欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DE/H/2184/006
药品名称
Risperdal 4 mg
活性成分
risperidone 4.0 mg
剂型
Film-coated tablet
上市许可持有人
Janssen-Cilag GmbH Johnson & Johnson Platz 1 41470 Neuss Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
Belgium (BE)
Denmark (DK)
Netherlands (NL)
Luxembourg (LU)
Iceland (IS)
Ireland (IE)
Austria (AT)
Risperdal 4 mg Filmtabletten
France (FR)
Portugal (PT)
Italy (IT)
Greece (GR)
Sweden (SE)
Norway (NO)
Finland (FI)
Poland (PL)
Rispolept
Latvia (LV)
Lithuania (LT)
Rispolept 4 mg plėvele dengtos tabletės
Estonia (EE)
RISPOLEPT 4 mg
Cyprus (CY)
Czechia (CZ)
Slovenia (SI)
许可日期
2010/04/28
最近更新日期
2024/07/05
药物ATC编码
N05AX08 risperidone
申请类型
TypeLevel1：
[not specified]
TypeLevel2：
[not specified]
TypeLevel3：
[not specified]
TypeLevel4：
[not specified]
TypeLevel5：
[not specified]
附件文件下载
Final Product Information
|
common_final_combined_2184_V080
Date of last change:2024/09/06
Final Labelling
|
DE2184_02_07_R01_Risperdal FT_common_interpack_clean_20140616_renewal
Date of last change:2024/09/06
Final PL
|
DE2184_02_12_16_R01_Risperdal_common_pl_clean_oral_20140616_renewal
Date of last change:2024/09/06
Final SPC
|
DE2184_02_12_16_R01_Risperdal_common_smpc_clean_oral_20140616_renewal
Date of last change:2024/09/06
Final Labelling
|
DE2184_08_R01_Risperdal oral solution_common_interpack_clean_20140616_renewal
Date of last change:2024/09/06
Final Labelling
|
DE2184_09_12_16_R01_Risperdal Quicklet_common_interpack_clean_20140616_renewal
Date of last change:2024/09/06
Final Labelling
|
DE2184_13_15_R01_Risperdal Consta_common_interpack_clean_20140616_renewal
Date of last change:2024/09/06
Final PL
|
DE2184_13_15_R01_Risperdal Consta_common_pl_clean_consta_20140616_renewal
Date of last change:2024/09/06
Final SPC
|
DE2184_13_15_R01_Risperdal Consta_common_smpc_clean_consta_20140616_renewal
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase