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

MR编号	NL/H/1919/001
药品名称	Irbesartan/Hydrochlorothiazide 150/12,5 Pharma Resources Dr. Schluttig film-coated tablets
活性成分	hydrochlorothiazide 12.5 mg irbesartan 150.0 mg
剂型	Film-coated tablet
上市许可持有人	Pharma Resources Dr. Schluttig GmbH Otto-Hahn-Strasse 46 63303 Dreieich Germany
参考成员国 - 产品名称	Netherlands (NL)
互认成员国 - 产品名称	Germany (DE) Vilbirine 150 mg/12,5 mg Filmtabletten Denmark (DK) Belgium (BE) Luxembourg (LU) France (FR) Spain (ES) Portugal (PT) Sweden (SE)
许可日期	2010/12/21
最近更新日期	2024/04/18
药物ATC编码	C09DA04 irbesartan and diuretics
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 \| SmPC_Irbesartan_HCT_NL1919_20220111_clDate of last change:2022/06/02 Final PL \| PL_Irbesartan_HCT_NL1919_20220111_clDate of last change:2022/06/02 Final Labelling \| 1.3.1-LAB-outer-common-en-NL-H-1919-001-clDate of last change:2019/07/12 Final Labelling \| 1.3.1-LAB-outer-common-en-NL-H-1919-002-clDate of last change:2019/07/12 Final Labelling \| 1.3.1-LAB-outer-common-en-NL-H-1919-003-clDate of last change:2019/07/12 Final Product Information \| 1.3.1-SPC-common-en-NL-H-1919-1920-001-003-clDate of last change:2018/04/21 Final Product Information \| 1.3.1-PIL-common-en-NL-H-1919-1920-001-003-clDate of last change:2018/04/21 Final Product Information \| Label 1919-001Date of last change:2018/04/21 Final Product Information \| Label 1919-002Date of last change:2018/04/21 Final Product Information \| Label 1919-003Date of last change:2018/04/21
市场状态	Positive