欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0323/001
药品名称
Valcyte 450 mg Film coated tablet
活性成分
valganciclovir 450.0 mg
剂型
Film-coated tablet
上市许可持有人
Roche Nederland BV Postbus 44 3440 AA Woerden
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Liechtenstein (LI)
Slovenia (SI)
Croatia (HR)
Bulgaria (BG)
Germany (DE)
Denmark (DK)
Belgium (BE)
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Austria (AT)
Valcyte 450 mg-Filmtabletten
France (FR)
Portugal (PT)
Italy (IT)
Greece (GR)
Norway (NO)
Latvia (LV)
Hungary (HU)
VALCYTE 450 mg filmtabletta
Cyprus (CY)
Czechia (CZ)
Finland (FI)
Poland (PL)
Iceland (IS)
许可日期
2002/03/05
最近更新日期
2024/05/29
药物ATC编码
J05AB14 valganciclovir
申请类型
TypeLevel1:
New Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Article 4.8 Di 65/65
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
VAL-EN-FCT-VII65-VII69-P002 250418-SPC
Date of last change:2018/05/22
Final PL
|
VAL-EN-FCT-VII65-VII69-P002 250418-PL
Date of last change:2018/05/22
Final Labelling
|
VAL-EN-FCT-VII65-VII69-P002 250418-Label
Date of last change:2018/05/22
PAR
|
170313 NL.H.0323.001.MR Valcyte PAR Update
Date of last change:2017/04/20
PAR Summary
|
170320 NL.H.0323.001.MR Valcyte summary EN
Date of last change:2017/04/20
Final Product Information
|
emea-combined
Date of last change:2014/06/12
市场状态
Positive
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