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化学仿制药参比制剂目录(第七十三批)73

化学仿制药参比制剂目录(第七十三批)73



序号药品通用名英文名规格持证商备注1备注2剂型
Jan-73盐酸丙卡巴肼胶囊Procarbazine hydrochloride Capsules50mg(按C12H19N3O计)Leadiant GmbH国内上市的原研药品原研进口胶囊剂
Feb-73注射用磷丙泊酚二钠Fospropofol Disodium for Injection/磷丙芬0.5g(按C13H19Na2O5P计)宜昌人福药业有限责任公司国内上市的原研药品
注射剂
Mar-73注射用甲苯磺酸奥马环素Omadacycline Tosilate for Injection/纽再乐0.1g(按C29H40N4O7计)再鼎医药(上海)有限公司国内上市的原研药品
注射剂
Apr-73依达拉奉口服混悬液Edaravone Oral Suspension/ RADICAVA ORS105mg/5mlMITSUBISHI TANABE PHARMA CORP未进口原研药品美国橙皮书口服混悬液
May-73劳拉西泮缓释胶囊Lorazepam Extended Release Capsules / Loreev XR1mgAlmatica Pharma LLC未进口原研药品美国橙皮书胶囊剂
Jun-73劳拉西泮缓释胶囊Lorazepam Extended Release Capsules / Loreev XR1.5mgAlmatica Pharma LLC未进口原研药品美国橙皮书胶囊剂
Jul-73劳拉西泮缓释胶囊Lorazepam Extended Release Capsules / Loreev XR2mgAlmatica Pharma LLC未进口原研药品美国橙皮书胶囊剂
Aug-73劳拉西泮缓释胶囊Lorazepam Extended Release Capsules / Loreev XR3mgAlmatica Pharma LLC未进口原研药品美国橙皮书胶囊剂
Sep-73右苯丙胺透皮贴剂Dextroamphetamine transdermal system/XELSTRYM4.5mg/9hNoven Pharmaceuticals, Inc.未进口原研药品美国橙皮书贴剂
Oct-73右苯丙胺透皮贴剂Dextroamphetamine transdermal system/XELSTRYM9mg/9hNoven Pharmaceuticals, Inc.未进口原研药品美国橙皮书贴剂
Nov-73右苯丙胺透皮贴剂Dextroamphetamine transdermal system/XELSTRYM13.5mg/9hNoven Pharmaceuticals, Inc.未进口原研药品美国橙皮书贴剂
Dec-73右苯丙胺透皮贴剂Dextroamphetamine transdermal system/XELSTRYM18mg/9hNoven Pharmaceuticals, Inc.未进口原研药品美国橙皮书贴剂
73-13利鲁唑口溶膜RILUZOLE/EXSERVAN50 MGAQUESTIVE THERAPEUTICS IN未进口原研药品美国橙皮书片剂
73-14苯甲酸利扎曲普坦口溶膜Rizatriptan Benzoate Oral Soluble Film / RizaFilm10mgINTELGENX CORP未进口原研药美国橙皮书片剂
73-15塞来昔布盐酸曲马多片Celecoxib and Tramadol hydrochloride Tablets/SEGLENTIS塞来昔布56mg、盐酸曲马多44mgKOWA PHARMACEUTICALS AMERICA INC未进口原研药品美国橙皮书片剂
73-16地西他滨西达尿苷片Decitabine and Cedazuridine Tablets /INQOVI35mg/100mgOtsuka Pharmaceutical Co., Ltd.未进口原研药品美国橙皮书片剂
73-17碳酸氢钠血滤置换液(无钾、无钙、0.6 mmol/L镁)Hemofiltration Replacement Fluid of Sodium Bicarbonate /PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER5000ml(250ml/4750ml)Baxter Healthcare Corporation未进口原研药品美国橙皮书注射剂
73-18维生素B12注射液Cyanocobalamin Injection1ml:1mgFresenius Kabi USA, LLC未进口原研药品美国橙皮书注射剂
73-19泼尼松口服溶液Prednisone5mg/5mlHIKMA PHARMACEUTICALS USA INC未进口原研药品美国橙皮书口服溶液
73-20地塞米松口服溶液DEXAMETHASONE0.5mg/5mlHIKMA PHARMACEUTICALS USA INC未进口原研药品美国橙皮书口服溶液
73-21注射用头孢洛生他唑巴坦钠Ceftolozane And Tazobactam For Injection /ZERBAXAEQ 1GM BASE/VIAL; EQ 0.5GM BASE/VIALMerck Sharp & Dohme Corp.未进口原研药品美国橙皮书注射剂
73-22替韦立马注射液tecovirimat injection/TPOXX200mg/20ml (10mg/ml)SIGA TECHNOLOGIES INC未进口原研药品美国橙皮书注射剂
73-23盐酸替洛利生片Pitolisant Hydrochloride Tablet/Wakix4.45mg(以C17H26ClNO计)BIOPROJET PHARMA未进口原研药品欧盟上市片剂
73-24盐酸替洛利生片Pitolisant Hydrochloride Tablet/Wakix17.8mg(以C17H26ClNO计)BIOPROJET PHARMA未进口原研药品欧盟上市片剂
73-25复方枸橼酸聚乙二醇(4000)钠钾散Compound Citrate Polyethylene Glycol (4000) Sodium Potassium Powder/clensiaA袋(56.33 g)+B袋(3.986 g)Alfasigma S.p.A.未进口原研药品欧盟上市散剂
73-26枸橼酸亚铁钠片Sodium Ferrous Citrate Tablets /Ferromia50mg(以铁计)ルフレッサ ファーマ株式会社未进口原研药品日本上市片剂
73-27缬沙坦氨氯地平口崩片Valsartan and Amlodipine Orally Disintegrating Tablets/Exforge每片含缬沙坦80mg,氨氯地平5mg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片剂
73-28锝[99mTc]二巯丁二酸盐注射液Kidneyscinti Tc-99m Injection /キドニーシンチTc-99m注185MBq/3mL日本メジフィジックス株式会社未进口原研药品日本上市片剂
73-29锝(99mTc)半乳糖酰人血清白蛋白二亚乙基三胺五乙酸注射液Technetium (99mTc) Galactosyl Human Serum Albumin Diethylenetriamine Pentaacetic Acid Injection/アシアロシンチ(Asialoscinti)185MBqメジフィジックス株式会社未进口原研药品日本上市注射剂
73-30托伐普坦片Tolvaptan Tablets/Samsca7.5mgOtsuka Pharmaceutical Netherlands B.V.未进口原研药品欧盟上市片剂
73-31卡马西平片Carbamazepine Tablets/Tegretol0.1gNovartis Pharmaceuticals UK Limited未进口原研药品英国上市片剂
73-32腹膜透析液(乳酸盐-G4.25%)Dianeal Pd-2 W/ Dextrose4.25% In Plastic Container含4.25%葡萄糖(5L/袋)Baxter Healthcare Corporation未进口原研药品美国橙皮书注射剂
73-33艾曲泊帕乙醇胺片Eltrombopag Olamine tablets75mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书片剂
/PROMACTA片剂
73-34达沙替尼片Dasatinib Tablets /Sprycel100 mgBRISTOL MYERS SQUIBB CO未进口原研药品美国橙皮书片剂
73-35来那度胺胶囊Lenalidomide Capsules/Revlimid2.5 mgBristol-Myers Squibb Pharma EEIG未进口原研药品欧盟上市胶囊剂
73-36来那度胺胶囊Lenalidomide Capsules/Revlimid15mgCelgene Europe B.V.未进口原研药品欧盟上市胶囊剂
73-37非洛地平缓释片Felodipine Sustained-release Tablets/Modip10mgAstraZeneca GmbH未进口原研药品欧盟上市片剂
73-38格拉司琼透皮贴片Granisetron Transdermal Patches / Sancuso34.3mg/52cm2(3.1mg/24h)Kyowa Kirin, Inc未进口原研药品美国橙皮书贴片
73-39环孢素软胶囊Ciclosporin Soft Capsules/Neoral25mgNovartis Pharmaceuticals Corporation未进口原研药品美国橙皮书胶囊剂
73-40西罗莫司片Sirolimus Tablets/Rapamune0.5mgPF PRISM CV未进口原研药品美国橙皮书片剂
73-41阿布昔替尼片Abrocitinib Tablets50mgPFIZER INC未进口原研药品美国橙皮书片剂
73-42阿布昔替尼片Abrocitinib Tablets100mgPFIZER INC未进口原研药品美国橙皮书片剂
73-43阿布昔替尼片Abrocitinib Tablets200mgPFIZER INC未进口原研药品美国橙皮书片剂
73-44盐酸沙丙蝶呤片Sapropterin Dihydrochloride Tablets/Kuvan100mgBIOMARIN PHARMACEUTICAL INC未进口原研药品美国橙皮书片剂
73-45达沙替尼片Dasatinib Tablets /Sprycel20 mgBRISTOL MYERS SQUIBB CO未进口原研药品美国橙皮书片剂
73-46达沙替尼片Dasatinib Tablets /Sprycel50 mgBRISTOL MYERS SQUIBB CO未进口原研药品美国橙皮书片剂
73-47达沙替尼片Dasatinib Tablets /Sprycel100 mgBRISTOL MYERS SQUIBB CO未进口原研药品美国橙皮书片剂
73-48左甲状腺素钠片Levothyroxine Sodium Tablets/Euthyrox200μg(以左甲状腺素钠计)Merck(Schweiz)AG,Zug未进口原研药品瑞士上市片剂
73-49黄体酮注射液Progesterone Injection10ml:500mgEUGIA PHARMA国际公认的同种药物美国橙皮书注射剂
73-50硫酸镁注射液Magnesium Sulfate Injection2g/50ml(40mg/ml)Hospira Inc未进口原研药品美国橙皮书注射剂
73-51硫酸沙丁胺醇口服溶液Salbutamol Sulfate Oral Solution2mg/5mlGlaxoSmithKline (Ireland) Limited未进口原研药品欧盟上市口服溶液
73-52注射用阿莫西林钠克拉维酸钾(10:1)Amoxicillin Sodium and Clavulanate Potassium for Injection(10:1)/Levmentin550mg(500/50)Laboratoires Delbert未进口原研药品欧盟上市注射剂
73-53注射用阿莫西林钠克拉维酸钾(10:1)Amoxicillin Sodium and Clavulanate Potassium for Injection(10:1)/Levmentin1.1g(1000/100)Laboratoires Delbert未进口原研药品欧盟上市注射剂
73-54注射用阿莫西林钠克拉维酸钾(10:1)Amoxicillin Sodium and Clavulanate Potassium for Injection(10:1)/Levmentin2.2g(2000/200)Laboratoires Delbert未进口原研药品欧盟上市注射剂
73-55瑞卢戈利片Relugolix Tablets/ Orgovyx120 mgAccord Healthcare S.L.U未进口原研药品欧盟上市片剂
73-56异维A酸软胶囊Isotretinoin Soft Capsules/Roaccutane20mgRoche Products Limited未进口原研药品欧盟上市(上市国家:英国;产地:德国和英国)胶囊剂
73-57拉米地坦片Lasmiditan Tablets/Reyvow50mg日本イーライリリー株式会社未进口原研药品日本上市片剂
73-58拉米地坦片Lasmiditan Tablets/Reyvow100mg日本イーライリリー株式会社未进口原研药品日本上市片剂
73-59盐酸异丙肾上腺素注射液Isoprenaline Hydrochloride Injection/ Isuprel0.2mg/mlOspedalia AG未进口原研药品瑞士上市注射剂
73-60盐酸利多卡因胶浆Lidocaine Hydrochloride Viscous/Xylocaine2%サンドファーマ株式会社未进口原研药品日本上市注射剂
73-61丙酸氟替卡松雾化吸入用混悬液Fluticasone Propionate Nebuliser Suspension/Flixotide Nebules2ml:2mgGlaxo Wellcome UK Limited未进口原研药品英国上市混悬液
73-62酒石酸伐尼克兰片Varenicline Tartrate Tablets1mgPAR PHARMACEUTICAL INC国际公认的同种药品美国橙皮书片剂
73-63硫酸羟氯喹片Hydroxychloroquine Sulfate Tablets/Plaquenil200mgConcordia Pharmaceuticals Inc未进口原研药品美国橙皮书片剂
73-64甲磺酸艾立布林注射液Eribulin Mesilate Injection/Halaven1mg/2ml (0.5mg/ml)Eisai Inc未进口原研药品美国橙皮书注射剂
73-65厄多司坦胶囊Erdosteine Capsules/Esteclin0.3gEdmond Pharma S.r.l.未进口原研药品欧盟上市胶囊剂
73-66罗替高汀贴片Rotigotine Patches/Neupro4.5mg/10cm2(释药量2mg/24h)UCB Pharma S.A.未进口原研药品欧盟上市片剂
73-67罗替高汀贴片Rotigotine Patches/Neupro9mg/20cm2(释药量4mg/24h)UCB Pharma S.A.未进口原研药品欧盟上市片剂
73-68罗替高汀贴片Rotigotine Patches/Neupro13.5mg/30cm2(释药量6mg/24h)UCB Pharma S.A.未进口原研药品欧盟上市片剂
73-69罗替高汀贴片Rotigotine Patches/Neupro18mg/40cm2(释药量8mg/24h)UCB Pharma S.A.未进口原研药品欧盟上市片剂
73-70吲达帕胺片Indapamide Tablets/Natrilix2.5mgServier Laboratories Ltd未进口原研药品英国上市片剂
73-71生理氯化钠溶液Sodium Chloride Irrigation900mg/100ml(250ml、500ml、1000ml、1500ml)ICU MEDICAL INC未进口原研药品美国橙皮书溶液
73-72艾曲泊帕乙醇胺干混悬剂Eltrombopag Olamine For Oral Suspension/Revolade25mg(以C25H22N4O4计)Novartis Europharm Limited未进口原研药品欧盟上市干混悬剂
73-73注射用多黏菌素E甲磺酸钠Colistimethate Sodium for Injection/Colomycin200万IUTeva UK Limited未进口原研药品英国上市注射剂
73-74利多卡因凝胶贴膏Lidocaine Cataplasms/Versatis5%Grünenthal Pharma Ltd未进口原研药品英国上市贴剂
73-75复方克霉唑乳膏(Ⅱ)Betamethasone Dipropionate,Clotrimazole and Gentamycin Sulfate Cream (Ⅱ)/Triderm Cream每克乳膏含有二丙酸倍他米松0.64mg(相当于倍他米松0.5mg)、克霉唑10mg、硫酸庆大霉素(以庆大霉素计)1.0mgOrganon未进口原研药品瑞士上市乳膏剂
73-76地拉罗司颗粒Deferasirox Granules/JADENU  Granules Sachet90mg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颗粒剂
73-77地拉罗司颗粒Deferasirox Granules/JADENU  Granules Sachet360mg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颗粒剂
73-78美沙拉嗪缓释胶囊Mesalamine Extended-Release Capsules/Pentasa500mgTAKEDA PHARMACEUTICALS USA INC未进口原研药品美国橙皮书胶囊剂
73-79美沙拉嗪缓释胶囊Mesalamine Extended-Release Capsules/Pentasa250mgTAKEDA PHARMACEUTICALS USA INC未进口原研药品美国橙皮书胶囊剂
73-80二十碳五烯酸乙酯软胶囊Icosapent Ethyl Soft Capsule/EPADEL900mg持田製薬株式会社未进口原研药品日本上市胶囊剂
73-81注射用多黏菌素E甲磺酸钠Colistimethate Sodium for Injection/Colomycin100万IUTeva UK Limited未进口原研药品英国上市注射剂
73-82硝酸舍他康唑乳膏Sertaconazole Nitrate Cream/Zalain2%Ferrer Internacional,S.A.
国内进口乳膏剂
73-83碳酸氢钠血滤置换液Hemofiltration Replacement Fluid of Sodium Bicarbonate/PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER5000ml(250ml/4750ml)BAXTER HEALTHCARE CORP/Gambro Lundia AB未进口原研药品美国橙皮书注射剂
73-84磷/碳酸氢钠血滤置换液Hemofiltration Replacement Fluid of Sodium Bicarbonate and Phosphate/PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER5000ml(250ml/4750ml)BAXTER HEALTHCARE CORP/Gambro Lundia AB未进口原研药品美国橙皮书注射剂
73-85盐酸非索非那定片Fexofenadine Hydrochloride Tablets/Allegra Allergy60mgCHATTEM INC DBA SANOFI CONSUMER HEALTHCARE未进口原研药品美国橙皮书片剂
73-86棕榈酸帕利哌酮注射液Paliperidone Palmitate Extended-release Injectable Suspension/ Invega Hafyera1092mg/3.5ml(以棕榈酸帕利哌酮计)Janssen Pharmaceuticals, Inc.未进口原研药品美国橙皮书注射剂
73-87棕榈酸帕利哌酮注射液Paliperidone Palmitate Extended-release Injectable Suspension/Invega Hafyera1560mg/5ml(以棕榈酸帕利哌酮计)Janssen Pharmaceuticals, Inc.未进口原研药品美国橙皮书注射剂
73-88盐酸二甲双胍缓释片Metformin Hydrochloride Extended-Release Tablets/Glumetza0.5gSantarus Inc未进口原研药品美国橙皮书片剂
73-89注射用苯巴比妥钠phenobarbital sodium for injection/Sezaby100mgSun Pharmaceutical Medicare Ltd未进口原研药品美国橙皮书注射剂
73-90熊去氧胆酸片Ursodiol Tablets/URSO FORTE500mgALLERGAN SALES LLC未进口原研药品美国橙皮书片剂
73-91枸橼酸铁片Ferric Citrate Tablet / Auryxia210mg(以铁计)Keryx Biopharmaceuticals,Inc未进口原研药品美国橙皮书片剂
73-92氨氯地平阿托伐他汀钙片Amlodipine Besylate and Atorvastatin Calcium Tablets/Caduet5mg/10mg(以氨氯地平/阿托伐他汀计)Pharmacia And Upjohn Co LLC未进口原研药品美国橙皮书片剂
73-93盐酸哌甲酯缓释片Methylphenidate  Hydrochloride Extended-Release Tablets/CONCERTA18 mgJanssen Pharmaceuticals Inc未进口原研药品美国橙皮书片剂
73-94盐酸普拉克索片Pramipexole Dihydrochloride Tablets/Mirapexin0.125mgBoehringer Ingelheim International GmbH未进口原研药品英国上市片剂
73-95盐酸阿莫罗芬搽剂Amorolfine Hydrochloride Liniment/Loceryl5%Galderma (U.K.) Limited未进口原研药品英国上市搽剂
73-96氯法齐明软胶囊Clofazimine Soft Capsules /Lamprene50mgNovartis Pharma AG未进口原研药品瑞士上市胶囊剂
73-97氯法齐明软胶囊Clofazimine Soft Capsules /Lamprene100mgNovartis Pharma AG未进口原研药品瑞士上市胶囊剂
73-98克霉唑乳膏Clotrimazole Cream/Canesten1%Bayer Plc未进口原研药品欧盟上市乳膏剂
73-99甲硝唑凝胶Metronidazole Gel/ Rozex0.75%マルホ株式会社未进口原研药品日本上市凝胶剂
73-100枸橼酸西地那非口溶膜Sildenafil Citrate Oral Soluble Film/バイアグラ(Viagra)25mgヴィアトリス製薬株式会社未进口原研药品日本上市溶膜
73-101枸橼酸西地那非口溶膜Sildenafil Citrate Oral Soluble Film/バイアグラ(Viagra)50mgヴィアトリス製薬株式会社未进口原研药品日本上市溶膜
73-102锝[99mTc]替马西普注射液Kit for the Preparation of Technetium Tc 99m Tilmanocept Injection/LYMPHOSEEK KIT每瓶含250µg(以替马西普计)Cardinal Health 414, LLC未进口原研药品美国橙皮书注射剂
73-103注射用替马西普Kit for the Preparation of Technetium Tc 99m Tilmanocept Injection/LYMPHOSEEK KIT50 µg(以替马西普计)Cardinal Health 414, LLC未进口原研药品美国橙皮书注射剂
31-43氨酚咖妥胶囊Butalbital, Acetaminophen, and Caffeine Capsules对乙酰氨基酚;布他比妥;咖啡因,300mg;50mg;40mgNexgen Pharma, Inc/LGM Pharma Solutions, LLC美国橙皮书增加变更后上市许可持有人LGM Pharma Solutions, LLC胶囊剂
22-74泊沙康唑肠溶片Posaconazole Enteric-coated Tablets NOXAFIL100mgMerck Sharp & Dohme Ltd/Merck Sharp & Dohme Corp.未进口原研药品增加变更后上市许可持有人Merck Sharp & Dohme Ltd/Merck Sharp & Dohme Corp.片剂
30-138制霉菌素口服混悬液Nystatin Oral Suspension/Mycostatin/Mycostatine100000IU/mlSubstipharm未进口原研药品增加商品名Mycostatine口服混悬液
56-37盐酸普罗帕酮注射液Propafenone Hydrochloride Injection/Rytmonorm70mg/20mlMylan Healthcare Gmbh/Viatris Healthcare Limited/Mylan Österreich GmbH/Teva Italia S.r.l./Viatris Healthcare GmbH未进口原研药品增加变更后上市许可持有人Viatris Healthcare GmbH注射剂
30-116丁溴东莨菪碱注射液Scopolamine Butylbromide Injection/ Buscapina/Buscopan1ml:20mgSanofi-aventis/Sanofi/Aventis/Sanofi S.p.A./ Opella Healthcare Italy S.r.l./A.Nattermann&Cie.GmbH/Opella Healthcare UK Limited /Opella Healthcare Spain, S.L.未进口原研药品增加上市许可持有人 Opella Healthcare Italy S.r.l./A.Nattermann&Cie.GmbH/Opella Healthcare UK Limited /Opella Healthcare Spain, S.L.注射剂
64-43亚叶酸钙注射液Calcium Folinate Injection/Leucovorin 10 mg/mL solution for injection/infusion1mL:10mg、2mL:20mg、3mL:30mg、5mL:50mg、10mL:100mg、20mL:200mg、25mL:250mg、30mL:300mg、50mL:500mgPfizer Pharma GmbH/Pfizer Ελλάς A.E.未进口原研药品增加上市许可持有人Pfizer Ελλάς A.E.注射剂
Sep-58氨基酸葡萄糖注射液Amino Acids and Glucose Injection/Clinimix N9 G15 E【1L/2L】:5.5%氨基酸-电解质溶液+15%葡萄糖-氯化钙溶液1000ml×2Baxter S.A.S / Baxter S.p.A.未进口原研药品增加上市许可持有人Baxter S.p.A.注射剂
8-242腺苷钴胺胶囊Cobamamide Capsules/ Hycobal0.5mgEisai Co.,Ltd/エーザイ株式会社日本橙皮书增加变更后上市许可持有人エーザイ株式会社胶囊剂
26-85西咪替丁注射液Cimetidine Injection/Tagamet2ml:0.2g大日本住友製薬株式会社/住友ファーマ株式会社未进口原研药品增增加变更后上市许可持有人住友ファーマ株式会社注射剂
40-16普瑞巴林口崩片Pregabalin Orally Disintegrating Tablets/LYRICA25mgPfizer Japan Inc.(ファイザー株式会社)/ヴィアトリス製薬株式会社未进口原研药品增加变更后上市许可持有人ヴィアトリス製薬株式会社片剂
40-18普瑞巴林口崩片Pregabalin Orally Disintegrating Tablets/LYRICA150mgPfizer Japan Inc.(ファイザー株式会社)/ヴィアトリス製薬株式会社未进口原研药品增加变更后上市许可持有人ヴィアトリス製薬株式会社片剂
47-14盐酸甲哌卡因注射液Mepivacaine Hydrochloride Injection /Carbocain10ml:200mgアスペンジャパン株式会社/サンド株式会社日本上市增加变更后上市许可持有人アスペンジャパン株式会社注射剂
31-36美沙拉秦缓释胶囊/美沙拉秦肠溶缓释胶囊Mesalamine extended release capsules(Mesalazine Enteric-coated Sustained-release Capsules)/Apriso375mgValeant Pharmaceuticals International未进口原研药品更新本品通用名称为美沙拉秦肠溶缓释胶囊,英文名称为Mesalazine Enteric-coated Sustained-release Capsules胶囊剂
29-53非诺贝特酸缓释胶囊/非诺贝特酸胆碱缓释胶囊Choline Fenofibrate Delayed release Capsule(Choline Fenofibrate Sustained-release Capsules)/Trilipix45mgAbbvie Inc未进口原研药品更新本品通用名称为非诺贝特酸胆碱缓释胶囊,英文名为Choline Fenofibrate Sustained-release Capsules胶囊剂
29-54非诺贝特酸缓释胶囊/非诺贝特酸胆碱缓释胶囊Choline Fenofibrate Delayed release Capsule(Choline Fenofibrate Sustained-release Capsules)/Trilipix135mgAbbvie Inc未进口原研药品更新本品通用名称为非诺贝特酸胆碱缓释胶囊,英文名为Choline Fenofibrate Sustained-release Capsules胶囊剂
27-345利格列汀片Linagliptin Tablets/Tradjenta27-345Boehringer Ingelheim Pharmaceuticals, Inc.未进口原研药品更新英文名为Linagliptin Tablets片剂
1月28日硫酸氢氯吡格雷片Clopidogrel Hydrogen Sulphate Tablets(Clopidogrel Bisulfate Tablets)/Plavix75mgSanofi Clir SNC/Sanofi Winthrop Industrie原研进口更新本品英文名为Clopidogrel Bisulfate Tablets,增加变更后上市许可持有人Sanofi Winthrop Industrie片剂
2月17日硫酸氢氯吡格雷片Clopidogrel Hydrogen Sulphate Tablets(Clopidogrel Bisulfate Tablets)/Plavix300mgSanofi Clir SNC/Sanofi Winthrop Industrie原研进口更新本品英文名为Clopidogrel Bisulfate Tablets,增加变更后上市许可持有人Sanofi Winthrop Industrie片剂
8-84坎地沙坦酯片Candesartan Cilexetil Tablets/Blopress8mgTakeda Pharmaceutical Company Limited/Teva Takeda Yakuhin Ltd.原研进口增加变更后上市许可持有人Teva Takeda Yakuhin Ltd.片剂
Mar-44甲氨蝶呤注射液Methotrexate Injection/美素生10ml:1gHospira Australia Pty Ltd/Pfizer Australia Pty Ltd原研进口增加变更后上市许可持有人Pfizer Australia Pty Ltd注射剂
Apr-44甲氨蝶呤注射液Methotrexate Injection/美素生20ml:0.5gHospira Australia Pty Ltd/Pfizer Australia Pty Ltd原研进口增加变更后上市许可持有人Pfizer Australia Pty Ltd注射剂
10-39伏立康唑片Voriconazole Tablets/Vfend50mgPfizer Limited/ Pfizer Europe MA EEIG原研进口增加变更后上市许可持有人Pfizer Europe MA EEIG片剂
10-40伏立康唑片Voriconazole Tablets/Vfend0.2gPfizer Limited/ Pfizer Europe MA EEIG原研进口增加变更后上市许可持有人Pfizer Europe MA EEIG片剂
23-145盐酸氮卓斯汀鼻喷雾剂Azelastine Hydrochloride Nasal Spray/Azep(爱赛平)10ml:10mg,60喷,每喷0.14mgMEDA Pharma GmbH & Co.KG/Viatris Healthcare GmbH原研进口增加变更后上市许可持有人Viatris Healthcare GmbH喷雾剂
24-108普乐沙福注射液Plerixafor Injection/释倍灵(Mozobil)1.2ml:24mgGenzyme Europe B.V./ Sanofi B.V.原研进口增加变更后上市许可持有人Sanofi B.V.注射剂
22-73泊沙康唑肠溶片Posaconazole Enteric-coated Tablets/NOXAFIL100mgMerck Sharp & Dohme Ltd/Merck Sharp & Dohme B.V国内上市的原研药品增加变更后上市许可持有人Merck Sharp & Dohme B.V片剂
30-2泊沙康唑口服混悬液Posaconazole Oral Suspension/Noxafil(诺科飞)40mg/mlMerck Sharp & Dohme Ltd/Merck Sharp & Dohme B.V.原研进口增加变更后上市许可持有人Merck Sharp & Dohme B.V.口服混悬液
21-36注射用阿扎胞苷Azacitidine For Injection/Vidaza(维达莎)100mgCelgene Europe Ltd./ Bristol-Myers Squibb Pharma EEIG.国内上市的原研药品增加变更后上市许可持有人Bristol-Myers Squibb Pharma EEIG.注射剂
10-72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欧盟上市增加变更后上市持有人CHEPLAPHARM Arzneimittel GmbH,不限定产地片剂



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