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

MR编号	NL/H/3021/001
药品名称	Valvirin 450 mg filmcoated tablets
活性成分	VALGANCICLOVIR HYDROCHLORIDE 450.0 mg
剂型	Film-coated tablet
上市许可持有人	EGIS Pharmaceuticals PLC Kereszturi 30-38 Budapest Hungary
参考成员国 - 产品名称	Netherlands (NL) Valvirin 450 mg filmomhulde tabletten
互认成员国 - 产品名称	Hungary (HU) VALDAMIN 450 mg filmtabletta Romania (RO) VALDAMIN 450 mg comprimate filmate Slovakia (SK) Valdamin 450 mg
许可日期	2014/11/21
最近更新日期	2023/08/31
药物ATC编码	J05AB14 valganciclovir
申请类型	TypeLevel1：Known Active Substance 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-smpc-cleanDate of last change:2018/09/10 Final Product Information \| common-pil-cleanDate of last change:2018/09/10 Final Product Information \| common-pil-trackedDate of last change:2018/09/10 Final SPC \| common-smpc-trackedDate of last change:2018/09/10 Final Labelling \| common-lab-cleanDate of last change:2018/09/10 Final Labelling \| common-lab-trackedDate of last change:2018/09/10 PAR \| PAR_3021_dc_valganciclovir_26 mei 2015Date of last change:2015/06/24 PAR Summary \| PAR_3021_dc_valganciclovir_26 mei 2015_summary EngDate of last change:2015/06/24
市场状态	Positive