欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2013/002
药品名称
Bupropion Bluefish
活性成分
Bupropion hydrochloride 150.0 mg
剂型
Modified-release tablet
上市许可持有人
Bluefish Pharmaceuticals AB Sweden
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Germany (DE)
Bupropion Bluefish 150 mg Tabletten mit veränderter Wirkstofffreisetzung
许可日期
2022/06/30
最近更新日期
2024/11/27
药物ATC编码
N06AX12 bupropion
申请类型
TypeLevel1:
Line Extension
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Art 10.1 and 10.2 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
|
Final SPC
Date of last change:2024/09/06
PubAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20210726000015
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20210726000015_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase