欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1276/001
药品名称
Vionate
活性成分
risedronate sodium salt 5.0 mg
剂型
Film-coated tablet
上市许可持有人
Mylan AB Ynglingagatan 14 Box 230 33 104 35 Stockholm Sweden
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Portugal (PT)
United Kingdom (Northern Ireland) (XI)
Italy (IT)
许可日期
2008/10/23
最近更新日期
2023/03/29
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 Product Information
|
common_outer_5mg_tracked_v026
Date of last change:2024/09/06
Final SPC
|
common_pl_1
Date of last change:2024/09/06
Final SPC
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common_pl_2
Date of last change:2024/09/06
Final SPC
|
common_pl_3
Date of last change:2024/09/06
Final PL
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common_pl_35mg_dk1276_v028_clean
Date of last change:2024/09/06
Final Product Information
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common_pl_35mg_tracked_dk1276_v026
Date of last change:2024/09/06
Final SPC
|
common_pl_4
Date of last change:2024/09/06
Final PL
|
common_pl_5mg_dk1276_v028_clean
Date of last change:2024/09/06
Final Product Information
|
common_pl_5mg_tracked_dk1276_v026
Date of last change:2024/09/06
Final SPC
|
common_spc_1
Date of last change:2024/09/06
Final SPC
|
common_spc_2
Date of last change:2024/09/06
Final SPC
|
common_spc_3
Date of last change:2024/09/06
Final SPC
|
common_spc_4
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase