欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/2274/003
药品名称
Lonatra
活性成分
calcium chloride dihydrate 0.18 g
glucose monohydrate 46.75 g
magnesium chloride hexahydrate 0.1 g
sodium lactate 7.85 g
sodium chloride 5.11 g
剂型
Solution for peritoneal dialysis
上市许可持有人
Fresenius AG Medical Care Deutschland Else-Kröner-Strasse 1 61352 Bad Homburg v.d.H Germany
参考成员国 - 产品名称
Denmark (DK)
balance LoSo 4.25 % Glucose, 1.25 mmol/l Calcium
互认成员国 - 产品名称
许可日期
2016/03/03
最近更新日期
2022/11/30
药物ATC编码
B05DB Hypertonic solutions
申请类型
TypeLevel1：
Known Active Substance
TypeLevel2：
Additional Strength/Form
TypeLevel3：
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final SPC
|
common-spc-lonatra-overall-feb19
Date of last change:2019/06/18
Final PL
|
common-pl-lonatra-15gluc-125ca-feb19
Date of last change:2019/06/18
Final Labelling
|
001 - common-impack-lonatra-15gluc-125ca-jun18-tracked
Date of last change:2018/07/12
Final Labelling
|
002 - common-outer-lonatra-23gluc-125ca-jun18-tracked
Date of last change:2018/07/12
Final Labelling
|
001 - common-outer-lonatra-15gluc-125ca-jun18-tracked
Date of last change:2018/07/12
Final Labelling
|
002 - common-impack-lonatra-23gluc-125ca-jun18-tracked
Date of last change:2018/07/12
Final Labelling
|
004 - common-impack-lonatra-15gluc-175ca-jun18-tracked
Date of last change:2018/07/12
Final Labelling
|
003 - common-impack-lonatra-425gluc-125ca-jun18-tracked
Date of last change:2018/07/12
Final Labelling
|
003 - common-outer-lonatra-425gluc-125ca-jun18-tracked
Date of last change:2018/07/12
Final Labelling
|
005 - common-outer-lonatra-23gluc-175ca-jun18-tracked
Date of last change:2018/07/12
Final Labelling
|
004 - common-outer-lonatra-15gluc-175ca-jun18-tracked
Date of last change:2018/07/12
Final Labelling
|
005 - common-impack-lonatra-23gluc-175ca-jun18-tracked
Date of last change:2018/07/12
Final Labelling
|
006 - common-outer-lonatra-425gluc-175ca-jun18-tracked
Date of last change:2018/07/12
Final Labelling
|
006 - common-impack-lonatra-425gluc-175ca-jun18-tracked
Date of last change:2018/07/12
Final Product Information
|
common-spc-lonatra-overall-v001-jan18
Date of last change:2018/05/17
Final Product Information
|
common-impack-lonatra-15gluc-125ca-v001-jan18
Date of last change:2018/05/17
Final Product Information
|
common-outer-lonatra-15gluc-125ca-v001-jan18
Date of last change:2018/05/17
Final Product Information
|
common-pl-lonatra-15gluc-125ca-v001-jan18
Date of last change:2018/05/17
市场状态
Withdrawn（注：已撤市）
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European Union HMA Authorisation of Medicines DataBase