欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
FI/H/1148/002
药品名称
Risperidone Grindeks 1 mg
活性成分
risperidone 1.0 mg
剂型
Film-coated tablet
上市许可持有人
Grindeks AS Krustpils Iela 53 Riga 1057, Latvia
参考成员国 - 产品名称
Finland (FI)
互认成员国 - 产品名称
Belgium (BE)
Latvia (LV)
Netherlands (NL)
Risperidone Baltijos Bite 1 mg, filmomhulde tabletten
Lithuania (LT)
-
Ireland (IE)
Estonia (EE)
Austria (AT)
Czechia (CZ)
Risperidone Baltijos Bite
France (FR)
Romania (RO)
Spain (ES)
Slovenia (SI)
Portugal (PT)
Croatia (HR)
Italy (IT)
Greece (GR)
Sweden (SE)
Norway (NO)
Germany (DE)
Risperidone Baltijos Bite 1 mg Filmtabletten
Poland (PL)
Risperidone Grindeks
许可日期
2023/06/19
最近更新日期
2024/05/03
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
|
Labelling outer_Risperidone Grindeks_common_EU_ 06_2023_clean
Date of last change:2024/09/06
PubAR
|
PAR_Risperidone Grindeks_FI_H_1148_001_006_DC_2023_11_21
Date of last change:2024/09/06
Final PL
|
PIL_Risperidone Grindeks_EU_common_D180_D195_en_07_06_2023
Date of last change:2024/09/06
Final SPC
|
SPC_Risperidone Grindeks_EU_common_D204_en 15_06_2023
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase