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国家药监局发布仿制药参比制剂目录（第三十批）
- 发布日期：2025-01-04 11:50 点击次数：171 国家药监局关于发布仿制药参比制剂目录（第三十批）的通告（2020年 第56号）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（第三十批）。特此通告。附件：仿制药参比制剂目录（第三十批）国家药监局2020年8月31日仿制药参比制剂目录（第三十批）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230-1 巴瑞替尼片Baricitinib Tablets /Olumiant（艾乐明）2mg（以C16H17N7O2S计）Eli Lilly Nederland B.V.国内上市的原研药品原研进口30-2 泊沙康唑口服混悬液Posaconazole Oral Suspension /Noxafil（诺科飞）40mg/mlMerck Sharp & Dohme Ltd国内上市的原研药品原研进口30-3 碘化油注射液Iodinated Oil Injection /Lipiodol Ultra Fluide10ml （含碘480mg/ml）Guerbet国内上市的原研药品原研进口30-4 聚甲酚磺醛阴道栓Policresulen Vaginal Suppositories /Albothyl（爱宝疗）90mgTakeda GmbH国内上市的原研药品原研进口30-5 甲磺酸艾立布林注射液Eribulin Mesilate Injection2ml:1mgEisai Europe Ltd国内上市的原研药品原研进口30-6 双氯芬酸二乙胺乳胶剂Diclofenac Diethylamine Emulgel1%（20g:0.2g；50g:0.5g；75g:0.75g）（以C14H10Cl2NNaO2计）GSK Consumer Healthcare Schweiz AG国内上市的原研药品原研进口30-7 盐酸阿莫罗芬搽剂Amorolfine Hydrochloride Liniment /Loceryl5%（2.5ml、5ml）Galderma International国内上市的原研药品原研进口30-8 四烯甲萘醌软胶囊Menatetrenone Soft Capsules/固力康15mgEisai Co.,Ltd.国内上市的原研药品原研进口30-9 酒石酸匹莫范色林胶囊Pimavanserin Tartrate Capsules/Nuplazid34mg （以匹莫范色林计）Acadia Pharmaceuticals Inc未进口原研药品美国橙皮书30-10 醋酸阿比特龙片Abiraterone Acetate Tablets/Zytiga250mgJanssen Biotech Inc未进口原研药品美国橙皮书30-11 利格列汀二甲双胍片Linagliptin and Metformin Hydrochloride Tablets /Jentadueto每片含利格列汀2.5mg与盐酸二甲双胍500mgBoehringer Ingelheim Pharmaceuticals Inc未进口原研药品美国橙皮书30-12 利格列汀二甲双胍片Linagliptin and Metformin Hydrochloride Tablets/Jentadueto每片含利格列汀2.5mg与盐酸二甲双胍850mgBoehringer Ingelheim Pharmaceuticals Inc未进口原研药品美国橙皮书30-13 L-甲状腺素钠软胶囊Levothyroxine Sodium Soft Capsules/Tirosint13μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书30-14 L-甲状腺素钠软胶囊Levothyroxine Sodium Soft Capsules/Tirosint25μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书30-15 L-甲状腺素钠软胶囊Levothyroxine Sodium Soft Capsules/Tirosint50μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书30-16 L-甲状腺素钠软胶囊Levothyroxine Sodium Soft Capsules/Tirosint75μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书30-17 L-甲状腺素钠软胶囊Levothyroxine Sodium Soft Capsules/Tirosint88μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书30-18 L-甲状腺素钠软胶囊Levothyroxine Sodium Soft Capsules/Tirosint100μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书30-19 L-甲状腺素钠软胶囊Levothyroxine Sodium Soft Capsules/Tirosint112μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书30-20 L-甲状腺素钠软胶囊Levothyroxine Sodium Soft Capsules/Tirosint125μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书30-21 L-甲状腺素钠软胶囊Levothyroxine Sodium Soft Capsules/Tirosint137μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书30-22 L-甲状腺素钠软胶囊Levothyroxine Sodium Soft Capsules/Tirosint150μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书30-23 L-甲状腺素钠软胶囊Levothyroxine Sodium Soft Capsules/Tirosint175μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书30-24 L-甲状腺素钠软胶囊Levothyroxine Sodium Soft Capsules/Tirosint200μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书30-25 布地奈德肠溶胶囊Budesonide Extended-release Capsules /Entocort EC3mgPerrigo Pharma International DAC未进口原研药品美国橙皮书30-26 布洛肾素片Ibuprofen and Phenylephrine Hydrochloride Tablets /Advil Congestion Relief;Advil Sinus Congestion & Pain布洛芬200mg和盐酸肾上腺素10mgGlaxoSmithKline Consumer Healthcare Holdings（US）LLC /Pfizer未进口原研药品美国橙皮书30-27 醋酸钙口服溶液Calcium Acetate Oral Solution/Phoslyra667mg/5mlFresenius Medical Care North America未进口原研药品美国橙皮书30-28 地拉罗司片Deferasirox Tablets/Jadenu90mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书30-29 地拉罗司片Deferasirox Tablets/Jadenu180mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书30-30 地拉罗司片Deferasirox Tablets/Jadenu360mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书30-31 盐酸缬更昔洛韦片Valganciclovir Hydrochloride Tablets/Valcyte450mg （以缬更昔洛韦计）Hoffmann La Roche Inc未进口原研药品美国橙皮书30-32 拉米夫定替诺福韦片Lamivudine and Tenofovir Disoproxil Fumarate Tablets/Cimduo拉米夫定300mg和富马酸替诺福韦酯300mgMylan Laboratories Ltd未进口原研药品美国橙皮书30-33 达格列净片Dapagliflozin Tablets/Farxiga5mgAstraZeneca AB未进口原研药品美国橙皮书30-34 达格列净片Dapagliflozin Tablets/Farxiga10mgAstraZeneca AB未进口原研药品美国橙皮书30-35 卡格列净二甲双胍缓释片Canagliflozin and Metformin Hydrochloride Extended Release Tables /Invokamet XR卡格列净50mg和盐酸二甲双胍500mgJanssen Pharmaceuticals Inc未进口原研药品美国橙皮书30-36 卡格列净二甲双胍缓释片Canagliflozin and Metformin Hydrochloride Extended Release Tables /Invokamet XR卡格列净150mg和盐酸二甲双胍500mgJanssen Pharmaceuticals Inc未进口原研药品美国橙皮书30-37 卡格列净二甲双胍缓释片Canagliflozin and Metformin Hydrochloride Extended Release Tables /Invokamet XR卡格列净50mg和盐酸二甲双胍1000mgJanssen Pharmaceuticals Inc未进口原研药品美国橙皮书30-38 卡格列净二甲双胍缓释片Canagliflozin and Metformin Hydrochloride Extended Release Tables /Invokamet XR卡格列净150mg和盐酸二甲双胍1000mgJanssen Pharmaceuticals Inc未进口原研药品美国橙皮书30-39 沙格列汀二甲双胍缓释片（II）Saxagliptin and Metformin Hydrochloride Sustained-release Tables/Kombiglyze XR每片含沙格列汀5mg与盐酸二甲双胍500mgAstraZeneca AB未进口原研药品美国橙皮书30-40 氨氯地平阿托伐他汀钙片Amlodipine Besylate and Atorvastatin Calcium Tablets/Caduet氨氯地平5mg和阿托伐他汀20mgPfizer Inc未进口原研药品美国橙皮书30-41 氨氯地平阿托伐他汀钙片Amlodipine Besylate and Atorvastatin Calcium Tablets/Caduet氨氯地平5mg和阿托伐他汀40mgPfizer Inc未进口原研药品美国橙皮书30-42 替莫唑胺胶囊Temozolomide Capsules /Temodar20mgMerck Sharp and Dohme Corp未进口原研药品美国橙皮书30-43 替莫唑胺胶囊Temozolomide Capsules /Temodar100mgMerck Sharp and Dohme Corp未进口原研药品美国橙皮书30-44 替莫唑胺胶囊Temozolomide Capsules /Temodar140mgMerck Sharp and Dohme Corp未进口原研药品美国橙皮书30-45 替莫唑胺胶囊Temozolomide Capsules /Temodar180mgMerck Sharp and Dohme Corp未进口原研药品美国橙皮书30-46 替莫唑胺胶囊Temozolomide Capsules /Temodar250mgMerck Sharp and Dohme Corp未进口原研药品美国橙皮书30-47 伊曲茶碱片Istradefylline Tablets /Nourianz20mgKyowa Kirin Inc未进口原研药品美国橙皮书30-48 伊曲茶碱片Istradefylline Tablets /Nourianz40mgKyowa Kirin Inc未进口原研药品美国橙皮书30-49 盐酸卡利拉嗪胶囊Cariprazine hydrochloride Capsules/Vraylar1.5mgAllergan Sales LLC未进口原研药品美国橙皮书30-50 盐酸卡利拉嗪胶囊Cariprazine hydrochloride Capsules/Vraylar3mgAllergan Sales LLC未进口原研药品美国橙皮书30-51 盐酸卡利拉嗪胶囊Cariprazine hydrochloride Capsules/Vraylar4.5mgAllergan Sales LLC未进口原研药品美国橙皮书30-52 盐酸卡利拉嗪胶囊Cariprazine hydrochloride Capsules/Vraylar6mgAllergan Sales LLC未进口原研药品美国橙皮书30-53 缬沙坦氨氯地平片（Ⅱ）Valsartan and Amlodipine Tablets/Exforge每片含缬沙坦160mg、氨氯地平5mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书30-54 对乙酰氨基酚缓释片Acetaminophen Sustained-release Tablets/Tylenol0.65gJohnson and Johnson Consumer Inc Mcneil Consumer Healthcare Division未进口原研药品美国橙皮书30-55 氯化琥珀胆碱注射液Succinylcholine Chloride Injection/Quelicin20mg/ml （10ml）Hospira INC未进口原研药品美国橙皮书30-56 非诺贝特片Fenofibrate Tablets/Tricor48mgAbbvie Inc.未进口原研药品美国橙皮书30-57 非诺贝特片Fenofibrate Tablets/Tricor145mgAbbvie Inc.未进口原研药品美国橙皮书30-58 恩他卡朋片Entacapone Tablets /Comtan0.2gOrion Pharma未进口原研药品美国橙皮书30-59 孟鲁司特钠咀嚼片Montelukast Sodium Chewable Tablets/Singulair5mgMerck Sharp And Dohme Corp A Sub Of Merck And Co Inc未进口原研药品美国橙皮书30-60 孟鲁司特钠咀嚼片Montelukast Sodium Chewable Tablets/Singulair4mgMerck Sharp And Dohme Corp A Sub Of Merck And Co Inc未进口原研药品美国橙皮书30-61 醋酸钙胶囊Calcium Acetate Capsules667mgFresenius Medical Care North America未进口原研药品美国橙皮书30-62 屈螺酮炔雌醇片Drospirenone and Ethinylestradiol Tablets/Yasmin屈螺酮3mg/炔雌醇0.03mgBayer Healthcare Pharmaceuticals Inc未进口原研药品美国橙皮书30-63 屈螺酮炔雌醇片Drospirenone and Ethinylestradiol Tablets/Yaz屈螺酮3mg/炔雌醇0.02mgBayer Healthcare Pharmaceuticals Inc未进口原研药品美国橙皮书30-64 月桂酰阿立哌唑注射液Aripiprazole Lauroxil Extended-release Injectable Suspension/Aristada441mg/1.6 ml （以C36H51Cl2N3O4计）Alkermes, Inc.未进口原研药品美国橙皮书30-65 月桂酰阿立哌唑注射液Aripiprazole Lauroxil Extended-release Injectable Suspension/Aristada662mg/2.4 ml （以C36H51Cl2N3O4计）Alkermes, Inc.未进口原研药品美国橙皮书30-66 月桂酰阿立哌唑注射液Aripiprazole Lauroxil Extended-release Injectable Suspension/Aristada882mg/3.2ml （以C36H51Cl2N3O4计）Alkermes, Inc.未进口原研药品美国橙皮书30-67 月桂酰阿立哌唑注射液Aripiprazole Lauroxil Extended-release Injectable Suspension/Aristada1064mg/3.9 ml （以C36H51Cl2N3O4计）Alkermes, Inc.未进口原研药品美国橙皮书30-68 氯氮平口腔崩解片Clozapine Orally Disintegrating Tablets25mgBarr Laboratories Inc美国橙皮书30-69 鲁比前列酮胶囊Lubiprostone Capsules /Amitiza24μgSucampo Pharma Americas, LLC.未进口原研药品美国橙皮书30-70 注射用磷酸特地唑胺Tedizolid Phosphate For Injection/Sivextro200mgMerck & CO.,INC.未进口原研药品美国橙皮书30-71 拉米夫定片Lamivudine Tablets/Epivir0.3gViiV Healthcare未进口原研药品美国橙皮书30-72 拉米夫定片Lamivudine Tablets/Epivir0.15gViiV Healthcare未进口原研药品美国橙皮书30-73 拉考沙胺口服溶液Lacosamide Oral Solution/Vimpat10mg/ml（200ml）UCB,Inc未进口原研药品美国橙皮书30-74 米诺地尔泡沫剂（男用）Minoxidil Foam /Men's Rogaine5%w/w （60g）Johnson And Johnson Group Consumer Companies未进口原研药品美国橙皮书30-75 米诺地尔泡沫剂（女用）Minoxidil Foam /Women's Rogaine5%w/w （60g）Johnson And Johnson Group Consumer Companies未进口原研药品美国橙皮书30-76 吸入用氯醋甲胆碱Methacholine Chloride /Provocholine100mgMethapharm Inc.未进口原研药品美国橙皮书30-77 盐酸右哌甲酯缓释胶囊Dexmethylphenidate Hydrochloride Exended-release Capsules /Focalin XR5mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书30-78 盐酸右哌甲酯缓释胶囊Dexmethylphenidate Hydrochloride Exended-release Capsules /Focalin XR20mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书30-79 注射用氢化可的松琥珀酸钠Hydrocortisone Sodium Succinate for Injection /Solu-Cortef100mgPharmacia & Upjohn Co未进口原研药品美国橙皮书30-80 盐酸考来维仑干混悬剂Colesevelam Hydrochloride for oral suspension /Welchol3.75gDaiichi Sankyo Inc未进口原研药品美国橙皮书30-81 双氯芬酸依泊胺贴Diclofenac Epolamine Patch/Flector1.3%，10cm×14cmInstitut Biochimique SA未进口原研药品美国橙皮书30-82 盐酸伐地那非口崩片Vardenafil Hydrochloride Orally disintegrating Tablets/Staxyn10mgBayer HealthCare Pharmaceuticals Inc.未进口原研药品美国橙皮书30-83 硝普钠氯化钠注射液Sodium Nitroprusside in 0.9% Sodium Chloride Injection100ml:50mg （0.5mg/ml）Exela Pharma Sciences, LLC未进口原研药品美国橙皮书30-84 硝普钠氯化钠注射液Sodium Nitroprusside in 0.9% Sodium Chloride Injection100ml:20mg （0.2mg/ml）Exela Pharma Sciences, LLC未进口原研药品美国橙皮书30-85 普乐沙福注射液Plerixafor Injection /Mozobil24mg/1.2mlGenzyme Corporation未进口原研药品美国橙皮书30-86 磷酸特地唑胺片Tedizolid Phosphate Tablets/Sivextro200mgCubist Pharmaceuticals LLC未进口原研药品美国橙皮书30-87 阿托伐他汀钙片Atorvastatin Calcium Tablets/Lipitor40mgPfizer Inc未进口原研药品美国橙皮书30-88 阿托伐他汀钙片Atorvastatin Calcium Tablets/Lipitor80mgPfizer Inc未进口原研药品美国橙皮书30-89 阿托伐他汀钙片Atorvastatin Calcium Tablets/Sortis10mgPfizer未进口原研药品欧盟上市30-90 阿托伐他汀钙片Atorvastatin Calcium Tablets/Sortis20mgPfizer未进口原研药品欧盟上市30-91 阿托伐他汀钙片Atorvastatin Calcium Tablets/Sortis40mgPfizer未进口原研药品欧盟上市30-92 阿托伐他汀钙片Atorvastatin Calcium Tablets/Sortis80mgPfizer未进口原研药品欧盟上市30-93 美法仑片Melphalan Tablets/Alkeran2mgApotex Inc未进口原研药品美国橙皮书30-94 美法仑片Melphalan Tablets/Alkeran2mgAspen Pharma Trading Limited未进口原研药品欧盟上市30-95 氢溴酸加兰他敏口腔崩解片Galantamine Hydrobromide Orally Disintegrating Tablets/Reminyl4mgヤンセンファーマ株式会社未进口原研药品日本上市30-96 氢溴酸加兰他敏口腔崩解片Galantamine Hydrobromide Orally Disintegrating Tablets/Reminyl8mgヤンセンファーマ株式会社未进口原研药品日本上市30-97 氢溴酸加兰他敏口腔崩解片Galantamine Hydrobromide Orally Disintegrating Tablets/Reminyl12mgヤンセンファーマ株式会社未进口原研药品日本上市30-98 氟比洛芬凝胶贴膏Flurbiprofen Cataplasms /Zepolas80mg/贴三笠制药株式会社未进口原研药品日本上市30-99 氟比洛芬凝胶贴膏Flurbiprofen Cataplasms /Zepolas40mg/贴三笠制药株式会社未进口原研药品日本上市30-100 复方卡比多巴片Compound Carbidopa Tablets卡比多巴25mg，左旋多巴250mgMSD株式会社未进口原研药品日本上市30-101 雷美替胺片Ramelteon Tablets/Rozerem8mg武田薬品工業株式会社未进口原研药品日本上市30-102 佩玛贝特片Pemafibrate Tablets0.1mg興和株式会社未进口原研药品日本上市30-103 那格列汀片Anagliptin Tablet /SUINY Tab.100mg100mg株式会社三和化学研究所未进口原研药品日本上市30-104 舒必利片Sulpiride Tablets/Dogmaty0.1gAstellas Pharma Inc未进口原研药品日本上市30-105 双氯芬酸钠贴剂Diclofenac sodium patch/Voltaren15mg/贴（7cm×10cm）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30-106 双氯芬酸钠贴剂Diclofenac sodium patch/Voltaren30mg/贴（10cm×14cm）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30-107 注射用美罗培南Meropenem for Injection/Meropen0.25g大日本住友制药株式会社未进口原研药品日本上市30-108 注射用美罗培南Meropenem for Injection/Meronem1gPfizer/AstraZeneca GmbH未进口原研药品欧盟上市30-109 替比培南匹伏酯细粒剂Tebipenem Pivoxil Fine Granules/Orapenem10% （1g中含替比培南100mg）Meiji Seikaファルマ未进口原研药品日本上市30-110 泛昔洛韦片Famciclovir Tablets/Famvir125mgPhoenix Labs未进口原研药品欧盟上市30-111 比拉斯汀口腔崩解片Bilastine Orally disintegrating Tablets/Opexa; Bilaxten; Antires; Bitosen10mgMenarini International Operations/Faes Farma未进口原研药品欧盟上市30-112 阿立哌唑长效肌肉注射剂Aripiprazole Powder and Solvent for Prolonged-release Suspension for Injection/Abilify Maintena300mgOtsuka Pharmaceutical Netherlands B.V.未进口原研药品欧盟上市30-113 阿立哌唑长效肌肉注射剂Aripiprazole Powder and Solvent for Prolonged-release Suspension for Injection/Abilify Maintena400mgOtsuka Pharmaceutical Netherlands B.V.未进口原研药品欧盟上市30-114 草酸艾司西酞普兰口服滴剂Escitalopram Oxalate Oral Drops/Cipralex20mg/mlH. Lundbeck A/S未进口原研药品欧盟上市30-115 洛芬待因片Ibuprofen and Codeine Phosphate Tablets /Nurofen Plus布洛芬200mg与磷酸可待因12.8mgRechitt Benchiser Healthcar（UK）Ltd未进口原研药品欧盟上市30-116 丁溴东莨菪碱注射液Scopolamine Butylbromide Injection /Buscapina; Buscopan1ml:20mgSanofi-aventis/Sanofi/Aventis未进口原研药品欧盟上市30-117 阿糖胞苷注射液Cytarabine Injection /Cytosar20mg/mlPfizer Limited未进口原研药品欧盟上市30-118 普瑞巴林胶囊Pregabalin Capsules /Lyrica100mgPfizer未进口原研药品欧盟上市30-119 尼替西农胶囊Nitisinone Capsules /Orfadin2mgSwedish Orphan Biovitrum International AB未进口原研药品欧盟上市30-120 尼替西农胶囊Nitisinone Capsules /Orfadin5mgSwedish Orphan Biovitrum International AB未进口原研药品欧盟上市30-121 尼替西农胶囊Nitisinone Capsules /Orfadin10mgSwedish Orphan Biovitrum International AB未进口原研药品欧盟上市30-122 尼替西农胶囊Nitisinone Capsules /Orfadin20mgSwedish Orphan Biovitrum International AB未进口原研药品欧盟上市30-123 厄贝沙坦片Irbesartan Tablets/Aprovel75mgSanofi Clir SNC未进口原研药品欧盟上市30-124 富马酸卢帕他定片Rupatadine Fumarate Tablets/Wystamm、Rupafin10mg（以C26H26ClN3计）J. Uriach y Compañía, S.A./Vifor Pharma España, S.L.未进口原研药品欧盟上市30-125 氟哌啶醇口服溶液Haloperidol Oral Solution/Haldol2mg/ml（120ml）Janssen-Cilag未进口原研药品欧盟上市30-126 吗替麦考酚酯干混悬剂Mycophenolate Mofetil for Suspension/Cellcept5ml:1gRoche Registration GmbH未进口原研药品欧盟上市30-127 泮托拉唑钠肠溶片Pantoprazole Enteric-Coated Tablets20mgTakeda GmbH未进口原研药品欧盟上市30-128 环孢素眼用乳剂Ciclosporin Eye Drops Emulsion/Ikervis1mg/ml（0.3ml）Santen Oy未进口原研药品欧盟上市30-129 硫酸妥布霉素注射液Tobramycin Sulfate Injection/Nebcin2ml:80mgFlynn Pharma Ltd.未进口原研药品欧盟上市30-130 美沙拉秦肠溶片Mesalazine Enteric-coated Tablets/Salofalk0.25gDr. Falk Pharma GmbH未进口原研药品欧盟上市30-131 注射用雷替曲塞Raltitrexed for Injection/Tomudex2mgPfizer Corporation Austria Ges.m.b.H未进口原研药品欧盟上市30-132 盐酸哌替啶注射液Meperidine Hydrochloride Injection/Dolantin2ml:100mgSanofi-Aventis Deutschland GmbH未进口原研药品欧盟上市30-133 瑞加诺生注射液Regadenoson Injection /Rapiscan0.4mg/5 mLGE Healthcare AS未进口原研药品欧盟上市30-134 甲氨蝶呤注射液Methotrexate injection500mg/20mlHospira UK Limited未进口原研药品欧盟上市30-135 甲氨蝶呤注射液Methotrexate injection1000mg/10mlHospira UK Limited未进口原研药品欧盟上市30-136 格隆溴铵新斯的明注射液Glycopyrronium Bromide and Neostigmine Metilsulfate Injection1ml:格隆溴铵0.5mg,甲硫酸新斯的明2.5mgMercury Pharmaceuticals Ltd未进口原研药品英国上市30-137 马来酸氯苯那敏注射液Chlorphenamine Maleate Injection1ml:10mgKyowa Kirin Limited国际公认的同种药品英国上市30-138 制霉菌素口服混悬液Nystatin Oral Suspension /Mycostatin100000IU/mlSubstipharm未进口原研药品欧盟上市30-139 盐酸阿比多尔干混悬剂Abidol Hydrochloride Suspension/Арбидол25mg/5ml（100ml）Отисифарм未进口原研药品俄罗斯上市30-140 钆特醇注射液Gadoteridol Injection/普海司10ml:2.793gBracco Imaging Italia s.r.l.国内上市的原研药品原研进口30-141 二十碳五烯酸乙酯软胶囊Icosapent Ethyl/Vascepa1g/粒Amarin Pharmaceuticals Ireland Ltd未进口原研药品美国橙皮书30-142 二十碳五烯酸乙酯软胶囊Icosapent Ethyl/Vascepa0.5g/粒Amarin Pharmaceuticals Ireland Ltd未进口原研药品美国橙皮书30-143 舒更葡糖钠注射液Sugammadex Sodium Injection/Bridion2ml:200mgMSD株式会社未进口原研药品日本上市30-144 舒更葡糖钠注射液Sugammadex Sodium Injection/Bridion5ml:500mgMSD株式会社未进口原研药品日本上市30-145 紫杉醇注射液Paclitaxel Injection/Taxol16.7ml:100mgBristol-Myers Squibb国内上市的原研药品原研进口30-146 中长链脂肪乳/氨基酸（16）/葡萄糖（30%）注射液Medium and Long Chain Fat Emulsion/Amino Acids（16）/Glucose（30%Injection/NuTRIflex Lipid plus1250mlB. Braun Melsungen AG未进口原研药品欧盟上市30-147 ω-3鱼油中长链脂肪乳/氨基酸（16）/葡萄糖（36%）注射液ω-3 Fish Oil Medium and Long Chain Fat Emulsion/Amino Acids（16）/Glucose（36%)Injection/NuTRIflex Omega plus1250ml、1875ml、2500mlB. Braun Melsungen AG未进口原研药品欧盟上市30-148 甲磺酸雷沙吉兰片Rasagiline Mesylate Tablets/Azilect1mgTeva Neuroscience Inc未进口原研药品美国橙皮书30-149 盐酸肾上腺素注射液/肾上腺素注射液Epinephrine Injection/ADRENALIN1ml:1mgPar Pharmaceutical, Inc未进口原研药品美国橙皮书30-150 盐酸肾上腺素注射液/肾上腺素注射液Epinephrine Injection/EPINEPHRINE1ml:1mgBelcher Pharmaceuticals , LLC未进口原研药品美国橙皮书30-151 格隆溴铵注射液Glycopyrronium Injection1ml:0.2mg、2ml:0.4mg、5ml:1mg、20ml:4mg、Hikma Farmaceutica（Portugal）SA国际公认的同种药品美国橙皮书30-152 格隆溴铵注射液Glycopyrrolate Injection1ml:0.2mg、3ml:0.6mgMercury Pharmaceuticals Ltd国际公认的同种药品欧盟上市30-153 格隆溴铵注射液Glycopyrrolate Injection1ml:0.2mg、2ml:0.4mgOmega Laboratories Ltd加拿大上市30-154 维生素K1注射液Vitamin K1 Injection/Konakion0.2ml:2mgCheplapharm Arzneimittel GmbH/Roche Pharma AG欧盟上市30-155 脂肪乳氨基酸（17）葡萄糖（11%）注射液Fat Emulsion,Amino Acids（17）and Glucose（11%）Injection900ml、1440ml、1920ml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30-156 盐酸洛美沙星滴眼液Lomefloxacin Hydrochloride Ophthalmic Solution/Lomeflon0.3%（5ml）千寿製薬株式会社未进口原研产品日本上市30-157 加压素注射液Vasopressin Injection /Vasostrict20unit/mlPar Sterile Products LLC未进口原研药品美国橙皮书30-158 硝苯地平控释片Nifedipine Controlled-Release tablets10mgバイエル薬品株式会社未进口原研药品日本上市30-159 硝苯地平控释片Nifedipine Controlled-Release tablets20mgバイエル薬品株式会社未进口原研药品日本上市30-160 硝苯地平控释片Nifedipine Controlled-Release tablets40mgバイエル薬品株式会社未进口原研药品日本上市30-161 磷酸西格列汀片Sitagliptin Phosphate Tablets/Januvia50mgMerck Sharp and Dohme Corp未进口原研药品美国橙皮书30-162 磷酸西格列汀片Sitagliptin Phosphate Tablets/Januvia100mgMerck Sharp and Dohme Corp未进口原研药品美国橙皮书30-163 依折麦布瑞舒伐他汀钙片Ezetimibe and Rosuvastatin Calcium Tablets/Rosuzet依折麦布10mg,瑞舒伐他汀2.5mgMSD株式会社未进口原研药品日本上市30-164 羧基麦芽糖铁注射液Ferric Carboxymaltose Injection/Ferinject50mg/ml（2ml、10ml、20ml）Vifor France未进口原研药品欧盟上市30-165 托吡司特片Topiroxostat Tablets/Topiloric40mg株式会社富士薬品未进口原研药品日本上市30-166 阿卡波糖片Acarbose Tablets/Precose50mgBayer HealthCare Pharmaceuticals Inc.未进口原研药品美国橙皮书23-153盐酸帕洛诺司琼注射液Palonosetron Hydrochloride Injection/Aloxi0.075mg:1.5ml（0.05mg/ml）（以C19H24N2O计）Helsinn Healthcare Sa/ Helsinn Birex Pharmaceuticals Ltd.未进口原研药品增加持证商Helsinn Birex Pharmaceuticals Ltd.6-16头孢地尼胶囊Cefdinir Capsules/Cefzon0.1gAstellas Pharma Inc/ LTL Pharma Co., Ltd.国内上市的原研药品持证商发生变更，增加新持证商：LTL Pharma Co., Ltd.21-39注射用伏立康唑Voriconazole for Injection/Vfend（威凡）0.2gPfizer Limited/Pfizer Europe MA EEIG国内上市的原研药品持证商发生变更，增加新持证商：Pfizer Europe MA EEIG23-322盐酸拉贝洛尔注射液Labetalol Hydrochloride Injection /Trandate5mg/ml（20ml）Aspen Pharma Schweiz GmbH/Aspen Pharma Trading Limited未进口原研药品勘误规格为20ml27-380盐酸表柔比星注射液Epirubicin Hydrochloride Injection/Pharmorubicin10mg/5mlPfizer Private Limited国内上市的原研药品商品名称勘误为Pharmorubicin27-381盐酸表柔比星注射液Epirubicin Hydrochloride Injection/Pharmorubicin50mg/25mlPfizer Private Limited国内上市的原研药品商品名称勘误为Pharmorubicin27-475托拉塞米片Torasemide Tablets/Unat10mgMEDA Pharma GmbH & Co. KG德国上市勘误持证商为MEDA Pharma GmbH & Co. KG备注1.未在国内上市品种，需参照原总局2015年第230号公告等的相关要求开展研究，通用名、剂型等经药典委核准后为准。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。
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