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

MR编号	DE/H/0844/001
药品名称	Lodotra 1 mg Tabletten mit veränderter Wirkstofffreisetzung
活性成分	prednisone 1.0 mg
剂型	Modified-release tablet
上市许可持有人	SkyePharma Production SAS 55 rue du Montmurier, Zone Industrielle Chesnes Ouest F-38070 Saint-Quentin-Fallavier France
参考成员国 - 产品名称	Germany (DE)
互认成员国 - 产品名称	Italy (IT)
许可日期	2008/12/17
最近更新日期	2023/11/27
药物ATC编码	H02AB07 prednisone
申请类型	TypeLevel1：Known Active Substance TypeLevel2：Initial Application TypeLevel3：Full Dossier Art 8.3(i) Dir 2001/83/EC TypeLevel4：Chemical Substance TypeLevel5：Prescription Only
附件文件下载	PAR \| DE_0844_0845_1_DC_PARDate of last change:2022/11/28 Final Product Information \| DE_H_0844_001-003_IB_051-Approval-12.1.13-20210323Date of last change:2021/03/23 Final Product Information \| final-common-pl-0844-051Date of last change:2021/03/23 Final Product Information \| final-common-spc-0844-051Date of last change:2021/03/23 Final SPC \| DE844_Lodotra_SmPC_clean_20140717_renewalDate of last change:2014/07/31 Final PL \| DE844_Lodotra_Pl_clean_20140717_renewalDate of last change:2014/07/31 Final Labelling \| DE844_Lodotra_inner packaging-1 mg_clean20140717_renewalDate of last change:2014/07/31 Final Labelling \| DE844_Lodotra_inner packaging-5 mg_clean20140717_renewalDate of last change:2014/07/31 Final Labelling \| DE844_Lodotra_inner packaging-2 mg_clean20140717_renewalDate of last change:2014/07/31 Final Labelling \| DE844_Lodotra_outer packaging-1 mg_clean20140717_renewalDate of last change:2014/07/31 Final Labelling \| DE844_Lodotra_outer packaging-2 mg_clean20140717_renewalDate of last change:2014/07/31 Final Labelling \| DE844_Lodotra_outer packaging-5 mg_clean20140717_renewalDate of last change:2014/07/31
市场状态	Positive