欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
AT/H/0632/001
药品名称
Cardioplexol
活性成分
MAGNESIUMSULFAT 4.0 mg/ml
potassium chloride 0.75 mg/ml
prilocaine hydrochloride 3.0 mg/ml
XYLITOL 4.5 mg/ml
剂型
Solution for cardioplegia
上市许可持有人
MIT Gesundheit GmbH Thaerstraße 4a 47533 Kleve, Germany
参考成员国 - 产品名称
Austria (AT)
互认成员国 - 产品名称
Germany (DE)
Cardioplexol Kardioplege Lösung
Belgium (BE)
Luxembourg (LU)
Spain (ES)
Cardioplexol solución para cardioplegía
Sweden (SE)
Finland (FI)
Czechia (CZ)
Cardioplexol roztok pro kardioplegii
Slovakia (SK)
Slovenia (SI)
许可日期
2024/04/04
最近更新日期
2024/05/20
药物ATC编码
B05XA16 cardioplegia solutions
申请类型
TypeLevel1：
Known Active Substance
TypeLevel2：
Initial Application
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
|
Final_LAB_Cardioplexol_AT_H_0632_001_DC
Date of last change:2024/09/06
Final PL
|
Final_PL_Cardioplexol_AT_H_0632_001_DC
Date of last change:2024/09/06
Final SPC
|
Final_SmPC_Cardioplexol_AT_H_0632_001_DC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase