欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
PT/H/2539/001
药品名称
Quetiapina Limeg
活性成分
quetiapine 50.0 mg
剂型
Prolonged-release tablet
上市许可持有人
Generis Farmacêutica, S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
许可日期
2022/05/20
最近更新日期
2024/08/21
药物ATC编码
N05AH04 quetiapine
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Initial Application
TypeLevel3：
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final PL
|
common_pl_clean
Date of last change:2024/09/06
Final SPC
|
common_spc_clean
Date of last change:2024/09/06
Final Product Information
|
DCP_Quetiapine film_coated tablets_LAB_2539_clean
Date of last change:2024/09/06
Final Product Information
|
DCP_Quetiapine film_coated tablets_PIL_2539_clean
Date of last change:2024/09/06
Final Product Information
|
DCP_Quetiapine film_coated tablets_SPC_2539_clean
Date of last change:2024/09/06
PubAR
|
PT_2539_PAR_final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase