仿制藥參比制劑目錄（第35批）

1、附件仿制藥參比制劑目錄（第三十五批）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2 35-1注射用六氟化硫微泡Sulfur Hexafluoride Microbubbles for Injection/ SonoVue（聲諾維）59 mgBracco International B.V.國內(nèi)上市的原研藥品原研進口35-2注射用利培酮微球Risperidone for Depot Suspension/ Risperdal Consta25 mgJanssen-Cilag AG/Janssen Pharmaceutica N.V.國內(nèi)上市的原研藥品原研進口35-3注射用利培酮微球Ris

2、peridone for Depot Suspension/ Risperdal Consta37.5 mgJanssen-Cilag AG/Janssen Pharmaceutica N.V.國內(nèi)上市的原研藥品原研進口35-4注射用利培酮微球Risperidone for Depot Suspension/ Risperdal Consta50 mgJanssen-Cilag AG/Janssen Pharmaceutica N.V.國內(nèi)上市的原研藥品原研進口35-5注射用利培酮微球Risperidone Long-acting Injection/ Risperdal Consta12.5

3、mgJanssen Pharmaceuticals, Inc.未進口原研藥品美國橙皮書35-6注射用利培酮微球Risperidone Long-acting Injection/ Risperdal Consta25 mgJanssen Pharmaceuticals, Inc.未進口原研藥品美國橙皮書35-7注射用利培酮微球Risperidone Long-acting Injection/ Risperdal Consta37.5 mgJanssen Pharmaceuticals, Inc.未進口原研藥品美國橙皮書35-8注射用利培酮微球Risperidone Long-acting I

4、njection/ Risperdal Consta50 mgJanssen Pharmaceuticals, Inc.未進口原研藥品美國橙皮書35-9注射用利培酮微球Risperidone powder and solvent for depot suspension for Injection/ Risperdal Consta25 mgJanssen-Cilag GmbH未進口原研藥品歐盟上市35-10注射用利培酮微球Risperidone powder and solvent for depot suspension for Injection/ Risperdal Consta37.

5、5 mgJanssen-Cilag GmbH未進口原研藥品歐盟上市35-11注射用利培酮微球Risperidone powder and solvent for depot suspension for Injection/ Risperdal Consta50 mgJanssen-Cilag GmbH未進口原研藥品歐盟上市35-12普拉曲沙注射液Pralatrexate Injection/Folotyn20mg/mlAcrotech Biopharma LLC未進口原研藥品美國橙皮書35-13酒石酸匹莫范色林片Pimavanserin Tartrate Tablets/Nuplazid10

6、mg（以匹莫范色林計）Acadia Pharmaceuticals Inc未進口原研藥品美國橙皮書35-14注射用苯唑西林鈉Oxacillin Sodium for Injection以C19H19N3O5S計1.0gSagent Pharmaceuticals Inc國際公認的同種藥品美國橙皮書35-15注射用苯唑西林鈉Oxacillin Sodium for Injection以C19H19N3O5S計2.0gSagent Pharmaceuticals Inc國際公認的同種藥品美國橙皮書35-16鹽酸去氧腎上腺素注射液Phenylephrine Hydrochloride Injecti

7、on/Vazculep10mg/mlAvaedl Legacy未進口原研藥品美國橙皮書35-17小兒復方氨基酸注射液（20AA）Amino Acid Solution for Infusion/Primene10%（100ml/250ml）Baxter未進口原研藥品歐盟上市35-18小兒復方氨基酸注射液（20AA）Amino Acid Intravenous Infusion/Primene10%（100ml/250ml）Baxter Healthcare Pty Ltd未進口原研藥品澳大利亞上市35-19琥珀酸呋羅曲坦片F(xiàn)rovatriptan Tablet/Isimig2.5mgMenar

8、ini International Operations Luxembourg SA未進口原研藥品歐盟上市35-20間苯三酚口服凍干片Phloroglucinol Oral Lyophilisates/ Spasfon Lyoc160mgTeva Sante未進口原研藥品歐盟上市35-21復方磺胺甲噁唑注射液Sulfamethoxazole and Trimethoprim Injection/Bactrim5ml，磺胺甲噁唑80mg/ml，甲氧芐啶16mg/mlRoche S.p.A未進口原研藥品歐盟上市35-22依托芬那酯凝膠Etofenamate Gel/Traumon5%（50g，10

9、0g）MEDA Manufacturing GmbH未進口原研藥品歐盟上市35-23依托芬那酯凝膠Etofenamate Gel/Traumon10%（50g，100g）MEDA Manufacturing GmbH未進口原研藥品歐盟上市35-24鹽酸非索非那定干糖漿Fexofenadine Hydrochloride Dry Syrup/Allegra1g中含鹽酸非索非那定50mg株式會社（賽諾菲株式會社）未進口原研藥品日本上市35-25甲基多巴片Methyldopa Tablets/Aldomet250mg株式會社製薬未進口原研藥品日本上市35-26注射用鹽酸羅沙替丁醋酸酯Roxatidi

10、ne Acetate Hydrochloride For Injection/Altat75mg製薬株式會社未進口原研藥品日本上市35-27瑞盧戈利片Relugolix Tablets/Relumina40mg武田藥品工業(yè)株式會社/制藥株式會社未進口原研藥品日本上市35-28拉考沙胺注射液Lacosamide Injection/Vimpat10mg/mlUCB Pharma S.A.國內(nèi)上市的原研藥品原研進口35-29注射用醋酸卡泊芬凈Caspofungin Acetate for Injection/Cancidas50mgMerck and Co INC未進口原研藥品美國橙皮書35-30

11、注射用醋酸卡泊芬凈Caspofungin Acetate for Injection/Cancidas70mgMerck and Co INC未進口原研藥品美國橙皮書35-31注射用唑來膦酸濃溶液Zoledronic Acid Concentrated Solution for Injection/Zometa5ml:4mgNovartis Pharmaceuticals Corp未進口原研藥品美國橙皮書35-32鹽酸多塞平片Doxepin Hydrochloride Tablets /Silenor6mgCurrax Pharmaceuticals LLC未進口原研藥品美國橙皮書35-33氯

12、氮平片Clozapine Tablets/Clozaril0.1gHeritage Life Sciences Barbados INC未進口原研藥品美國橙皮書35-34麥考酚鈉腸溶片Mycophenolate Sodium Enteric-coated tablets/Myfortic180mgNovartis Pharmaceuticals Corporation未進口原研藥品美國橙皮書35-35鹽酸二甲雙胍緩釋片Metformin Hydrochloride Extended-release Tablets/Fortamet1gAndrx Labs LLC未進口原研藥品美國橙皮書35-3

13、6司來帕格片Selexipag Tablets/ Uptravi0.4mgJanssen-Cilag International NV未進口原研藥品歐盟上市35-37左氧氟沙星氯化鈉注射液Levofloxacin and Sodium Chloride Injection /Tavanic50ml:250mgSanofi-Aventis Deutschland GmbH未進口原研藥品德國上市35-38托拉塞米片Torasemide Tablets /Unat5mgMEDA Pharma GmbH & Co. KG未進口原研藥品德國上市35-39紫杉醇注射液Paclitaxel Inje

14、ction/Taxol16.7ml:100mgBristol-Myers Squibb S.R.L.未進口原研藥品瑞士上市35-40氨甲環(huán)酸注射液Tranexamic Acid Injection/Transamin5%（5ml:0.25g）第一三共株式會社未進口原研藥品日本上市35-41氨甲環(huán)酸注射液Tranexamic Acid Injection/Transamin10%（2.5ml:0.25g、10ml:1g）第一三共株式會社未進口原研藥品日本上市35-42氨甲環(huán)酸注射液Tranexamic Acid Injection/Cyklokapron5ml:0.5g、10ml:1gPfize

15、r未進口原研藥品歐盟上市35-43氨甲環(huán)酸注射液Tranexamic Acid Injection/Cyklokapron10ml:1gPharmacia and Upjohn Co未進口原研藥品美國橙皮書8-88利巴韋林片Ribavirin Tablets/Copegus0.2gRoche Products Limited/Roche S.p.A/Roche Pharma AG歐盟上市增加持證商Roche S.p.A/Roche Pharma AG；不限定產(chǎn)地8-179鹽酸替扎尼定片Tizanidine Hydrochloride Tablets /Sirdalud2mgNovartis P

16、harma GmbH歐盟上市修訂，不限定產(chǎn)地8-147硝苯地平控釋片Nifedipine Controlled-release Tablets/Adalat30mgBayer Pharma AG /Bayer AG原研進口持證商變更，增加變更后持證商Bayer AG8-236硝苯地平控釋片Nifedipine Controlled-release Tablets/Adalat60mgBayer Pharma AG /Bayer AG原研進口持證商變更，增加變更后持證商Bayer AG22-40丙戊酸鈉注射用濃溶液Sodium Valproate Concentrated Solution fo

17、r Injection /Depacon5ml:500mgABBVIE INC未進口原研藥品修訂藥品通用名稱及英文名稱為丙戊酸鈉注射用濃溶液及Sodium Valproate Concentrated Solution for Injection23-334丙戊酸鈉注射用濃溶液Sodium Valproate Concentrated Solution for Injection /Orfiril3ml:300mgDesitin Arzneimittel GmbH修訂藥品通用名稱及英文名稱為丙戊酸鈉注射用濃溶液及Sodium Valproate Concentrated Solution fo

18、r Injection23-335丙戊酸鈉注射用濃溶液Sodium Valproate Concentrated Solution for Injection /Orfiril10ml:1gDesitin Arzneimittel GmbH修訂藥品通用名稱及英文名稱為丙戊酸鈉注射用濃溶液及Sodium Valproate Concentrated Solution for Injection26-15丙戊酸鈉注射用濃溶液Sodium Valproate Concentrated Solution for Injection /Ergenyl100mg/ml（以丙戊酸鈉計）（4ml）Sanofi

19、-Aventis Deutschland GmbH修訂藥品通用名稱及英文名稱為丙戊酸鈉注射用濃溶液及Sodium Valproate Concentrated Solution for Injection29-85丙戊酸鈉注射用濃溶液Sodium Valproate Concentrated Solution for Injection100mg/ml（以丙戊酸計）（5ml）Hikma Farmaceutica （Portugal）SA國際公認的同種藥品修訂藥品通用名稱及英文名稱為丙戊酸鈉注射用濃溶液及Sodium Valproate Concentrated Solution for Injection30-147-3魚油