1、参比制剂第十批附件仿制药参比制剂目录(第十批)序号药品通用名称英文名称/商品名规格剂型持证商备注1备注210-1阿司匹林双嘧达莫缓释胶囊Aspirin andDipyridamole Sustained-release Capsules/ Aggrenox阿司匹林25mg 与双嘧达莫 200mg胶囊剂(缓释胶囊)Boehringer Ingelheim Pharma GmbH & Co.KG欧盟上市(上市 国:德国;产地: 德国)10-2艾司奥美拉唑镁肠溶片EsomeprazoleMagnesium Enteric-coated Tablets/NEXIUM20mg片剂(肠溶片)AstraZe
2、neca AB原研进口10-3艾司奥美拉唑镁肠溶片EsomeprazoleMagnesium Enteric-coated Tablets/NEXIUM40mg片剂(肠溶片)AstraZeneca AB原研进口序号药品通用名称英文名称/商品名规格剂型持证商备注1备注210-4氨苄西林胶囊Ampicillin Capsules/AMPICILLI N TRIHYDRATE500mg(以C16H19N3O4S 计)胶囊剂DAVA Pharmaceuticals INC美国橙皮书10-5氨酚曲马多片Paracetamol and Tramadol Hydrochloride Tablets/ULTR
3、ACET盐酸曲马多37.5mg;对乙 酰氨基酚325mg片剂JANSSEN PHARMACEUTICA LS INC美国橙皮书美国橙皮书收载名称:Acetaminoph en and TramadolHydrochlorid e Tablets10-6氨酚双氢可待因片Paracetamol andDihydrocodeine Tartrate Tablets/Co-dydramol对乙酰氨基酚 500mg ;酒 石酸双氢可 待因 10mg片剂Actavis UK Limited欧盟上市(上市国家:英国;产地:英国)序号药品通用名称英文名称/商品名规格剂型持证商备注1备注210-7氨磺必利片Am
4、isulprideTablets/Solian50mg片剂SANOFI欧盟上市(上市国家:英国;产地:法国)持证商为AventisPharmaLimited 的产品亦可10-8氨磺必利片AmisulprideTablets/Solian0.2g片剂SANOFI-AVENTIS FRANCE原研进口10-9奥卡西平片OxcarbazepineTablets/Trileptal0.3g片剂Novartis PharmaSchweiz AG原研进口10-10奥美拉唑碳酸氢钠胶囊Omeprazole and Sodium Bicarbonate Capsules/ZEGERID奥美拉唑20mg,碳酸氢
5、钠 1.1g胶囊剂SANTARUS INC美国橙皮书10-11奥美沙坦酯片OlmesartanMedoxomil Tablets/BENICAR20mg片剂DAIICHI SANKYO INC美国橙皮书序号药品通用名称英文名称/商品名规格剂型持证商备注1备注210-12奥美沙坦酯片OlmesartanMedoxomil Tablets/BENICAR40mg片剂DAIICHI SANKYO INC美国橙皮书10-13奥沙拉秦钠胶囊Olsalazine SodiumCapsules/DIPENTUM0.25g胶囊剂Mylan SPECIALTY LP美国橙皮书10-14奥沙西泮片Oxazepam
6、Tablets/Sobril15mg片剂Pfizer AB欧盟上市(上市国家:瑞典;产地:意大利)10-15巴氯芬片BaclofenTablets/Lioresal10mg片剂Novartis PharmaSchweiz AG原研进口10-16苯甲酸利扎曲普坦片Rizatriptan BenzoateTablets/Maxalt5mg(以C15H19N5 计)片剂MERCK AND CO INC美国橙皮书10-17比沙可啶肠溶片BisacodylEnteric-coatedTablets/-5mg片剂(肠溶片)Boehringer Ingelheim France原研进口序号药品通用名称英文名
7、称/商品名规格剂型持证商备注1备注210-18吡罗昔康胶囊Piroxicam Capsules /FELDENE10mg胶囊剂PFIZER LABORATORIES DIV PFIZER INC美国橙皮书10-19吡罗昔康胶囊Piroxicam Capsules /FELDENE20mg胶囊剂PFIZER LABORATORIES DIV PFIZER INC美国橙皮书10-20醋氯芬酸片AceclofenacTablets/AIRTAL100mg片剂Almirall, S.A.欧盟上市(上市国家:西班牙;产地:西班牙)10-21醋酸钙片Calcium Acetate Tablets/CALC
8、IUM ACETATE0.667g片剂PADDOCK LABORATORIES LLC美国橙皮书10-22单硝酸异山梨酯缓释胶囊IsosorbideMononitrate Sustained-release Capsules/Elantan50mg胶囊剂(缓释胶囊)UCB Pharma欧盟上市(产地:德国)德国上市名 称:Isosorbidmon onitratRetardkapsel n序号药品通用名称英文名称/商品名规格剂型持证商备注1备注210-23单硝酸异山梨酯缓释片Isosorbide Mononitrate Sustained-release Tablets/Ismo retard
9、40mg片剂(缓释片)Riemser Pharma GmbH欧盟上市(上市国家:德国;产地:西班牙)德国上市名 称:Isosorbidmon onitratRetardtablett en10-24单硝酸异山梨酯缓释片IsosorbideMononitrate Sustained-release Tablets/Imdur60mg片剂(缓释片)AstraZeneca UK Limited欧盟上市(上市国家:英国;产地:英国)英国上市名称:Isosorbide MononitrateExtended release film coated tablet10-25单硝酸异山梨酯片Isosorbid
10、e Mononitrate Tablets /Monoket10mg片剂KREMERS URBAN PHARMACEUTICA LS INC美国橙皮书10-26单硝酸异山梨酯片IsosorbideMononitrate Tablets/Monoket20mg片剂KREMERS URBAN PHARMACEUTICA LS INC美国橙皮书序号药品通用名称英文名称/商品名规格剂型持证商备注1备注210-27对乙酰氨基酚 维生素 C 泡腾 片Compound Paracetamol and Vitamin C Effervescent Tablets/EFFERALGA N每片含对乙 酰氨基酚33
11、0mg,维生素 C 200mg片剂(泡腾片)UPSA SAS欧盟上市(上市国家:法国;产地:法国)持证商为 Bristol-Myer s Squibb ,S.A.的产品亦可10-28多索茶碱颗粒Doxofylline Granules /ANSIMAR0.2g颗粒剂ABC FARMACEUTICI S.P.A.欧盟上市(上市国家:意大利;产地:意大利)10-29泛昔洛韦片FamciclovirTablets/Famvir0.125g片剂NovartisPharmaceuticals UK Limited欧盟上市(产地:西班牙)10-30泛昔洛韦片FamciclovirTablets/Famvi
12、r0.25g片剂NovartisPharmaceuticals UK Limited欧盟上市(产地:西班牙)序号药品通用名称英文名称/商品名规格剂型持证商备注1备注210-31非布司他片FebuxostatTablets/ULORIC40mg片剂TAKEDA PHARMACEUTICA LS USA INC美国橙皮书10-32非布司他片FebuxostatTablets/ULORIC80mg片剂TAKEDA PHARMACEUTICA LS USA INC美国橙皮书10-33非洛地平缓释片FelodipineSustained-release Tablets/Plendil10mg片剂(缓释片
13、)AstraZeneca UK Limited欧盟上市(上市国家:英国)英国上市名称:Felodipine Prolonged-rel ease Tablets10-34非洛地平缓释片FelodipineSustained-release Tablets/Plendil5mg片剂(缓释片)AstraZeneca A/S欧盟上市(上市国家:丹麦)丹麦上市名 称:FelodipinDepottabletter10-35非那雄胺片FinasterideTablets/PROPECIA1mg片剂MSD PHARMA (SINGAPORE)PTE.L TD.原研进口10-36非那雄胺片Finasteri
14、deTablets/PROSCAR5mg片剂Merck Sharp&Dohme Limited原研进口序号药品通用名称英文名称/商品名规格剂型持证商备注1备注210-37非诺贝特胶囊FenofibrateCapsules/Lipanthyl0.2g胶囊剂Abbott LaboratoriesLimit ED原研进口10-38酚咖片Paracetamol and Caffeine Tablets/Hedex Extra对乙酰氨基酚 500mg ;咖啡因 65mg片剂Omega Pharma Ltd.欧盟上市(上市国家:英国;产地:爱尔兰)商品名为Solpadeine Headache 的 亦可1
15、0-39伏立康唑片Voriconazole Tablets/Vfend50mg片剂Pfizer Limited原研进口10-40伏立康唑片Voriconazole Tablets/Vfend0.2g片剂Pfizer Limited原研进口10-41氟伐他汀钠胶囊Fluvastatin Sodium Capsules/LESCOL20mg(按C24H25FNO4 计)胶囊剂NOVARTIS FARMACUTICA, S.A.欧盟上市(产地:西班牙)10-42氟伐他汀钠胶囊Fluvastatin Sodium Capsules/LESCOL40mg(按C24H25FNO4 计)胶囊剂NOVARTI
16、S FARMACUTICA, S.A.欧盟上市(产地:西班牙)序号药品通用名称英文名称/商品名规格剂型持证商备注1备注210-43氟氯西林钠胶囊Flucloxacillin Sodium Capsules/FLOXAPEN0.25g(按C19H17ClFN3O5S 计)胶囊剂Actavis UK Ltd欧盟上市(上市国家:英国;产地:荷兰,冰岛)10-44氟氯西林钠颗粒Flucloxacillin Sodium Granules/-0.125g/5ml(按C19H17ClFN3O5S 计)颗粒剂Actavis UK Ltd欧盟上市(上市国家:英国;产地:爱尔兰)英国上市名称:Flucloxac
17、illin Sugar-Free Powder forOral Solution10-45富马酸替诺福韦二吡呋酯片Tenofovir Disoproxil Fumarate Tablets/VIREAD0.3g片剂Gilead Sciences Inc.原研进口10-46富马酸酮替芬胶囊Ketotifen Fumarate Capsules/Zaditen1mg ( 按C19H19NOS 计)胶囊剂Sun Pharmaceutical Industries Limited日本橙皮书序号药品通用名称英文名称/商品名规格剂型持证商备注1备注210-47富马酸酮替芬片Ketotifen Fumara
18、teTablets/Zaditen1mg ( 按C19H19NOS 计)片剂Novartis PharmaSchweiz AG上市国家:瑞士;产地:瑞士10-48格列齐特缓释片GliclazideSustained-release Tablets/Diamicron30mg片剂(缓释片)Les Laboratoires Servier欧盟上市(上市国家:英国)英国上市名称:GliclazideModified Release Tablets10-49格列齐特缓释片GliclazideSustained-releaseTablets/-60mg片剂(缓释片)Les Laboratoires Se
19、rvier原研进口10-50格列齐特片GliclazideTablets/Diamicron80mg片剂Servier LaboratoriesLtd欧盟上市(上市国家:英国)10-51格列齐特片GliclazideTablets/Glimicron40mg片剂Dainippon SumitomoPharma Co., Ltd.日本橙皮书序号药品通用名称英文名称/商品名规格剂型持证商备注1备注210-52枸橼酸氯米芬片Clomifene CitrateTablets/Clomid50mg片剂SANOFI-AVENTIS FRANCE欧盟上市(上市国家:法国;产地:法国)10-53枸橼酸莫沙必利
20、片Mosapride CitrateTablets/Gasmotin5mg(按 C21H25ClFN3 O3C 6H8O7 计算)片剂Sumitomo DainipponPharma Co., Ltd.原研进口10-54枸橼酸西地那非片Sildenafil Citrate Tablets/VIAGRA25mg(按C22H30N6O4S 计)片剂PFIZER INC美国橙皮书10-55枸橼酸西地那非片Sildenafil Citrate Tablets/VIAGRA50mg(按C22H30N6O4S 计)片剂PFIZER INC美国橙皮书序号药品通用名称英文名称/商品名规格剂型持证商备注1备注2
21、10-56枸橼酸西地那非片Sildenafil Citrate Tablets/VIAGRA100mg(按C22H30N6O4S 计)片剂PFIZER INC美国橙皮书10-57骨化三醇软胶囊Calcitriol SoftCapsules/Rocaltrol0.5g胶囊剂(软胶囊)Roche Pharma(Schweiz)AG上市国家:瑞士;产地:德国10-58骨化三醇软胶囊Calcitriol SoftCapsules/Rocaltrol0.25g胶囊剂(软胶囊)Roche Pharma (Schweiz) Ltd.原研进口10-59茴三硫片Anethel Trithione Tablets
22、 /SULFARLEM12.5mg片剂EXOD欧盟上市(上市国家:法国;产地:法国)10-60茴三硫片Anethel Trithione Tablets /SULFARLEM S25mg片剂EXOD欧盟上市(上市国家:法国;产地:法国)序号药品通用名称英文名称/商品名规格剂型持证商备注1备注210-61甲钴胺片MecobalaminTablets/Methycobal0.5mg片剂Eisai Co., Ltd.日本橙皮书10-62酒石酸托特罗定片Tolterodine TartrateTablets/Detrol1mg片剂Pharmacia AndUpjohn Co美国橙皮书10-63酒石酸托
23、特罗定片Tolterodine TartrateTablets/Detrol2mg片剂Pharmacia AndUpjohn Co美国橙皮书10-64酒石酸唑吡坦片Zolpidem Tartrate Tablets/AMBIEN5mg片剂SANOFI AVENTIS US LLC美国橙皮书10-65酒石酸唑吡坦片Zolpidem TartrateTablets/Stilnox10mg片剂SANOFI-AVENTISFRANCE原研进口10-66卡维地洛片CarvedilolTablets/Dilatrend6.25mg片剂Roche Pharma AG欧盟上市(上市国家:德国;产地:意大利)1
24、0-67卡维地洛片CarvedilolTablets/ARTIST10mg片剂Daiichi Sankyo Co., Ltd.日本橙皮书序号药品通用名称英文名称/商品名规格剂型持证商备注1备注210-68卡维地洛片CarvedilolTablets/Dilatrend12.5mg片剂Roche Pharma AG欧盟上市(上市国家:德国;产地:意大利)10-69卡维地洛片CarvedilolTablets/ARTIST20mg片剂Daiichi Sankyo Co., Ltd.日本橙皮书10-70卡维地洛片CarvedilolTablets/Dilatrend25mg片剂Roche Pharm
25、a AG欧盟上市(上市国家:德国;产地:意大利)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 12.5mg片剂Takeda GmbH欧盟上市(上市国家:德国;产地:意大利)序号药品通用名称英文名称/商品名规格剂型持证商备注1备注210-72坎地氢噻片Candesartan cilexetil and Hydrochlorothiazide Tablets/Blopress每片含坎地 沙坦酯 8mg, 氢氯噻嗪12.5mg片剂Takeda GmbH欧盟上市(
26、上市国家:德国;产地:意大利)10-73拉呋替丁片LafutidineTablets/PROTECADIN10mg片剂TAIHO PHARMACEUTICA L CO., LTD.日本橙皮书10-74拉西地平片Lacidipine Tablets /Lacipil4mg片剂GLAXOSMITHKLINE,S.A原研进口10-75拉西地平片Lacidipine Tablets /Lacipil6mg片剂GlaxoSmithKlineS.p.A.欧盟上市(上市国家:意大利)10-76消旋卡多曲散RacecadotrilPowder/-10mg散剂Laboratoire bioprojet Pharma原研进口10-77消旋卡多
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