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

MR编号	DE/H/4015/001
药品名称	Cyclolux 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	Sanochemia Pharmazeutika GmbH Landegger Straße 7 A-2491 Neufeld an der Leitha Austria
参考成员国 - 产品名称	Germany (DE) Cyclolux 0,5 mmol/ml Anmerkung: Einmalgebrauch) Injektionslösung
互认成员国 - 产品名称	Czechia (CZ) CYCLOLUX 279 MG/ML INJEKČNÍ ROZTOK Estonia (EE) Lithuania (LT) Italy (IT) Portugal (PT) Ireland (IE) Netherlands (NL) Cyclolux 0,5 mmol/ml, oplossing voor injectie Croatia (HR) Belgium (BE) Slovakia (SK) Cyclolux 0,5 mmol/ml injekčný roztok Hungary (HU) CYCLOLUX 0,5 mmol/ml oldatos injekció, egyadagos Poland (PL) Cyclolux Greece (GR) CYCLOLUX Spain (ES) Slovenia (SI) Austria (AT) Cyclolux 0,5 mmol/ml Injektionslösung im Einzeldosisbehältnis United Kingdom (Northern Ireland) (XI) Romania (RO) Cyprus (CY) CYCLOLUX 0.5mmol/ml solution for injection Latvia (LV)
许可日期	2015/06/03
最近更新日期	2023/03/22
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	Final PL \| common_final_pl_4015_001__V019GDate of last change:2023/03/16 Final Labelling \| common_final_label_4015_001__V019GDate of last change:2023/01/26 Final SPC \| common_final_spc_4015_001__V019GDate of last change:2022/11/23 Final Product Information \| common-final-pl-4015(002)-V017Date of last change:2021/10/15 Final Product Information \| common-final-pl-4015(001)-V017.Date of last change:2021/10/15 Final Product Information \| common-final-spc-4015(001)-V017Date of last change:2021/10/15 Final Product Information \| common-final-spc-4015(002)-V017Date of last change:2021/10/15 PAR \| 01_DE_H_3944_4015_01-02_DC_Gadoteric acid Final PARDate of last change:2019/09/18
市场状态	Positive