欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
SE/H/1070/002
药品名称
Octanate 100 I.E./ml
活性成分
Human plasma coagulation factor VIII 100.0 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 100 I.U./ml
Romania (RO)
OCTANATE 100 UI/ml pulbere şi solvent pentru soluţie injectabilă
Slovenia (SI)
Malta (MT)
Austria (AT)
Octanate 50 I.E./ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Denmark (DK)
Belgium (BE)
Netherlands (NL)
Luxembourg (LU)
France (FR)
Latvia (LV)
Octanate 1000 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
Lithuania (LT)
Octanate 100 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_002_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1070_002_Final SPC
Date of last change:2024/09/06
Final Labelling
|
Lab_Folding Box Equipment Pack_outer_packaging_Octanate_100IU
Date of last change:2024/09/06
Final Labelling
|
Lab_Folding Box_outer packaging_Octanate_100IU
Date of last change:2024/09/06
Final Labelling
|
Lab_vial_immediate_packaging_Octanate_100IU
Date of last change:2024/09/06
Final Labelling
|
Lab_vial_solvent_immediate_packaging_Octanate_100IU
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase