欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
FI/H/1148/004
药品名称
Risperidone Grindeks 3 mg
活性成分
risperidone 3.0 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
Romania (RO)
Spain (ES)
Slovenia (SI)
Portugal (PT)
Croatia (HR)
Italy (IT)
Greece (GR)
Sweden (SE)
Norway (NO)
Germany (DE)
Risperidone Baltijos Bite 3 mg Filmtabletten
Poland (PL)
Risperidone Grindeks
Belgium (BE)
Latvia (LV)
Netherlands (NL)
Risperidone Baltijos Bite 3 mg, filmomhulde tabletten
Lithuania (LT)
-
Ireland (IE)
Estonia (EE)
Austria (AT)
Czechia (CZ)
Risperidone Baltijos Bite
France (FR)
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