【第九十八批】仿制药参比制剂目录序号药品通用名称英文名规格持证商备注1备注2剂型98-1盐酸来罗西利片Lerociclib Hydrochloride Tablets/汝佳宁50mg（按 C26H34N8O 计）Genor Biopharma（USA）, Inc.国内上市的原研药品原研进口片剂98-2罗氟司特乳膏Roflumilast cream/ZORYVE0.15%ARCUTIS BIOTHERAPEUTICS INC未进口原研药品美国橙皮书乳膏剂98-3罗氟司特乳膏Roflumilast ...
2025/11/19 10:24:21
【第九十六批】仿制药参比制剂目录序号药品通用名称英文名规格持证商备注1备注2剂型96-1格隆溴铵福莫特罗吸入气雾剂Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol每罐120揿，每揿含格隆铵7.2μg与富马酸福莫特罗（以二水合物计）5.0μg。AstraZeneca AB国内上市的原研药品原研进口吸入气雾剂96-2注射用盐酸依拉环素Eravacycline Hydrochloride for Injection/依嘉...
2025/9/17 14:54:24
【第八十二批】仿制药参比制剂目录序号药品通用名称英文名规格持证商备注1备注2剂型82-1氟替美维吸入粉雾剂Fluticasone Furoate, Umeclidinium Bromide and Vilanterol TrifenatatePowder for Inhalation每泡含糠酸氟替卡松100µg、乌美溴铵62.5µg（按C29H24NO2计）与三苯乙酸维兰特罗25µg（按C24H33Cl2NO5计），递送剂量为糠酸氟替卡松92µg、乌美溴铵...
2024/9/4 15:54:00
【第八十批】仿制药参比制剂目录序号药品通用名称英文名规格上市许可持有人备注1备注2剂型80-1甲苯磺酸尼拉帕利胶囊Niraparib Tosilate Capsules/则乐100mg再鼎医药（上海）有限公司国内上市的原研药品胶囊剂80-2甲磺酸贝舒地尔片Belumosudil MesylateTablets/易来克0.2 g（按C26H24N6O2 计）KadmonPharmaceuticals, LLC国内上市的原研药品原研进口片剂80-3盐酸氢吗啡酮片HydromorphoneHydroc...
2024/5/31 18:46:46
【第七十九批】仿制药参比制剂目录序号药品通用名称英文名规格上市许可持有人备注1备注2剂型79-1维生素B1注射液ThiamineHydrochlorideInjection/Vitamin B1Injection100mg/mlFRESENIUS KABI USALLC未进口原研药品美国橙皮书注射剂79-2玛伐凯泰胶囊Mavacamtencapsules/CAMZYOS2.5 mgBristol-Myers Squibb Co未进口原研药品美国橙皮书胶囊剂79-3玛伐凯泰胶囊Mavacamten...
2024/4/23 17:38:12
【第七十五批】仿制药参比制剂目录序号药品通用名称英文名规格上市许可持有人备注1备注2剂型75-1奥特康唑胶囊Oteseconazole Capsules0.15geVENUS PHARMACEUTICAL LABORATORIES INC.国内上市的原研药品原研进口胶囊剂75-2右美沙芬安非他酮缓释片Dextromethorphan Hydrobromide and Bupropion Hydrochloride Extended-Release Tablets /Auvelity45mg（以C...
2024/3/13 10:03:55
【第七十四批】仿制药参比制剂目录序号药品通用名称英文名规格持证商备注1备注2剂型74-1替戈拉生片Tegoprazan Tablets50mg山东罗欣药业集团股份有限公司国内上市原研产品片剂74-2维奈克拉片Venetoclax Tablets/唯可来10mgAbbVie Inc.国内上市的原研药品原研进口片剂74-3维奈克拉片Venetoclax Tablets/唯可来50mgAbbVie Inc.国内上市的原研药品原研进口片剂74-4维奈克拉片Venetoclax Tablets/唯可来10...
2024/3/12 15:23:16
【第七十一批】仿制药参比制剂目录序号药品通用名称英文名规格持证商备注1备注271-1丁丙诺啡纳洛酮舌下膜buprenorphine and naloxone sublingual film/SUBOXONE2mg/0.5mgINDIVIOR INC未进口原研药品美国橙皮书71-2丁丙诺啡纳洛酮舌下膜buprenorphine and naloxone sublingual film/SUBOXONE4mg/1mgINDIVIOR INC未进口原研药品美国橙皮书71-3丁丙诺啡纳洛酮舌下膜bupr...
2023/9/12 10:28:50