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

MR编号	DE/H/5021/003
药品名称	Crusia 12.000 IE (120 mg)/0,8 ml Injektionslösung in einer Fertigspritze
活性成分	enoxaparin sodium 12.0 IU/ml
剂型	Solution for injection in prefilled syringe
上市许可持有人	Laboratorios Farmaceuticos Rovi, S.A. C/Julian Camarillo, 35 E-28037 Madrid Spain
参考成员国 - 产品名称	Germany (DE) Crusia 120 mg (12,000 IU/0,8 ml) solution for injection in pre-filled syringe
互认成员国 - 产品名称	Belgium (BE) Teuro 6.000 IE (60 mg)/0,6 ml oplossing voor injectie in een voorgevulde spuit United Kingdom (Northern Ireland) (XI) Poland (PL)
许可日期	2017/02/24
最近更新日期	2024/04/19
药物ATC编码	B01AB05 enoxaparin
申请类型	TypeLevel1：Abridged TypeLevel2：Additional Strength/Form TypeLevel3：Similar biological Art 10.4 Dir 2001/83/EC TypeLevel4：Biological: Other TypeLevel5：Prescription Only
附件文件下载	Final SPC \| common_spc_crusia_120_150_cleanDate of last change:2023/01/26 Final PL \| common_pl_crusia_120_150_cleanDate of last change:2023/01/09 PAR \| DE_H_5020_5021_01_07_DC_Enoxaparin _final PAR_2Date of last change:2022/10/14 Final Product Information \| final-common-outer-crusia-100Date of last change:2019/03/28 Final Product Information \| final-common-outer-crusia-150Date of last change:2019/03/28 Final Product Information \| final-common-pl-crusia-20-40-60-80-100Date of last change:2019/03/28 Final Product Information \| final-common-spc-crusia-150Date of last change:2019/03/28 Final Product Information \| final-common-pl-crusia-150Date of last change:2019/03/28 Final Product Information \| final-common-spc-crusia-20-40-60-80-10Date of last change:2019/03/28 PAR Summary \| DE_H_5020_5021_01-07_DC_Enoxaparin _final PARDate of last change:2018/04/25
市场状态	Positive