欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0947/001
药品名称
Valaciclovir "Sandoz"
活性成分
valaciclovir hydrochloride 250.0 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz A/S Edvard Thomsens Vej 14 2300 København S Denmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Norway (NO)
Italy (IT)
Sweden (SE)
Netherlands (NL)
许可日期
2007/03/22
最近更新日期
2024/08/20
药物ATC编码
J05AB11 valaciclovir
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
|
DK_H_0947_IA_053 common PIL cl
Date of last change:2023/03/15
Final SPC
|
DK_H_0947_IA_053 common SPC cl
Date of last change:2023/03/15
Final Product Information
|
1_3_1 spc_label_pl _ common_spc _ 12_539_clean
Date of last change:2022/08/09
Final Labelling
|
pllab_dk947valaciclovirsandoz_par.pdf_2
Date of last change:2022/06/02
PAR
|
parmod5_dk947valaciclovirsandoz_par_pdf
Date of last change:2022/06/02
市场状态
Positive
©2006-2024
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European Union HMA Authorisation of Medicines DataBase