欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
NL/H/4781/003
药品名称
Quetiapine 400mg Prolonged-release Tablets
活性成分
quetiapine hemifumarate 400.0 mg
剂型
Prolonged-release tablet
上市许可持有人
ACCORD HEALTHCARE LIMITED
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
PL 20075/0216-0014
Germany (DE)
Quetiapine Accord 400 mg Retardtabletten
Denmark (DK)
Quetiapine "Accord"
Ireland (IE)
Austria (AT)
Quetiapin Accord 400 mg Retardtabletten
Spain (ES)
Portugal (PT)
Italy (IT)
Greece (GR)
Sweden (SE)
Norway (NO)
Finland (FI)
Lithuania (LT)
Quetiapine Accord 400 mg pailginto atpalaidavimo tabletės
Estonia (EE)
QUETIAPINE ACCORD
Hungary (HU)
QUETIAPINE ACCORD 400 mg retard filmtabletta
Bulgaria (BG)
Quetiapine Accord
Cyprus (CY)
QUETIAPINE 400mg PR TABS
Czechia (CZ)
Quetiapine Accord 400mg Tablety s prodlouženým uvolňováním
Romania (RO)
Quetiapina Accord 400 mg comprimate cu eliberare prelungita
Slovakia (SK)
许可日期
2011/06/16
最近更新日期
2024/12/03
药物ATC编码
N05AH04 quetiapine
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 PL
|
common_pl_clean_50_200_300_400mg
Date of last change:2024/09/09
Final SPC
|
common_spc_clean_200_300_400mg
Date of last change:2024/09/09
Final Product Information
|
common_pl
Date of last change:2024/09/06
Final Labelling
|
Final LABEL
Date of last change:2024/09/06
PubAR
|
PAR_4781_1_3_Quetiapine Accord_2Mar2023
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase