欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/1229/001
药品名称
Fertin 1 mg, tabletten
活性成分
glimepiride 1.0 mg
剂型
Tablet
上市许可持有人
Medochemie Ltd 1-10 Constantinoupoleus street 3011 Limassol Cyprus
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Latvia (LV)
Fertin 1 mg tabletes
Bulgaria (BG)
Fertin
Cyprus (CY)
FERTIN 1 MG
许可日期
2009/02/06
最近更新日期
2022/07/29
药物ATC编码
A10BB12 glimepiride
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
|
common-combined-pil-june2020-clean
Date of last change:2020/09/23
Final SPC
|
common-combined-spc-june2020-clean
Date of last change:2020/09/23
Final Labelling
|
NLH_1229_1-4_R_001 - Labelling-final_Sept2018-clean
Date of last change:2019/01/11
Final Product Information
|
NLH_1229_1-4_R_001 - Labelling-final_clean
Date of last change:2013/07/29
Final Product Information
|
NLH_1229_1-4_R_001 - PIL_Jan2013_clean
Date of last change:2013/07/29
Final Product Information
|
NLH_1229_1-4_R_001 - SPC_April 2013_clean
Date of last change:2013/07/29
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase