欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
BE/H/0368/001
药品名称
Sedistress 500
活性成分
PASSIFLORA INCARNATA dry extract 500.0 mg
剂型
Film-coated tablet
上市许可持有人
Tilman SA, ZI SUD 15, 5377 Baillonville, Belgium
参考成员国 - 产品名称
Belgium (BE)
互认成员国 - 产品名称
Italy (IT)
Malta (MT)
SEDISTRESS 500mg film-coated tablets
Greece (GR)
Croatia (HR)
Sweden (SE)
Norway (NO)
Finland (FI)
Poland (PL)
SEDISTRESS 500, tabletki powlekane
Bulgaria (BG)
Sedistress
Denmark (DK)
Sedix Forte
Cyprus (CY)
SEDISTRESS 500 film-coated tablets
Luxembourg (LU)
Czechia (CZ)
SEDISTRESS 500mg
France (FR)
Romania (RO)
SEDISTRESS 500 mg Film-coated tablet
Spain (ES)
Slovakia (SK)
Portugal (PT)
Slovenia (SI)
许可日期
2024/01/24
最近更新日期
2025/07/12
药物ATC编码
N05CM Other hypnotics and sedatives
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Initial Application
TypeLevel3：
Article 16a Dir 2001/83/EC
TypeLevel4：
Herbal
TypeLevel5：
Non Prescription (including OTC)
附件文件下载
PubAR
|
PAR BE_H_0368_001_DC fyto Sedistress 500 ID 104070
Date of last change:2025/03/11
PubAR Summary
|
Summary PAR BE_H_0368_001_DC fyto Sedistress 500 ID 104070
Date of last change:2025/03/11
Final PL
|
final PL Track
Date of last change:2024/10/16
Final Labelling
|
sedistress_500_D210_labelling
Date of last change:2024/09/06
Final SPC
|
sedistress_500_D210_smpc
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase