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第七十批仿制药参比目录




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
70-1环硅酸锆钠散Sodium Zirconium Cyclosilicate Powder/利倍卓® /LOKELMA ®5gAstraZeneca AB国内上市的原研药品原研进口
70-2环硅酸锆钠散Sodium Zirconium Cyclosilicate Powder/利倍卓® /LOKELMA ®10gAstraZeneca AB国内上市的原研药品原研进口
70-3硫酸瑞美吉泮口崩片Rimegepant Sulfate/Nurtec Odt75mgBiohaven Pharmaceutical Ireland Designated Activity Co/Pfizer Inc未进口原研药品美国橙皮书
70-4氨氯地平缬沙坦氢氯噻嗪片Amlodipine, Valsartan, and Hydrochlorothiazide Tablets/Exforge HCT5/160/12.5 mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
70-5氨氯地平缬沙坦氢氯噻嗪片Amlodipine, Valsartan, and  Hydrochlorothiazide Tablets/Exforge HCT10/160/12.5 mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
70-6氨氯地平缬沙坦氢氯噻嗪片Amlodipine, Valsartan, and  Hydrochlorothiazide Tablets/Exforge HCT5/160/25 mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
70-7氨氯地平缬沙坦氢氯噻嗪片Amlodipine, Valsartan, and  Hydrochlorothiazide Tablets/Exforge HCT10/160/25 mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
70-8氨氯地平缬沙坦氢氯噻嗪片Amlodipine, Valsartan, and  Hydrochlorothiazide Tablets/Exforge HCT10/320/25 mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
70-9奥氮平萨米多芬片Olanzapine and Samidorphan tablets / LYBALVI®5mg/10mg(奥氮平/萨米多芬)Alkermes,Inc.未进口原研药品美国橙皮书
70-10奥氮平萨米多芬片Olanzapine and Samidorphan tablets / LYBALVI®10mg/10mg(奥氮平/萨米多芬)Alkermes,Inc.未进口原研药品美国橙皮书
70-11奥氮平萨米多芬片Olanzapine and Samidorphan tablets / LYBALVI®15mg/10mg(奥氮平/萨米多芬)Alkermes,Inc.未进口原研药品美国橙皮书
70-12奥氮平萨米多芬片Olanzapine and Samidorphan tablets / LYBALVI®20mg/10mg (奥氮平/萨米多芬)Alkermes,Inc.未进口原研药品美国橙皮书
70-13注射用替马西普Lymphoseek 50 micrograms kit for radiopharmaceutical preparation tilmanocept/Lymphoseek50 µg(以替马西普计)Navidea Biopharmaceuticals Europe Ltd.未进口原研药品欧盟上市
70-14锝[99mTc]替马西普注射液technetium Tc 99m tilmanocept injection/LymphoseekN/ANavidea Biopharmaceuticals Europe Ltd.未进口原研药品欧盟上市
70-15二丁酰环磷腺苷钠软膏Bucladesine Sodium ointment/ Actosin ointment3%(每克含二丁酰环磷腺苷钠30mg)ニプロファーマ株式会社未进口原研药品日本上市
70-16阿伐替尼片Avapritinib Tablets/泰吉华®Ayvakit®100mgBlueprint Medicines Corporation国内上市的原研药品原研进口
70-17阿伐替尼片Avapritinib Tablets/泰吉华® Ayvakit®200mgBlueprint Medicines Corporation国内上市的原研药品原研进口
70-18阿伐替尼片Avapritinib Tablets/泰吉华® Ayvakit®300mgBlueprint Medicines Corporation国内上市的原研药品原研进口
70-19丙硫氧嘧啶片Propylthiouracil Tablets50mgHemony Pharmaceutical Germany GmbH国内上市的原研药品原研进口
70-20福辛普利钠片Fosinopril sodium/蒙诺10mg中美上海施贵宝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
70-21磷酸西格列汀片Sitagliptin Phosphate Tablets/捷诺维100 mg杭州默沙东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
8-44对乙酰氨基酚泡腾片Paracetamol Effervescent Tablets/Panadol ActiFast Soluble Tablets0.5gGlaxoSmithKline Consumer Healthcare未进口原研药品欧盟上市
22-443盐酸左沙丁胺醇雾化吸入溶液Levalbuterol hydrochloride Inhalation Solution / XOPENEX0.63mg/3mlOAK PHARMACEUTICALS INC SUBSIDIARY OF AKORN INC/Akorn未进口原研药品增加持证商Akorn
22-444盐酸左沙丁胺醇雾化吸入溶液Levalbuterol hydrochloride Inhalation Solution / XOPENEX0.31mg/3mlOAK PHARMACEUTICALS INC SUBSIDIARY OF AKORN INC/Akorn未进口原研药品增加持证商Akorn
23-179盐酸他喷他多缓释片Tapentadol Hydrochloride  Extended Release Tablets/Nucynta ErEq 50mg BaseDepo Nf Sub LLC A Sub Of Assertio Therapeutics Inc/Collegium Pharmaceutical Inc未进口原研药品增加持证商Collegium Pharmaceutical Inc
23-180盐酸他喷他多缓释片Tapentadol Hydrochloride Extended Release Tablets/Nucynta ErEq100mg BaseDepo Nf Sub LLC A Sub Of Assertio Therapeutics Inc/Collegium Pharmaceutical Inc未进口原研药品增加持证商Collegium Pharmaceutical Inc
23-181盐酸他喷他多缓释片Tapentadol Hydrochloride  Extended Release Tablets/Nucynta ErEq150mg BaseDepo Nf Sub LLC A Sub Of Assertio Therapeutics Inc/Collegium Pharmaceutical Inc未进口原研药品增加持证商Collegium Pharmaceutical Inc
23-182盐酸他喷他多缓释片Tapentadol Hydrochloride  Extended Release Tablets/Nucynta ErEq200mg BaseDepo Nf Sub LLC A Sub Of Assertio Therapeutics Inc/Collegium Pharmaceutical Inc未进口原研药品增加持证商Collegium Pharmaceutical Inc
23-183盐酸他喷他多缓释片Tapentadol Hydrochloride Extended Release Tablets/Nucynta ErEq250mg BaseDepo Nf Sub LLC A Sub Of Assertio Therapeutics Inc/Collegium Pharmaceutical Inc未进口原研药品增加持证商Collegium Pharmaceutical Inc
23-197依折麦布瑞舒伐他汀钙片Ezetimibe rosuvastatin calcium film-coated tablet依折麦布10mg/瑞舒伐他汀10mgSanofi-Aventis, S.R.O./Sanofi-Aventis Ireland Limited T/A SANOFI未进口原研药品增加持证商Sanofi-Aventis Ireland Limited T/A SANOFI
26-36阿奇霉素滴眼液Azithromycin Ophthalmic Solution/ Azasite0.01Oka Pharmaceuticals Inc Subsidary Of Akorn Inc/Thea pharma inc未进口原研药品增加持证商Thea pharma inc
26-87盐酸非索非那定口服混悬液Fexofenadine Hydrochloride Oral Suspension / Children’s Allegra Allergy30mg/5mlSanofi Aventis US LLC/Chattem Inc Dba Sanofi Consumer Healthcare未进口原研药品增加持证商Chattem Inc Dba Sanofi Consumer Healthcare
27-421左甲状腺素钠片Levothyroxine Sodium Tablets/Euthyrox;Levothyrox25μg(以左甲状腺素钠计) Merck Serono GmbH/Merck Sante/Merck Gesellschaft mbH/Merck BV未进口原研药品增加持证商Merck BV
27-423左甲状腺素钠片Levothyroxine Sodium Tablets/Euthyrox;Levothyrox100μg(以左甲状腺素钠计) Merck Serono GmbH/Merck Sante/Merck Gesellschaft mbH/Merck BV未进口原研药品增加持证商Merck BV
30-116丁溴东莨菪碱注射液Scopolamine Butylbromide Injection/ Buscapina/Buscopan1ml:20mgSanofi-aventis/Sanofi/Aventis/Sanofi S.p.A./Sanofi-Aventis Deutschland GmbH未进口原研药品增加持证商Sanofi-Aventis Deutschland GmbH
39-39左甲状腺素钠片Levothyroxine Sodium Tablets200μg(以左甲状腺素钠计) Merck Serono GmbH/Merck Sante/Merck Gesellschaft mbH/Merck BV未进口原研药品增加持证商Merck BV
42-25盐酸氟西汀口服溶液Fluoxetine Hydrochloride Oral Solution/PROZAC20mg/5mlLilly France/Eli Lilly Italia S.p.A./Eli Lilly Nederland B.V.未进口原研药品增加持证商Eli Lilly Nederland B.V.
63-3无水乙醇注射液Anhydrous Ethanol Injection/ABLYSINOL99%(5ml)BELCHER PHARMACEUTICALS LLC / BPI Labs, LLC未进口原研药品增加持证商BPI Labs, LLC
8-7阿仑膦酸钠维D3片Alendronate Sodium and Vitamin D3 Tablets/--阿仑膦酸钠(以C4H13NO7P2计)70mg和维生素D3 2800IUMerck Sharp & Dohme Ltd./N.V. Organon原研进口增加持证商N.V. Organon
8-220阿仑膦酸钠维D3片Alendronate Sodium and Vitamin D3 Tablets/--阿仑膦酸钠(以C4H13NO7P2计)70mg和维生素D3 5600IUMerck Sharp & Dohme Ltd./N.V. Organon原研进口增加持证商N.V. Organon
10-58骨化三醇软胶囊/骨化三醇胶丸Calcitriol Soft Capsules/Rocaltrol0.25μgRoche Pharma(Schweiz) Ltd./Atnahs Pharma UK Limited/Roche Pharma(Schweiz)AG原研进口增加持证商Roche Pharma(Schweiz) AG
10-219伏立康唑干混悬剂Voriconazole for Oral Suspension/Vfend45g:3gPfizer Limited/Pfizer Europe MA EEIG原研进口增加持证商Pfizer Europe MA EEIG
21-151糠酸莫米松鼻喷雾剂Mometasone Furoate Aqueous Nasal Spray/ Nasonex(内舒拿)50μg/揿(0.05%)MSD Belgium BVBA/SPRL国内上市的原研药品增加持证商Organon Belgium
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/Organon GmbH国内上市的原研药品增加持证商Organon GmbH
69-8碳酸氢钠血滤置换液Hemofiltration Replacement Fluid of Sodium Bicarbonate5000mlGambro Lundia AB / Baxter Holding B.V.国内上市的原研药品增加持证商Baxter Holding B.V.
24-57氨己烯酸口服溶液用散Vigabatrin For Oral Solution/Vigabatrin Powder for Oral Solution/Sabril500mg/packetLundbeck Pharmaceuticals LLC未进口原研药品药品通用名称修订为氨己烯酸口服溶液用散,英文名称增加Vigabatrin Powder for Oral Soluti更正on。
56-29注射用培门冬酶Pegaspargase For Injection / Oncaspar3750U(750U/Ml)Les Laboratoires Servier未进口原研药品持证商修订为:Les Laboratoires Servier
56-31西罗莫司凝胶Sirolimus Topical Gel /Sirolimus Gel/Rapalimus0.002ノーベルファーマ株式会社未进口原研药品药品通用名称修订为西罗莫司凝胶,英文名称增加Sirolimus Gel
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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