欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
CZ/H/0109/004
药品名称
AMPRILAN 10
活性成分
ramipril 10.0 mg
剂型
Tablet
上市许可持有人
KRKA d.d. Šmarješka cesta 6, 8501 Novo mesto Slovenia
参考成员国 - 产品名称
Czechia (CZ)
85326/12
互认成员国 - 产品名称
Poland (PL)
Ampril 10 mg tabletki
Estonia (EE)
AMPRIL 10 MG
Hungary (HU)
AMPRILAN 10 mg tabletta
Slovakia (SK)
Lithuania (LT)
Ampril 10 mg tabletės
Denmark (DK)
Ireland (IE)
Austria (AT)
Ramipril Krka 10 mg Tabletten
Sweden (SE)
Bulgaria (BG)
Ampril
Slovenia (SI)
许可日期
2005/08/17
最近更新日期
2023/12/11
药物ATC编码
C09AA05 ramipril
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic [Article 10.1.(a)(iii), first paragraph]
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
Ampril SPC CZ day 90
Date of last change:2024/09/06
Final Product Information
|
common_combined_1
Date of last change:2024/09/06
Final Labelling
|
CZ_H_109_ 1_4_E_01_Labelling_final
Date of last change:2024/09/06
Final SPC
|
CZ_H_109_ 1_4_E_01_Labelling_final_2
Date of last change:2024/09/06
Final PL
|
CZ_H_109_ 1_4_E_01_PIL_final
Date of last change:2024/09/06
Final SPC
|
CZ_H_109_ 1_4_E_01_PIL_final_2
Date of last change:2024/09/06
Final SPC
|
CZ_H_109_ 1_4_E_01_SmPC_final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase