欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/1010/001
药品名称
Vantas
活性成分
histrelin acetate 50.0 mg
剂型
Implant
上市许可持有人
Orion Corporation Orionintie 1 FI-02200 Espoo Finland
参考成员国 - 产品名称
Denmark (DK)
Vantas
互认成员国 - 产品名称
许可日期
2007/07/30
最近更新日期
2015/10/08
药物ATC编码
L02AE05 histrelin
申请类型
TypeLevel1：
Known Active Substance
TypeLevel2：
Initial Application
TypeLevel3：
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final SPC
|
common-spc-clean DK_H_1010_001_IB_027 Vantas implant
Date of last change:2015/02/26
Final PL
|
common-pl-clean DK_H_1010_001_IB_027 Vantas implant
Date of last change:2015/02/26
Final Labelling
|
common-outer-vantas50mgimplantmrplabelling16112010
Date of last change:2010/12/11
Final Labelling
|
Vantas 50mg impl device Label 01042010annotated
Date of last change:2010/12/11
Final Labelling
|
Vantas 50mg impl device Label 01042010clean
Date of last change:2010/12/11
Final Labelling
|
Vantas 50mg implant MRP implant labelling consolidated version 16112010trackchanges
Date of last change:2010/12/11
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase