欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2324/002
药品名称
Sondate XL
活性成分
Quetiapine fumarate 150.0 mg
剂型
Prolonged-release tablet
上市许可持有人
TEVA Pharma B.V. Computerweg 10, 3542DR Utrecht The Netherlands
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
Sondate XL
Spain (ES)
许可日期
2011/11/30
最近更新日期
2025/08/21
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 Labelling
|
quetiapine_pt_h_2324_001_5_oup_imp_01_07_25_clean
Date of last change:2025/08/21
Final PL
|
quetiapine_pt_h_2324_001_5_pil_01_07_25_clean
Date of last change:2025/08/21
Final SPC
|
quetiapine_pt_h_2324_001_5_smpc_01_07_25_clean
Date of last change:2025/08/21
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase