欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
BG/H/0111/002
药品名称
Bilamcar 8mg/10mg
活性成分
AMLODIPINE BESILATE 10.0 mg
candesartancilexetil 8.0 mg
剂型
Capsule, hard
上市许可持有人
Swyssi AG 14 Lyoner Strasse Frankfurt am Main 60528 Germany
参考成员国 - 产品名称
Bulgaria (BG)
Bilamcar
互认成员国 - 产品名称
Austria (AT)
Tilamcar 8 mg/10 mg Hartkapseln
Portugal (PT)
Greece (GR)
Czechia (CZ)
Bilamcar 8mg/ 10 mg
Romania (RO)
Slovakia (SK)
许可日期
2018/10/15
最近更新日期
2023/10/20
药物ATC编码
C09DB07 candesartan and amlodipine
申请类型
TypeLevel1：
Known Active Substance
TypeLevel2：
Initial Application
TypeLevel3：
Fixed combination Art 10b Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final Product Information
|
common_smpc_clean_4
Date of last change:2022/07/26
Final Product Information
|
common_smpc_track_4
Date of last change:2022/07/26
Final Product Information
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common_pl_track_4
Date of last change:2022/07/26
Final Product Information
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common_pl_clean_4
Date of last change:2022/07/26
Final SPC
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common-lbl-8mg-10mg-clean
Date of last change:2021/12/01
Final SPC
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common-lbl-8mg-5mg-clean
Date of last change:2021/12/01
Final SPC
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common-lbl-8mg-5mg-track
Date of last change:2021/12/01
Final SPC
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common-lbl-16mg-5mg-clean
Date of last change:2021/12/01
Final SPC
|
common-lbl-16mg-5mg-track
Date of last change:2021/12/01
Final SPC
|
common-lbl-8mg-10mg-track
Date of last change:2021/12/01
Final SPC
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common-lbl-16mg-10mg-track
Date of last change:2021/12/01
Final SPC
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common-lbl-16mg-10mg-clean
Date of last change:2021/12/01
Final SPC
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common-smpc-clean
Date of last change:2021/12/01
Final SPC
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common-pl-clean
Date of last change:2021/12/01
Final SPC
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common-pl-track
Date of last change:2021/12/01
Final SPC
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common-smpc-track
Date of last change:2021/12/01
Final PL
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common-pl-clean-210_OK
Date of last change:2018/10/15
Final PL
|
common-lbl-8mg-5mg-clean-210_OK
Date of last change:2018/10/15
Final PL
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common-lbl-8mg-10mg-clean-210_OK
Date of last change:2018/10/15
Final PL
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common-lbl-16mg-10mg-clean-210_OK
Date of last change:2018/10/15
Final PL
|
common-lbl-16mg-5mg-clean-210_OK
Date of last change:2018/10/15
Final PL
|
common-smpc-clean-210_OK
Date of last change:2018/10/15
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase