欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0943/001
药品名称
Ácido Zoledrónico Norpharm
活性成分
Zoledronic acid 4.0 mg/5 ml
剂型
Concentrate for solution for infusion
上市许可持有人
Norpharm Regulatory Services
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Italy (IT)
Romania (RO)
Acid Zoledronic SANTA 4 mg/5 ml concentrat pentru solutie perfuzabila
Denmark (DK)
Zoledronsyre Neogen
Bulgaria (BG)
Zolendronic acid ACEpharma
许可日期
2013/07/11
最近更新日期
2024/12/12
药物ATC编码
M05BA08 zoledronic acid
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
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 Labelling
|
common_impack
Date of last change:2024/09/06
Final Labelling
|
common_outer
Date of last change:2024/09/06
Final SPC
|
common_spc
Date of last change:2024/09/06
Final PL
|
plEN_clean_rev_8Jan14
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase