欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1164/004
药品名称
Dibiglim
活性成分
glimepiride 4.0 mg
剂型
Tablet
上市许可持有人
1A Farma A/S Edvard Thomsens Vej 14 2300 København S Denmark
参考成员国 - 产品名称
Denmark (DK)
Dibiglim
互认成员国 - 产品名称
许可日期
2008/06/12
最近更新日期
2019/10/14
药物ATC编码
A10BB12 glimepiride
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
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
|
1_3_1 common_outer_1164_final_clean
Date of last change:2024/09/06
Final Product Information
|
1_3_1 spc_label_pl _ common_pl _ 1164 _ clean
Date of last change:2024/09/06
Final Product Information
|
1_3_1 spc_label_pl _ common_spc _ 1164 _ clean
Date of last change:2024/09/06
Final PL
|
1_3_1_common_pl_1164_final_clean
Date of last change:2024/09/06
Final SPC
|
1_3_1_common_spc_1164_final_clean
Date of last change:2024/09/06
PubAR
|
parmod5_dk1164dibliglim_pdf
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Withdrawn(注:已撤市)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