欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
AT/H/0519/001
药品名称
Solacutan 3% Gel
活性成分
diclofenac sodium 30.0 mg/g
剂型
Gel
上市许可持有人
Dermapharm GmbH, Türkenstraße 25/12, 1090 Wien, Österreich
参考成员国 - 产品名称
Austria (AT)
Solacutan 3 % Gel
互认成员国 - 产品名称
Germany (DE)
Solacutan 30 mg/g Gel
Poland (PL)
Diclofenak sodowy SUN-FARM
许可日期
2016/07/08
最近更新日期
2024/05/29
药物ATC编码
D11AX18 diclofenac
申请类型
TypeLevel1:
Known Active Substance
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
|
final_common_PL_AT_H_XXXX_WS_0214_clean_2022_10_28
Date of last change:2024/09/06
Final SPC
|
final_common_SPC_AT_H_XXXX_WS_0214_clean_2022_10_28
Date of last change:2024/09/06
Final Labelling
|
final_LAB_Diclofenac 3_ Gel_519
Date of last change:2024/09/06
PubAR
|
updated PAR_AT_H_0519_001
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase