欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
AT/H/0987/001
药品名称
Aqualibra Filmtabletten
活性成分
Ononidis radix 80.0 mg
Orthosiphonis folium 90.0 mg
Solidaginis herba 180.0 mg
剂型
Film-coated tablet
上市许可持有人
Medice Arzneimittel Pütter GmbH
参考成员国 - 产品名称
Austria (AT)
Aqualibra Filmtabletten
互认成员国 - 产品名称
Slovenia (SI)
Slovakia (SK)
Flaverol filmom obalené tablety
Hungary (HU)
FLAVEROL filmtabletta
许可日期
2020/07/02
最近更新日期
2024/12/05
药物ATC编码
G04BX Other urologicals
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Herbal
TypeLevel5:
Non Prescription (including OTC)
附件文件下载
Final PL
|
PIL_final_AT_H_0987_001_II_008_clean
Date of last change:2024/11/21
Final SPC
|
SPC_final_AT_H_0987_001_II_008_clean
Date of last change:2024/11/21
PubAR
|
updated PAR_AT_H_0987_001_DC_barrierefrei
Date of last change:2024/10/17
Final Labelling
|
AT_H_0987_001_DC_final_LAB
Date of last change:2024/09/06
市场状态
Positive
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