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【第三十八批】仿制药参比制剂目录


【第三十八批】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
38-1噻托溴铵奥达特罗吸入喷雾剂Tiotropium Bromide and Olodaterol Hydrochloride Inhalation SpraySpiolto(思合华)每瓶60喷,每喷含噻托铵2.5μg(相当于噻托溴铵一水合物3.124μg)和奥达特罗2.5μg(相当于盐酸奥达特罗2.736μg)Boehringer Ingelheim International GmbH国内上市的原研药品原研进口
38-2噻托溴铵喷雾剂Tiotropium Bromide Spray-每瓶60喷,每喷含噻托铵2.5μg,药液浓度含噻托铵0.2262mg/mlBoehringer Ingelheim International GmbH国内上市的原研药品原研进口
38-3硝酸咪康唑阴道软胶囊Miconazole Nitrate Vaginal Soft CapsulesGyno-Daktarin(达克宁)0.4gJanssen-Cilag N.V.国内上市的原研药品原研进口
38-4硝酸咪康唑阴道软胶囊Miconazole Nitrate Vaginal Soft CapsulesGyno-Daktarin(达克宁)1.2gJanssen-Cilag N.V.国内上市的原研药品原研进口
38-5丁丙诺啡纳洛酮舌下片Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Tablets
丁丙诺啡2mg/纳洛酮0.5mg(均以碱基计)Indivior UK Limited国内上市的原研药品原研进口
38-6丁丙诺啡纳洛酮舌下片Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Tablets
丁丙诺啡8mg/纳洛酮2mg(均以碱基计)Indivior UK Limited国内上市的原研药品原研进口
38-7羧甲基纤维素钠滴眼液Carboxymethylcellulose Sodium Eye Drops-0.4ml:2mgAllergan Pharmaceuticals Ireland国内上市的原研药品原研进口
38-8复方倍他米松注射液Compound Betamethasone Injection得宝松1ml:二丙酸倍他米松(以倍他米松计)5mg与倍他米松磷酸钠(以倍他米松计)2mgMSD Merck Sharp & Dohme AG国内上市的原研药品原研进口
38-9注射用全氟丁烷微球Perflubutane Microspheres for InjectionSonazoid(示卓安)每瓶中含微球的体积为16μlGE Healthcare AS国内上市的原研药品原研进口
38-10索磷维伏片Sofosbuvir,Velpatasvir and Voxilaprevir tabletsVosevi(沃士韦)每片含 400mg 索磷布韦、100mg 维帕他韦和 100mg 伏西瑞韦Gilead Sciences Ireland UC国内上市的原研药品原研进口
38-11复合维生素片Vitamin Complex TabletsElevit Pronatal(爱乐维)复方制剂Bayer S.A.国内上市的原研药品原研进口
38-12盐酸奥洛他定鼻喷雾剂Olopatadine Hydrochloride Nasal SprayPatanase0.665mg/sprayNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书
38-13盐酸环丙沙星滴眼液Ciprofloxacin Ophthalmic SolutionCiloxan0.003Novartis Pharmaceuticals Corp未进口原研药品美国橙皮书
38-14硫酸麻黄碱注射液Ephedrine Sulfate InjectionAkovaz50mg/mlExela Pharma Sciences LLC未进口原研药品美国橙皮书
38-15艾考糊精腹膜透析液Icodextrin Peritoneal Dialysis SolutionExtraneal含7.5%艾考糊精(2L/袋、2.5L/袋)Baxter Healthcare Corporation未进口原研药品美国橙皮书
38-16艾考糊精腹膜透析液Icodextrin Peritoneal Dialysis SolutionExtraneal含7.5%艾考糊精(1.5L/袋、2L/袋、2.5L/袋)Baxter A/S未进口原研药品欧盟上市
38-17氨基酸(15)腹膜透析液Amino Acids (15) Peritoneal Dialysis Solution-2.0LBaxter Healthcare Ltd.未进口原研药品欧盟上市
38-18氨基酸(15)腹膜透析液Amino Acids (15) Peritoneal Dialysis Solution-2.5LBaxter Healthcare Ltd.未进口原研药品欧盟上市
38-19麦芽酚铁胶囊Ferric Maltol Capsules Feraccru每片含铁30mgNorgine B.V.未进口原研药品欧盟上市
38-20氯甲西泮注射液Lormetazepam InjectionSedalam10ml:2mgDr. Franz Köhler Chemie GmbH未进口原研药品欧盟上市
38-21硝酸异康唑阴道片Isoconazole Nitrate Vaginal Tablets-300mgバイエル薬品株式会社未进口原研药品日本上市
38-22盐酸头孢卡品酯片Cefcapene Pivoxil Hydrochloride TabletFlomox100mg塩野義製薬株式会社未进口原研药品日本上市
38-23氧氟沙星滴耳液Ofloxacin Ear Drops-0.003アルフレッサ ファーマ株式会社/第一三共株式会社未进口原研药品日本上市
38-24氟骨化三醇片Falecalcitriol TabletsFulstan0.15μg大日本住友製薬株式会社未进口原研药品日本上市
38-25氟骨化三醇片Falecalcitriol TabletsFulstan0.3μg大日本住友製薬株式会社未进口原研药品日本上市
38-26注射用盐酸吡柔比星Pirarubicin Hydrochloride for InjectionPinorubin10mg日本マイクロバイオファーマ株式会社未进口原研药品日本上市
38-27注射用盐酸吡柔比星Pirarubicin Hydrochloride for InjectionPinorubin20mg日本マイクロバイオファーマ株式会社未进口原研药品日本上市
38-28注射用盐酸吡柔比星Pirarubicin Hydrochloride for InjectionPinorubin30mg日本マイクロバイオファーマ株式会社未进口原研药品日本上市
38-29注射用盐酸多柔比星Doxorubicin Hydrochloride for Injection Adriacin10mgアスペンジャパン株式会社未进口原研药品日本上市
38-30美沙拉秦缓释颗粒Mesalazine Sustained-release Granules Pentasa1g,按美沙拉秦(C7H7NO3)计Ferring S.A.S未进口原研药品法国上市
38-31美沙拉秦缓释颗粒Mesalazine Sustained-release Granules Pentasa2g,按美沙拉秦(C7H7NO3)计Ferring S.A.S未进口原研药品法国上市
38-32富马酸伏诺拉生片Vonoprazan Fumarate Tablets Vocinti(沃克)10mgTakeda Pharmaceutical Company Limited国内上市的原研药品原研进口
38-33富马酸伏诺拉生片Vonoprazan Fumarate Tablets Vocinti(沃克)20mgTakeda Pharmaceutical Company Limited国内上市的原研药品原研进口
38-34碳酸镧颗粒Lanthanum Carbonate Oral PowderFosrenol1000mgShire Development LLC/Takeda Pharmmaceuticals USA INC未进口原研药品美国橙皮书
38-35尼莫地平口服溶液Nimodipine Oral Solution Nymalize6mg/mlArbor Pharmaceuticals, LLC未进口原研药品美国橙皮书
38-36氟尿嘧啶注射液Fluorouracil InjectionFluorouracil500mg/10mlAccord Healthcare, Inc国际公认的同种药品美国橙皮书
38-37小儿复方氨基酸注射液(19AA-Ⅰ)10% Amino Acid Injection Trophamine 10%10%(500ml)B Braun Medical Inc未进口原研药品美国橙皮书
38-38氯化钾缓释片Potassium Chloride Extended Release TabletsK-Tab20mEq(相当于1.5g氯化钾)Abbvie Inc未进口原研药品美国橙皮书
38-39盐酸吡格列酮片Pioglitazone Hydrochloride TabletsActos45mgTakeda Pharmaceuticals USA Inc未进口原研药品美国橙皮书
38-40盐酸丁螺环酮片Buspirone Hydrochloride Tablet-15mgTeva Pharmaceuticals USA Inc.国际公认的同种药品美国橙皮书
38-41盐酸罗匹尼罗缓释片Ropinirole Hydrochloride Sustained-release Tablets-8mgGLAXO SMITHKLINE/SmithKline Beecham Limited未进口原研药品欧盟上市
38-42亚叶酸钙注射液Calcium Folinate Injection-5ml:50mgHospira UK Ltd未进口原研药品欧盟上市
38-43苯磺酸氨氯地平片Amlodipine Besylate Tablets-10mg(以C20H25CLN2O5计)Pfizer未进口原研药品欧盟上市
38-44甲氨蝶呤注射液Methotrexate Injection-2ml:50mgPfizer Pharma Pfe GmbH未进口原研药品欧盟上市
38-45多西他赛注射液Docetaxel InjectionTaxotere20mg/1mlSanofi Mature IP未进口原研药品欧盟上市
38-46盐酸罗哌卡因注射液Ropivacaine Hydrochloride InjectionNaropin/Naropeine/Naropina20mg/10mlAspen Pharma Trading Limited未进口原研药品欧盟上市
38-47盐酸坦索罗辛口崩缓释片Tamsulosin Hydrochloride Oral Dispersible Sustained Release Tablets-0.2mgAstellas Pharma Inc/アステラス製薬株式会社未进口原研药品日本上市
38-48钆特醇注射液Gadoteridol InjectionProHance10ml:2.793gブラッコスイス株式会社未进口原研药品日本上市
38-49钆特醇注射液Gadoteridol InjectionProHance15ml:4.1895gブラッコスイス株式会社未进口原研药品日本上市
38-50注射用头孢他啶Ceftazidime For InjectionModacin1.0g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
38-51注射用氨曲南Aztreonam For Injection-1.0g日本エーザイ株式会社未进口原研药品日本上市
5-19卡托普利片Captopril TabletsCaptopril12.5mgDaiichi Sankyo Espha Co.,  Ltd./アルフレッサファーマ株式会社日本橙皮书增加持证商アルフレッサファーマ株式会社
5-20卡托普利片Captopril TabletsCaptopril25mgDaiichi Sankyo Espha Co.,  Ltd./アルフレッサファーマ株式会社日本橙皮书增加持证商アルフレッサファーマ株式会社
21-102注射用环磷酰胺Cyclophosphamide for InjectionEndoxan(安道生)1gBaxter Oncology GmbH/Baxter Healthcare Ltd国内上市的原研药品增加持证商Baxter Healthcare Ltd
23-48阿普司特片Apremilast Tablet Otezla10mgCelgene Corp/Amgen Inc未进口原研药品增加持证商Amgen Inc
23-49阿普司特片Apremilast Tablet Otezla20mgCelgene Corp/Amgen Inc未进口原研药品增加持证商Amgen Inc
27-412阿普司特片Apremilast Tablet Otezla30mgCelgene Corp/Amgen Inc未进口原研药品增加持证商Amgen Inc
27-372苯磺酸氨氯地平片Amlodipine Besylate Tablets-5mg(以C20H25CLN2O5计)Pfizer Luxembourg Sarl/Pfizer Limited/Pfizer未进口原研药品增加持证商Pfizer Luxembourg Sarl/Pfizer;不限定商品名
8-175盐酸齐拉西酮胶囊Ziprasidone Hydrochloride  CapsulesZeldox20mg(按齐拉西酮计)Pfizer Australia Pty Limited / Pfizer Pharma PFE GmbH原研进口持证商变更,增加变更后持证商Pfizer Pharma PFE GmbH
8-225盐酸齐拉西酮胶囊Ziprasidone Hydrochloride  CapsulesZeldox40mg(按齐拉西酮计)Pfizer Australia Pty Limited / Pfizer Pharma PFE GmbH原研进口持证商变更,增加变更后持证商Pfizer Pharma PFE GmbH
21-111沙美特罗替卡松吸入粉雾剂Salmeterol Xinafoate and Fluticasone Propionate Powder for InhalationSeretide(舒利迭)50ug/100ug/泡Laboratoire GlaxoSmithKline国内上市的原研药品药品通用名称修订为“沙美特罗替卡松吸入粉雾剂”
21-112沙美特罗替卡松吸入粉雾剂Salmeterol Xinafoate and Fluticasone Propionate Powder for InhalationSeretide(舒利迭)50ug/250ug/泡Laboratoire GlaxoSmithKline国内上市的原研药品药品通用名称修订为“沙美特罗替卡松吸入粉雾剂”
21-113沙美特罗替卡松吸入粉雾剂Salmeterol Xinafoate and Fluticasone Propionate Powder for InhalationSeretide(舒利迭)50ug/500ug/泡Laboratoire GlaxoSmithKline国内上市的原研药品药品通用名称修订为“沙美特罗替卡松吸入粉雾剂”
21-116沙美特罗替卡松吸入气雾剂Salmeterol Xinafoate and Fluticasone Propionate AerosolSeretide(舒利迭)25ug/125ug/揿Laboratoire GlaxoSmithKline国内上市的原研药品药品通用名称修订为“沙美特罗替卡松吸入气雾剂”
22-122氟维司群注射液Fulvestrant InjectionFaslodex(芙仕得5ml:0.25gAstraZeneca UK Limited/AstraZeneca AB国内上市的原研药品持证商发生变更,增加变更后持证商AstraZeneca AB
23-217中长链脂肪乳/氨基酸(16)/葡萄糖(36%)注射液Medium and Long Chain Fat Emulsion,Amino Acids(16)and Glucose(36%) Injection-625mlB. Braun melsungen ag国际公认的同种药品英文名称修订为“Medium and Long Chain Fat Emulsion,Amino Acids(16)and Glucose(36%) Injection”
23-218中长链脂肪乳/氨基酸(16)/葡萄糖(36%)注射液Medium and Long Chain Fat Emulsion,Amino Acids(16)and Glucose(36%) Injection-1250mlB. Braun melsungen ag国际公认的同种药品英文名称修订为“Medium and Long Chain Fat Emulsion,Amino Acids(16)and Glucose(36%) Injection”
27-326琥珀酸索利那新片Solifenacin Succinate TabletsVesicare5mgAstellas Pharma US Inc未进口原研药品更新持证商为Astellas Pharma US Inc
27-327琥珀酸索利那新片Solifenacin Succinate TabletsVesicare10mgAstellas Pharma US Inc未进口原研药品更新持证商为Astellas Pharma US Inc


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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