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【第四批】仿制药参比制剂目录


【第四批】仿制药参比制剂目录


序号药品通用名称英文名称/商品名规格剂型持证商备注1备注2
4-1氟康唑片Fluconazole Tablets/Diflucan0.15g片剂Pfizer Central Research美国橙皮书
4-2氟康唑胶囊Fluconazole Capsules/Triflucan0.15g胶囊剂Pfizer Holding France欧盟上市(产地:法国)
4-3盐酸克林霉素胶囊Clindamycin Hydrochloride Capsules/Cleocin Hydrochloride按克林霉素(C18H33ClN2O5S)计75mg胶囊剂Pharmacia and Upjohn Co美国橙皮书
4-4盐酸克林霉素胶囊Clindamycin Hydrochloride Capsules/Cleocin Hydrochloride按克林霉素(C18H33ClN2O5S)计0.3g胶囊剂Pharmacia and Upjohn Co美国橙皮书
4-5盐酸克林霉素棕榈酸酯颗粒Clindamycin Palmitate Hydrochloride Granules/Cleocin按克林霉素(C18H33ClN2O5S)计75mg/5ml颗粒剂Pharmacia and Upjohn Co美国橙皮书
4-6苯磺酸氨氯地平片Amlodipine BesilateTablets/Norvasc按氨氯地平(C20H25ClN2O5)计2.5mg片剂Pfizer Inc美国橙皮书
4-7苯磺酸氨氯地平片Amlodipine BesilateTablets/Norvasc按氨氯地平(C20H25ClN2O5)计10mg片剂Pfizer Inc美国橙皮书
4-8苯磺酸氨氯地平胶囊Amlodipine Besilate Capsules/Amlor按氨氯地平(C20H25ClN2O5)计5mg胶囊剂Pfizer SA欧盟上市
4-9格列吡嗪片Glipizide Tablets/Mindiab2.5mg片剂Pfizer AB欧盟上市(上市国家:瑞典)
4-10格列吡嗪控释片Glipizide Controlled Tablets/Glucotrol XL5mg片剂(控释片)Pfizer Inc.原研进口
4-11利培酮口崩片Risperidone Orally Disintegrating Tablets/Risperdal0.5mg片剂(口崩片)Janssen Pharmaceuticals Inc美国橙皮书
4-12利培酮口崩片Risperidone Orally Disintegrating Tablets/Risperdal1mg片剂(口崩片)Janssen Pharmaceuticals Inc美国橙皮书
4-13利培酮口崩片Risperidone Orally Disintegrating Tablets/Risperdal2mg片剂(口崩片)Janssen Pharmaceuticals Inc美国橙皮书
4-14布洛芬片IbuprofenTablets/Ibuprofen0.4g片剂The Boots Company PLC欧盟上市
4-15布洛芬咀嚼片 Ibuprofen Chewable Tablets/Children's Motrin50mg片剂(咀嚼片)Johnson and Johnson Consumer Inc McNeil Consumer Healthcare Division美国橙皮书
4-16布洛芬软胶囊Ibuprofen Soft Capsules/Advil0.2g胶囊剂(软胶囊)Pfizer Inc美国橙皮书
4-17布洛芬口崩片Ibuprofen Orally Disintegrating Tablets/ Nurofen0.1g片剂(口崩片)Boots Healthcare Deutschland GmbH欧盟上市
4-18布洛芬口崩片Ibuprofen Orally Disintegrating Tablets/Nurofen0.2g片剂(口崩片)Reckitt Benckiser Healthcare (UK) Ltd欧盟上市
4-19阿司匹林缓释胶囊Aspirin Sustained-Release Capsules/Durlaza162.5mg胶囊剂(缓释胶囊)New Haven Pharmaceuticals Inc美国橙皮书
4-20阿司匹林肠溶片Aspirin Enteric-Coated Tablets/Bayaspirin0.1g片剂(肠溶片)Bayer S.p.A原研进口(产地:意大利)
4-21阿莫西林胶囊Amoxicillin Capsules/Amoxil0.5g(按C16H19N3O5S计)胶囊剂Beecham Group plc欧盟上市(产地:法国;上市国:英国)
4-22阿莫西林咀嚼片Amoxicillin Chewable Tablets/Amoxicillin0.125g(按C16H19N3O5S计)片剂(咀嚼片)Teva Pharmaceuticals USA Inc 美国橙皮书
4-23阿莫西林咀嚼片Amoxicillin Chewable Tablets/Amoxicillin0.25g(按C16H19N3O5S计)片剂(咀嚼片)Teva Pharmaceuticals USA Inc 美国橙皮书
4-24阿莫西林干混悬剂Amoxicillin for Suspension/Clamoxyl250mg/5ml(按C16H19N3O5S计)口服混悬剂(干混悬剂)GlaxoSmithKline Pharmaceuticals s.a.欧盟上市(产地:法国;上市国家:比利时)
4-25阿莫西林干混悬剂Amoxicillin for Suspension/Clamoxyl125mg/5ml(按C16H19N3O5S计)口服混悬剂(干混悬剂)GlaxoSmithKline Pharmaceuticals s.a.欧盟上市(产地:法国;上市国家:比利时)
4-26阿替洛尔片Atenolol Tablets/Tenormin0.1g片剂Alvogen Malta Operations Ltd美国橙皮书
4-27瑞舒伐他汀钙片Rosuvastatin Calcium Tables/Crestor5mg(按C22H27FN3O6S)计)片剂Astrazeneca UK Limited原研进口
4-28瑞舒伐他汀钙片Rosuvastatin Calcium Tables/Crestor10mg(按C22H27FN3O6S)计)片剂Astrazeneca UK Limited原研进口
4-29瑞舒伐他汀钙片Rosuvastatin Calcium Tables/Crestor20mg(按C22H27FN3O6S)计)片剂Astrazeneca UK Limited原研进口
4-30卡马西平缓释片Carbamazepine Sustained-release Tablets/Tegretol-XR0.2g片剂(缓释片)Novartis Pharmaceuticals Corp美国橙皮书
4-31阿奇霉素片Azithromycin Tablets/Sumamed0.125g片剂Pliva Croatia Ltd. 原研进口
4-32阿奇霉素片Azithromycin Tablets/Sumamed0.5g片剂Pliva Croatia Ltd. 原研进口
4-33阿奇霉素干混悬剂Azithromycin for Suspension/Sumamed100mg/5ml口服混悬剂(干混悬剂)Pliva Croatia Ltd.原研进口

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。

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