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

MR编号	NL/H/2568/001
药品名称	Irbesartan Unichem 150mg film coated tablets
活性成分	irbesartan 150.0 mg
剂型	Film-coated tablet
上市许可持有人	Unichem Laboratories Limited Studio 8b, Ard Gaoithe Commercial Centre, Ard Goaithe Business Park, Cashel Road, Clonmel, Co. Tipperary, Ireland. Ireland
参考成员国 - 产品名称	Netherlands (NL) Irbesartan Unichem 150mg filmomhulde tabletten
互认成员国 - 产品名称	United Kingdom (Northern Ireland) (XI)
许可日期	2012/12/18
最近更新日期	2023/09/25
药物ATC编码	C09CA04 irbesartan
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 SPC \| common-spc-cleanDate of last change:2021/12/31 Final PL \| common-pl-cleanDate of last change:2021/12/31 Final Labelling \| common-outer-150mgtrackDate of last change:2017/08/25 Final Labelling \| common-impack-150mg-currentlyapprovedDate of last change:2017/08/25 Final Labelling \| common-impack-300mg-currentlyapprovedDate of last change:2017/08/25 Final Labelling \| common-outer-300mgtrackDate of last change:2017/08/25 PAR \| PAR_2568_dc_irbesartan_2 mei 2013Date of last change:2013/09/16
市场状态	Positive