欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
SE/H/0734/001
药品名称
MonoFer
活性成分
iron(III) isomaltoside 1000 100.0 mg/ml
剂型
solution for injection or infusion
上市许可持有人
Pharmacosmos A/S Denmark
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Germany (DE)
MonoFer 100 mg/ml Infusions- und Injektionslösung
Denmark (DK)
MonoFer
Netherlands (NL)
Luxembourg (LU)
Iceland (IS)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Austria (AT)
Monofer 100 mg/ml Injektions- oder Infusionslösung
Portugal (PT)
Norway (NO)
Finland (FI)
Poland (PL)
Latvia (LV)
Monofer 100 mg/ml šķīdums injekcijām vai infūzijām
Lithuania (LT)
Monofer 100 mg/ml injekcinis ar infuzinis tirpalas
Estonia (EE)
Bulgaria (BG)
MonoFer
Romania (RO)
MONOFER 100 mg/ml soluţie injectabilă/perfuzabilă
Italy (IT)
Slovenia (SI)
Croatia (HR)
Monofer 100 mg/ml otopina za injekciju/infuziju
Belgium (BE)
许可日期
2009/11/26
最近更新日期
2024/03/20
药物ATC编码
B03AC Iron, parenteral preparations
申请类型
TypeLevel1：
Known Active Substance
TypeLevel2：
Initial Application
TypeLevel3：
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
PAR Summary
|
SE/H/0734/001_PAR Summary
Date of last change:2017/12/07
Final PL
|
SE/H/0734/001_Final PL
Date of last change:2014/01/15
Final SPC
|
SE/H/0734/001_Final SPC
Date of last change:2014/01/15
PAR
|
SE/H/0734/001_PAR
Date of last change:2014/01/15
市场状态
Positive
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