欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2051/001
药品名称
Valora
活性成分
desloratadine 5.0 mg
剂型
Film-coated tablet
上市许可持有人
Stada Arzneimittel AG Stadastrasse 2-8 61118 Bad Vilbel Germany
参考成员国 - 产品名称
Denmark (DK)
Valora
互认成员国 - 产品名称
Italy (IT)
Bulgaria (BG)
Clarimax
许可日期
2011/12/21
最近更新日期
2023/01/18
药物ATC编码
R06AX27 desloratadine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) 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 Labelling
|
1_3_1_Lab_outer_inner_common_DK_H_2051_001_cl
Date of last change:2024/09/06
PubAR
|
PAR2051
Date of last change:2024/09/06
Final PL
|
PL_Desloratadine_DK2051_20220607_clean
Date of last change:2024/09/06
Final SPC
|
SmPC_Desloratadine_DK2051_20220602_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase