CapsulesQudexy XR100mgUpsher Smith Laboratories LLC未进口原研药品美国橙皮书
31-86托吡酯缓释胶囊Topiramate Extended-release CapsulesQudexy XR150mgUpsher Smith Laboratories LLC未进口原研药品美国橙皮书
31-87托吡酯缓释胶囊Topiramate Extended-release CapsulesQudexy XR200mgUpsher Smith Laboratories LLC未进口原研药品美国橙皮书
31-88注射用紫杉醇（白蛋白结合型）Paclitaxel For Injection（Albumin Bound）Abraxane100mgAbraxis Bioscience LLC未进口原研药品美国橙皮书
31-89注射用紫杉醇（白蛋白结合型）Paclitaxel Powder For Suspension For InfusionAbraxane100mgCelgene Europe B.V未进口原研药品欧盟上市
31-90注射用氨苄西林钠舒巴坦钠Ampicillin Sodium and Sulbactam Sodium For InjectionUnasyn2g/Vial;1g/Vial（以氨苄西林;舒巴坦计）Pfizer Inc未进口原研药品美国橙皮书
31-91盐酸吡格列酮片Pioglitazone Hydrochloride TabletsActos15mgTakeda Pharmaceuticals USA Inc未进口原研药品美国橙皮书
31-92盐酸吡格列酮片Pioglitazone Hydrochloride TabletsActos30mgTakeda Pharmaceuticals USA Inc未进口原研药品美国橙皮书
31-93盐酸吡格列酮片Pioglitazone Hydrochloride TabletsActos15mg武⽥テバ薬品株式会社未进口原研药品日本上市
31-94沙格列汀片Saxagliptin TabletsOnglyza2.5mgAstrazeneca AB未进口原研药品美国橙皮书
31-95注射用氨苄西林钠Ampicillin Sodium For Injection
0.5gSandoz Inc国际公认的同种药品美国橙皮书
31-96ω-3鱼油中长链脂肪乳/氨基酸（16）/葡萄糖（36%）注射液ω-3 Fish Oil Medium and Long Chain Fat EmulsionAmino Acids （16）625mlB. Braun Melsungen AG未进口原研药品欧盟上市
31-97甲磺酸伊马替尼片Imatinib MesylateTabletsGlivec400mgNovartis Europharm Limited未进口原研药品欧盟上市
31-98二甲双胍恩格列净片Metformin Hydrochloride And Empagliflozin TabletsSynjardy每片含盐酸二甲双胍1000mg与恩格列净5mgBoehringer Ingelheim未进口原研药品欧盟上市
31-99二甲双胍恩格列净片Metformin Hydrochloride And Empagliflozin TabletsSynjardy每片含盐酸二甲双胍1000mg与恩格列净12.5mgBoehringer Ingelheim未进口原研药品欧盟上市
31-100注射用头孢他啶Ceftazidime For InjectionFortum0.25gGlaxosmithkline S.P.A/Glaxosmithkline Laboratory未进口原研药品欧盟上市
31-101注射用头孢他啶Ceftazidime For InjectionModacin0.5g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
31-102注射用头孢他啶Ceftazidime For InjectionFortum1gGlaxo Operations Uk Ltd.未进口原研药品英国上市
31-103甲氨蝶呤注射液Methotrexate Injection
1ml:25mgPfizer Pharma Pfe GmbH未进口原研药品欧盟上市
31-104氯雷他定片Loratadine TabletsClaritine10mgBayer SA-NV未进口原研药品欧盟上市
31-105托吡司特片Topiroxostat TabletsTopiloric60mg株式会社富士薬品未进口原研药品日本上市
31-106托伐普坦片Tolvaptan Tablets Samsca15mg大塚製薬株式会社未进口原研药品日本上市
31-107托伐普坦片Tolvaptan Tablets Samsca30mg大塚製薬株式会社未进口原研药品日本上市
31-108坎地沙坦酯氢氯噻嗪片Candesartan Cilexetil and Hydrochlorothiazide Tablets
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
31-109坎地沙坦酯氢氯噻嗪片Candesartan Cilexetil and Hydrochlorothiazide Tablets
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
31-110盐酸非索非那定片Fexofenadine Hydrochloride TabletsTelfast180mgSanofi未进口原研药品英国上市
31-111头孢呋辛酯干混悬剂Cefuroxime Axetil For SuspensionZinnat以头孢呋辛（C16H16N4O8S）计125mg/5mlGlaxo WeLLCome UK Limited未进口原研药品英国上市
5-15琥珀酸亚铁片Ferrous Succinate TabletsInofer0.1gLaboratoire De L’ Inofer/Laboratoire X.O欧盟上市持证商发生变更，增加持证商Laboratoire X.O
8-22奥利司他胶囊Orlistat CapsulesXenical0.12gRoche Pharma （Schweiz） Ltd./Cheplapharm Arzneimittel GmbH原研进口持证商发生变更，增加持证商Cheplapharm Arzneimittel GmbH
13-15枸橼酸氢钾钠颗粒Potassium Sodium Hydrogen Citrate GranulesUralyt-U97.1g/100gMadaus GmbH/Meda Pharm GmbH & Co.K原研进口持证商发生变更，增加持证商Meda Pharm GmbH & Co.K
21-214头孢呋辛酯片Cefuroxime Axetil TabletsZinnat头孢呋辛（以C16H16N4O8S计0.125g）Glaxo SmithKline/ Glaxo Wellcome UK Limited未进口原研药品持证商发生变更，增加持证商Glaxo Wellcome UK Limited
22-360伊曲康唑口服液Itraconazole Oral SolutionSporanox OS（斯皮仁诺）150ml:1.5gJanssen-Cilag NV国内上市的原研药品药品通用名称更正为伊曲康唑口服液
23-89利丙双卡因乳膏Lidocaine And Prilocaine CreamEmla1g：利多卡因25mg，丙胺卡因25mgAspen Pharma Trading Limited未进口原研药品药品通用名称更正为利丙双卡因乳膏
23-319复方氨基酸（15AA-II）/葡萄糖（10%）电解质注射液Compound Amino Acids（15AA-II），Glucose（10%）And Electrolyte InjectionClinimix E 2.75/52000mlBaxter Healthcare Corp未进口原研药品药品通用名称更正为复方氨基酸（15AA-II）/葡萄糖（10%）电解质注射液，英文名称更正为Compound Amino Acids（15AA-II），Glucose（10%）And Electrolyte Injection
29-8丙酸氟替卡松雾化吸入用混悬液Fluticasone Propionate Nebuliser Suspension
2ml：0.5mgGlaxoSmithKline Australia Pty Ltd./Eddingpharm B.V.国内上市的原研药品持证商发生变更，增加持证商Eddingpharm B.V.；不限定商品名。


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