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 Labelling
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001 _ common_impack_lonatra_15gluc_125ca_jun18_tracked
Date of last change:2024/09/06
Final Labelling
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001 _ common_outer_lonatra_15gluc_125ca_jun18_tracked
Date of last change:2024/09/06
Final Labelling
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002 _ common_impack_lonatra_23gluc_125ca_jun18_tracked
Date of last change:2024/09/06
Final Labelling
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002 _ common_outer_lonatra_23gluc_125ca_jun18_tracked
Date of last change:2024/09/06
Final Labelling
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003 _ common_impack_lonatra_425gluc_125ca_jun18_tracked
Date of last change:2024/09/06
Final Labelling
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003 _ common_outer_lonatra_425gluc_125ca_jun18_tracked
Date of last change:2024/09/06
Final Labelling
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004 _ common_impack_lonatra_15gluc_175ca_jun18_tracked
Date of last change:2024/09/06
Final Labelling
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004 _ common_outer_lonatra_15gluc_175ca_jun18_tracked
Date of last change:2024/09/06
Final Labelling
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005 _ common_impack_lonatra_23gluc_175ca_jun18_tracked
Date of last change:2024/09/06
Final Labelling
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005 _ common_outer_lonatra_23gluc_175ca_jun18_tracked
Date of last change:2024/09/06
Final Labelling
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006 _ common_impack_lonatra_425gluc_175ca_jun18_tracked
Date of last change:2024/09/06
Final Labelling
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006 _ common_outer_lonatra_425gluc_175ca_jun18_tracked
Date of last change:2024/09/06
Final Product Information
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common_impack_lonatra_15gluc_125ca_v001_jan18
Date of last change:2024/09/06
Final Product Information
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common_outer_lonatra_15gluc_125ca_v001_jan18
Date of last change:2024/09/06
Final PL
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common_pl_lonatra_15gluc_125ca_feb19
Date of last change:2024/09/06
Final Product Information
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common_pl_lonatra_15gluc_125ca_v001_jan18
Date of last change:2024/09/06
Final SPC
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common_spc_lonatra_overall_feb19
Date of last change:2024/09/06
Final Product Information
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common_spc_lonatra_overall_v001_jan18
Date of last change:2024/09/06
市场状态
Withdrawn（注：已撤市）
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European Union HMA Authorisation of Medicines DataBase