欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IT/H/0696/002
药品名称
Bosentan Medac
活性成分
bosentan 125.0 mg
剂型
Film-coated tablet
上市许可持有人
Medac Pharna S.r.l. Via Viggiano, 90 Rome 00178 IT
参考成员国 - 产品名称
Italy (IT)
互认成员国 - 产品名称
许可日期
2015/07/29
最近更新日期
2023/10/12
药物ATC编码
C02KX01 bosentan
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
Final PL
|
pil_bosentan medac_common_tracked
Date of last change:2024/09/06
Final SPC
|
spc_bosentan medac_common_tracked_07_04_2020
Date of last change:2024/09/06
Final Labelling
|
IS_H_0236_0239_d200_PI_Bosentan_Actavis_final clean
Date of last change:2024/09/06
PubAR
|
IS_H_0236_9_001_002_DC_PAR_Bosentan Actavis
Date of last change:2024/09/06
PubAR Summary
|
IS_H_0236_9_001_002_DC_Summary PAR_Bosentan Actavis
Date of last change:2024/09/06
Final Product Information
|
IS_H_0239_001_002_IA_006_PI_Clean_Bosenzpen_Sigillata_15_11_2017
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase