欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2231/001
药品名称
Testosteron Medical Valley
活性成分
testosterone undecanoate 250.0 mg/ml
剂型
Solution for injection
上市许可持有人
Medical Valley Invest AB
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Germany (DE)
Testosteronundecanoat AXiromed 1000 mg/4 ml Injektionslösung
Denmark (DK)
Netherlands (NL)
Iceland (IS)
Norway (NO)
许可日期
2022/12/07
最近更新日期
2024/05/14
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
Final SPC
|
Final SPC
PAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20211221000050
PAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20211221000050_2
市场状态
Positive
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