欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1627/005
药品名称
Stadaquel
活性成分
quetiapine fumarate 300.0 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)
Sweden (SE)
Romania (RO)
TREKSTA 300 mg comprimate filmate
Netherlands (NL)
许可日期
2009/02/12
最近更新日期
2023/01/06
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_1_
Date of last change:2022/06/13
PAR
|
parmod5_dk1627stadaquel_pdf
Date of last change:2022/06/02
PAR
|
spc_dk1627stadaquel_pdf
Date of last change:2022/06/02
PAR
|
pllab_dk1627stadaquel_pdf
Date of last change:2022/06/02
Final SPC
|
Stadaquel_SPC_common_cl
Date of last change:2022/06/02
Final Product Information
|
1.3.1-PIL-common-en-DK1086-001-005-cl
Date of last change:2019/03/22
Final Product Information
|
1.3.1-Lab-outer-common-en-DK1086-001-005-cl
Date of last change:2019/03/22
Final Product Information
|
1.3.1-Lab-outer-common-en-DK1627-cl
Date of last change:2019/03/22
Final Product Information
|
1.3.1-SPC-common-en-DK1086-001-005-cl
Date of last change:2019/03/22
Final Product Information
|
1.3.1-Lab-outer-common-en-DK1630-cl
Date of last change:2019/03/22
Final Product Information
|
1.3.1-PIL-common-en-DK1627-001-005-cl
Date of last change:2019/03/22
Final Product Information
|
1.3.1-SPC-common-en-DK1627-001-005-cl
Date of last change:2019/03/22
Final Product Information
|
1.3.1-PIL-common-en-DK1630-001-005-cl
Date of last change:2019/03/22
Final Labelling
|
DK_H_1627_001-005_IB_024_G_Stadaquel_Final_OLAB_CL
Date of last change:2016/10/17
Final Labelling
|
DK_H_1627_001-005_IB_024_G_Stadaquel_Final_ILAB_CL
Date of last change:2016/10/17
市场状态
Positive
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