欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2098/005
药品名称
Daruph
活性成分
DASATINIB 79.0 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
Germany (DE)
Uxil 79mg Filmtabletten
Italy (IT)
Poland (PL)
Uxil
Hungary (HU)
Spain (ES)
Romania (RO)
Uxil 79 mg comprimate filmate
Czechia (CZ)
Daruph
Slovakia (SK)
许可日期
2022/07/19
最近更新日期
2024/05/21
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
Final SPC
|
Final SPC
PAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20200901000053
PAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20200901000053_2
市场状态
Positive
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