欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
CZ/H/0132/003
药品名称
Valsacor 160 mg
活性成分
Valsartan 160.0 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)
Denmark (DK)
Belgium (BE)
Netherlands (NL)
Iceland (IS)
Spain (ES)
Italy (IT)
Sweden (SE)
Norway (NO)
Finland (FI)
Lithuania (LT)
Cyprus (CY)
Malta (MT)
Austria (AT)
Poland (PL)
Latvia (LV)
Estonia (EE)
Hungary (HU)
Bulgaria (BG)
Slovakia (SK)
许可日期
2007/05/09
最近更新日期
2025/06/26
药物ATC编码
C09CA03 valsartan
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
|
CZ_H_132_001_003_common_combined_clean
Date of last change:2025/04/24
Final Labelling
|
Labeling 40 mg CZ_H_0132_001_003_E_001
Date of last change:2024/09/06
Final PL
|
Valsacor PIL CZ_H_0132_001_003_E_001
Date of last change:2024/09/06
Final SPC
|
Valsacor SPC CZ_H_0132_001_003_E_001
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