欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FR/H/0106/001
药品名称
VESANOID 10 mg, capsule molle
活性成分
[No Active-Substance specified] 0.0 -
Tretinoin 10.0 mg
剂型
Capsule, soft
上市许可持有人
CHEPLAPHARM Arzneimittel GmbH
参考成员国 - 产品名称
France (FR)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
Germany (DE)
Netherlands (NL)
Ireland (IE)
Austria (AT)
VESANOID "Roche" 10 mg Kapseln
Spain (ES)
Portugal (PT)
Italy (IT)
Finland (FI)
Belgium (BE)
许可日期
1996/08/05
最近更新日期
2025/04/24
药物ATC编码
L01XX Other antineoplastic agents
申请类型
TypeLevel1:
New 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 SPC
|
Vesanoid Leaflet 10136676 _ Version 3
Date of last change:2024/09/06
Final PL
|
Vesanoid MRP variation UT
Date of last change:2024/09/06
Final Product Information
|
Vesanoid MRP variation UT_2
Date of last change:2024/09/06
Final SPC
|
Vesanoid MRP variation UT_3
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase