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【第六十二批】仿制药参比制剂目录


【第六十二批】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
62-1波生坦分散片Bosentan Dispersible Tablets/Tracleer(全可利)32mgActelion Pharmaceuticals Ltd国内上市的原研药品原研进口
62-2西尼莫德片Siponimod Tablets/ Mayzent(万立能)0.25mg(按C58H70F6N4O6计)Novartis Pharma Ag/Novartis Pharma Schweiz AG国内上市的原研药品原研进口
62-3西尼莫德片Siponimod Tablets/ Mayzent(万立能)2mg(按C58H70F6N4O6计)Novartis Pharma Ag/Novartis Pharma Schweiz AG国内上市的原研药品原研进口
62-4达罗他胺片Darolutamide Tablets/ Nubeqa(诺倍戈)300mgBayer Healthcare Pharmaceuticals Inc.国内上市的原研药品原研进口
62-5复方电解质注射液Multiple Electrolytes Injection/勃脉力A500ml上海百特医疗用品有限公司经审核确定的国外原研企业在中国境内生产的药品原研地产化
62-6盐酸多佐胺马来酸噻吗洛尔滴眼液Dorzolamide Hydrochloride Timolol Maleate Eye Drops /Cosopt含多佐胺20mg/ml(2.0%)和噻吗洛尔5mg/ml(0.5%)Thea Pharma Inc未进口原研产品美国橙皮书
62-7锝[99mTc]喷替酸盐注射液Technetium[99mtc] Pentetate Injection / Draximage DtpaN/AJubilant Draximage Inc Dba Jubilant Radiopharma未进口原研药品美国橙皮书
62-8锝[99mTc]亚甲基二膦酸盐注射液Technetium[99mtc] Methylenediphosphonate Injection / Draximage Mdp-25N/AJubilant Draximage Inc Dba Jubilant Radiopharma未进口原研药品美国橙皮书
62-9锝[99mTc]甲氧异腈注射液Technetium[99mtc] Sestamibi Injection / CardioliteN/ALantheus Medical Imaging Inc未进口原研药品美国橙皮书
62-10血管紧张素II注射液Angiotensin II Injection/Giapreza2.5mg/mLLa Jolla Pharma Llc未进口原研药品美国橙皮书
62-11注射用西罗莫司(白蛋白结合型)Sirolimus Protein-Bound Particles For Injectable Suspension (Albumin-Bound)/Fyarro100mgAadi Bioscience Inc.未进口原研药品美国橙皮书
62-12注射用贝林司他Belinostat For Injection/ Beleodaq500mg/VialSpectrum Pharmaceuticals,Inc./Acrotech Biopharma Llc未进口原研药品美国橙皮书
62-13奥美拉唑镁/阿莫西林/利福布汀肠溶胶囊Amoxicillin;Omeprazole Magnesium;Rifabutin Enteric Capsules/Talicia奥美拉唑镁(相当于奥美拉唑10mg),阿莫西林250mg,利福布汀12.5mgRedhill Biopharma Ltd.未进口原研药品美国橙皮书
62-14硝唑尼特干混悬剂Nitazoxanide For Oral Suspension/Alinia100mg/5mlRomark Laboratories未进口原研药品美国橙皮书
62-15复方电解质注射液Multiple Electrolytes Injection, Type 1/ Plasma-Lyte A Injection PH7.4500ml、1000mlBaxter Healthcare Corporation未进口原研药品美国橙皮书
62-16盐酸维洛沙秦缓释胶囊Viloxazine Hydrochloride Extended-Release Capsules / Qelbree100mgSupernus Pharmaceuticals未进口原研药品美国橙皮书
62-17盐酸维洛沙秦缓释胶囊Viloxazine Hydrochloride Extended-Release Capsules / Qelbree150mgSupernus Pharmaceuticals未进口原研药品美国橙皮书
62-18盐酸维洛沙秦缓释胶囊Viloxazine Hydrochloride Extended-Release Capsules / Qelbree200mgSupernus Pharmaceuticals未进口原研药品美国橙皮书
62-19阿仑膦酸钠口服溶液Alendronate Sodium Tablets  SolutionEQ 70MG BASE /75MLHikma Pharmaceuticals Usa Inc国际公认的同种药品美国橙皮书
62-20利多卡因软膏Lidocaine Ointment/ Xylocaine5%Aspen Pharma Trading Limited未进口原研药品欧盟上市
62-21苯酰甲硝唑口服混悬液Metronidazole Benzoateoral Suspension / Flagyl125mg甲硝唑/5ml(相当于200mg苯酰甲硝唑/5ml)Sanofi-Aventis, S.A.未进口原研药品欧盟上市
62-22硝酸咪康唑阴道乳膏Miconazole Nitrate Vaginal Cream2%Janssen/Johnson & Johnson未进口原研药品欧盟上市
62-23高锝[99mTc]酸钠注射液Sodium Pertechnetate [99mtc] Injection / ウルトラテクネカウ0.925、1.85、2.78、3.70、4.63、5.55、7.40、11.1、14.8、18.5GBq(99Mo-99mTc发生器)富士フイルム富山化学株式会社/Pdrファーマ株式会社未进口原研药品日本上市
62-24维生素D口服溶液Vitamin D Oral Solution/Uvedose2ml:2.5mg(10万单位)Laboratoires Crinex未进口原研药品法国上市
62-25多种微量元素注射液(III)Multi-Trace Elements Injection (III)10mlFresenius Kabi Norge AS国内上市的原研药品原研进口
62-26醋酸艾替班特注射液Icatibant Acetate Injection3ml: 30mg (按C59H89N19O13S计)Shire Pharmaceuticals Ireland Limited国内上市的原研药原研进口
62-27利伐沙班干混悬剂Rivaroxaban Granules For Oral Suspension/ Xarelto51.7mgBayer AG国内上市的原研药品原研进口
62-28利伐沙班干混悬剂Rivaroxaban Granules For Oral Suspension/ Xarelto103.4mgBayer AG国内上市的原研药品原研进口
62-29环孢素滴眼液(III)Ciclosporin Eye Drops(III) 0.3ml:0.3mg (0.1%)Santen Oy国内上市的原研药品原研进口
62-30西洛他唑片Cilostazol Tablets/培达50mg浙江大冢制药有限公司经审核确定的国外原研企业在中国境内生产的药品原研地产化
62-31丙氨酰谷氨酰胺注射液Alanyl Glutamine Injection/力太100ml:20g费森尤斯卡比华瑞制药有限公司经审核确定的国外原研企业在中国境内生产的药品原研地产化
62-32盐酸奥洛他定滴眼液Olopatadine Hydrochloride Ophthalmic Solution/Pataday0.1%(5ml:5mg)Alcon Laboratories Inc未进口原研药品美国橙皮书
62-33低钙腹膜透析液(乳酸盐)Low Magnesium, Low Calcium Peritoneal Dialysis Solution含4.25%葡萄糖(2L/袋,5L/袋)Fresenius Medical Care North America未进口原研药品美国橙皮书
62-34低钙腹膜透析液(乳酸盐)Low Magnesium, Low Calcium Peritoneal Dialysis Solution含2.5%葡萄糖(2L/袋,5L/袋)Fresenius Medical Care North America未进口原研药品美国橙皮书
62-35低钙腹膜透析液(乳酸盐)Low Magnesium, Low Calcium Peritoneal Dialysis Solution含1.5%葡萄糖(2L/袋,5L/袋)Fresenius Medical Care North America未进口原研药品美国橙皮书
62-36噻托溴铵粉吸入剂Tiotropium Bromide Powder For Inhalation/Spiriva18ΜG(按噻托铵计,相当于噻托溴铵一水合物22.5ΜG)Boehringer Ingelheim International Gmbh未进口原研药品美国橙皮书
62-37亚甲蓝注射液Methylthionine Chloride Injection/ Provayblue50mg/10ml(5mg/ml)Provepharm SAS未进口原研药品美国橙皮书
62-38帕利哌酮缓释片Paliperidone Extend-Release Tablets9mgJanssen Pharmaceuticals, Inc.未进口原研药品美国橙皮书
62-39贝美前列素滴眼液Bimatoprost Eye Drops/Lumigan0.01%Allergan Inc.未进口原研药品美国橙皮书
62-40乙酰唑胺缓释胶囊Acetazolamide Extended-Release Capsules500mgCadila Healthcare Limited国际公认的同种药品美国橙皮书
62-41布地奈德福莫特罗吸入粉雾剂(I)Budesonide And Formoterol Fumarate Powder For Inhalation (I) / Symbicort Mite Turbuhaler每支60吸,每吸含布地奈德80μg和富马酸福莫特罗4.5μgAstrazeneca AB未进口原研药品欧盟上市
62-42布地奈德福莫特罗吸入粉雾剂(II)Budesonide And Formoterol Fumarate Powder For Inhalation (II) / Symbicort Turbuhaler每支60吸,每吸含布地奈德160μg和富马酸福莫特罗4.5μgAstrazeneca AB未进口原研药品欧盟上市
62-43布地奈德福莫特罗吸入粉雾剂(II)Budesonide And Formoterol Fumarate Powder For Inhalation (II) / Symbicort Turbuhaler每支120吸,每吸含布地奈德160μg和富马酸福莫特罗4.5μgAstrazeneca AB未进口原研药品欧盟上市
62-44布地奈德福莫特罗吸入粉雾剂(II)Budesonide And Formoterol Fumarate Powder For Inhalation (II) / Symbicort Forte Turbuhaler每支60吸,每吸含布地奈德320μg和富马酸福莫特罗9μgAstrazeneca AB未进口原研药品欧盟上市
62-45盐酸西替利嗪滴剂Cetirizine Dihydrochloride Oral Drops10mg/ml(20ml)UCB Pharma未进口原研药品欧盟上市
62-46克拉霉素缓释片Clarithromycin Modified-Release Tablets / Klacid SR)/ Klacid RM/ KLACID UNIDÍA/ Klacid SR/ Klacid Uno/ Klacid LA/ Klacid SR/ Biclar Uno/ Klacid XL500mgMylan Healthcare B.V./ Mylan Italia  S.R.L./ Mylan IRE Healthcare Limited/ MYLAN HEALTHCARE Gmbh/ Mylan Healthcare Sp. Z O.O./ Mylan IRE Healthcare Limited/ Mylan EPD Bvba/Sprl/ Mylan IRE Healthcare Limited未进口原研药品欧盟上市
62-47硝酸咪康唑乳膏Miconazole Nitrate Cream2%Janssen/Johnson & Johnson未进口原研药品欧盟上市
62-48枸橼酸西地那非注射液Sildenafil Citrate Injection/Revatio12.5ml:10mg(以西地那非计)Upjohn EESV未进口原研药品欧盟上市
62-49注射用盐酸兰地洛尔Landiolol Hydrochloride For Injection/Onoact12.5mg(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
62-50注射用盐酸兰地洛尔Landiolol Hydrochloride For Injection/Onoact150mg(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
62-51米格列奈钙片Mitiglinide Calcium Tablets/Glufast5mgKissei Pharmaceutical Co.,Ltd./キッセイ薬品工業株式会社未进口原研药品日本上市
62-52聚乙二醇钠钾散/复方聚乙二醇(3350)电解质散MOVICOL Chocolate 13.9g Sachet, Powder For Oral Solution/ MOVICOL13.9gNorgine Limited未进口原研药品英国上市
62-53乙酰半胱氨酸注射液Acetylcysteine Injection/Flumil /Fluimucil3ml:300mgZambon S.A.U /Zambon Gmbh未进口原研药品欧盟上市
62-54门冬氨酸帕瑞肽注射液Pasireotide Diaspeartate Injection1ml:0.6mgRecordati AG未进口原研药品瑞士上市
62-55熊去氧胆酸片Ursodeoxycholic Acid Tablets/ Delursan0.25gTEVA B.V.未进口原研药品法国上市
4-16布洛芬软胶囊Ibuprofen Soft Capsules/Advil0.2gPfizer Inc/ Glaxosmithkline Consumer Healthcare Holdings Us Llc美国橙皮书增加持证商Glaxosmithkline Consumer Healthcare Holdings Us Llc
7-64碳酸锂片Lithium Carbonate Tablets/TERALITHE0.25gSANOFI-AVENTIS France未进口原研药品不限定上市国及产地
8-71己酮可可碱缓释片Pentoxifylline  Modified Release Tablets/Trental400mgAventis Pharma Limited/Sanofi/Sanofi-Produtos Farmaceuticos Lda欧盟上市增加持证商Sanofi-Produtos Farmaceuticos Lda
23-349盐酸多柔比星脂质体注射液Doxorubicin Hydrochloride Liposome Injection/Caelyx /Caelyx Pegylated Liposomal10ml:20mgJanssen-Cilag International NV /Baxter Holding B.V.未进口原研药品增加持证商Baxter Holding B.V.;增加商品名Caelyx Pegylated Liposomal
23-350盐酸多柔比星脂质体注射液Doxorubicin Hydrochloride Liposome Injection/Caelyx /Caelyx Pegylated Liposomal25ml:50mgJanssen-Cilag International NV /Baxter Holding B.V.未进口原研药品增加持证商Baxter Holding B.V.;增加商品名Caelyx Pegylated Liposomal
53-71特立齐酮胶囊Terizidon Capsules250mgRiemser Pharma Gmbh/Esteve Pharmaceuticals Gmbh国际公认的同种药品持证商发生变更,增加变更后的持证商Esteve Pharmaceuticals Gmbh
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/ Galderma International S.A.S/ Galderma International/ Galderma Benelux B.V./ Galderma Laboratorium Gmbh/ Laboratorios Galderma S.A./ Galderma Italia S.P.A./ Galderma (UK) Limited未进口原研药品增加持证商Galderma International S.A.S/ Galderma International/ Galderma Benelux B.V./ Galderma Laboratorium Gmbh/ Laboratorios Galderma S.A./ Galderma Italia S.P.A./ Galderma (UK) Limited
8-218他达拉非片Tadalafil Tablets/Cialis5mgEli Lilly Nederland B.V./A. Menarini GmbH原研进口持证商变更,增加变更后持证商A. Menarini GmbH
16-4他达拉非片Tadalafil Tablets/CIALIS20mgEli Lilly Nederland B.V./A. Menarini GmbH原研进口持证商变更,增加变更后持证商A. Menarini GmbH
16-5他达拉非片Tadalafil Tablets/CIALIS10mgEli Lilly Nederland B.V./A. Menarini GmbH原研进口持证商变更,增加变更后持证商A. Menarini GmbH
16-6他达拉非片Tadalafil Tablets/CIALIS2.5mgEli Lilly Nederland B.V./A. Menarini GmbH原研进口持证商变更,增加变更后持证商A. Menarini GmbH
22-228注射用盐酸美法仑Melphalan Hydrochloride for Injection/EVOMELA(迈维宁)50mgSpectrum Pharmaceuticals, Inc./ Acrotech Biopharma,LLC      国内上市的原研药品持证商变更,增加变更后持证商Acrotech Biopharma,LLC      
23-67咪唑斯汀缓释片Mizolastine Sustained Release Tablets /Mizollen(皿治林)10mgTherabel Pharmaceuticals Limited/ Therabel Healthcare Limited国内上市的原研药品持证商变更,增加变更后持证商Therabel Healthcare Limited
24-62恩他卡朋片Entacapone Tablets/Comtan(珂丹)0.2gOrion Pharma AG/Orion Corporation国内上市的原研药品持证商变更,增加变更后持证商Orion Corporation
27-426氨氯地平贝那普利胶囊Amlodipine and Benazepril Hydrochloride Capsules/Lotrel氨氯地平5mg;盐酸贝那普利10mgNovartis Pharmaceuticals Corp未进口原研药品英文名称更新为Amlodipine and Benazepril Hydrochloride Capsules
备注1.目录中所列尚未在国内上市品种的通用名、剂型等,以药典委核准的为准。
2.参比制剂目录公示后,未正式发布的品种将进行专题研究,根据研究结果另行发布。
3.欧盟上市的参比制剂包括其在英国上市的同一药品。
4.选择未进口参比制剂开展仿制药研究除满足其质量要求外,还需满足现行版《中国药典》和相关指导原则要求。
5.放射性药物不同于普通化学药物,具有一定的特殊性如放射性、时效性、按放射性活度给药等特点,参比制剂主要用于明确其研发目标和基本要求,可根据其药物特性同时结合参比制剂的可获得性进行研究。


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