欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FR/H/0296/001
药品名称
VOLTARENOPHTABAK
活性成分
Diclofenac sodium 1.0 mg/ml
剂型
Eye drops, solution
上市许可持有人
THEA
参考成员国 - 产品名称
France (FR)
互认成员国 - 产品名称
Denmark (DK)
Dicloabak
Austria (AT)
Voltaren Ophtha Abak 1 mg/ml Augentropfen
Greece (GR)
Sweden (SE)
Dicloabak
Norway (NO)
Finland (FI)
Bulgaria (BG)
Dicoabak
Czechia (CZ)
DICLOABAK
Belgium (BE)
Netherlands (NL)
Luxembourg (LU)
Spain (ES)
Portugal (PT)
Dicloabak
Italy (IT)
Poland (PL)
DICLOABAK
许可日期
2006/12/21
最近更新日期
2025/01/16
药物ATC编码
S01BC03 diclofenac
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 PL
|
FR_H_0296_01_IB_26_common_PIL_proposed _clean__d20 RMS
Date of last change:2025/01/16
Final SPC
|
FR_H_0296_01_IB_26_common_SmPC_proposed _clean__D20 RMS
Date of last change:2025/01/16
市场状态
Positive
©2006-2025
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European Union HMA Authorisation of Medicines DataBase