欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0958/003
药品名称
Valaciclovir HEXAL
活性成分
Valaciclovir hydrochloride 1000.0 mg
剂型
Film-coated tablet
上市许可持有人
HEXAL A/S Kanalholmen 8-12 2650 Hvidovre Denmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
许可日期
2007/03/22
最近更新日期
2025/02/05
药物ATC编码
J05AB11 valaciclovir
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
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 Product Information
|
1_3_1 spc_label_pl _ common_spc _ 12_539_clean
Date of last change:2024/09/06
Final PL
|
DK_H_0958_IA_045 Common PIL_cl
Date of last change:2024/09/06
Final SPC
|
DK_H_0958_IA_045 Common SPC_cl
Date of last change:2024/09/06
PubAR
|
parmod5_dk958hexal_pdf
Date of last change:2024/09/06
Final Labelling
|
pllab_dk958hexal_pdf_2
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
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European Union HMA Authorisation of Medicines DataBase