欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0541/001
药品名称
Rhesonativ
活性成分
human anti-D immunoglobulin 625.0 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
Denmark (DK)
Netherlands (NL)
Luxembourg (LU)
Iceland (IS)
Portugal (PT)
Rhesonativ
Norway (NO)
Finland (FI)
Poland (PL)
Rhesonativ
Latvia (LV)
Rhesonativ 625 SV/ml šķīdums injekcijām
Lithuania (LT)
Rhesonativ 625 TV/ml injekcinis tirpalas
Estonia (EE)
RHESONATIV
Hungary (HU)
Rhesonativ 625 NE/ml oldatos injekció
Cyprus (CY)
25M0179
Czechia (CZ)
12350/06
Romania (RO)
Rhesonativ 625 UI/ml solutie injectabila
Slovakia (SK)
Rhesonativ
Slovenia (SI)
Austria (AT)
Rhesonativ 625 I.E./ml Injektionslösung
France (FR)
Italy (IT)
Bulgaria (BG)
Malta (MT)
许可日期
2006/03/06
最近更新日期
2024/01/26
药物ATC编码
J06BB01 anti-D (rh) immunoglobulin
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier [Article 8.3(i)]
TypeLevel4:
Biological: Blood Product
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
SE/H/0541/001_Final PL
Date of last change:2014/01/15
Final SPC
|
SE/H/0541/001_Final SPC
Date of last change:2014/01/15
PAR
|
SE/H/0541/001_PAR
Date of last change:2014/01/15
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase