欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2333/004
药品名称
Biquetan
活性成分
quetiapine 300.0 mg
剂型
Prolonged-release tablet
上市许可持有人
STADA Arzneimittel AG Stadastrasse 2-18 Bad Vilbel Germany
参考成员国 - 产品名称
Denmark (DK)
Biquetan
互认成员国 - 产品名称
Luxembourg (LU)
Finland (FI)
Sweden (SE)
Belgium (BE)
Biquetan 300mg tabletten met verlengde afgifte
Ireland (IE)
Austria (AT)
Quetiapin STADA 300 mg Retardtabletten
Spain (ES)
Italy (IT)
许可日期
2014/11/11
最近更新日期
2024/02/20
药物ATC编码
N05AH04 quetiapine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
PIL_common_cl
Date of last change:2022/06/02
Final SPC
|
Biquetan_SPC_common_cl
Date of last change:2022/06/02
PAR
|
Rev Final_PAR_Biquetan_prolonged-release_tablets_DKH2333_001-005_DC
Date of last change:2018/01/25
Final Labelling
|
1.3.1-Lab-outer-common-en-DK-H-2333-2434-001-005-cl
Date of last change:2017/04/07
PAR Summary
|
2nd Final sPAR Biquetan prolonged-release tablets DKH2333_001-005_DC
Date of last change:2016/01/26
市场状态
Positive
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