欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/4781/002
药品名称
Quetiapine 300mg Prolonged-release Tablets
活性成分
quetiapine hemifumarate 300.0 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
Cyprus (CY)
QUETIAPINE ACCORD 300mg PR TABS
Slovak Republic (SK)
Romania (RO)
Quetiapina Accord 300 mg comprimate cu eliberare prelungita
Czech Republic (CZ)
Quetiapine Accord 300mg Tablety s prodlouženým uvolňováním
Bulgaria (BG)
Quetiapine Accord
Hungary (HU)
QUETIAPINE ACCORD 300 mg retard filmtabletta
Estonia (EE)
QUETIAPINE ACCORD
Latvia (LV)
Finland (FI)
Norway (NO)
Italy (IT)
Portugal (PT)
Spain (ES)
Austria (AT)
Quetiapin Accord 300 mg Retardtabletten
Denmark (DK)
Quetiapine "Accord"
United Kingdom (Northern Ireland) (XI)
PL 20075/0215-0014
Sweden (SE)
Greece (EL)
Ireland (IE)
Germany (DE)
Quetiapine Accord 300 mg Retardtabletten
Lithuania (LT)
Quetiapine Accord 300 mg pailginto atpalaidavimo tabletės
许可日期
2011/06/16
最近更新日期
2025/03/11
药物ATC编码
N05AH04 quetiapine
申请类型
TypeLevel1:
TypeLevel2:
TypeLevel3:
TypeLevel4:
TypeLevel5:
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