欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0703/003
药品名称
Budesonid "Arrow"
活性成分
budesonide 500.0 µg
剂型
Nebuliser suspension
上市许可持有人
Teva B.V. Swensweg 5 2031 GA Haarlem Holland
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Germany (DE)
Belgium (BE)
Netherlands (NL)
United Kingdom (Northern Ireland) (XI)
Spain (ES)
Italy (IT)
许可日期
2005/05/13
最近更新日期
2019/11/28
药物ATC编码
R03BA02 budesonide
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic [Article 10.1.(a)(iii), first paragraph]
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Product Information
|
PIL_budesonide_nebsusp_DK_H_0703_01_03_V0xx_v5_3_03062016_cl
Date of last change:2024/09/06
Final PL
|
PIL_budesonide_nebsusp_DK_H_0703_01_03_V0xx_v6_2_20012017_Clean
Date of last change:2024/09/06
Final Product Information
|
SmPC_budesonide_nebsusp_DK_H_0703_01_03_V0xx_v2_3_09062016_cl
Date of last change:2024/09/06
Final SPC
|
SmPC_budesonide_nebsusp_DK_H_0703_01_03_V0xx_v3_1_22112016_Clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase