欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2429/001
药品名称
Eribulin STADA Arzneimittel AG
活性成分
Eribulin mesilate 0.44 mg/ml
剂型
Solution for injection
上市许可持有人
STADA Arzneimittel AG
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Germany (DE)
Eribulin STADA 0,44 mg/ml Injektionslösung
许可日期
2023/10/04
最近更新日期
2024/08/30
药物ATC编码
L01XX41 eribulin
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_20230321000098_eribulin_stada_arzneimittel_ag_0_44_mg_ml_injektionsvatska_losning
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_20230321000098_eribulin_stada_arzneimittel_ag_0_44_mg_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