欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0802/001
药品名称
Glimepirid "Sandoz"
活性成分
glimepiride 1.0 mg
剂型
Tablet
上市许可持有人
Sandoz A/S Edvard Thomsens Vej 14 2300 København S Denmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Austria (AT)
Glimepirid Sandoz 1 mg - Tabletten
Czechia (CZ)
Glimepirid Sandoz 1 mg tablety
Slovenia (SI)
许可日期
2005/08/02
最近更新日期
2023/10/20
药物ATC编码
A10BB12 glimepiride
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic [Article 10.1.(a)(iii), first paragraph]
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
1_3_1 spc_label_pl _ common_outer _ 5_357 _ clean
Date of last change:2024/09/06
Final PL
|
1_3_1 spc_label_pl _ common_pl _ 11_239 _ clean
Date of last change:2024/09/06
Final Product Information
|
1_3_1 spc_label_pl _ common_pl_0802 _ clean
Date of last change:2024/09/06
Final Product Information
|
1_3_1 spc_label_pl _ common_spc _ 0802 _ clean
Date of last change:2024/09/06
Final SPC
|
Common_spc 0802 _ clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase