欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
NO/H/0279/001
药品名称
Dasatinib Teva
活性成分
DASATINIB monohydrate 20.0 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
互认成员国 - 产品名称
Ireland (IE)
Germany (DE)
Dasa-AbZ 20 mg Filmtabletten
Belgium (BE)
Dasatinib Teva 20 mg filmomhulde tabletten
Luxembourg (LU)
Dasatinib Teva, 20 mg, Comprimé pelliculé
United Kingdom (Northern Ireland) (XI)
Latvia (LV)
France (FR)
Greece (GR)
Sweden (SE)
Hungary (HU)
DASATINIB TEVA 20 mg filmtabletta
Cyprus (CY)
Dasatinib/Teva 20mg FC tablets
Lithuania (LT)
Romania (RO)
Dasatinib Teva 20 mg comprimate filmate
Croatia (HR)
Dasatinib Teva 20 mg filmom obložene tablete
Bulgaria (BG)
Dasatinib TEVA
Slovakia (SK)
Czechia (CZ)
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