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
2024/05/28
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:2024/09/06
Final Product Information
|
common_pl_imat400mg_v019_clean
Date of last change:2024/09/06
Final Product Information
|
common_spc_imat100mg_v019_clean
Date of last change:2024/09/06
Final Product Information
|
common_spc_imat400mg_v019_clean
Date of last change:2024/09/06
Final Labelling
|
Imat100mg_common_lab_p001_clean_201804
Date of last change:2024/09/06
Final PL
|
Imat100mg_common_pil_renewal_clean
Date of last change:2024/09/06
Final SPC
|
Imat100mg_common_spc_renewal_clean
Date of last change:2024/09/06
PubAR
|
PAR_2554_dc_imatinib_4 sept 2013
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase