欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
CZ/H/0142/001
药品名称
Sibutramine Teva 10 mg tobolky
活性成分
sibutramine hydrochloride 10.0 mg
剂型
Capsule, hard
上市许可持有人
TEVA PHARMACEUTICALS CR s.r.o. Brno Czech Republic
参考成员国 - 产品名称
Czechia (CZ)
互认成员国 - 产品名称
Sweden (SE)
Sibutramine Teva
Germany (DE)
Sibutramin Teva 10 mg Hartkapseln
Belgium (BE)
Netherlands (NL)
Sibutramine HCl 10 mg
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
France (FR)
Italy (IT)
Latvia (LV)
Sibutramine Teva 10 mg cietās kapsulas
Lithuania (LT)
Sibutramine Teva 10 mg kietos kapsulės
Estonia (EE)
Bulgaria (BG)
Meissa
Romania (RO)
Sibutramină Teva 10 mg capsule
Denmark (DK)
Sibutramin "Teva"
Ireland (IE)
Austria (AT)
Sibutramin Teva 10 mg Kapseln
Spain (ES)
Portugal (PT)
Greece (GR)
许可日期
2008/02/06
最近更新日期
2018/10/29
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 SPC
|
CZ-H-142-01-2-DC_SibutramineTeva10mg_SPC_Day210 - corr - final
Date of last change:2022/05/03
Final PL
|
CZ-H-142-01-2-DC_SibutramineTeva10mg-15mg_PIL_Day210 - corr - final
Date of last change:2022/05/03
Final Labelling
|
CZ-H-142-01-2-DC_SibutramineTeva10mg_Labelling_Day210 - corr - final
Date of last change:2022/05/03
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase