欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DE/H/5017/001
药品名称
Bosentan AL 62.5 mg Filmtabletten
活性成分
Bosentan 62.5 mg
剂型
Film-coated tablet
上市许可持有人
ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
参考成员国 - 产品名称
Germany (DE)
Bosentan AL 62 mg Filmtabletten
互认成员国 - 产品名称
许可日期
2015/06/03
最近更新日期
2025/11/25
药物ATC编码
C02KX01 bosentan
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Initial Application
TypeLevel3：
Generic
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final PL
|
final_common_pl_125mg_5017_013
Date of last change:2025/11/25
Final SPC
|
final_common_spc_5017_013
Date of last change:2025/11/25
Final Product Information
|
common_final_lab_5017_001__V001G
Date of last change:2024/09/06
Final Product Information
|
common_final_lab_5017_002__V001G
Date of last change:2024/09/06
Final Product Information
|
common_final_lab_5018_001__V003G
Date of last change:2024/09/06
Final Product Information
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common_final_lab_5018_002__V003G
Date of last change:2024/09/06
Final Product Information
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common_final_pl_5017_001__V001G
Date of last change:2024/09/06
Final Product Information
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common_final_pl_5017_002__V001G
Date of last change:2024/09/06
Final Product Information
|
common_final_pl_5018_001__V003G
Date of last change:2024/09/06
Final Product Information
|
common_final_pl_5018_002__V003G
Date of last change:2024/09/06
Final Product Information
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common_final_spc_5017_001__V001G
Date of last change:2024/09/06
Final Product Information
|
common_final_spc_5017_002__V001G
Date of last change:2024/09/06
Final Product Information
|
common_final_spc_5018_001__V003G
Date of last change:2024/09/06
Final Product Information
|
common_final_spc_5018_002__V003G
Date of last change:2024/09/06
PubAR Summary
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DE_H_5017_5018_01_02_DC Bosentan AL_Stada_ Public AR
Date of last change:2024/09/06
PubAR
|
DE_H_5017_5018_01_02_DC Bosentan AL_Stada_ Public AR _2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase