欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FI/H/0373/001
药品名称
Risperidon Sandoz 1 mg
活性成分
Risperidone 1.0 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz A/S C.F. Tietgens Boulevard 40 5220 Odense SQ DENMARK
参考成员国 - 产品名称
Finland (FI)
互认成员国 - 产品名称
Italy (IT)
Sweden (SE)
Risperidon Sandoz
Norway (NO)
Denmark (DK)
United Kingdom (Northern Ireland) (XI)
许可日期
2005/02/22
最近更新日期
2025/01/20
药物ATC编码
N05AX08 risperidone
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic [Article 10.1.(a)(iii), first paragraph]
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
FI_H_0373_1_2_3_4_WS_1526_Risperidone_FINAL_PIL_cv
Date of last change:2024/09/06
Final SPC
|
FI_H_0373_1_2_3_4_WS_1526_Risperidone_FINAL_SmPC_cv
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase