欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
SE/H/2363/001
药品名称
Testosterone Besins
活性成分
Testosterone undecanoate 250.0 mg/ml
剂型
Solution for injection
上市许可持有人
Besins Healthcare Ireland Limited
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Czechia (CZ)
Androject 1000 mg/4ml Injekční roztok
Romania (RO)
Androject 1000 mg/4 ml soluţie injectabilă
Slovakia (SK)
Germany (DE)
Testosterone Besins 1000 mg/4 ml Injektionslösung
Belgium (BE)
Luxembourg (LU)
Spain (ES)
Ireland (IE)
Portugal (PT)
France (FR)
Italy (IT)
Poland (PL)
Testosteron Besins
许可日期
2023/10/04
最近更新日期
2025/02/04
药物ATC编码
G03BA03 testosterone
申请类型
TypeLevel1：
Abridged
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
Final PL
|
Final PL
Date of last change:2024/09/06
Final SPC
|
Final SPC
Date of last change:2024/09/06
PubAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_20221223000019_testosterone_besins_1000_mg_4_ml_injektionsvatska_losning
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_20221223000019_testosterone_besins_1000_mg_4_ml_injektionsvatska_losning_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase