欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
CZ/H/0132/001
药品名称
Valsacor 40 mg
活性成分
valsartan 40.0 mg
剂型
Film-coated tablet
上市许可持有人
Krka, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
参考成员国 - 产品名称
Czechia (CZ)
互认成员国 - 产品名称
Germany (DE)
Valsartan TAD 40 mg Filmtabletten
Denmark (DK)
Belgium (BE)
Netherlands (NL)
France (FR)
Spain (ES)
Italy (IT)
Sweden (SE)
Poland (PL)
Valsacor 40 mg tabletki powlekane
Norway (NO)
Estonia (EE)
VALSACOR
Finland (FI)
Hungary (HU)
Valsacor 40-80-160 mg filmtabletta
Lithuania (LT)
Valsacor 40 mg plėvele dengtos tabletės
Slovakia (SK)
Valsacor 40mg
Cyprus (CY)
VALSACOR 40mg TABS
Austria (AT)
Valsacor 40 mg Filmtabletten
Malta (MT)
Bulgaria (BG)
Valsacor
Romania (RO)
Valsacor 40 mg comprimate filmate
Iceland (IS)
许可日期
2007/05/09
最近更新日期
2024/02/09
药物ATC编码
C09CA03 valsartan
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 Labelling
|
Labeling 40 mg CZ_H_0132_001-003_E_001
Date of last change:2022/05/03
Final PL
|
Valsacor PIL CZ_H_0132_001-003_E_001
Date of last change:2022/05/03
Final SPC
|
Valsacor SPC CZ_H_0132_001-003_E_001
Date of last change:2022/05/03
Final Product Information
|
common-combined-clean_40,80,160.doc
Date of last change:2021/06/01
Final Product Information
|
common-combined-clean_320.doc
Date of last change:2021/06/01
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase