欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0541/002
药品名称
Rhesonativ
活性成分
human anti-D immunoglobulin 750.0 IU/ml
剂型
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)
Poland (PL)
Hungary (HU)
Bulgaria (BG)
Rhesonativ 750 IU
Romania (RO)
Slovakia (SK)
Rhesonativ 750 IU/ml
Slovenia (SI)
Rhesonativ 750 i.e./ml raztopina za injiciranje
许可日期
2017/07/06
最近更新日期
2024/07/01
药物ATC编码
J06BB01 anti-D (rh) immunoglobulin
申请类型
TypeLevel1:
Known Active Substance
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
|
SE_H_0541_002_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_0541_002_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_0541_002_PAR
Date of last change:2024/09/06
PubAR Summary
|
SE_H_0541_002_PAR Summary
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase