欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1055/001
药品名称
Risperidona Aurobindo
活性成分
risperidone 1.0 mg/l
剂型
Oral solution
上市许可持有人
Aurobindo Pharma (PT), Unipessoal Limitada
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
France (FR)
Italy (IT)
许可日期
2013/12/04
最近更新日期
2024/04/10
药物ATC编码
N05AX08 risperidone
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
PubAR
|
5684_20140430_PAR_GBB
Date of last change:2024/09/06
Final Product Information
|
Clean_Risperidone Aurobindo Oral Solution_Lab_08_04_2013
Date of last change:2024/09/06
Final Product Information
|
Clean_Risperidone Aurobindo Oral Solution_PIL_19_11_2013
Date of last change:2024/09/06
Final Product Information
|
Clean_Risperidone Aurobindo Oral Solution_SPC_19_11_2013
Date of last change:2024/09/06
市场状态
Positive
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