欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2019/001
药品名称
Isedril
活性成分
risedronate sodium salt 75.0 mg
剂型
Film-coated tablet
上市许可持有人
Ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm Germany
参考成员国 - 产品名称
Denmark (DK)
Isedril
互认成员国 - 产品名称
许可日期
2011/05/18
最近更新日期
2018/10/29
药物ATC编码
M05BA07 risedronic acid
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 PL
|
1_3_1 pil_eu clean
Date of last change:2024/09/06
Final SPC
|
1_3_1 risedronate sodium_75mg_spc_eu clean _2019
Date of last change:2024/09/06
Final Labelling
|
1_3_1_combined_label_eu_clean
Date of last change:2024/09/06
Final Product Information
|
Common_PIL_tracked_DK_H_1338_001_IB_18
Date of last change:2024/09/06
Final Product Information
|
common_pil_tracked_DK_H_1818_001_IB_10
Date of last change:2024/09/06
Final Product Information
|
common_pil_tracked_DK_H_2020_001_IB_007
Date of last change:2024/09/06
Final Product Information
|
common_pl_tracked_DK_H_2019_001_IB_009
Date of last change:2024/09/06
Final Product Information
|
Common_SPC_tracked_DK_H_1338_001_IB_18
Date of last change:2024/09/06
Final Product Information
|
common_spc_tracked_DK_H_1818_001_IB_10
Date of last change:2024/09/06
Final Product Information
|
common_spc_tracked_DK_H_2019_001_IB_009
Date of last change:2024/09/06
Final Product Information
|
common_spc_tracked_DK_H_2020_001_IB_007
Date of last change:2024/09/06
PubAR
|
Final PAR Isedril DKH2019_001_DC
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
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European Union HMA Authorisation of Medicines DataBase