NMPA发布化学仿制药参比制剂目录汇总（第1－90批）.pdf

附件

仿制药参比制剂目录（第一批）

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2

Amiodarone

1-1盐酸胺碘酮片Hydrochloride0.2g片剂Sanofi-AventisFrance原研进口

Tablets/Cordarone

Acarbose

1-2阿卡波糖片50mg片剂BayerVitalGmbH原研进口

Tablets/Glucobay

Nimodipine

1-3尼莫地平片30mg片剂BayerVitalGmbH原研进口

Tablets/Nimotop

按头孢呋辛

CefuroximeAxetil

1-4头孢呋辛酯片(C16H16N4O8S片剂GlaxoSmithKline美国橙皮书

Tablets/Ceftin

)计0.125g

按头孢呋辛

CefuroximeAxetil

1-5头孢呋辛酯片(C16H16N4O8S片剂GlaxoWellcomeUKLimited原研进口

Tablets/Zinacef

)计0.25g

SimvastatinMerckSharpDohme

1-6辛伐他汀片10mg片剂原研进口

Tablets/Zocor(Australia)Pty.Ltd.

Simvastatin

1-7辛伐他汀片20mg片剂MerckSharpDohmeB.V.原研进口

Tablets/Zocor

Ambroxol

BoehringerIngelheim

1-8盐酸氨溴索片Hydrochloride30mg片剂