欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）

MR编号	DE/H/3245/001
药品名称	Zoledronsäure AL 4 mg/5 ml Konzentrat zur Herstellung einer Infusionslösung
活性成分	zoledronic acid 0.8 mg
剂型	Concentrate for solution for infusion
上市许可持有人	RAFARM S.A. 12, Korinthou str. 154 51 N. PSIHIKO ATHENS Greece
参考成员国 - 产品名称	Germany (DE) Zoledronic Acid Pharmabide
互认成员国 - 产品名称	Greece (GR) Cyprus (CY) NORDELOZ CON FOR SOL FOR INF
许可日期	2012/08/07
最近更新日期	2023/11/30
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	PAR \| 04_DE_3245_3329_3342_01_DC_Zoledronic acid 4mg_5ml PHARMABIDE_final PARDate of last change:2022/06/02 Final Product Information \| common-final-labip-3245-V010Date of last change:2019/04/05 Final Product Information \| common-final-labop-3245-V010Date of last change:2019/04/05 Final Product Information \| common-final-pl-3245-V010Date of last change:2019/04/05 Final Product Information \| common-final-spc-3245-V010Date of last change:2019/04/05 Final SPC \| 1.3.1_SPC_markedDate of last change:2016/10/13 Final SPC \| 1.3.1_SPC_cleanDate of last change:2016/10/13 Final SPC \| ARD CTD format_Carton_2Date of last change:2016/10/13 Final PL \| 1.3.1_PIL_markedDate of last change:2016/10/13 Final PL \| 1.3.1_PIL_cleanDate of last change:2016/10/13 Final PL \| ARD CTD format_ PILDate of last change:2016/10/13 Final Labelling \| 1.3.1_LABELLING_outer_markedDate of last change:2016/10/13 Final Labelling \| 1.3.1_LABELLING_inner_cleanDate of last change:2016/10/13 Final Labelling \| 1.3.1_LABELLING_inner_markedDate of last change:2016/10/13 Final Labelling \| 1.3.1_LABELLING_outer_cleanDate of last change:2016/10/13 Final Labelling \| ARD CTD format _LabelDate of last change:2016/10/13 Final Labelling \| ARD CTD format_CartonDate of last change:2016/10/13
市场状态	Positive