欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1469/002
药品名称
Noctissin
活性成分
desmopressin acetate 0.2 mg
剂型
Tablet
上市许可持有人
Actavis Group PTC ehf. Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Norway (NO)
Lithuania (LT)
Estonia (EE)
Portugal (PT)
Sweden (SE)
Desmopresssin Actavis
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Italy (IT)
Poland (PL)
Latvia (LV)
Desmopressin Actavis 0,2 mg tabletes
Bulgaria (BG)
Noctissin
Romania (RO)
Desmopressin Actavis 0.2 mg comprimate
Slovakia (SK)
Radessin 0,2 mg
Belgium (BE)
许可日期
2009/04/16
最近更新日期
2024/08/19
药物ATC编码
H01BA02 desmopressin
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
|
Annex 2 _ PIL clean 14_01_2010
Date of last change:2024/09/06
Final Labelling
|
Annex 4 _Label clean_ DK_H_1469_1_2_P_001_
Date of last change:2024/09/06
PubAR
|
parmod5_dk1469noctissin_pdf
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase