欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0315/001
药品名称
Relestat
活性成分
epinastine 0.5 mg/ml
剂型
Eye drops, solution
上市许可持有人
Allergan Pharmaceuticals Ireland
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Greece (GR)
Hungary (HU)
Czechia (CZ)
2764/07
Slovakia (SK)
PURIVIST
Poland (PL)
Germany (DE)
Denmark (DK)
Belgium (BE)
Netherlands (NL)
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Austria (AT)
Relestat 0,5 mg/ml Augentropfen
许可日期
2003/03/04
最近更新日期
2024/06/12
药物ATC编码
S01GX10 epinastine
申请类型
TypeLevel1:
New 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_0315_001_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_0315_001_Final SPC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase