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

MR编号	DE/H/4317/002
药品名称	bicaVera 2,3 % Glucose, 1,25 mmol/l Calcium, Peritonealdialyselösungsung
活性成分	CALCIUMCHLORID dihydrate 0.18 g glucose monohydrate 25.0 g magnesium chloride hexahydrate 0.1 g sodium carbonate 2.94 g sodium chloride 5.79 g
剂型	Solution for peritoneal dialysis
上市许可持有人	Fresenius Medical Care Deutschland GmbH Else- Kröner Str.1 61352 Bad Homburg v.d.H. Germany
参考成员国 - 产品名称	Germany (DE) bicaVera 2,3 % Glucose, 1,25 mmol/l Calcium, Peritonealdialyselösungsung
互认成员国 - 产品名称	Denmark (DK) Belgium (BE) bicaVera 2,3 % Glucose, 1,25 mmol/l Calcium solution for peritoneal dialysis Netherlands (NL) Luxembourg (LU) bicaVera 2,3 % Glucose, 1,25 mmol/I Calcium, Solution pour dialyse péritonéale United Kingdom (Northern Ireland) (XI) Austria (AT) bicaVera 2,3 % Glucose, 1,25 mmol/l Calcium, Peritonealdialyselösung France (FR) Spain (ES) Portugal (PT) Italy (IT) Greece (GR) Sweden (SE) Norway (NO) bicaVera Finland (FI) Poland (PL) bicaVera z 2,3% glukozą i wapniem 1,25 mmol/l Latvia (LV) Bicavera 2,3 % glikoze, 1,25 mmol/l kalcijs, šķīdums peritoneālai dialīzei Cyprus (CY) Czechia (CZ) bicaVera 2,3 % glucose, 1,25 mmol-l calcium roztok pro peritoneální dialýzu Croatia (HR)
许可日期	2016/09/09
最近更新日期	2023/02/27
药物ATC编码	B05DB Hypertonic solutions
申请类型	TypeLevel1：Abridged TypeLevel2：Additional Strength/Form TypeLevel3：Bibliographic Art 10 a Dir 2001/83/EC TypeLevel4：Chemical Substance TypeLevel5：Prescription Only
附件文件下载	Final SPC \| common_final_spc_4317_002__V009Date of last change:2023/03/16 Final Labelling \| common_final_label_4317_002__V009Date of last change:2023/03/16 Final PL \| common-pl-bicavera425gluc125ca-202005-trackDate of last change:2021/03/31 Final PL \| common-pl-bicavera15gluc125ca-202005-trackDate of last change:2021/03/31 Final PL \| common-pl-bicavera23gluc125ca-202005-trackDate of last change:2021/03/31 PAR \| 01_DE_H_4317_01-03_DC_bicaVera_Fresenius_Final PARDate of last change:2019/07/01
市场状态	Positive