欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
CZ/H/1162/001
药品名称
Moniret
活性成分
DIMETINDENE MALEATE 1.0 mg/g
剂型
Gel
上市许可持有人
Zentiva k.s., U Kabelovny 130, Praha 10 10237 Czech Republic
参考成员国 - 产品名称
Czechia (CZ)
Moniret
互认成员国 - 产品名称
Germany (DE)
DIMETIN ADGC 1 mg/g Gel
Portugal (PT)
Poland (PL)
Zidenac
Slovakia (SK)
许可日期
2023/05/04
最近更新日期
2024/07/15
药物ATC编码
D04AA13 dimetindene
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Non Prescription (including OTC)
附件文件下载
PubAR
|
CZ_H_1162_001_DC_PAR
Date of last change:2024/09/06
Final Product Information
|
Dimetindene gel CZ_H_1162_PI_cl_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase