欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1494/001
药品名称
Ximaract
活性成分
cefuroxime 50.0 mg
剂型
Powder for solution for injection
上市许可持有人
Bausch Health Ireland Ltd
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Germany (DE)
Ximaract 50 mg Pulver zur Herstellung einer Injektionslösung
Belgium (BE)
Ximaract 50 mg poudre pour solution injectable
Netherlands (NL)
United Kingdom (Northern Ireland) (XI)
Austria (AT)
Ximaract 50 mg Pulver zur Herstellung einer Injektionslösung
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Norway (NO)
Ximaract
Poland (PL)
Ximaract
Lithuania (LT)
Ximaract 50 mg milteliai injekciniam tirpalui
Estonia (EE)
XIMARACT
Hungary (HU)
XIMARACT 50 mg filmtabletta
Slovakia (SK)
Ximaract 50 mg prášok na injekčný roztok
许可日期
2016/05/23
最近更新日期
2023/03/06
药物ATC编码
S01AA27 cefuroxime
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Bibliographic Art 10 a Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
PAR Summary
|
SE/H/1494/001_PAR Summary
Date of last change:2016/10/03
PAR
|
SE/H/1494/001_PAR
Date of last change:2016/10/03
Final SPC
|
SE/H/1494/001_Final SPC
Date of last change:2016/08/29
市场状态
Positive
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