欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
LT/H/0160/002
药品名称
Sunitinib Viasana
活性成分
SUNITINIB 25.0 mg
剂型
Capsule, hard
上市许可持有人
UAB Visana J. Jasinskio str. 17 Vilnius, LT-01111 Lithuania
参考成员国 - 产品名称
Lithuania (LT)
互认成员国 - 产品名称
Latvia (LV)
Estonia (EE)
许可日期
2022/01/25
最近更新日期
2022/01/25
药物ATC编码
L01XE04 sunitinib
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
PubAR
|
LT_H_0160_001_003_DC_PAR Scientific discussion_updated
Date of last change:2024/09/06
PubAR
|
LT_H_0160_001_003_DC_PAR Summary_I_R_JA
Date of last change:2024/09/06
Final Labelling
|
LT_H_0160_001_003_DC_Sunitinib Viasana_Labelling_ pack_20220125_cl
Date of last change:2024/09/06
Final PL
|
LT_H_0160_001_003_DC_Sunitinib Viasana_PL_20220125_cl
Date of last change:2024/09/06
Final SPC
|
LT_H_0160_001_003_DC_Sunitinib Viasana_SPC_20220125_cl
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase