欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1535/004
药品名称
Famciclovir "Actavis"
活性成分
famciclovir 750.0 mg
剂型
Film-coated tablet
上市许可持有人
Actavis Group PTC ehf Hafnafjordur Iceland
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Austria (AT)
Spain (ES)
Italy (IT)
许可日期
2009/05/13
最近更新日期
2019/11/06
药物ATC编码
J05AB09 famciclovir
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
Famciclovir Actavis_ final labelling
Date of last change:2024/09/06
Final PL
|
Famciclovir Actavis_ final PL
Date of last change:2024/09/06
Final SPC
|
Famciclovir Actavis_ final SPC
Date of last change:2024/09/06
PubAR
|
parmod5_dk1535famcicloviractavis_pdf
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
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European Union HMA Authorisation of Medicines DataBase