仿制藥參比制劑目錄（第44批）

1、 附件仿制藥參比制劑目錄（第四十四批）序號藥品通用名稱英文名稱/商品名規(guī)格持證商備注1備注244-1十一酸睪酮軟膠囊Testosterone Undecanoate Soft Capsules/Andriol Testocaps（安特爾）40mgN.V.Organon國內(nèi)上市的原研藥品原研進口44-2氯苯唑酸葡胺軟膠囊Tafamidis Meglumine Soft Capsules/Vyndaqel（維達全）20mg（按C14H7Cl2NO3·C7H17NO5計）Pfizer Europe MA EEIG國內(nèi)上市的原研藥品原研進口44-3阿帕他胺片Apalutamide Table

2、ts60mgJanssen Biotech Inc未進口原研藥品美國橙皮書44-4咪達唑侖鼻用噴霧劑Midazolam Nasal Spray/Nayzilam5 mg/噴UCB Inc未進口原研藥品美國橙皮書44-5注射用達巴萬星Dalbavancin For Injection/Dalvance500mgAllergan Sales LLC未進口原研藥品美國橙皮書44-6克林霉素磷酸酯陰道乳膏Clindamycin Phosphate Vaginal Cream/ Cleocin2%Pfizer Inc未進口原研藥品美國橙皮書44-7注射用硫酸多黏菌素BPolymyxin B sulfat

3、e for Injection50萬單位/瓶Gland Pharma LTD國際公認的同種藥品美國橙皮書44-8呋塞米口服溶液Furosemide Oral Solution10mg/mlHikma Pharmaceuticals USA INC國際公認的同種藥品美國橙皮書44-9右酮洛芬氨丁三醇片Dexketoprofen Trometamol Tablets12.5mg（按C16H14O3計）Laboratorios Menarini，S.A.未進口原研藥品歐盟上市44-10間苯三酚口崩片Phloroglucinol Orally Disintegrating Tablets80mgTev

4、a Sante未進口原研藥品歐盟上市44-11注射用坎格雷洛Cangrelor for Injection/Kengrexal50mgChiesi Farmaceutici S.p.A.未進口原研藥品歐盟上市44-12伊拉地平緩釋膠囊Isradipine Sustained-release Capsules/Vascal2.5mgCheplapharm Arzneimittel GmbH未進口原研藥品歐盟上市44-13伊拉地平緩釋膠囊Isradipine Sustained-release Capsules/Vascal5mgCheplapharm Arzneimittel GmbH未進口原研

5、藥品歐盟上市44-14達蘆那韋片Darunavir Tablets/Prezista600mgJanssen-Cilag International NV未進口原研藥品歐盟上市44-15恩那司他片Enarodustat Tablets/Enaroy2mg日本産業(yè)株式會社未進口原研藥品日本上市44-16恩那司他片Enarodustat Tablets/Enaroy4mg日本産業(yè)株式會社未進口原研藥品日本上市44-17二硫化硒洗劑Selenium Sulfide Lotion/Selsun2.5%Sanofi未進口原研藥品英國上市44-18注射用阿莫西林鈉Amoxicillin Sodium fo

6、r Injection500mgBeecham Group plc未進口原研藥品英國上市44-19注射用阿莫西林鈉Amoxicillin Sodium for Injection1.0gBeecham Group plc未進口原研藥品英國上市44-20美沙拉秦腸溶片Mesalazine Enteric-coated Tablets400mgTillotts Pharma AG國內(nèi)上市的原研藥品原研進口44-21美沙拉秦腸溶片Mesalazine Enteric-coated Tablets800mgTillotts Pharma AG國內(nèi)上市的原研藥品原研進口44-22甲氨蝶呤注射液Metho

7、trexate Injection/美素生10ml:1gHospira Australia Pty Ltd國內(nèi)上市的原研藥品原研進口44-23甲氨蝶呤注射液Methotrexate Injection/美素生20ml:0.5gHospira Australia Pty Ltd國內(nèi)上市的原研藥品原研進口44-24-3魚油脂肪乳注射液-3 Fish Oil Fat Emulsion Injection/ Omegaven100ml:10g（精制魚油）:1.2g（卵磷脂）Fresenius Kabi Austria GmbH國內(nèi)上市的原研藥品原研進口44-25卡貝縮宮素注射液Carbetocin I

8、njection1ml: 100g輝凌制藥（中國）有限公司經(jīng)審核確定的國外原研企業(yè)在中國境內(nèi)生產(chǎn)的藥品原研地產(chǎn)化44-26依折麥布辛伐他汀片Ezetimibe and Simvastatin Tablets/Vytorin10mg/10mgOrganon Llc A Sub Of Organon And Co未進口原研藥品美國橙皮書44-27依折麥布辛伐他汀片Ezetimibe and Simvastatin Tablets/Vytorin10mg/20mgOrganon Llc A Sub Of Organon And Co未進口原研藥品美國橙皮書44-28依折麥布辛伐他汀片Ezetimib

9、e and Simvastatin Tablets/Vytorin10mg/40mgOrganon Llc A Sub Of Organon And Co未進口原研藥品美國橙皮書44-29鹽酸西替利嗪滴眼液Cetirizine Ophthalmic Solution/Zerviate0.24%（0.2ml）Eyevance Pharmaceuticals Llc未進口原研藥品美國橙皮書44-30鹽酸氯普魯卡因注射液Chloroprocaine Hydrochloride Injection/Nesacaine-MPF2%Fresenius Kabi USA LLC未進口原研藥品美國橙皮書44-

10、31鹽酸氯普魯卡因注射液Chloroprocaine Hydrochloride Injection/Nesacaine-MPF3%Fresenius Kabi USA LLC未進口原研藥品美國橙皮書44-32賽洛多辛膠囊Silodosin Capsules/Rapaflo4mgAllergan Sales LLC未進口原研藥品美國橙皮書44-33西洛他唑片Cilostazol Tablets50mgTeva Pharmaceuticals USA Inc國際公認的同種藥品美國橙皮書44-34格列吡嗪片Glipizide Tablets/Minidiab5mgPfizer Italia s.r

11、.l.未進口原研藥品歐盟上市44-35注射用醋酸奧曲肽微球Octreotide Acetate Microspheres for Injection /Sandostatin LAR10mgNovartis Pharma GmbH未進口原研藥品歐盟上市44-36注射用醋酸奧曲肽微球Octreotide Acetate Microspheres for Injection /Sandostatin LAR20mgNovartis Pharma GmbH未進口原研藥品歐盟上市44-37注射用醋酸奧曲肽微球Octreotide Acetate Microspheres for Injection /

12、Sandostatin LAR30mgNovartis Pharma GmbH未進口原研藥品歐盟上市44-38培唑帕尼片Pazopanib Tablets /Votrient200mg（按培唑帕尼計）Novartis Europharm Limited未進口原研藥品歐盟上市44-39培唑帕尼片Pazopanib Tablets /Votrient400mg（按培唑帕尼計）Novartis Europharm Limited未進口原研藥品歐盟上市44-40-3魚油中長鏈脂肪乳氨基酸（16）葡萄糖（30%）注射液-3 Fish Oil Medium and Long Chain Fat Emuls

13、ion/Amino Acids （16）/Glucose（30%） Injection1875mlB.Braun Melsungen AG未進口原研藥品歐盟上市44-41中長鏈脂肪乳/氨基酸（16）/葡萄糖（16%）注射液Medium and Long Chain Fat Emulsion/Amino Acids（16）/Glucose（16%）Injection1875mlB.Braun Melsungen AG未進口原研藥品歐盟上市44-42艾曲泊帕乙醇胺片Eltrombopag Olamine Tablets/Revolade50mgNovartis Europharm Limited未

14、進口原研藥品歐盟上市44-43鹽酸溴己新口服溶液Bromhexine Hydrochloride Oral Solution/Bisolvon2mg/ml（40ml、100ml）Sanofi未進口原研產(chǎn)品歐盟上市44-44苯丁酸甘油酯口服液Glycerol phenylbutyrate oral liquid/Ravicti1.1g/mlImmedica Pharma AB未進口原研藥品歐盟上市44-45氟尿嘧啶注射液Fluorouracil Injection 10ml:0.25gHospira UK Limited國際公認的同種藥品歐盟上市44-46頭孢氨芐膠囊Cefalexin Caps

15、ules0.25g共和薬品工業(yè)株式會社未進口原研藥品日本上市44-47那格列奈片Nateglinide Tablets/ Fastic30mgEA制藥株式會社未進口原研藥品日本上市44-48洛索洛芬鈉貼劑Loxoprofen Sodium Patches/Loxonin100mg/貼（10cm×14cm）株式會社未進口原研藥品日本上市44-49依折麥布片Ezetimibe Tablets/Zetia10mgMSD株式會社未進口原研藥品日本上市44-50阿糖胞苷注射液Cytarabine Injection/Cytosar5ml:100mgPfizer PFE Switzerland

16、GmbH/Pfizer AG未進口原研藥品瑞士上市44-51阿糖胞苷注射液Cytarabine Injection/Cytosar25ml:500mgPfizer AG未進口原研藥品瑞士上市44-52腺苷注射液Adenosine Injection/Adenoscan10ml:30mgAventis Pharma Limited未進口原研藥品英國上市44-53腺苷注射液Adenosine Injection/Adenocor2ml:6mgAventis Pharma Limited未進口原研藥品英國上市44-54鹽酸倍他司汀片Betahistine Dihydrochloride Tablet

17、s / Serc8mgMylan Products Ltd未進口原研藥品英國上市9-3雙氯芬酸鈉緩釋片Diclofenac Sodium Sustained-release Tablets/VOLTAREN0.1gNovartis Pharma GmbH歐盟上市不限定上市國及產(chǎn)地12-7尼麥角林片Nicergoline Tablets/Sermion5mgPfizer Italia S.r.l./Upjohn EESV歐盟上市增加持證商Upjohn EESV12-8尼麥角林片Nicergoline Tablets/Sermion10mgPfizer Italia S.r.l./Upjohn E

18、ESV歐盟上市增加持證商Upjohn EESV12-9尼麥角林片Nicergoline Tablets/Sermion30mgPfizer Italia S.r.l./Pfizer Europe MA EEIG/Upjohn EESV歐盟上市增加持證商Pfizer Europe MA EEIG、Upjohn EESV23-204依托泊苷注射液Etoposide Injection/Vepesid5ml:100mg 株式會社/株式會社未進口原研藥品持證商變更，增加持證商株式會社10-233磷酸西格列汀片Sitagliptin Phosphate Tablets/JANUVIA100mgMerck

19、 Sharp & Dohme Ltd./ Merck Sharp & Dohme B.V.原研進口持證商變更，增加持證商Merck Sharp & Dohme B.V.27-441富馬酸依美斯汀滴眼液Emedastine Difumarate Eye Drops/Emadine（埃美?。?ml:2.5mg（0.05%，以依美斯汀計）Novartis Europharm Limited/ Novartis Pharma Schweiz AG國內(nèi)上市的原研藥品持證商變更，增加持證商Novartis Pharma Schweiz AG31-82釓特酸葡胺注射液Gadoteric Acid Meglumine Salt Injection/Dotarem376.9mg/mlGuerbet LLC未進口原研藥品規(guī)格更新為376.9mg/ml42-610%脂肪乳（OO）/5.5%氨基酸（15）/葡萄糖（2