欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FR/H/0411/001
药品名称
ZALERG 0,25 mg/ml
活性成分
ketotifen hydrogen fumarate 0.25 mg/ml
剂型
Eye drops, solution
上市许可持有人
Laboratoire THEA
参考成员国 - 产品名称
France (FR)
互认成员国 - 产品名称
Denmark (DK)
Belgium (BE)
Netherlands (NL)
Luxembourg (LU)
Austria (AT)
ZADITEN Ophtha ABAK 0,25 mg/ml Augentropfen
Portugal (PT)
Italy (IT)
Greece (GR)
Poland (PL)
Bulgaria (BG)
Zabak
Romania (RO)
Zabak 0,25 mg/ml, picături oftalmice, soluţie
Sweden (SE)
许可日期
2010/05/19
最近更新日期
2023/10/02
药物ATC编码
S01GX08 ketotifen
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
common_pl_clean _var Farmila_
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase