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【第三十七批】仿制药参比制剂目录


【第三十七批】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
37-1聚甲酚磺醛溶液Policresulen SolutionAlbothyl(爱宝疗)36%(w/w)Takeda GmbH国内上市的原研药品原研进口
37-2卡波姆眼用凝胶Carbomer Eye GelLiposic(立宝舒)10g:20mg(0.2%)Dr Gerhard Mann Chem-Pharma Fabrik GmbH国内上市的原研药品原研进口
37-3美沙拉秦栓Mesalazine SuppositoriesSalofalk(莎尔福)500mgDr. Falk Pharma GmbH国内上市的原研药品原研进口
37-4阿格列汀二甲双胍片Alogliptin Metformin TabletsKazano阿格列汀12.5mg,盐酸二甲双胍500mgTakeda Pharmaceuticals USA Inc未进口原研药品美国橙皮书
37-5盐酸考尼伐坦预混型葡萄糖注射液Vaprisol In 5% Dextrose In Plastic Container(Conivaptan Hydrochloride)
20mg/100mL(0.2mg/mL)Cumberland Pharmaceuticals Inc未进口原研药品美国橙皮书
37-6布洛芬去氧肾上腺素氯苯那敏片Chlorpheniramine maleate, Ibuprofen, Phenylephrine HCl Tablet
每片含布洛芬200mg、盐酸去氧肾上腺素10mg、马来酸氯苯那敏4mgGlaxosmithkline Consumer Healthcare Holdings US Llc未进口原研药品美国橙皮书
37-7盐酸氯普鲁卡因注射液Chloroprocaine Hydrochloride InjectionClorotekal50mg/5ml(10mg/ml)B Braun Medical Inc未进口原研药品美国橙皮书
37-8盐酸米诺环素缓释微球Minocycline Hydrochloride Extended PowderArestin1mgOrapharma Inc未进口原研药品美国橙皮书
37-9氨苯砜凝胶Dapsone GelAczone0.05Allergan Inc未进口原研药品美国橙皮书
37-10环孢素滴眼液Cyclosporine Ophthalmic SolutionCequa0.0009Sun Pharma Global FZE未进口原研药品美国橙皮书
37-11注射用达卡巴嗪Dacarbazine for InjectionDacarbazine100mgFresenius Kabi USA国际公认的同种药品美国橙皮书
37-12注射用达卡巴嗪Dacarbazine for InjectionDacarbazine200mgFresenius Kabi USA国际公认的同种药品美国橙皮书
37-13盐酸氨酮戊酸外用散Aminolevulinic Acid Hydrochloride for Topical PowderLevulan354mg(复溶后浓度为20%)Dusa Pharmaceuticals Inc未进口原研药品美国橙皮书
37-14门冬氨酸帕瑞肽注射液Pasireotide Diaspeartate InjectionSignifor1ml:0.6mgRecordati Rare Diseases未进口原研药品欧盟上市
37-15琥珀酰明胶电解质注射液Succinylated Gelatin Electrolytes Injection-500ml:20gB.Braun Melsungen AG未进口原研药品欧盟上市
37-16琥珀酰明胶注射液Succinylated Gelatin Injection-500ml:20gB.Braun Melsungen AG未进口原研药品欧盟上市
37-17盐酸氯普鲁卡因注射液Chloroprocaine Hydrochloride InjectionClorotekal10mg/mlSintetica GmbH未进口原研药品欧盟上市
37-18阿格列汀二甲双胍片Alogliptin Metformin TabletsInisync阿格列汀25mg,盐酸二甲双胍500mg武田药品工业株式会社未进口原研药品日本上市
37-19奥泽沙星洗剂Ozenoxacin LotionZebiax0.02マルホ株式会社未进口原研药品日本上市
37-20苯磺贝他斯汀口崩片Bepotastine Besilate Orally Disintegrating TabletsTalion10mg田辺三菱製薬株式会社未进口原研药品日本上市
37-21奈立膦酸钠注射液Neridronate Sodium InjectionNerixia2ml:25mgAbiogen Pharma S.p.A.未进口原研药品意大利上市
37-22奈立膦酸钠注射液Neridronate Sodium InjectionNerixia8ml:100mgAbiogen Pharma S.p.A.未进口原研药品意大利上市
37-23艾曲泊帕乙醇胺片Eltrombopag Olamine TabletsRomacta50mgNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书
37-24氟维司群注射液Fulvestrant InjectionFaslodex5ml:0.25gAstrazeneca Pharmaceuticals LP未进口原研药品美国橙皮书
37-25二甲磺酸利右苯丙胺胶囊Lisdexamfetamine Dimesylate CapsulesVyvanse10mgShire Development INC/Takeda Pharmaceuticals USA INC未进口原研药品美国橙皮书
37-26佐匹克隆片Zopiclone TabletsImovane7.5mgSanofi Aventis France未进口原研药品欧盟上市
37-27环孢素软胶囊Ciclosporin Soft Capsules Neoral10mgNovartis Pharma K.K.未进口原研药品日本上市
37-28盐酸依匹斯汀片Epinastine Hydrochloride Tablets-20mgNippon Boehringer Ingelheim Co., Ltd.未进口原研药品日本上市
8-267醋酸地塞米松片Dexamethasone Acetate TabletsDectancyl0.5mgSanofi Aventis France欧盟上市修订,不限上市国及产地
24-24酮咯酸氨丁三醇注射液Ketorolac TrometamolTaradyl1ml:10mgAtnahs Pharma UK Limited/Atnahs Pharma Netherlands B.V.未进口原研药品增加持证商Atnahs Pharma Netherlands B.V.
24-45地奈德洗剂Desonide LotionDesowen0.05%(20ml)Galderma Australia Pty Ltd / Galderma Hong Kong Limited国际公认的同种药品增加持证商Galderma Hong Kong Limited
24-46地奈德洗剂Desonide LotionDesowen0.05%(60ml)Galderma Australia Pty Ltd / Galderma Hong Kong Limited国际公认的同种药品增加持证商Galderma Hong Kong Limited
24-47地奈德洗剂Desonide LotionDesowen0.05%(120ml)Galderma Australia Pty Ltd / Galderma Hong Kong Limited国际公认的同种药品增加持证商Galderma Hong Kong Limited
27-240硫酸镁钠钾口服用浓溶液Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral SolutionSuprep Bowel Prep Kit每瓶6盎司口服溶液,包含:硫酸镁:1.6g;硫酸钾:3.13g;硫酸钠:17.5gBraintree Laboratories Inc未进口原研药品药品通用名称更正为硫酸镁钠钾口服用浓溶液,英文名称更正为Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution



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。

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