国家药监局关于发布仿制药参比制剂目录(第三十一批)的通告(2020年第75号通告)

经国家药品监督管理局仿制药质量和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(第三十一批)。

特此通告。

附件:仿制药参比制剂目录(第三十一批)

国家药监局
2020年11月18日

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 l/Benzihex(班赛)5%Galderma 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 Capsules/Ultibro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 Drops0.1%(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 Drops/Duotrav(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 Drops/Azarga5ml: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 Drops/Azopt5ml: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 Tablets/Tribenzor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 Tablets/Tribenzor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 Tablets/Tribenzor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 Tablets/Tribenzor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 Tablets/Tribenzor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 Drops/Children’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 Solution/Virazole6gValeant 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 Tablets/Nerlynx40mgPuma 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 powder/Flovent 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 powder/Flovent 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 powder/Flovent 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 Injection/Vyxeos44mg: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 Tablets/Odefsey200mg: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 solution/Latisse3ml:0.9mgAllergan INC未进口原研药品美国橙皮书
31-25奥泽沙星乳膏Ozenoxacin Cream/Xepi1%(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 Tablet/Roxicodone15mgSpecgx LLC未进口原研药品美国橙皮书
31-27盐酸羟考酮片Oxycodone Hydrochloride Tablet/Roxicodone30mgSpecgx 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 Tablets/Intuniv1mgShire 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 Cream/Pliaglis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 Capsules/TriliPix45mgAbbvie 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 Capsules/TriliPix135mgAbbvie 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 Gel/Zirgan0.15%(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 capsules/Apriso375mgValeant 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 capsules/Amrix15mgTeva 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 capsules/Amrix30mgTeva 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 Tablets/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 Injection10mgSun 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 Injection/Kybella; 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 Injection/Celestone; 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 suspension/Ursofalk250mg: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 Lyophilisates80mgTeva Sante未进口原研药品欧盟上市
31-49醋丙甲泼尼龙乳膏Methylprednisolone Aceponate Cream/Advantan0.1%(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 Cream/Pliaglis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 Capsules/Cresemba100mg(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 Injection/Cresemba200mg(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 Injection2ml: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 Solution/Ebastel1mg: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 Injection/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
31-58泰比培南酯细粒Tebipenem Pivoxil Fine Granules For Pediatric/Orapenem10%(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 Iodide20ml: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 Injection5mg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 Injection50mg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 Tablets/Deberza20mg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 Tablets3mg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 Tablets/Foipan100mg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 Solution/Mycospor1%(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 Granules/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
31-67阿莫西林细粒剂Amoxicillin Fine Granules/Sawacillin10%(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 Inhalation/Relenza5mgGlaxosmithkline 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 Drops/Cyclogyl(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 Tablets/Uptravi(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 Tablets/Zoloft100mg(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 Injection/Clinimix 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 Injection/Firazyr30mg/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 Capsules/Pradaxa110mg(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 Capsules/Pradaxa150mg(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 Tablets150mg(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 Tablets/Adalat 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 Tablets/Adalat 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 Injection/Reclast100ml: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 Injection/Dotarem337mg: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 Capsules/Qudexy 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 Capsules/Qudexy 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 Capsules/Qudexy 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 Capsules/Qudexy 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 Capsules/Qudexy 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 Infusion/Abraxane100mgCelgene 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 Injection/Unasyn2g/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 Tablets/Actos15mgTakeda 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 Tablets/ Actos30mgTakeda 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 Tablets/ Actos15mg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 Tablets/Onglyza2.5mgAstrazeneca 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 Injection0.5gSandoz 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 Emulsion/Amino Acids (16)/Glucose(36%) Injection/NuTRIflex Omega plus625mlB. 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 MesylateTablets/Glivec400mgNovartis 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 Tablets/Synjardy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 Tablets/Synjardy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 Injection/Fortum0.25gGlaxosmithkline 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 Injection/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
31-102注射用头孢他啶Ceftazidime For Injection/Fortum1gGlaxo Operations Uk Ltd.未进口原研药品英国上市
31-103甲氨蝶呤注射液Methotrexate Injection1ml:25mgPfizer Pharma Pfe GmbH未进口原研药品欧盟上市
31-104氯雷他定片Loratadine Tablets/Claritine10mgBayer SA-NV未进口原研药品欧盟上市
31-105托吡司特片Topiroxostat Tablets/Topiloric60mg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 Tablets/Telfast180mgSanofi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 Suspension/Zinnat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 Tablets/Inofer0.1gLaboratoire 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 Capsules/ Xenical0.12gRoche 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 Granules/Uralyt-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 Tablets/Zinnat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 Solution/Sporanox 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 Cream/Emla1g: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 Injection/Clinimix 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 Suspension2ml: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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未经允许不得转载:药通社 » 国家药监局关于发布仿制药参比制剂目录(第三十一批)的通告(2020年第75号通告)
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