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

MR编号	DE/H/4808/003
药品名称	Novantron 20 mg/10 ml Konzentrat zur Herstellung einer Infusionslösung oder zur Herstellung einer Lösung zur intrapleuralen oder intraperiotonealen Anwendung
活性成分	mitoxantrone hydrochloride 20.0 mg/ 10 ml
剂型	Concentrate for solution for infusion
上市许可持有人	MEDA Pharma GmbH & Co. KG Benzstraße 1, 61352 Bad Homburg, Germany Art 30 referral (EMEA/H/A-30/1399)
参考成员国 - 产品名称	Germany (DE) Novantron 20 mg/10 ml
互认成员国 - 产品名称	France (FR) Greece (GR) Cyprus (CY) Romania (RO)
许可日期	2016/08/03
最近更新日期	2023/06/30
药物ATC编码	L01DB07 mitoxantrone
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	Final SPC \| SmPC_10 mg_V010RTQ_common_annotatedDate of last change:2022/07/18 Final SPC \| SmPC_10 mg_V010RTQ_commonDate of last change:2022/07/18 Final SPC \| SmPC_20 mg_V010RTQ_common_annotatedDate of last change:2022/07/18 Final SPC \| SmPC_20 mg_V010RTQ_commonDate of last change:2022/07/18 Final SPC \| SmPC_2 mg_V010RTQ_common_annotatedDate of last change:2022/07/18 Final SPC \| SmPC_2 mg_V010RTQ_commonDate of last change:2022/07/18 Final PL \| Patient Information Leaflet_20mg_V010RTQ_commonDate of last change:2022/07/18 Final PL \| Patient Information Leaflet_10mg_V010RTQ_common_annotatedDate of last change:2022/07/18 Final PL \| Patient Information Leaflet_2mg_V010RTQ_common_annotatedDate of last change:2022/07/18 Final PL \| Patient Information Leaflet_10mg_V010RTQ_commonDate of last change:2022/07/18 Final PL \| Patient Information Leaflet_20mg_V010RTQ_common_annotatedDate of last change:2022/07/18 Final PL \| Patient Information Leaflet_2mg_V010RTQ_commonDate of last change:2022/07/18 Final Product Information \| common-final-labop-4808(002)-V007GDate of last change:2019/10/31 Final Product Information \| common-final-labop-4808(001)-V007GDate of last change:2019/10/31 Final Product Information \| common-final-pl-4808(002)-V007GDate of last change:2019/10/31 Final Product Information \| common-final-labop-4808(003)-V007GDate of last change:2019/10/31 Final Product Information \| common-final-pl-4808(001)-V007GDate of last change:2019/10/31 Final Product Information \| common-final-spc-4808(002)-V007GDate of last change:2019/10/31 Final Product Information \| common-final-pl-4808(003)-V007GDate of last change:2019/10/31 Final Product Information \| common-final-spc-4808(001)-V007GDate of last change:2019/10/31 Final Product Information \| common-final-spc-4808(003)-V007GDate of last change:2019/10/31
市场状态	Positive