欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0858/001
药品名称
Setrogen
活性成分
ondansetron hydrochloride 2.0 mg/ml
剂型
Solution for injection
上市许可持有人
Viatris Limited Damastown Industrial Park Mulhuddart Dublin 15 Ireland
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Germany (DE)
Belgium (BE)
Iceland (IS)
Italy (IT)
Slovakia (SK)
许可日期
2005/09/27
最近更新日期
2024/03/28
药物ATC编码
A04AA01 ondansetron
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic [Article 10.1.(a)(iii), first paragraph]
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Product Information
|
common_combined_dk0858_clean
Date of last change:2024/09/06
Final PL
|
common_pl
Date of last change:2024/09/06
Final SPC
|
common_spc
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase