欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/2554/001
药品名称
Imatinib
活性成分
imatinib mesilate 100.0 mg
剂型
Film-coated tablet
上市许可持有人
Glenmark
参考成员国 - 产品名称
Netherlands (NL)
Imatinib Glenmark 100 mg, filmomhulde tabletten RVG 111195
互认成员国 - 产品名称
Czechia (CZ)
Imatinib Glenmark 100 mg
Slovakia (SK)
Imatinib Glenmark 100 mg filmom obalené tablety
许可日期
2013/01/15
最近更新日期
2023/06/19
药物ATC编码
L01XE01 imatinib
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-pl-imat100mg-v019-clean
Date of last change:2019/05/09
Final Product Information
|
common-pl-imat400mg-v019-clean
Date of last change:2019/05/09
Final Product Information
|
common-spc-imat100mg-v019-clean
Date of last change:2019/05/09
Final Product Information
|
common-spc-imat400mg-v019-clean
Date of last change:2019/05/09
Final Labelling
|
Imat100mg-common-lab-p001-clean-201804
Date of last change:2018/07/12
Final SPC
|
Imat100mg-common-spc-renewal-clean
Date of last change:2018/05/16
Final PL
|
Imat100mg-common-pil-renewal-clean
Date of last change:2018/05/16
PAR
|
PAR_2554_dc_imatinib_4 sept 2013
Date of last change:2013/09/12
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase