欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
CZ/H/0128/001
药品名称
Lindaxa 10
活性成分
sibutramine hydrochloride 15.0 mg
剂型
Capsule, hard
上市许可持有人
Zentiva, k.s. U kabelovny 130, Dolni Mecholupy 102 37 Praha 10 Czech Republic
参考成员国 - 产品名称
Czechia (CZ)
互认成员国 - 产品名称
Poland (PL)
LINDAXA 15
Estonia (EE)
LINDAXA 10
Hungary (HU)
Lindaxa 15 mg kemény kapszula
Bulgaria (BG)
Lindaxa
Slovakia (SK)
Lindaxa 15
Latvia (LV)
许可日期
2007/12/17
最近更新日期
2011/10/20
药物ATC编码
A08AA10 sibutramine
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 Labelling
|
Lindaxa LAB en final
Date of last change:2024/09/06
Final PL
|
Lindaxa PIL en final
Date of last change:2024/09/06
Final SPC
|
Lindaxa SPC en final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase