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

MR编号	DE/H/3944/001
药品名称	Dotagraf 0,5 mmol/ml Injektionslösung
活性成分	gadoteric acid 279.32 mg/ml
剂型	Solution for injection
上市许可持有人	Jenapharm GmbH & Co. KG Otto-Schott-Str. 15 07745 Jena Germany
参考成员国 - 产品名称	Germany (DE) Gadoteric acid Sanochemia (single use) Injektionslösung
互认成员国 - 产品名称	Denmark (DK) Netherlands (NL) Luxembourg (LU) Ireland (IE) Portugal (PT) Greece (GR) DOTAGRAF Sweden (SE) Poland (PL) Latvia (LV) Dotagraf 0,5 mmol/ml šķīdums injekcijām Lithuania (LT) Dotagraf 0,5 mmol/ml injekcinis tirpalas Cyprus (CY) Estonia (EE) DOTAGRAF Croatia (HR) Hungary (HU) DOTAGRAF 0,5 mmol/ml oldatos injekció, egyadagos Malta (MT) Romania (RO) DOTAGRAF 0,5 mmol/ml soluţie injectabilă în flacon unidoză Slovenia (SI) Bulgaria (BG) Belgium (BE) Dotagraph 0,5 mmol/ml oplossing voor injectie Spain (ES) Italy (IT) Iceland (IS)
许可日期	2015/06/03
最近更新日期	2024/04/19
药物ATC编码	V08CA02 gadoteric 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 \| 01_DE_H_3944_4015_01-02_DC_Gadoteric acid Final PARDate of last change:2019/09/18 Final Labelling \| 1.3.1 Immediate Packaging Vial (Date of last change:2018/10/25 Final Labelling \| 1.3.1 Outer Packaging Vial (ApprDate of last change:2018/10/25 Final SPC \| common-spc-de-h-3944-001_hlvDate of last change:2018/10/12 Final SPC \| common-spc-de-h-3944-001_cvDate of last change:2018/10/12 Final PL \| common-pl-de-h-3944-001_cvDate of last change:2018/10/12 Final SPC \| common-spc-de-h-3944-002_cvDate of last change:2018/10/12 Final SPC \| common-spc-de-h-3944-002_hlvDate of last change:2018/10/12 Final PL \| common-pl-de-h-3944-002_hlvDate of last change:2018/10/12 Final PL \| common-pl-de-h-3944-001_hlvDate of last change:2018/10/12 Final PL \| common-pl-de-h-3944-002_cvDate of last change:2018/10/12
市场状态	Positive