欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FR/H/0273/001
药品名称
MYDRIASERT
活性成分
phenylephrine 5.38 mg
tropicamide 0.28 mg
剂型
Ophthalmic insert
上市许可持有人
Laboratoires THEA
参考成员国 - 产品名称
France (FR)
互认成员国 - 产品名称
Germany (DE)
Mydriasert Augeninsert
Denmark (DK)
Belgium (BE)
Netherlands (NL)
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
Austria (AT)
Mydriasert 0,28 mg/5,4 mg Augeninsert
Spain (ES)
Portugal (PT)
Italy (IT)
Sweden (SE)
Mydriasert
Finland (FI)
许可日期
2006/06/14
最近更新日期
2023/01/24
药物ATC编码
S01FA56 tropicamide, combinations
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Fixed combination Art 10b Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
FR_H_0273_001_IB_039_common PIL
Date of last change:2024/09/06
Final SPC
|
SPC
Date of last change:2024/09/06
市场状态
Positive
©2006-2024
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European Union HMA Authorisation of Medicines DataBase