欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
CZ/H/1078/001
药品名称
Hevascol
活性成分
Iodine 480.0 mg/ml
剂型
Solution for injection
上市许可持有人
Guerbet 15 Rue des Vanesses 93420 Villepinte
参考成员国 - 产品名称
Czechia (CZ)
Hevascol
互认成员国 - 产品名称
Italy (IT)
Poland (PL)
Cyprus (CY)
Ethyl esters of iodised fatty acids of poppy seed oil Guerbet
Romania (RO)
Slovakia (SK)
Slovenia (SI)
Croatia (HR)
Spain (ES)
Greece (GR)
Sweden (SE)
Norway (NO)
Finland (FI)
许可日期
2022/06/02
最近更新日期
2024/06/10
药物ATC编码
V08AD01 ethyl esters of iodised fatty acids
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
PubAR
|
CZ_H_1078_001_DC _ PAR
Date of last change:2024/09/06
Final Labelling
|
Labelling_approved DCP_1_22_02895_0_2
Date of last change:2024/09/06
Final PL
|
PIL_approved DCP_1_22_04418_2
Date of last change:2024/09/06
Final SPC
|
SmPC_Approved DCP_1_22_04421_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase