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【第五十六批】仿制药参比制剂目录


【第五十六批】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
56-1吸入用乙酰半胱氨酸溶液Acetylcysteine  Solution For Inhalation/Fluimucil(富露施)3ml:0.3gZambon Italia S.R.L国际公认的同种药品国际公认进口
56-2注射用多特安肽药盒Kit For The Preparation Of Gallium Ga 68 Dotatate Injection/ Netspot2.1~5.5mci/MlAdvanced Accelerator Applications Usa Inc未进口原研药品美国橙皮书
56-3镓[68Ga]多特安肽注射液Gallium[68Ga ] Dotatate Injection /Netspot2.1-5.5 Mci/MlAdvanced Accelerator Applications Usa Inc未进口原研药品美国橙皮书
56-4醋酸亮丙瑞林注射用混悬剂Leuprolide Acetate For Injectable Suspension/Eligard7.5mgTolmar Pharmaceuticals, Inc.未进口原研药品美国橙皮书
56-5艾曲泊帕乙醇胺干混悬剂Eltrombopag Lamine For Oral Suspension/ Promacta Kit25mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
56-6艾曲泊帕乙醇胺干混悬剂Eltrombopag Lamine For Oral Suspension/ Promacta Kit12.5mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
56-7盐酸地尔硫卓缓释片Diltiazem Hydrochloride Extended-Release Tablets/Cardizem La120mgBausch Health Us Llc未进口原研药品美国橙皮书
56-8盐酸地尔硫卓缓释片Diltiazem Hydrochloride Extended-Release Tablets/Cardizem La180mgBausch Health Us Llc未进口原研药品美国橙皮书
56-9盐酸地尔硫卓缓释片Diltiazem Hydrochloride Extended-Release Tablets/ Cardizem La240mgBausch Health Us Llc未进口原研药品美国橙皮书
56-10盐酸地尔硫卓缓释片Diltiazem Hydrochloride Extended-Release Tablets/ Cardizem La300mgBausch Health Us Llc未进口原研药品美国橙皮书
56-11盐酸地尔硫卓缓释片Diltiazem Hydrochloride Extended-Release Tablets/ Cardizem La360mgBausch Health Us Llc未进口原研药品美国橙皮书
56-12美沙拉嗪缓释胶囊Mesalamine Extended-Release Capsules / Apriso375mgValeant Pharmaceuticals International未进口原研药品美国橙皮书
56-13卢非酰胺口服混悬液Rufinamide Oral Suspension/Banzel40mg/MlEisai Inc未进口原研药品美国橙皮书
56-14壬二酸乳膏Azelaic Acid Cream/Azelex20%Almirall Llc未进口原研药品美国橙皮书
56-15盐酸毛果芸香碱滴眼液Pilocarpine Hydrochloride Ophthalmic Solution /Vuity1.25%Abbvie Inc未进口原研药品美国橙皮书
56-16异丙托溴铵沙丁胺醇吸入喷雾剂Ipratropium Bromide And Salbutamol Inhalation Spray20/100微克/揿Boehringer Ingelheim Pharmaceuticals,Inc.未进口原研药品美国橙皮书
56-17布地奈德吸入粉雾剂Budesonide Inhalation Powder/Pulmicort Flexhaler0.16 Mg/吸(标定剂量0.18 Mg/吸)Astrazeneca LP未进口原研药品美国橙皮书
56-18布地奈德吸入粉雾剂Budesonide Inhalation Powder/Pulmicort Flexhaler0.08 Mg/吸(标定剂量0.09 Mg/吸)Astrazeneca LP未进口原研药品美国橙皮书
56-19噻托溴铵吸入喷雾剂Tiotropium Bromide Inhalation Spray/Spiriva Respimat1.25mcg/揿Boehringer Ingelheim Pharmaceuticals,Inc.未进口原研药品美国橙皮书
56-20复合磷酸氢钾注射液Potassium Phosphates Injection1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)Fresenius Kabi USA LLC未进口原研药品美国橙皮书
56-21氯化钾注射液Potassium Chloride Injection20 Meq/10 MlHospira, Inc.国际公认的同种药物美国橙皮书
56-22氯化钾注射液Potassium Chloride Injection40 Meq/20 MlHospira, Inc.国际公认的同种药物美国橙皮书
56-23乙酰半胱氨酸注射液Acetylcysteine Injection/ Hidonac AntÍDoto25ml:5gZambon, S.A.U.未进口原研药品欧盟上市
56-24对乙酰氨基酚布洛芬口服混悬液Paracetamol And Ibuprofen Oral Suspension / Tachifenekid每毫升含对乙酰氨基酚32mg,布洛芬9.6mgAziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.P.A未进口原研药品欧盟上市
56-25复方聚乙二醇(3350)电解质散MOVICOL Paediatric Plain 6.9 G Sachet, Powder For Oral Solution6.9g/袋,含聚乙二醇3350 6.563g;氯化钠0.1754g;碳酸氢钠0.0893g;氯化钾0.0251gNorgine Pharmaceuticals Limited未进口原研药品欧盟上市
56-26复方聚乙二醇(3350)电解质口服溶液MOVICOL Ready To Take Sachet, Powder For Oral Solution25ml/袋,每袋含:聚乙二醇3350 13.125 G;氯化钠 0.3508 G;氯化钾 0.0502 G;碳酸氢钠 0.1786 GNorgine Pharmaceuticals Limited未进口原研药品欧盟上市
56-27克林霉素磷酸酯凝胶Clindamycin Phosphate Gel / Dalacin T1%Pfizer Italia S.R.L.未进口原研药品欧盟上市
56-28富马酸酮替芬滴眼液Ketotifen Fumarate Ophthalmic Solution/Zaditen0.025%(0.4ml)Laboratoires Théa未进口原研药品欧盟上市
56-29注射用培门冬酶Pegaspargase For Injection / Oncaspar3750U(750U/Ml)Les Laboratories Servier未进口原研药品欧盟上市
56-30复方电解质醋酸钠注射液Multiple Electrolytes and Sodium Acetate Injection/Ionolyte500mlFresenius Kabi Nederland BV/Fresenius Kabi Pharma Portugal, Lda
欧盟上市
56-31西罗莫司外用凝胶Sirolimus Topical Gel /Rapalimus0.20%ノーベルファーマ株式会社未进口原研药品日本上市
56-32醋酸葡萄糖维持液Acetate And Glucose  Electrolytes Injection / Veen-3G Inj200ml扶桑薬品工業株式会社未进口原研药品日本上市
56-33醋酸葡萄糖维持液Acetate And Glucose  Electrolytes Injection / Veen-3G Inj500ml扶桑薬品工業株式会社未进口原研药品日本上市
56-34碳酸氢钠林格注射液Sodium Bicarbonate Ringer’s Injection/Bicanate500ml株式会社大塚製薬工場未进口原研药品日本上市
56-35低钙腹膜透析液(乳酸盐- G1.76%)Low Calcium Peritoneal Dialysis Solution (Lactate)/PERISATE360NL2000mlJMS株式会社未进口原研药品日本上市
56-36低钙腹膜透析液(乳酸盐- G2.55%)Low Calcium Peritoneal Dialysis Solution (Lactate)/PERISATE400NL2000mlJMS株式会社未进口原研药品日本上市
56-37盐酸普罗帕酮注射液Propafenone Hydrochloride Injection/Rytmonorm70mg/20mlMylan Healthcare Gmbh未进口原研药品德国上市
56-38盐酸丁卡因凝胶Tetracaine Hydrochloride Gel / Ametop4%(以丁卡因计)Alliance Pharmaceuticals Limited未进口原研药品英国上市
56-39盐酸奈福泮注射液Nefopam Hydrochloride Injection/Acupan2ml:20mgBiocodex未进口原研药品法国上市
56-40他氟前列素滴眼液Tafluprost Eye Drops/Tapros(泰普罗斯)0.0015%(0.3ml:4.5μg)Santen Pharmaceutical Co., Ltd.国内上市的原研药品原研进口
56-41盐酸奥洛他定滴眼液Olopatadine Hydrochloride Eye Drops0.2%(2.5ml:5mg,按C21H23NO3计)Novartis Pharmaceuticals Corporation国内上市的原研药品原研进口
56-42艾地骨化醇软胶囊Eldecalcitol Soft Capsules0.5μgChugai Pharmaceutical Co.,Ltd国内上市的原研药品原研进口
56-43艾地骨化醇软胶囊Eldecalcitol Soft Capsules0.75μgChugai Pharmaceutical Co.,Ltd国内上市的原研药品原研进口
56-44氨苯砜凝胶Dapsone Gel/Aczone7.50%Almirall, LLC未进口原研药品美国橙皮书
56-45左卡尼汀注射液Levocarnitine Injection/ Carnitor200mg/mlLeadiant Biosciences Inc未进口原研药品美国橙皮书
56-46瑞舒伐他汀钙片Rosuvastatin Calcium Tables/Crestor5mgAstrazeneca Pharmaceuticals LP/ IPR Pharmaceuticals Inc未进口原研药品美国橙皮书
56-47瑞舒伐他汀钙片Rosuvastatin Calcium Tables/Crestor10mgAstrazeneca Pharmaceuticals LP/ IPR Pharmaceuticals Inc未进口原研药品美国橙皮书
56-48左甲状腺素钠片Levothyroxine Sodium Tablets /Synthroid25μgAbbvie Inc.未进口原研药品美国橙皮书
56-49左甲状腺素钠片Levothyroxine Sodium Tablets /Synthroid50μgAbbvie Inc.未进口原研药品美国橙皮书
56-50左甲状腺素钠片Levothyroxine Sodium Tablets /Synthroid100μgAbbvie Inc.未进口原研药品美国橙皮书
56-51左甲状腺素钠片Levothyroxine Sodium Tablets /Synthroid200μgAbbvie Inc.未进口原研药品美国橙皮书
56-52左甲状腺素钠片Levothyroxine Sodium Tablets /Synthroid300μgAbbvie Inc.未进口原研药品美国橙皮书
56-53左甲状腺素钠片Levothyroxine Sodium Tablets/Unithroid50 μgSTEVENS J未进口原研药品美国橙皮书
56-54左甲状腺素钠片Levothyroxine Sodium Tablets/Unithroid100 μgSTEVENS J未进口原研药品美国橙皮书
56-55左甲状腺素钠片Levothyroxine Sodium Tablets/Unithroid200 μgSTEVENS J未进口原研药品美国橙皮书
56-56左甲状腺素钠片Levothyroxine Sodium Tablets/Unithroid300μgSTEVENS J未进口原研药品美国橙皮书
56-57依折麦布瑞舒伐他汀钙片Rosuvastatin And Ezetimibe Tablets/ ROSZET依折麦布10mg/瑞舒伐他汀10mgAlthera Pharmaceuticals LLC未进口原研药品美国橙皮书
56-58依折麦布瑞舒伐他汀钙片Rosuvastatin And Ezetimibe Tablets/ ROSZET依折麦布10mg/瑞舒伐他汀5mgAlthera Pharmaceuticals LLC未进口原研药品美国橙皮书
56-59甲磺酸多沙唑嗪缓释片Doxazosin Mesylate Extended Release Tablets/cardura xl4mgUPJOHN US 1 LLC未进口原研药品美国橙皮书
56-60普瑞巴林胶囊Pregabalin Capsules/Lyrica200mgUPJOHN US 2 LLC未进口原研药品美国橙皮书
56-61阿达帕林过氧苯甲酰凝胶Adapalene And Benzoyl Peroxide Gel/Epiduo0.1%;2.5%(包装规格:2g、45g/管,45g/Pump)Galderma Laboratories LP未进口原研药品美国橙皮书
56-62阿达帕林过氧苯甲酰凝胶Adapalene And Benzoyl Peroxide Gel/Epiduo0.1%;2.5%(包装规格:5g、15g、30g、45g、60g、90g/管和15g、30g、45g、60g/Pump)Galderma Nordic AB未进口原研药品欧盟上市
56-63泊沙康唑口服混悬液Posaconazole Oral Suspension/Noxafil40mg/mlMerck Sharp And Dohme B.V.未进口原研药品欧盟上市 
56-64溴夫定片Brivudine Tablets/ Zostex125mgBerlin-Chemie AG未进口原研药品欧盟上市
56-65达格列净片Dapagliflozin Tablets /FORXIGA5mgAstra Zeneca AB未进口原研药品欧盟上市
56-66精氨酸培哚普利片Perindopril Arginine Tablets/Coversyl5mgLes Laboratoires Servier未进口原研药品欧盟上市 
56-67精氨酸培哚普利片Perindopril Arginine Tablets/Coversyl10mgLes Laboratoires Servier未进口原研药品欧盟上市 
56-68美沙拉秦栓Mesalazine Suppositories/Salofalk1gDr. Falk Pharma Gmbh未进口原研药品欧盟上市
56-69盐酸依匹斯汀滴眼液Epinastine Hydrochloride Ophthalmic Solution/Aleison LX0.1%(5mg:5ml)Santen Pharmaceutical Co., Ltd.未进口原研药品日本上市 
56-70卡络磺钠注射液Carbazochrome Sodium Sulfonate Injection/Adona2ml:10mgニプロ ES ファーマ株式会社未进口原研药品日本上市
56-71倍他洛尔滴眼液Betaxolol Hydrochloride Ophthalmic Solution/Betoptic0.50%ノバルティスファーマ株式会社未进口原研药品日本上市
56-72吡格列酮二甲双胍片 Pioglitazone Hydrochloride And Metformin Hydrochloride Tablets (15mg/500mg)/メタクト 配合錠LD15mg/500mg武田テバ薬品株式会社未进口原研药品日本上市 
56-73注射用氟氯西林钠Flucloxacillin Sodium For Injection/Floxapen500mg(以C19H17CLFN3O5S计)Teva Pharma AG,Basel未进口原研药品瑞士上市
56-74注射用氟氯西林钠Flucloxacillin Sodium For Injection/Floxapen1g(以C19H17CLFN3O5S计)Teva Pharma AG,Basel未进口原研药品瑞士上市
27-465卡贝缩宫素注射液Carbetocin Injection/Pabal1ml:100μgFerring Pharmaceuticals Ltd/Ferring Arzneimittel Gmbh未进口原研药品增加持证商Ferring Arzneimittel Gmbh
24- 38 注射用厄他培南Ertapenem For Injection/Invanz(怡万之)1g(以厄他培南计)Merck Sharp & Dohme Limited/ Merck Sharp & Dohme B.V.国内上市的原研药品持证商发生变更,增加变更后的持证商Merck Sharp & Dohme B.V.


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