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

MR编号	NL/H/3868/002
药品名称	Olmesartan/Amlodipin STADA
活性成分	AMLODIPINE BESILATE 5.0 mg olmesartan medoxomil 40.0 mg
剂型	Film-coated tablet
上市许可持有人	STADA Arzneimittel AG Stadastrasse 2-18 Bad Vilbel 61118
参考成员国 - 产品名称	Netherlands (NL) Olmesartan/Amlodipine STADA 40 mg/5 mg filmomhulde tabletten
互认成员国 - 产品名称	Belgium (BE) Olmesartan/Amlodipine EG 40 mg/5 mg filmomhulde tabletten Luxembourg (LU) Ireland (IE) Spain (ES) Portugal (PT) Italy (IT) Germany (DE) Olmesartan/Amlodipin STADA 20 mg/5 mg Filmtabletten
许可日期	2017/08/10
最近更新日期	2024/02/15
药物ATC编码	C09DB02 olmesartan medoxomil and amlodipine
申请类型	TypeLevel1：Abridged TypeLevel2：Additional Strength/Form 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 \| 1_3_1_PIL_COM_en_NL_H_3868_001_003_V017_clDate of last change:2022/08/31 Final SPC \| 1_3_1 SmPC_COM Amlodipin_Olmesartan NL3868 20220113 JCB _ cleanDate of last change:2022/06/02 Final Labelling \| label CDate of last change:2021/04/13 PAR Summary \| 180806 NL.H.3868.001-003.DC OlmesartanmedoxomilAmlodipine summary ENDate of last change:2018/11/13 PAR \| 181102 NL.H.3868.001-003.DC OlmesartanmedoxomilAmlodipine PARDate of last change:2018/11/13 Final Product Information \| 1.3.1-common-Lab-outer OlmeAmlo_finalDate of last change:2017/12/27 Final Product Information \| 1.3.1-common-Lab inner OlmeAmlo_finalDate of last change:2017/12/27 Final Product Information \| 1.3.1-PL_OlmeAmlo_NL3868_finalDate of last change:2017/12/27 Final Product Information \| 1.3.1-SmPC_OlmeAmlo_NL3868_finalDate of last change:2017/12/27
市场状态	Positive