欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
CZ/H/0178/004
药品名称
RIDONER 4 mg
活性成分
risperidone 4.0 mg
剂型
Film-coated tablet
上市许可持有人
Labochem Ltd. 1, Aristonikou Str., 116 36, Athens Greece
参考成员国 - 产品名称
Czechia (CZ)
互认成员国 - 产品名称
许可日期
2008/10/02
最近更新日期
2023/12/14
药物ATC编码
N05AX08 risperidone
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
CZ_H_0177_01_04_MR_Rispemar_labelling
Date of last change:2024/09/06
Final PL
|
CZ_H_0177_01_04_MR_Rispemar_PIL
Date of last change:2024/09/06
Final SPC
|
CZ_H_0177_01_04_MR_Rispemar_SPC
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
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European Union HMA Authorisation of Medicines DataBase