欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DE/H/7983/002
药品名称
Zoledronsäure HEXAL 4 mg/100 ml
活性成分
Zoledronic acid monohydrate 4264.0 mg
剂型
Solution for infusion
上市许可持有人
Hexal Aktiengesellschaft Industriestraße 25 83607 Holzkirchen Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
许可日期
2012/05/17
最近更新日期
2025/05/26
药物ATC编码
M05BA08 zoledronic acid
申请类型
TypeLevel1：
[not specified]
TypeLevel2：
[not specified]
TypeLevel3：
[not specified]
TypeLevel4：
[not specified]
TypeLevel5：
[not specified]
附件文件下载
PubAR
|
AT_H_0412_001_002_PAR_Zoledronsaeure_Hexal
Date of last change:2024/09/06
Final Product Information
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AT_H_411_413_001_II_002_005_004_Zoledons_ure 4mg_5ml_Konzentrat_final_PL_revised
Date of last change:2024/09/06
Final Product Information
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AT_H_411_413_001_II_002_005_004_Zoledons_ure 4mg_5ml_Konzentrat_final_SmPC_revised
Date of last change:2024/09/06
Final Product Information
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AT_H_411_413_001_II_002_005_004_Zoledrons_ure 4mg_5ml_Konzentrat_final LAB
Date of last change:2024/09/06
Final Product Information
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AT_H_411_413_002_II_002_005_004_Zoledrons_ure 4mg_100ml_Infusionsl_sung_final_PL_revised
Date of last change:2024/09/06
Final Product Information
|
AT_H_411_413_002_II_002_005_004_Zoledrons_ure 4mg_100ml_Infusionsl_sung_final_SmPC_revised
Date of last change:2024/09/06
Final Labelling
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final_common_LAB_AT_H_0411_0412_001_IB_021_clean
Date of last change:2024/09/06
Final Labelling
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final_common_LAB_AT_H_0411_0412_002_IB_021_clean
Date of last change:2024/09/06
Final PL
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common_final_pil_7983_028
Date of last change:2024/09/06
Final SPC
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common_final_spc_7983_028
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase