欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0169/001
药品名称
Cosmofer
活性成分
iron(III)-hydroxide dextran complex 50.0 mg/ml
剂型
Solution for injection
上市许可持有人
Pharmacosmos A/S Rørvangsvej 30 4300 Holbæk Denmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Germany (DE)
Netherlands (NL)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Sweden (SE)
Norway (NO)
Latvia (LV)
CosmoFer 50 mg/ml solution for injection and infusion
Lithuania (LT)
CosmoFer 50 mg/ml injekcinis/infuzinis tirpalas
Estonia (EE)
许可日期
2000/11/28
最近更新日期
2023/06/29
药物ATC编码
B03AC06 ferric oxide dextran complexes
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Bibliographic Article 4.8 (a) (ii)
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
commom_spc_track_0054 _ final Clean
Date of last change:2024/09/06
Final Product Information
|
common_final_clean
Date of last change:2024/09/06
Final PL
|
common_pl_track_0054 _ Final Clean
Date of last change:2024/09/06
Final Labelling
|
Final labelling_clean DK_H_0169_001_IB_034 Cosmofer
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase