欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0225/001
药品名称
Zaditen
活性成分
Ketotifen fumarate 0.25 mg/ml
剂型
Eye drops, solution
上市许可持有人
Laboratoires Théa, France
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
Germany (DE)
Denmark (DK)
Netherlands (NL)
Luxembourg (LU)
Iceland (IS)
Ireland (IE)
Austria (AT)
Zaditen 0,025% - Augentropfen
Spain (ES)
Portugal (PT)
Greece (GR)
Norway (NO)
Finland (FI)
许可日期
2000/10/31
最近更新日期
2024/12/06
药物ATC编码
S01GX08 ketotifen
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Article 4.8 Di 65/65
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
SE_H_0225_001_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_0225_001_Final SPC
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
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European Union HMA Authorisation of Medicines DataBase