欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0855/001
药品名称
Ondantriwa
活性成分
ondansetron hydrochloride 4.0 mg
剂型
Film-coated tablet
上市许可持有人
Pharmathen S.A. 6, Dervenakion Str. 15351 Pallini, Attikis Greece
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Ireland (IE)
Greece (GR)
许可日期
2005/10/25
最近更新日期
2022/06/16
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
|
Ondansetron FCT 4 _ 8mg 855_IA015 var_ common_PL_tracked
Date of last change:2024/09/06
Final Product Information
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Ondansetron FCT 4 _ 8mg 855_IA015 var_ common_SPC_tracked
Date of last change:2024/09/06
Final PL
|
Ondansetron FCT 4 _ 8mg 855_IA019 var_ common_PIL_clean
Date of last change:2024/09/06
Final SPC
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Ondansetron FCT 4 _ 8mg 855_IA019 var_ common_SPC_clean
Date of last change:2024/09/06
Final Labelling
|
Proposed Labelling Ondansetron _film coated_4mg and 8mg tabs_general TRACK CHANGES
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase