欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
BE/H/0175/001
药品名称
Sedistress
活性成分
passiflora incarnata extract for oral use 400.0 mg
剂型
Coated tablet
上市许可持有人
Tilman sa ZI Sud 15 B-5377 Baillonville Belgium
参考成员国 - 产品名称
Belgium (BE)
Sedistress, coated tablets
互认成员国 - 产品名称
Poland (PL)
Sedistress
Slovenia (SI)
Austria (AT)
Italy (IT)
Luxembourg (LU)
Spain (ES)
Greece (GR)
Cyprus (CY)
SEDANXIO FORTE COATED TABS
Netherlands (NL)
Sofytol
France (FR)
Sweden (SE)
Norway (NO)
Finland (FI)
许可日期
2011/04/21
最近更新日期
2023/10/20
药物ATC编码
N05CM Other hypnotics and sedatives
申请类型
TypeLevel1：
Known Active Substance
TypeLevel2：
Initial Application
TypeLevel3：
Article 16a Dir 2001/83/EC
TypeLevel4：
Herbal
TypeLevel5：
Non Prescription (including OTC)
附件文件下载
Final Product Information
|
common-impack
Date of last change:2016/06/14
Final Product Information
|
common-outer
Date of last change:2016/06/14
Final Product Information
|
common-pl
Date of last change:2016/06/14
Final Product Information
|
common-spc
Date of last change:2016/06/14
Final SPC
|
SmPC
Date of last change:2015/10/20
Final PL
|
Leaflet
Date of last change:2015/10/20
Final Labelling
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Labeling
Date of last change:2015/10/20
PAR
|
20110421_Sedistress_BE_175_Day_210_-_RMS_labellingen
Date of last change:2011/10/10
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase