欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FR/H/0324/001
药品名称
Oxaliplatine Mylan
活性成分
Oxaliplatin 5.0 mg/g
剂型
Powder for solution for infusion
上市许可持有人
Mylan
参考成员国 - 产品名称
France (FR)
互认成员国 - 产品名称
Czechia (CZ)
Slovakia (SK)
许可日期
2007/08/06
最近更新日期
2024/11/26
药物ATC编码
L01XA03 oxaliplatin
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Product Information
|
Combined Product Information_clean
Date of last change:2024/11/26
Final SPC
|
commom_combined_v025
Date of last change:2024/09/06
Final SPC
|
commom_combined_v025_annotated
Date of last change:2024/09/06
Final Labelling
|
Oxaliplatine mylan R01 common_outer
Date of last change:2024/09/06
Final PL
|
Oxaliplatine mylan R01 common_pl_trackchanges
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase