欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1866/002
药品名称
octaplasLG
活性成分
human plasma proteins 0.0 mg/ml
剂型
Powder and solvent for solution for infusion
上市许可持有人
Octapharma AB
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Austria (AT)
Octaplas LG 45 - 70 mg/ml Infusionslösung
France (FR)
Spain (ES)
Norway (NO)
Finland (FI)
OctaplasLG Lyo
Hungary (HU)
OCTAPLASLG 45-70 mg/ml oldatos infúzió
Bulgaria (BG)
Denmark (DK)
Czechia (CZ)
octaplas LG LYO
Belgium (BE)
Malta (MT)
octaplasLG Lyo, powder and solvent for solution for infusion
Netherlands (NL)
Omniplasma Lyo
Croatia (HR)
Luxembourg (LU)
Ireland (IE)
许可日期
2023/02/01
最近更新日期
2025/09/23
药物ATC编码
B05AA Blood substitutes and plasma protein fractions
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
Final PL
|
Final PL
Final SPC
|
Final SPC
PubAR
|
PAR
PubAR Summary
|
PAR Summary
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase