欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1070/001
药品名称
Octanate 50 I.E./ml
活性成分
Human plasma coagulation factor VIII 50.0 IU
剂型
Powder and solvent for solution for injection
上市许可持有人
Octapharma AB Sweden
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Portugal (PT)
Italy (IT)
Poland (PL)
Czechia (CZ)
Octanate 50 I.U./ml
Romania (RO)
OCTANATE 50 UI/ml pulbere şi solvent pentru soluţie injectabilă
Slovenia (SI)
Malta (MT)
Austria (AT)
Octanate 100 I.E./ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Denmark (DK)
Belgium (BE)
Netherlands (NL)
Luxembourg (LU)
Ireland (IE)
France (FR)
Latvia (LV)
Octanate 250 SV; 500 pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
Lithuania (LT)
Octanate 50 TV/ml milteliai ir tirpiklis injekciniam tirpalui
Cyprus (CY)
许可日期
2007/12/09
最近更新日期
2024/04/19
药物ATC编码
B02BD02 coagulation factor VIII
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
Final PL
|
SE/H/1070/001_Final PL
Date of last change:2014/01/15
Final SPC
|
SE/H/1070/001_Final SPC
Date of last change:2014/01/15
Final Labelling
|
Lab_Folding Box Equipment Pack_outer_packaging_Octanate_50IU
Date of last change:2010/07/23
Final Labelling
|
Lab_Folding Box_outer_packaging_Octanate_50IU
Date of last change:2010/07/23
Final Labelling
|
Lab_vial_immediate_packaging_Octanate_50IU
Date of last change:2010/07/23
Final Labelling
|
Lab_vial_solvent_immediate_packaging_Octanate_50IU
Date of last change:2010/07/23
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase