欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2211/002
药品名称
Budesonide Zentiva
活性成分
budesonide 0.5 mg/ml
剂型
Nebuliser suspension
上市许可持有人
Zentiva k.s., Czech Republic
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Norway (NO)
Poland (PL)
ONDEMET
许可日期
2022/12/07
最近更新日期
2023/08/18
药物ATC编码
R03BA02 budesonide
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 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_20211101000217
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20211101000217_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase