您好,欢迎来到桐晖药业!
服务热线: 020-6639 2416
18922121079
会员中心

【第三十批】仿制药参比制剂目录


【第三十批】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
30-1巴瑞替尼片Baricitinib TabletsOlumiant(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 SuspensionNoxafil(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 InjectionLipiodol 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 SuppositoriesAlbothyl(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 Injection
2ml: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 Emulgel
1%(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 LinimentLoceryl5%(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 CapsulesNuplazid34mg(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 TabletsZytiga250mgJanssen 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 TabletsJentadueto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 TabletsJentadueto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
30-13L-甲状腺素钠软胶囊Levothyroxine Sodium Soft CapsulesTirosint13μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书
30-14L-甲状腺素钠软胶囊Levothyroxine Sodium Soft CapsulesTirosint25μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书
30-15L-甲状腺素钠软胶囊Levothyroxine Sodium Soft CapsulesTirosint50μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书
30-16L-甲状腺素钠软胶囊Levothyroxine Sodium Soft CapsulesTirosint75μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书
30-17L-甲状腺素钠软胶囊Levothyroxine Sodium Soft CapsulesTirosint88μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书
30-18L-甲状腺素钠软胶囊Levothyroxine Sodium Soft CapsulesTirosint100μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书
30-19L-甲状腺素钠软胶囊Levothyroxine Sodium Soft CapsulesTirosint112μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书
30-20L-甲状腺素钠软胶囊Levothyroxine Sodium Soft CapsulesTirosint125μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书
30-21L-甲状腺素钠软胶囊Levothyroxine Sodium Soft CapsulesTirosint137μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书
30-22L-甲状腺素钠软胶囊Levothyroxine Sodium Soft CapsulesTirosint150μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书
30-23L-甲状腺素钠软胶囊Levothyroxine Sodium Soft CapsulesTirosint175μgIBSA Institut Biochimique SA未进口原研药品美国橙皮书
30-24L-甲状腺素钠软胶囊Levothyroxine Sodium Soft CapsulesTirosint200μgIBSA 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 CapsulesEntocort 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 TabletsAdvil Congestion Relief;Advil Sinus Congestion & Pain布洛芬200mg和盐酸肾上腺素10mgGlaxoSmithKline Consumer Healthcare Holdings(US)LLC未进口原研药品美国橙皮书
30-27醋酸钙口服溶液Calcium Acetate Oral SolutionPhoslyra667mg/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 TabletsJadenu90mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
30-29地拉罗司片Deferasirox TabletsJadenu180mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书
30-30地拉罗司片Deferasirox TabletsJadenu360mgNovartis 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 TabletsValcyte450mg(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 TabletsCimduo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 TabletsFarxiga5mgAstraZeneca AB未进口原研药品美国橙皮书
30-34达格列净片Dapagliflozin TabletsFarxiga10mgAstraZeneca 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 TablesInvokamet 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 TablesInvokamet 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 TabletsCaduet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 TabletsCaduet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 CapsulesVraylar1.5mgAllergan 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 CapsulesVraylar3mgAllergan 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 CapsulesVraylar4.5mgAllergan 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 CapsulesVraylar6mgAllergan 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 TabletsExforge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 TabletsTylenol0.65gJohnson 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 InjectionQuelicin20mg/ml(10ml)Hospira INC未进口原研药品美国橙皮书
30-56非诺贝特片Fenofibrate TabletsTricor48mgAbbvie Inc.未进口原研药品美国橙皮书
30-57非诺贝特片Fenofibrate TabletsTricor145mgAbbvie 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 TabletsSingulair5mgMerck 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 TabletsSingulair4mgMerck 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 Capsules
667mgFresenius 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 TabletsYasmin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 TabletsYaz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 SuspensionAristada441mg/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 SuspensionAristada662mg/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 SuspensionAristada882mg/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 SuspensionAristada1064mg/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 Tablets
25mgBarr 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 InjectionSivextro200mgMerck & CO.,INC.未进口原研药品美国橙皮书
30-71拉米夫定片Lamivudine TabletsEpivir0.3gViiV Healthcare未进口原研药品美国橙皮书
30-72拉米夫定片Lamivudine TabletsEpivir0.15gViiV 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 SolutionVimpat10mg/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 PatchFlector1.3%,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 TabletsStaxyn10mgBayer 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 Injection
100ml: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 Injection
100ml: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 TabletsSivextro200mgCubist 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 TabletsLipitor40mgPfizer Inc未进口原研药品美国橙皮书
30-88阿托伐他汀钙片Atorvastatin Calcium TabletsLipitor80mgPfizer Inc未进口原研药品美国橙皮书
30-89阿托伐他汀钙片Atorvastatin Calcium TabletsSortis10mgPfizer未进口原研药品欧盟上市
30-90阿托伐他汀钙片Atorvastatin Calcium TabletsSortis20mgPfizer未进口原研药品欧盟上市
30-91阿托伐他汀钙片Atorvastatin Calcium TabletsSortis40mgPfizer未进口原研药品欧盟上市
30-92阿托伐他汀钙片Atorvastatin Calcium TabletsSortis80mgPfizer未进口原研药品欧盟上市
30-93美法仑片Melphalan TabletsAlkeran2mgApotex Inc未进口原研药品美国橙皮书
30-94美法仑片Melphalan TabletsAlkeran2mgAspen 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 TabletsReminyl4mg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 TabletsReminyl8mg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 TabletsReminyl12mg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
40mg/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 TabletsRozerem8mg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 Tablets
0.1mg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 TabletsDogmaty0.1gAstellas Pharma Inc未进口原研药品日本上市
30-105双氯芬酸钠贴剂Diclofenac sodium patchVoltaren15mg/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 patchVoltaren30mg/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 InjectionMeropen0.25g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 InjectionMeronem1gPfizer/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 GranulesOrapenem0.1(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 TabletsFamvir125mgPhoenix 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 TabletsOpexa; 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 InjectionAbilify 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 InjectionAbilify 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 DropsCipralex20mg/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 TabletsAprovel75mgSanofi 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 TabletsWystamm、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 SolutionHaldol2mg/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 SuspensionCellcept5ml: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 Tablets
20mgTakeda 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 InjectionNebcin2ml: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 TabletsSalofalk0.25gDr. 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 InjectionTomudex2mgPfizer 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 InjectionDolantin2ml: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 injection
500mg/20mlHospira UK Limited未进口原研药品欧盟上市
30-135甲氨蝶呤注射液Methotrexate injection
1000mg/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 Injection
1ml: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 Injection
1ml: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 SuspensionАрбидол25mg/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 EthylVascepa1g/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 EthylVascepa0.5g/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 InjectionBridion2ml: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 InjectionBridion5ml: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 InjectionTaxol16.7ml: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
30-147ω-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%)InjectionNuTRIflex Lipid 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 TabletsAzilect1mgTeva 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 InjectionADRENALIN1ml: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 InjectionEPINEPHRINE1ml: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 Injection
1ml: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 Injection
1ml: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 Injection
1ml:0.2mg、2ml:0.4mgOmega Laboratories Ltd
加拿大上市
30-154维生素K1注射液Vitamin K1 InjectionKonakion0.2ml: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%)Injection
900ml、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 SolutionLomeflon0.3%(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 tablets
10mg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 tablets
20mg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 tablets
40mg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 TabletsJanuvia50mgMerck 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 TabletsJanuvia100mgMerck 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 TabletsRosuzet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 InjectionFerinject50mg/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 TabletsTopiloric40mg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 TabletsPrecose50mgBayer 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 InjectionAloxi0.075mg: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 CapsulesCefzon0.1gAstellas 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 InjectionVfend(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 EEIG
23-322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20ml
27-380盐酸表柔比星注射液Epirubicin Hydrochloride InjectionPharmorubicin10mg/5mlPfizer Private Limited国内上市的原研药品商品名称勘误为Pharmorubicin
27-381盐酸表柔比星注射液Epirubicin Hydrochloride InjectionPharmorubicin50mg/25mlPfizer Private Limited国内上市的原研药品商品名称勘误为Pharmorubicin
27-475托拉塞米片Torasemide TabletsUnat10mgMEDA Pharma GmbH & Co. KG德国上市勘误持证商为MEDA Pharma GmbH & Co. KG


1、参比制剂选择原则:有原研进口的应选择原研进口药作为参比制剂首选。

2、本网站所有仿制药参比制剂目录数据源自国家药品监督管理局官方网站,如有纰漏请以国家官网为准。


广州市桐晖药业有限公司
业务咨询热线:020-66392416 / 18026299762
售后服务及投诉电话:020-62312853 / 18122390687(服务时间:周一至周五9:00-17:30)
传真:020-66392525
地址:广州市黄埔区科学城科汇金谷二街3号四、五楼

桐晖药业公众号

桐晖药业小程序
Copyright ©2020 广州市桐晖药业有限公司 粤ICP备16102594号
服务热线

18922121079

18026299762

(微信同号)
企业QQ

2355398386

参比制剂 进口原料药 一致性评价 仿制药项目引进 海外高端制剂技术 创新药项目引进 进口原辅料注册 进口制剂注册
回到顶部