欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1627/004
药品名称
Stadaquel
活性成分
Quetiapine fumarate 200.0 mg
剂型
Film-coated tablet
上市许可持有人
STADA Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Belgium (BE)
Luxembourg (LU)
Ireland (IE)
Italy (IT)
Bulgaria (BG)
Brevenox
Romania (RO)
TREKSTA 200 mg comprimate filmate
Netherlands (NL)
Sweden (SE)
许可日期
2009/02/12
最近更新日期
2024/09/20
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
|
1_3_1_PIL_common_en_DK_H_1627_001_005_cl
Date of last change:2024/09/20
Final SPC
|
1_3_1_SPC_common_en_DK_H_1627_001_005_cl
Date of last change:2024/09/20
Final Product Information
|
1_3_1_Lab_outer_common_en_DK1086_001_005_cl
Date of last change:2024/09/06
Final Product Information
|
1_3_1_Lab_outer_common_en_DK1627_cl
Date of last change:2024/09/06
Final Product Information
|
1_3_1_Lab_outer_common_en_DK1630_cl
Date of last change:2024/09/06
Final Product Information
|
1_3_1_PIL_common_en_DK1086_001_005_cl
Date of last change:2024/09/06
Final Product Information
|
1_3_1_PIL_common_en_DK1627_001_005_cl
Date of last change:2024/09/06
Final Product Information
|
1_3_1_PIL_common_en_DK1630_001_005_cl
Date of last change:2024/09/06
Final Product Information
|
1_3_1_SPC_common_en_DK1086_001_005_cl
Date of last change:2024/09/06
Final Product Information
|
1_3_1_SPC_common_en_DK1627_001_005_cl
Date of last change:2024/09/06
PubAR
|
parmod5_dk1627stadaquel_pdf
Date of last change:2024/09/06
PubAR
|
pllab_dk1627stadaquel_pdf
Date of last change:2024/09/06
PubAR
|
spc_dk1627stadaquel_pdf
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase