欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
SE/H/2098/003
药品名称
Daruph
活性成分
DASATINIB 55.3 mg
剂型
Film-coated tablet
上市许可持有人
Zentiva k.s., Czechia
参考成员国 - 产品名称
Sweden (SE)
Daruph
互认成员国 - 产品名称
Italy (IT)
Poland (PL)
Uxil
Hungary (HU)
Romania (RO)
Uxil 55.3 mg comprimate filmate
Slovakia (SK)
Austria (AT)
Spain (ES)
Czechia (CZ)
Daruph
Germany (DE)
Uxil 55,3mg Filmtabletten
许可日期
2022/07/19
最近更新日期
2024/11/19
药物ATC编码
L01XE06 dasatinib
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Additional Strength/Form
TypeLevel3：
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final PL
|
Final PL
Date of last change:2024/09/06
Final SPC
|
Final SPC
Date of last change:2024/09/06
PubAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20200901000039
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20200901000039_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase