欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1906/002
药品名称
Bosentan Accord
活性成分
Bosentan 125.0 mg
剂型
Film-coated tablet
上市许可持有人
Accord Healthcare B.V. The Netherlands
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
Bosentan 125 mg Film-coated Tablets
Germany (DE)
Bosentan Accord 62,5 mg Filmtabletten
Denmark (DK)
Belgium (BE)
Bosentan Accord 125 mg filmomhulde tabletten
Netherlands (NL)
Austria (AT)
Bosentan Accord 125 mg Filmtabletten
France (FR)
Portugal (PT)
Italy (IT)
Norway (NO)
Finland (FI)
Lithuania (LT)
Bosentan Accord 125 mg plėvele dengtos tabletės
Estonia (EE)
BOSENTAN ACCORD
Bulgaria (BG)
Bosentan Accord
Cyprus (CY)
BOSTENTAN ACCORD TABS
Czechia (CZ)
Bosentan Accord 125 mg potahované tablety
Slovakia (SK)
Bosentan Accord 125 mg filmom obalené tablety
Ireland (IE)
Poland (PL)
Latvia (LV)
Romania (RO)
许可日期
2014/11/07
最近更新日期
2025/09/09
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
|
Final PL
Final SPC
|
Final SPC
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase