欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2233/001
药品名称
Topotecano Mylan
活性成分
topotecan hydrochloride 1.0 mg/ml
剂型
Concentrate for solution for infusion
上市许可持有人
RMS transfer from UK/H/3114 Topotecano Mylan
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
PL 04569/1104 - 0012
Belgium (BE)
France (FR)
Italy (IT)
许可日期
2010/12/11
最近更新日期
2019/05/10
药物ATC编码
L01XX17 topotecan
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
PubAR
|
con111537_pdf
Date of last change:2024/09/06
Final Labelling
|
m1_3_1_full_impack
Date of last change:2024/09/06
Final Labelling
|
m1_3_1_full_outer
Date of last change:2024/09/06
Final SPC
|
m1_3_1_full_spc
Date of last change:2024/09/06
Final PL
|
m1_3_1_pl
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase