欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
AT/H/0124/001
药品名称
Skinoren 15 % Gel
活性成分
azelaic acid 15.0 g/g
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)
Skinoren 15% - Gel
互认成员国 - 产品名称
Cyprus (CY)
Germany (DE)
Denmark (DK)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Greece (GR)
Sweden (SE)
Norway (NO)
Finland (FI)
许可日期
2002/11/15
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 Article 4.8 Di 65/65
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
|
AT_H_0124_001_E_001_Skinoren Gel_final Labelling
Date of last change:2018/07/02
PAR
|
AT_H_0124_001_PAR_Skinoren
Date of last change:2016/07/26
市场状态
Positive
©2006-2024
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase