欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2232/001
药品名称
Testosterone Teva
活性成分
Testosterone undecanoate 250.0 mg/ml
剂型
Solution for injection
上市许可持有人
Teva B.V.
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Germany (DE)
Testosteron-ratiopharm 1000 mg/4 ml Injektionslösung
Denmark (DK)
Netherlands (NL)
Iceland (IS)
Austria (AT)
Norway (NO)
Finland (FI)
Bulgaria (BG)
Testosterone Teva
Romania (RO)
Testosteron Teva 1000 mg/4 ml solutie injectabila
许可日期
2022/12/07
最近更新日期
2024/09/11
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_id_20211221000067
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20211221000067_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase