您好,欢迎来到桐晖药业!
服务热线: 020-6639 2416
18922121079
会员中心

【第三十二批】仿制药参比制剂目录


【第三十二批】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
32-1比克恩丙诺片Bictegravir Sodium, Emtricitabine and Tenofovir Alafenamide Fumarate Tablets Biktarvy(必妥维)比克替拉韦钠(以比克替拉韦计)50mg,恩曲他滨200mg,富马酸丙酚替诺福韦(以丙酚替诺福韦计)25mgGilead Sciences Ireland UC国内上市的原研药品原研进口
32-2来迪派韦索磷布韦片Ledipasvir and Sofosbuvir Tablets Harvoni(夏帆宁)90mg来迪派韦,400mg索磷布韦Gilead Sciences International Ltd.国内上市的原研药品原研进口
32-3卡泊三醇搽剂Calcipotriol Scalp Solution Daivonex(达力士)0.005%(30ml:1.50mg)LEO Pharma A/S国内上市的原研药品原研进口
32-4溴夫定片Brivudine Tablets Zostex(左代)125mgBerlin-Chemie AG国内上市的原研药品原研进口
32-5法莫替丁钙镁咀嚼片Famotidine,Calcium Carbonate and Magnesium Hydroxide Chewable TabletsPepcid Complete法莫替丁10mg,碳酸钙800mg,氢氧化镁165mgJohnson And Johnson Consumer Inc Mcneil Consumer Healthcare Division未进口原研药品美国橙皮书
32-6利多卡因凝胶贴膏Lidocaine Cataplasms Lidoderm0.05Teikoku Pharma Usa Inc未进口原研药品美国橙皮书
32-7注射用德拉沙星Delafloxacin for Injection  Baxdela300mgMelinta Subsidiary Corp未进口原研药品美国橙皮书
32-8美沙拉秦灌肠液Mesalazine Enemas Rowasa4g/60mlMylan Specialty LP未进口原研药品美国橙皮书
32-9蔗糖氢氧化氧铁咀嚼片Sucroferric oxyhydroxide Chewable Tablet Velphoro500mgVifor Fresenius Medical Care Renal Pharma France未进口原研药品美国橙皮书
32-10眼用丝裂霉素溶液用粉末Mitomycin for SolutionMitosol0.2mgMobius Therapeutics  LLC未进口原研药品美国橙皮书
32-11盐酸去氧肾上腺素注射液Phenylephrine Hydrochloride Injection Biorphen5ml:0.5mgEton Pharmaceuticals未进口原研药品美国橙皮书
32-12盐酸去氧肾上腺素注射液Phenylephrine Hydrochloride Injection
1mL:10mgWest Ward Pharmaceutical Corp未进口原研药品美国橙皮书
32-13马来酸阿伐曲泊帕片Avatrombopag Tablets Doptelet20mgAkaRx, Inc未进口原研药品美国橙皮书
32-14曲安奈德乳膏Triamcinolone Acetonide Cream
0.001Fougera Pharmaceuticals Inc国际公认的同种药品美国橙皮书
32-15头孢地尼干混悬剂Cefdinir for Suspension
250mg/5mlSandoz Inc国际公认的同种药品美国橙皮书
32-16丙戊酸钠缓释片Compound Sodium Valproate and 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
32-17倍他米松磷酸钠注射液Betamethasone Sodium Phosphate InjectionCelestone; Celestan; Celeston4mg/ml(以倍他米松计)MSD Belgium BVBA/SPRL/MSD Sharp & Dohme GmbH/Merck Sharp & Dohme BV/MSD Polska Sp. z o.o.未进口原研药品欧盟上市
32-18盐酸氯米帕明注射液Clomipramine Hydrochloride Injection  Anafranil25mg/2mlAlfasigma France/Alfasigma S.p.A.未进口原研药品欧盟上市
32-19盐酸氮卓斯汀丙酸氟替卡松鼻喷雾剂Azelastine hydrochloride Fluticasone Propionate Nasal Spray Dymista每瓶120喷,每喷含盐酸氮卓斯汀和丙酸氟替卡松137μg和50μgMEDA Pharma GmbH & Co. KG未进口原研药品欧盟上市
32-20盐酸格拉司琼片Granisetron Hydrochloride TabletsKytril1mgAtnahs Pharma Netherlands B.V.未进口原研药品欧盟上市
32-21盐酸屈他维林片Drotaverine Hydrochloride Tablets NO-SPA40mgSanofi-Aventis未进口原研药品欧盟上市
32-22氯化锰口服溶液Manganese Chloride Oral Solution  Bothdel Oral Solution 10250mL/袋,含有36mg氯化锰四水合物(相当于锰10mg)Meiji Seikaファルマ株式会社未进口原研药品日本上市
32-23洛索洛芬钠凝胶Loxoprofen sodium hydrate gel
0.01第一三共株式会社未进口原研药品日本上市
32-24硫酸亚铁缓释片Ferrous Sulfate Extended-release TabletsFero-Gradumet105mg(以铁元素计)マイランEPD合同会社未进口原研药品日本上市
32-25注射用二丁酰环磷腺苷钠Bucladesine Sodium  Injectionアクトシン300mgアルフレッサ ファーマ株式会社未进口原研药品日本上市
32-26盐酸乐卡地平片Lercanidipine Hydrochloride TabletsZanidip(再宁平)20mgRecordati S.P.A.国内上市的原研药品原研进口
32-27拉莫三嗪片Lamotrigine TabletsLamictal100mgThe Wellcome Foundation Ltd国内上市的原研药品原研进口
32-28依非韦伦片Efavirenz TabletsSustiva600mgBristol-Myers Squibb Pharma Compay未进口原研药品美国橙皮书
32-29阿立哌唑口崩片Aripiprazole Orally Disintegrating tabletsAbilify10mgOtsuka Pharmaceutical Co.Ltd未进口原研药品美国橙皮书
32-30阿立哌唑口崩片Aripiprazole Orally Disintegrating tabletsAbilify15mgOtsuka Pharmaceutical Co.Ltd未进口原研药品美国橙皮书
32-31复方磺胺甲噁唑片Compound Sulfamethoxazole TabletsBactrim磺胺甲噁唑800g,甲氧苄啶 160mgSun Pharmaceutical Industries Inc未进口原研药品美国橙皮书
32-32艾曲泊帕乙醇胺片Eltrombopag Olamine TabletsPromacta25mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书
32-33注射用替加环素Tigecycline for InjectionTygacil50mgPF Prism CV未进口原研药品美国橙皮书
32-34他克莫司胶囊Tacrolimus Capsules Prograf5mgAstellas Pharma US Inc未进口原研药品美国橙皮书
32-35他克莫司胶囊Tacrolimus Capsules Prograf1mgAstellas Pharma US Inc未进口原研药品美国橙皮书
32-36他克莫司胶囊Tacrolimus Capsules Prograf0.5mgAstellas Pharma US Inc未进口原研药品美国橙皮书
32-37硝酸甘油片Nitroglycerin Sublingual Tablets Nitrostat0.6mgPfizer Pharmaceuticals LTD未进口原研药品美国橙皮书
32-38米拉贝隆缓释片Mirabegron Extended-release TabletsMyrbetriq25mgAstellas Pharma Global Development Inc未进口原研药品美国橙皮书
32-39盐酸伊立替康注射液Irinotecan Hydrochloride InjectionCamptosar5ml:0.1gPfizer Inc未进口原研药品美国橙皮书
32-40盐酸伊立替康注射液Irinotecan Hydrochloride InjectionCamptosar2ml:40mgPfizer Inc未进口原研药品美国橙皮书
32-41替米沙坦片Telmisartan TabletsMicardis40mgBoehringer Ingelheim未进口原研药品美国橙皮书
32-42替米沙坦片Telmisartan TabletsMicardis80mgBoehringer Ingelheim未进口原研药品美国橙皮书
32-43伏立康唑片Voriconazole TabletsVfend50mgPF Prism CV未进口原研药品美国橙皮书
32-44注射用伏立康唑Voriconazole for InjectionVfend200mgPF Prism CV未进口原研药品美国橙皮书
32-45碳酸司维拉姆片Sevelamer Carbonate Tablets  Renvela800mgSanofi Genzyme未进口原研药品美国橙皮书
32-46注射用磷酸特地唑胺Tedizolid Phosphate For InjectionSivextro200mgCubist Pharmaceuticals LLC/Merck & CO.,INC未进口原研药品美国橙皮书
32-47氟尿嘧啶注射液Fluorouracil InjectionFluorouracil1g/20mlFresenius Kabi USA LLC国际公认的同种药品美国橙皮书
32-48地高辛注射液Digoxin InjectionLanoxin2mL:0.5mgAspen Pharma Trading Limited未进口原研药品欧盟上市
32-49奥氮平片Olanzapine TabletsZyprexa2.5mgEli Lilly Nederland B.V.未进口原研药品欧盟上市
32-50黄体酮注射液Progesterone Injection
1.112ml:25mgIBSA Farmaceutici Italia Srl未进口原研药品欧盟上市
32-51阿普司特片Apremilast TabletsOtezla10mgCelgene Europe B.V.未进口原研药品欧盟上市
32-52阿普司特片Apremilast TabletsOtezla30mgCelgene Europe B.V.未进口原研药品欧盟上市
32-53利福平胶囊Rifampicin CapsulesRifadin150mgSanofi未进口原研药品欧盟上市
32-54丙酸倍氯米松吸入气雾剂Beclometasone Dipropionate Inhalation Aerosol Qvar每瓶200揿,每揿含丙酸倍氯米松50μgTeva UK Limited未进口原研药品欧盟上市
32-55丙酸倍氯米松吸入气雾剂Beclometasone Dipropionate Inhalation Aerosol Qvar每瓶200揿,每揿含丙酸倍氯米松50μgTeva UK Limited未进口原研药品日本上市
32-56丙酸倍氯米松吸入气雾剂Beclometasone Dipropionate Inhalation Aerosol Clenil Modulite每瓶200揿,每揿含丙酸倍氯米松250μgChiesi Limited/ Chiesi Farmaceutici S.p.A.未进口原研药品欧盟上市
32-57苯磺顺阿曲库铵注射液Cisatracurium Besylate InjectionNimbex2.5ml:5mgAspen Pharma Trading Limited未进口原研药品欧盟上市
32-58硝呋太尔片Nifuratel Tablets Macmiror200mgPolichem S.R.L./ Polichem SA未进口原研药品欧盟上市
32-59马尿酸乌洛托品片Methenamine Hippurate Tablets Hippex1gMylan Products Ltd未进口原研药品欧盟上市
32-60环孢素眼用乳剂Ciclosporin Eye Drops Emulsion Verkazia0.001Santen Oy未进口原研药品欧盟上市
32-61盐酸罗哌卡因注射液Ropivacaine Hydrochloride InjectionNaropin10ml:75mgAspen Pharma Trading Limited未进口原研药品欧盟上市
32-62盐酸罗哌卡因注射液Ropivacaine Hydrochloride InjectionNaropin10ml:100mgAspen Pharma Trading Limited未进口原研药品欧盟上市
32-63马来酸阿法替尼片Afatinib Dimaleate TabletsGiotrif50mgBoehringer Ingelheim International GmbH未进口原研药品欧盟上市
32-64盐酸阿罗洛尔片Arotinolol Hydrochloride Tablets
5mg大日本住友製薬株式会社未进口原研药品日本上市
32-65盐酸法舒地尔注射液Fasudil Hydrochloride InjectionEril2ml:30mgAsahi Kasei Pharma Corporatio未进口原研药品日本上市
32-66盐酸托莫西汀口服溶液Atomoxetine Hydrochloride Oral Solution Strattera100ml∶0.4g日本イーライリリー株式会社未进口原研药品日本上市
32-67盐酸咪达普利片Imidapril Hydrochloride Tablets Tanatril2.5mg田辺三菱製薬株式会社未进口原研药品日本上市
32-68米库氯铵注射液Mivacurium Chloride InjectionMivacron10ml:20mgAspen Pharma Trading Limited未进口原研药品英国上市
32-69萘普生钠片Naproxen Sodium Tablets Apranax275mgAtnahs Pharma Netherlands B.V.未进口原研药品法国上市
32-70克霉唑乳膏Clotrimazole CreamCanesten0.01Bayer Inc未进口原研药品加拿大上市
32-71注射用阿莫西林钠克拉维酸钾Amoxicillin Sodium and Clavulanate Potassium for injection(10:1)
550mg(500/50)GlaxoSmithKline AG未进口原研药品瑞士上市
32-72注射用阿莫西林钠克拉维酸钾Amoxicillin Sodium and Clavulanate Potassium for injection(10:1)
1.1g(1000/100)GlaxoSmithKline AG未进口原研药品瑞士上市
32-73注射用阿莫西林钠克拉维酸钾Amoxicillin Sodium and Clavulanate Potassium for injection(10:1)
2.2g(2000/200)GlaxoSmithKline AG未进口原研药品瑞士上市
32-74马来酸咪达唑仑片Midazolam Maleate TabletsDormicum7.5mg(以咪达唑仑计)CPS Cito Pharma Services未进口原研药品瑞士上市
32-75醋酸去氨加压素注射液Desmopressin Acetate InjectionMinirin1ml:4μg(按去氨加压素计3.56μg)Ferring AG未进口原研药品瑞士上市
32-76醋酸去氨加压素注射液Desmopressin Acetate InjectionOctostim1ml:15μg(按去氨加压素计13.4μg)Ferring AG未进口原研药品瑞士上市
10-66卡维地洛片Carvedilol TabletsDilatrend6.25mgRoche Pharma AG/Cheplapharm Arzneimittel GmbH欧盟上市持证商发生变更,增加持证商Cheplapharm Arzneimittel GmbH
10-68卡维地洛片Carvedilol TabletsDilatrend12.5mgRoche Pharma AG/Cheplapharm Arzneimittel GmbH欧盟上市持证商发生变更,增加持证商Cheplapharm Arzneimittel GmbH
30-86磷酸特地唑胺片Tedizolid Phosphate TabletsSivextro200mgCubist Pharmaceuticals LLC/MSD Pharma(Singapore)Pte. Ltd.未进口原研药品增加持证商MSD Pharma(Singapore)Pte. Ltd
21-93盐酸罗哌卡因注射液Ropivacaine hydrochloride injectionNaropin(耐乐品)20mg/10mlAstraZeneca AB/Aspen Pharmacare Australia Pty Ltd国内上市的原研药品持证商发生变更,增加持证商Aspen Pharmacare Australia Pty Ltd
21-94盐酸罗哌卡因注射液Ropivacaine hydrochloride injectionNaropin(耐乐品)50mg/10mlAstraZeneca AB/Aspen Pharmacare Australia Pty Ltd国内上市的原研药品持证商发生变更,增加持证商Aspen Pharmacare Australia Pty Ltd
21-95盐酸罗哌卡因注射液Ropivacaine hydrochloride injectionNaropin(耐乐品)75mg/10mlAstraZeneca AB/Aspen Pharmacare Australia Pty Ltd国内上市的原研药品持证商发生变更,增加持证商Aspen Pharmacare Australia Pty Ltd
21-96盐酸罗哌卡因注射液Ropivacaine hydrochloride injectionNaropin(耐乐品)100mg/10mlAstraZeneca AB/Aspen Pharmacare Australia Pty Ltd国内上市的原研药品持证商发生变更,增加持证商Aspen Pharmacare Australia Pty Ltd


1、参比制剂选择原则:有原研进口的应选择原研进口药作为参比制剂首选。

2、本网站所有仿制药参比制剂目录数据源自国家药品监督管理局官方网站,如有纰漏请以国家官网为准。


广州市桐晖药业有限公司
业务咨询热线:020-66392416 / 18026299762
售后服务及投诉电话:020-62312853 / 18122390687(服务时间:周一至周五9:00-17:30)
传真:020-66392525
地址:广州市黄埔区科学城科汇金谷二街3号四、五楼

桐晖药业公众号

桐晖药业小程序
Copyright ©2020 广州市桐晖药业有限公司 粤ICP备16102594号-2

服务热线

18922121079

18026299762

(微信同号)
企业QQ

2355398386

参比制剂 进口原料药 一致性评价 仿制药项目引进 海外高端制剂技术 创新药项目引进 进口原辅料注册 进口制剂注册
回到顶部