欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1863/001
药品名称
Aklief
活性成分
trifarotene 50.0 µg/g
剂型
Cream
上市许可持有人
Galderma
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Bulgaria (BG)
Aklief
Germany (DE)
Selgamis 50 Mikrogramm/g Creme
Denmark (DK)
Aklief
Belgium (BE)
Aklief 50 microgram/g crème
Netherlands (NL)
Malta (MT)
Aklief 50 microgram/g cream
Luxembourg (LU)
Iceland (IS)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Norway (NO)
Aklief
Finland (FI)
Poland (PL)
Cyprus (CY)
Aklief 50 micrograms/g/ cream
Czechia (CZ)
AKLIEF
Croatia (HR)
Estonia (EE)
Greece (GR)
Hungary (HU)
AKLIEF 50 mikrogramm/g krém
Lithuania (LT)
Aklief 50 mikrogramų/g kremas
Latvia (LV)
Aklief 50 mikrogrami/g krēms
Romania (RO)
Aklief 50 micrograme/g cremă
Slovakia (SK)
许可日期
2019/12/18
最近更新日期
2024/09/16
药物ATC编码
D10AD06 trifarotene
申请类型
TypeLevel1:
New 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
|
SE_H_1863_001_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1863_001_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_1863_001_PAR
Date of last change:2024/09/06
PubAR Summary
|
SE_H_1863_001_PAR Summary
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase