欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1825/006
药品名称
Elvanse Vuxen
活性成分
lisdexamfetamine dimesylate 60.0 mg
剂型
Capsule, hard
上市许可持有人
Takeda Pharmaceuticals International AG Ireland Branch
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Germany (DE)
Elvanse Adult
Denmark (DK)
Iceland (IS)
Austria (AT)
Norway (NO)
Finland (FI)
许可日期
2022/11/18
最近更新日期
2024/11/22
药物ATC编码
N06BA12 lisdexamfetamine
申请类型
TypeLevel1:
Line Extension
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 PL
Date of last change:2024/09/06
Final SPC
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20211004000055
Date of last change:2024/09/06
PubAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20211004000055_2
Date of last change:2024/09/06
PubAR Summary
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https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20211004000055_3
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase