欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1670/001
药品名称
Zoxilid
活性成分
Linezolid 600.0 mg
剂型
Film-coated tablet
上市许可持有人
Medochemie Ltd. Cyprus
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Spain (ES)
Latvia (LV)
Apel 600 mg apvalkotās tabletes
Lithuania (LT)
DISENIL 600 mg plėvele dengtos tabletės
Estonia (EE)
APEL
Bulgaria (BG)
APEL 600 mg film-coated tablet
Cyprus (CY)
APEL 600MG FC TABS
Czechia (CZ)
APEL
Romania (RO)
Slovakia (SK)
APEL 600 mg filmom obalené tablety
Malta (MT)
Croatia (HR)
Zoxilid 600 mg filmom obložene tablete
许可日期
2018/09/27
最近更新日期
2025/01/17
药物ATC编码
J01XX08 linezolid
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
SE_H_1670_001_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1670_001_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_1670_001_PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase