欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0334/001
药品名称
Enacecor
活性成分
enalapril maleate 20.0 mg
hydrochlorothiazide 12.5 mg
剂型
Tablet
上市许可持有人
Stada Arzneimittel AG Stadastrasse 2-18 D-6118 Bad Vilbel Germany
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Belgium (BE)
Luxembourg (LU)
Austria (AT)
Corenistad 20/12,5 mg
Italy (IT)
Sweden (SE)
许可日期
2002/09/11
最近更新日期
2022/12/01
药物ATC编码
C09BA02 enalapril and diuretics
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
1_3_1 PIL_common_en_enalapril_dk334_II040_cl_response
Date of last change:2022/09/22
Final Product Information
|
1_3_1 spc_common_en_enalapril_dk0334_II040_cl_NHL
Date of last change:2022/09/22
Final SPC
|
SPC-cc-en-enalapril-dk334-IB038-cl-RTQ
Date of last change:2020/11/23
Final Labelling
|
Enacecor lab clean
Date of last change:2016/09/14
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase