欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
AT/H/0167/001
药品名称
Finacea 150 mg/g Gel
活性成分
azelaic acid 15.0 %
剂型
Gel
上市许可持有人
LEO Pharma A/S Industriparken 55 2750 Ballerup Dänemark
参考成员国 - 产品名称
Austria (AT)
Finacea 150 mg/g Gel
互认成员国 - 产品名称
Poland (PL)
Latvia (LV)
Lithuania (LT)
Finacea 150 mg/g gelis
Estonia (EE)
FINACEA
Slovakia (SK)
许可日期
2009/01/21
最近更新日期
2023/12/08
药物ATC编码
D10AX03 azelaic acid
申请类型
TypeLevel1：
Known Active Substance
TypeLevel2：
Initial Application
TypeLevel3：
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final PL
|
final_common_PIL_AT_H_0167_001_Finacea Gel_clean
Date of last change:2022/11/22
Final SPC
|
final_common_SPC_AT_H_0167_001_Finacea_clean
Date of last change:2022/11/22
Final PL
|
final_common_PIL_AT_H_0124_001_Skinoren gel_clean_docx
Date of last change:2022/11/22
Final SPC
|
final_common_SPC_AT_H_0124_001_Skinoren gel_clean
Date of last change:2022/11/22
Final Labelling
|
LAB_final_AT_H_0167_001_P_001_clean
Date of last change:2018/01/10
Final Product Information
|
AT_H_0167_01_IB_007-approval
Date of last change:2013/04/27
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase