欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1405/001
药品名称
Xamiol
活性成分
betamethasone dipropionate 0.5 mg/g
calcipotriol hydrate 50.0 µg/g
剂型
Gel
上市许可持有人
LEO Pharma Industriparken 55 2750 Ballerup Danmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Czechia (CZ)
Xamiol
Germany (DE)
Xamiol
Belgium (BE)
Luxembourg (LU)
Ireland (IE)
France (FR)
Italy (IT)
Greece (GR)
许可日期
2008/08/15
最近更新日期
2023/01/16
药物ATC编码
D05AX52 calcipotriol, combinations
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Fixed combination Art 10b Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
EU_common-pl-clean-updated-xamiol
Date of last change:2019/10/29
Final SPC
|
EU_common-spc-clean-xamiol
Date of last change:2019/10/29
Final Labelling
|
1405 common-lab-clean
Date of last change:2018/09/05
市场状态
Positive
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