欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2690/001
药品名称
Galli Ad
活性成分
gallium ((68)Ga) chloride 0.74 GBq
剂型
Radionuclide generator
上市许可持有人
IRE-Elit Avenue de l'Espérance B-6220 Fleurus Belgium
参考成员国 - 产品名称
Denmark (DK)
Galli Ad
互认成员国 - 产品名称
Germany (DE)
Galli Ad 0,74 – 1,85 GBq Radionuklidgenerator
Belgium (BE)
Galli Ad 0,74 – 1,85 GBq, générateur radiopharmaceutique
Netherlands (NL)
Luxembourg (LU)
Galli Ad, 074-1,85 GBq, Générateur radiopharmaceutique
United Kingdom (Northern Ireland) (XI)
Austria (AT)
Galli Ad 0,74 -1,85 GBq Radionuklidgenerator
France (FR)
Spain (ES)
Italy (IT)
Sweden (SE)
Norway (NO)
Galliad
Finland (FI)
许可日期
2018/05/09
最近更新日期
2024/07/03
药物ATC编码
V09X OTHER DIAGNOSTIC RADIOPHARMACEUTICALS
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
|
common_interpack_clean10b18
Date of last change:2024/09/06
Final PL
|
common_pl_clean09D18
Date of last change:2024/09/06
Final SPC
|
common_spc_clean 04E18
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase