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国家药监局发布仿制药参比制剂目录(第七十四批)-爱游戏app官方网站
2024年01月12日

经国家药品监督管理局仿制药质量和疗效一致性评价专家委员会审核确定,现发布仿制药参比制剂目录(第七十四批)。  特此通告。  附件:化学仿制药参比制剂目录(第七十四批)序号药品通用名英文名规格持证商备注1备注2替戈拉生片Tegoprazan Tablets50mg山东罗欣药业集团股份有限公司国内上市原研产品 维奈克拉片Venetoclax Tablets/唯可来10mgAbbVie Inc.国内上市的原研药品原研进口维奈克拉片Venetoclax Tablets/唯可来50mgAbbVie Inc.国内上市的原研药品原研进口维奈克拉片Venetoclax Tablets/唯可来100mgAbbVie Inc.国内上市的原研药品原研进口拉替拉韦钾片Raltegravir Potassium Tablets/ISENTRESS(艾生特)400mg(按C20H20FN6O5计)Merck Sharp & Dohme B.V.国内上市的原研药品原研进口茚达格莫吸入粉雾剂(II)Indacaterol Acetate, Glycopyrronium Bromide and Mometasone Furoate Powder for Inhalation(II)每粒含醋酸茚达特罗150μg(以C₂₄H₂₈N₂O₃计)、格隆溴铵50μg(以C₁₉H₂₈NO₃计)和糠酸莫米松160μgNovartis Pharma AG国内上市的原研药品原研进口茚达格莫吸入粉雾剂(I)Indacaterol Acetate, Glycopyrronium Bromide and Mometasone Furoate Powder for Inhalation(I)每粒含醋酸茚达特罗150μg(以C₂₄H₂₈N₂O₃计)、格隆溴铵50μg(以C₁₉H₂₈NO₃计)和糠酸莫米松80μgNovartisPharma AG国内上市的原研药品原研进口复方肝素钠尿囊素凝胶Compound Heparin Sodium and Allantoin Gel/康瑞保每100g含10.0克洋葱提取物,5000IU肝素钠,1.0克尿囊素Merz Pharmaceuticals GmbH国内上市的原研药品原研进口氟[18F]妥司特注射液Flotufolastat F-18 Gallium Injection296 -5846 MBq/ml (8 - 158 mCi/ml)Blue Earth Diagnostics Ltd.未进口原研药品美国橙皮书维生素B12注射液Cyanocobalamin Injection1ml:1mgAMERICAN REGENT, INC.未进口原研药品美国橙皮书盐酸沙丙蝶呤散剂Sapropterin dihydrochloride power for oral solution/ KUVAN®100mgBioMarin Pharmaceutical Inc.未进口原研药品美国橙皮书硫普罗宁肠溶片Tiopronin Enteric-coated Tablets/THIOLA EC100mgMISSION PHARMACAL CO未进口原研药品美国橙皮书苯磺酸氨氯地平口服溶液Amlodipine besylate oral solution / NORLIQVA1mg/mlCMP DEVELOPMENT LLC未进口原研药品美国橙皮书氨氯地平缬沙坦氢氯噻嗪片Amlodipine, Valsartan, and Hydrochlorothiazide Tablets/Exforge HCT5/160/12.5mg:每片含氨氯地平5mg、缬沙坦160mg与氢氯噻嗪12.5mgNovartis Europharm Limited未进口原研药品欧盟上市联苯乙酸贴剂Felbinac tape/Seltouch Tapes70mg/贴帝國製薬株式会社未进口原研药品日本上市缬沙坦口崩片Valsartan Orally Disintegrating Tablets /DIOVAN20mg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缬沙坦口崩片Valsartan Orally Disintegrating Tablets /DIOVAN40mg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缬沙坦口崩片Valsartan Orally Disintegrating Tablets /DIOVAN80mg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缬沙坦口崩片Valsartan Orally Disintegrating Tablets /DIOVAN160mg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匹伐他汀钙口崩片Pitavastatin Calcium Orally Disintegrating Tablets/Livalo OD1mg興和株式会社未进口原研药品日本上市匹伐他汀钙口崩片Pitavastatin Calcium Orally Disintegrating Tablets/Livalo OD2mg興和株式会社未进口原研药品日本上市匹伐他汀钙口崩片Pitavastatin Calcium Orally Disintegrating Tablets/Livalo OD4mg興和株式会社未进口原研药品日本上市茚达特罗莫米松吸入粉雾剂(I)Indacaterol Acetate and Mometasone Furoate Powder for Inhalation(I)每粒含醋酸茚达特罗150μg(以C₂₄H₂₈N₂O₃计)和糠酸莫米松80μgNovartis Pharma AG/Grand Medical Pty Ltd.国内上市的原研药品原研进口茚达特罗莫米松吸入粉雾剂(II)Indacaterol Acetate and Mometasone Furoate Powder for Inhalation(Ⅱ)每粒含醋酸茚达特罗150μg(以C₂₄H₂₈N₂O₃计)和糠酸莫米松160μgNovartis Pharma AG/Grand Medical Pty Ltd.国内上市的原研药品原研进口茚达特罗莫米松吸入粉雾剂(III)Indacaterol Acetate and Mometasone Furoate Powder for Inhalation(III)每粒含醋酸茚达特罗150μg(以C₂₄H₂₈N₂O₃计)和糠酸莫米松320μgNovartis Pharma AG/Grand Medical Pty Ltd.国内上市的原研药品原研进口二十碳五烯酸乙酯软胶囊Icosapent Ethyl Soft Capsules1.0gAmarin Pharmaceuticals Ireland Ltd.国内上市的原研药品原研进口西罗莫司凝胶Sirolimus Gel0.2%(10g:20mg)Nobelpharma Co., Ltd.国内上市的原研药品原研进口注射用两性霉素B脂质体Amphotericin B Liposome for Injection50mg(5万单位)Gilead Sciences Ireland UC国内上市的原研药品原研进口甲氨蝶呤注射液Methotrexate Injection50mg/2mlPfizer Australia Pty Ltd国内上市的原研药品原研进口丙戊酸钠口服溶液Sodium Valproate Oral Solution/德巴金300ml:12g赛诺菲(杭州)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硝普钠注射液Sodium Nitroprusside Injection2ml:6mg丸石製薬株式会社未进口原研药品日本上市硝普钠注射液Sodium Nitroprusside Injection10ml:30mg丸石製薬株式会社未进口原研药品日本上市7-90叶酸片Folic Acid Tablets/SPECIAFOLDINE5mgMERUS LABS LUXCO S.à R.L/ MERUS LABS LUXCO Ⅱ S.à R.L.欧盟上市增加上市许可持有人MERUS LABS LUXCO Ⅱ S.à R.L,不限定上市国8-71己酮可可碱缓释片Pentoxifylline Modified Release Tablets/Trental400mgAventis Pharma Limited/Sanofi/ Sanofi-Produtos Farmaceuticos Lda/ Sanofi-Aventis Deutschland GmbH欧盟上市增加上市许可持有人Sanofi-Aventis Deutschland GmbH8-97米氮平片Mirtazapine Tablets/Remeron15mgORGANON USA INC/ORGANON USA LLC美国橙皮书增加上市许可持有人ORGANON USA LLC8-265呋喃妥因胶囊Nitrofurantoin Macrocrystals Capsules/Macrodantin50mgALVOGEN MALTA OPERATIONS LTD/Almatica Pharma LLC美国橙皮书增加上市许可持有人Almatica Pharma LLC8-266呋喃妥因胶囊Nitrofurantoin Macrocrystals Capsules/Macrodantin100mgALVOGEN MALTA OPERATIONS LTD/Almatica Pharma LLC美国橙皮书增加上市许可持有人Almatica Pharma LLC 10-71坎地氢噻片Candesartan Cilexetil and Hydrochlorothiazide Tablets/Blopress每片含坎地沙坦酯16mg,氢氯噻嗪12.5mgTakeda GmbH/ CHEPLAPHARM Arzneimittel GmbH欧盟上市(上市国家:德国;产地:意大利)增加上市许可持有人CHEPLAPHARM Arzneimittel GmbH10-72坎地氢噻片Candesartan Cilexetil and Hydrochlorothiazide Tablets/Blopress每片含坎地沙坦酯8mg,氢氯噻嗪12.5mgTakeda GmbH/ CHEPLAPHARM Arzneimittel GmbH欧盟上市(上市国家:德国;产地:意大利)增加上市许可持有人CHEPLAPHARM Arzneimittel GmbH17-4阿莫西林克拉维酸钾干糖浆(14:1)CLAVAMOX Dry Syrup642.9mg(1.01g)Glaxo Smithkline K.K.日本橙皮书修订规格表述为642.9mg(1.01g)23-161盐酸林可霉素注射液Lincomycin Injection/LincocinEq 300mg Base/Ml(以C18H34N2O6S计)(1ml、2ml、10ml)Pharmacia And Upjohn Co/Pfizer Inc未进口原研药品增加上市许可持有人Pfizer Inc23-285碳酸镧咀嚼片Lanthanum Carbonate Chewable Tablets/Fosrenol/Foznol1000mgShire Pharmaceutical Contracts Ltd/Takeda Pharmaceuticals International AG Ireland Branch/ Takeda UK Ltd未进口原研药品增加上市许可持有人Takeda Pharmaceuticals International AG Ireland Branch/Takeda UK Ltd23-323盐酸左西替利嗪口服溶液Levocetirizine dihydrochloride Oral Solution0.05%(75ml、150ml、200ml)UCB Pharma GmbH/ UCB Pharma Limited/ UCB s.r.o./ UCB Pharma Oy Finland未进口原研药品增加上市许可持有人UCB Pharma GmbH/ UCB Pharma Limited/ UCB s.r.o./UCB Pharma Oy Finland24-104培哚普利氨氯地平片(I)Perindopril Arginine And Amlodipine besilate Tablets(I)/开素达(Coveram)每片含精氨酸培哚普利5mg和苯磺酸氨氯地平(以氨氯地平计)5mgLes Laboratoires Servier国内上市的原研药英文名由Perindopril Arginine And Amlodipine Besylate Tablets(I)更新为Perindopril Arginine And Amlodipine besilate Tablets(I)24-105培哚普利氨氯地平片(I)Perindopril Arginine And Amlodipine besilate Tablets(I)/开素达(Coveram)每片含精氨酸培哚普利10mg和苯磺酸氨氯地平(以氨氯地平计)10mgLes Laboratoires Servier国内上市的原研药英文名由Perindopril Arginine And Amlodipine Besylate Tablets(I)更新为Perindopril Arginine And Amlodipine besilate Tablets(I)24-106培哚普利氨氯地平片(Ⅱ)Perindopril Arginine And Amlodipine besilate Tablets(II)/开素达(Coveram)每片含精氨酸培哚普利5mg和苯磺酸氨氯地平(以氨氯地平计)10mgLes Laboratoires Servier国内上市的原研药英文名由Perindopril Arginine And Amlodipine Besylate Tablets(II)更新为Perindopril Arginine And Amlodipine besilate Tablets(II)24-107培哚普利氨氯地平片(III)Perindopril Arginine And Amlodipine besilate Tablets(III)/开素达(Coveram)每片含精氨酸培哚普利10mg和苯磺酸氨氯地平(以氨氯地平计)5mgLes Laboratoires Servier国内上市的原研药英文名由Perindopril Arginine And Amlodipine Besylate Tablets(III)更新为Perindopril Arginine And Amlodipine besilate Tablets(III)24-190阿莫西林胶囊Amoxicillin Capsules/Clamoxyl500mgGlaxosmithkline/GlaxoSmithKline Pharmaceuticals s.a./n.v.未进口原研药品增加上市许可持有人GlaxoSmithKline Pharmaceuticals s.a./n.v.26-4色甘酸钠滴眼液Sodium Cromoglicate Eye Drops/Opticrom; Lomudal;Alleoptical2%或20mg/ml(以色甘酸钠计)包装规格5、10、13.5、0.3、0.35mlSanofi/ Sanofi-Aventis/ Melisana sa/ Opella Healthcare France SAST/ A Sanofi未进口原研药品增加上市许可持有人Opella Healthcare France SAS T/ A Sanofi26-63氨溴特罗口服溶液Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution/Spasmo-Mucosolvan Saft1ml:盐酸氨溴索1.5mg与盐酸克仑特罗1μgSanofi-Aventis Deutschland GmbH./ A. Nattermann & Cie. GmbH未进口原研药品增加上市许可持有人A. Nattermann & Cie. GmbH,不限定包装规格26-86盐酸氨溴索滴剂Ambroxol Hydrochloride Drops/Mucosolvan30mg/2mlSanofi-Aventis Deutschland GmbH/ A. Nattermann & Cie. GmbH未进口原研药品增加上市许可持有人A. Nattermann & Cie. GmbH,不限定包装规格27-319度他雄胺软胶囊Dutasteride Soft Capsules/Avodart0.5mgGlaxoSmithKline/ Woodward Pharma Services LLC未进口原研药品增加上市许可持有人GlaxoSmithKline/Woodward Pharma Services LLC38-43苯磺酸氨氯地平片Amlodipine Besylate Tablets10mg(以C20H25CLN2O5计)Pfizer/Viatris Netherlands bv未进口原研药品增加上市许可持有人Viatris Netherlands bv41-14盐酸达克罗宁局部溶液剂Dyclonine Hydrochloride Topical Solution/Dyclopro0.50%Novocol Inc /SEPTODONT INC国际公认的同种药品更新英文名为Dyclonine Hydrochloride Topical Solution,增加上市许可持有人SEPTODONT INC41-15盐酸达克罗宁局部溶液剂Dyclonine Hydrochloride Topical Solution/Dyclopro1%Novocol Inc /SEPTODONT INC国际公认的同种药品更新英文名为Dyclonine Hydrochloride Topical Solution,增加上市许可持有人SEPTODONT INC49-17盐酸苯海拉明注射液Diphenhydramine Hydrochloride Injection1mL:50mgWest-Ward Pharmaceuticals International Ltd/Hikma Pharmaceuticals USA Inc国际公认的同种药品增加上市许可持有人Hikma Pharmaceuticals USA Inc54-59聚甲酚磺醛溶液Policresulen Solution/Albothyl36%(w/w)Orifarm Healthcare A/S未进口原研药品增加上市许可持有人Takeda Gmb/HOrifarm Healthcare A/S59-66乙酰半胱氨酸注射液Acetylcysteine Injection/Fluimucil25ml:5gZambon Switzerland Ltd/ Zambon Schweiz AG/ Zambon Suisse SA/ Zambon Svizzera SA未进口原研药品增加上市许可持有人Zambon Schweiz AG/ Zambon Suisse SA/ Zambon Svizzera SA62-53乙酰半胱氨酸注射液Acetylcysteine Injection/Flumil /Fluimucil3ml:300mgZambon S.A.U / Zambon Gmbh/ Zambon Italia S.R.L.未进口原研药品增加上市许可持有人Zambon Italia S.R.L.66-14聚乙烯醇滴眼液Polyvinyl Alcohol Eye Drops/ Liquifilm1.4%(0.4ml:5.6mg)(以聚乙烯醇计)ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED/ AbbVie Logistics B.V.未进口原研药品增加上市许可持有人AbbVie Logistics B.V.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。  国家药监局  2023年12月19日

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