欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1930/001
药品名称
Zilola
活性成分
levocetirizine dihydrochloride 5.0 mg
剂型
Film-coated tablet
上市许可持有人
Gedeon Richter Plc. 1103 Budapest, Gyömroi út 19-21 Hungary
参考成员国 - 产品名称
Denmark (DK)
Zilola
互认成员国 - 产品名称
Hungary (HU)
ZILOLA 5 mg filmtabletta
许可日期
2011/08/10
最近更新日期
2024/04/11
药物ATC编码
R06AE09 levocetirizine
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
Final Labelling
|
common_other_otc_pom
Date of last change:2024/09/06
Final PL
|
DKH1930_009_Zilola_common_pil_clean
Date of last change:2024/09/06
Final SPC
|
DKH1930_009_Zilola_common_spc_clean
Date of last change:2024/09/06
PubAR
|
Final PAR Zilola DKH1930_001_DC
Date of last change:2024/09/06
市场状态
Positive
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