欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/4961/001
药品名称
Abiraterone 250 mg
活性成分
Abiraterone acetate 250.0 mg
剂型
Tablet
上市许可持有人
Synthon BV, Netherlands
参考成员国 - 产品名称
Netherlands (NL)
Abiraterone Synthon 250 mg, tabletten
互认成员国 - 产品名称
Luxembourg (LU)
许可日期
2021/03/10
最近更新日期
2024/10/15
药物ATC编码
L02BX03 abiraterone
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) 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 Labelling
|
Label_common_combined_4
Date of last change:2024/09/06
PubAR
|
PAR_4961_Abirateron Synthon_4 aug
Date of last change:2024/09/06
Final PL
|
PIL_common_combined_6
Date of last change:2024/09/06
Final SPC
|
SmPC_common_combined_2
Date of last change:2024/09/06
PubAR Summary
|
summaryPAR_4961 Abirateron Synthon_4 aug_EN
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase