欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0685/001
药品名称
Ácido Zoledrónico Hikma
活性成分
Zoledronic acid 4.0 mg/5ml
剂型
Concentrate for solution for infusion
上市许可持有人
Hikma Farmacêutica (Portugal), S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
Ribometa 4 mg/5 ml
Netherlands (NL)
Zoledroninezuur Hikma 4mg/5 ml concentraat voor oplossing voor infusie
Austria (AT)
Zoledronsäure Hikma 4 mg/5 ml Konzentrat zur Herstellung einer Infusionslösung
Italy (IT)
许可日期
2012/09/04
最近更新日期
2024/12/27
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 PL
|
common_pl_zoledronicacid_dcp_var021_tracked FINAL VERSION
Date of last change:2024/12/27
Final SPC
|
common_spc_zoledronicacid_dcp_varp21_tracked FINAL VERSION
Date of last change:2024/12/27
Final Labelling
|
common_outer_4mg5ml_07102013_clean
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase