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	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_clDate of last change:2024/09/20 Final SPC \| 1_3_1_SPC_common_en_DK_H_1627_001_005_clDate of last change:2024/09/20 Final Product Information \| 1_3_1_Lab_outer_common_en_DK1086_001_005_clDate of last change:2024/09/06 Final Product Information \| 1_3_1_Lab_outer_common_en_DK1627_clDate of last change:2024/09/06 Final Product Information \| 1_3_1_Lab_outer_common_en_DK1630_clDate of last change:2024/09/06 Final Product Information \| 1_3_1_PIL_common_en_DK1086_001_005_clDate of last change:2024/09/06 Final Product Information \| 1_3_1_PIL_common_en_DK1627_001_005_clDate of last change:2024/09/06 Final Product Information \| 1_3_1_PIL_common_en_DK1630_001_005_clDate of last change:2024/09/06 Final Product Information \| 1_3_1_SPC_common_en_DK1086_001_005_clDate of last change:2024/09/06 Final Product Information \| 1_3_1_SPC_common_en_DK1627_001_005_clDate of last change:2024/09/06 Final Labelling \| DK_H_1627_001_005_IB_024_G_Stadaquel_Final_ILAB_CLDate of last change:2024/09/06 Final Labelling \| DK_H_1627_001_005_IB_024_G_Stadaquel_Final_OLAB_CLDate of last change:2024/09/06 PubAR \| parmod5_dk1627stadaquel_pdfDate of last change:2024/09/06 PubAR \| pllab_dk1627stadaquel_pdfDate of last change:2024/09/06 PubAR \| spc_dk1627stadaquel_pdfDate of last change:2024/09/06
市场状态	Positive