欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
SE/H/1070/003
药品名称
Octanate LV
活性成分
blood coagulation factor VIII human 100.0 IU/ml
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
Denmark (DK)
Belgium (BE)
Octanate 100 IU/ml poeder en oplosmiddel voor injectie
Netherlands (NL)
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Austria (AT)
Octanate LV 100 I.E./ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Poland (PL)
Octanate LV
Latvia (LV)
Octanate 500 SV/5 ml pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
Lithuania (LT)
Octanate 100 TV/ml milteliai ir tirpiklis injekciniam tirpalui
Cyprus (CY)
OCTANATE C PWD AND SOLVENT FOR SOL FOR INJ
Czechia (CZ)
Octanate (100 IU/ml)
Romania (RO)
Octanate LV 100 UI/ml pulbere şi solvent pentru soluţie injectabilă
Slovenia (SI)
Malta (MT)
Octanate C 100 IU/ml powder and solvent for solution for injection
许可日期
2014/10/13
最近更新日期
2024/04/19
药物ATC编码
B02BD02 coagulation factor VIII
申请类型
TypeLevel1：
Line Extension
TypeLevel2：
Additional Strength/Form
TypeLevel3：
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4：
Biological: Blood Product
TypeLevel5：
Prescription Only
附件文件下载
PAR Summary
|
SE/H/1070/003_PAR Summary
Date of last change:2015/01/08
PAR
|
SE/H/1070/003_PAR
Date of last change:2014/12/15
Final PL
|
SE/H/1070/003_Final PL
Date of last change:2014/12/09
Final SPC
|
SE/H/1070/003_Final SPC
Date of last change:2014/12/09
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase