欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
BE/H/0110/001
药品名称
Glucotrace
活性成分
fludeoxyglucose (18F) 0.0 [no unit]
剂型
Solution for injection
上市许可持有人
Nucleis SA Allée du Six-Août, 8 BE-4000 Liège Belgium
参考成员国 - 产品名称
Belgium (BE)
Glucotrace
互认成员国 - 产品名称
Germany (DE)
Glucotrace
Netherlands (NL)
Luxembourg (LU)
France (FR)
许可日期
2004/04/08
最近更新日期
2023/03/27
药物ATC编码
V09X OTHER DIAGNOSTIC RADIOPHARMACEUTICALS
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Article 4.8 Di 65/65
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
Final SPC clean_common_spc_clean
Date of last change:2022/06/02
Final SPC
|
Final SPC annotated_common_spc_annotated
Date of last change:2022/06/02
Final PL
|
common-pl-clean
Date of last change:2018/10/05
Final Labelling
|
20170726_labelling_inner_BE-H-110-01-IB-13_clean
Date of last change:2017/08/05
Final Labelling
|
20170726_labelling_outer_BE-H-110-01-IB-13_clean
Date of last change:2017/08/05
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase