欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
AT/H/1263/001
药品名称
Iberogast Balance
活性成分
bitter candytuft, fresh, extract ethanolic 15.0 ml
caraway fruit, extract ethanolic 20.0 ml
liquorice root, extract ethanolic 10.0 ml
matricaria flower, extract ethanolic 30.0 ml
melissa leaf, extract ethanolic 15.0 ml
peppermint leaf, extract ethanolic 10.0 ml
剂型
Oral liquid
上市许可持有人
Bayer Austria GmbH Herbststrasse 6-10 1160 Vienna, Austria
参考成员国 - 产品名称
Austria (AT)
互认成员国 - 产品名称
Poland (PL)
Iberogast Balance
Latvia (LV)
Lithuania (LT)
-
Estonia (EE)
Hungary (HU)
Bulgaria (BG)
Iberogast compact
Romania (RO)
Slovakia (SK)
Slovenia (SI)
Croatia (HR)
Sweden (SE)
Norway (NO)
许可日期
2023/03/08
最近更新日期
2024/10/23
药物ATC编码
A03AX Other drugs for functional gastrointestinal disorders
申请类型
TypeLevel1：
Known Active Substance
TypeLevel2：
Initial Application
TypeLevel3：
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4：
Herbal
TypeLevel5：
Non Prescription (including OTC)
附件文件下载
Final Labelling
|
AT_H_1263_001_DC_final_LAB
Date of last change:2024/09/06
Final PL
|
AT_H_1263_001_DC_final_PIL
Date of last change:2024/09/06
Final SPC
|
AT_H_1263_001_DC_final_SmPC
Date of last change:2024/09/06
PubAR
|
PAR_AT_H_1263_001_barrierefrei
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase