欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2523/002
药品名称
Desmurin
活性成分
desmopressin acetate 120.0 µg
剂型
Orodispersible tablet
上市许可持有人
2care4 Tømrervej 9 6710 Esbjerg Denmark
参考成员国 - 产品名称
Denmark (DK)
Desmurin
互认成员国 - 产品名称
许可日期
2016/04/21
最近更新日期
2017/01/04
药物ATC编码
H01B POSTERIOR PITUITARY LOBE HORMONES
H01BA Vasopressin and analogues
H01BA02 desmopressin
H SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
H01 PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
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 SPC
|
ANNEX A Final SmPC clean
Date of last change:2024/09/06
Final PL
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ANNEX B Final PIL Clean
Date of last change:2024/09/06
Final Labelling
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ANNEX C Final Labelling
Date of last change:2024/09/06
PubAR
|
Final PAR Desmurin 60_ 120_ 240 micg sublingual tablets DKH2523_001_003_DC
Date of last change:2024/09/06
PubAR Summary
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Final sPAR Desmurin sublingual tablets DKH2525_001_003_DC
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
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European Union HMA Authorisation of Medicines DataBase