欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/1111/001
药品名称
Pentaglobin
活性成分
human normal immunoglobulin 50.0 mg/ml
剂型
Solution for infusion
上市许可持有人
Biotest Landstreinerstr.5 63303 Dreieich Gerrmany
参考成员国 - 产品名称
Germany (DE)
Pentaglobin
互认成员国 - 产品名称
Austria (AT)
Italy (IT)
Greece (GR)
Poland (PL)
Hungary (HU)
许可日期
2009/06/09
最近更新日期
2019/08/20
药物ATC编码
J06BA02 immunoglobulins, normal human, for intravascular adm.
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
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
|
Final common PIL Pentaglobin
Date of last change:2023/06/28
Final SPC
|
Final common SmPC Pentaglobin
Date of last change:2023/06/28
PAR
|
DE_1111_1115_1_2_DC_PAR
Date of last change:2023/03/16
市场状态
Positive
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