欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NO/H/0281/004
药品名称
Dasatinib Teva Pharma B.V.
活性成分
DASATINIB monohydrate 80.0 mg
剂型
Film-coated tablet
上市许可持有人
Teva B.V.
参考成员国 - 产品名称
Norway (NO)
Dasatinib Teva Pharma B.V.
互认成员国 - 产品名称
Germany (DE)
Dasatinib-ratiopharm 80 mg Filmtabletten
许可日期
2018/12/13
最近更新日期
2024/11/15
药物ATC编码
L01XE06 dasatinib
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
|
1_3_1 label_inner_blister
Date of last change:2024/09/06
Final PL
|
1_3_1_ pil_Dasatinib_D210
Date of last change:2024/09/06
Final Product Information
|
1_3_1_ pil_Dasatinib_D210_2
Date of last change:2024/09/06
Final SPC
|
1_3_1_spc_Dasatinib_D210
Date of last change:2024/09/06
Final Product Information
|
1_3_1_spc_Dasatinib_D210_2
Date of last change:2024/09/06
Final Product Information
|
1_31_ label_outer
Date of last change:2024/09/06
PubAR
|
Dasatinib Teva PAR final
Date of last change:2024/09/06
PubAR Summary
|
Dasatinib Teva Summary PAR final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase