欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
PT/H/1090/001
药品名称
Linezolida Kabi
活性成分
linezolid 2.0 mg/ml
剂型
Solution for infusion
上市许可持有人
Fresenius Kabi Pharma Portugal, Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
Linezolid Kabi 2 mg/ml Infusionslösung
Denmark (DK)
Belgium (BE)
Linezolid Fresenius Kabi 2mg/ml, oplossing voor infusie
Netherlands (NL)
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Austria (AT)
Linezolid Kabi 2 mg/ml Infusionslösung
France (FR)
Spain (ES)
Italy (IT)
Greece (GR)
LINEZOLID/KABI
Norway (NO)
Poland (PL)
Linezolid Kabi
Bulgaria (BG)
Linezolid Kabi
Czechia (CZ)
Linezolid Kabi
Romania (RO)
Linezolid Kabi 2 mg/ml soluţie perfuzabilă
Slovakia (SK)
Slovenia (SI)
Croatia (HR)
Linezolid Kabi 2 mg/ml otopina za infuziju
Hungary (HU)
Linezolid Fresenius
许可日期
2014/10/01
最近更新日期
2024/07/01
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
PubAR
|
578840_20150327_PAR_RCM
Date of last change:2024/09/06
Final PL
|
Linezolid Kabi_PIL Sep 2014_clean
Date of last change:2024/09/06
Final SPC
|
Linezolid Kabi_SmPC sep 2014_clean
Date of last change:2024/09/06
Final Labelling
|
Linezolid_inner label_May 2014_clean
Date of last change:2024/09/06
Final Labelling
|
Linezolid_outer label_May 2014_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase