欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0421/001
药品名称
SMOFlipid
活性成分
dl-alfa-tocopherol 0.0 mg
medium chain triglycerides 60.0 g
purified fish oil 30.0 g
refined olive oil 50.0 g
soybean oil 60.0 g
剂型
Emulsion for infusion
上市许可持有人
Fresenius Kabi AB Sweden
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Hungary (HU)
Cyprus (CY)
SMOFLIPID EMULSION FOR INFUSION
Czechia (CZ)
Slovakia (SK)
SMOFlipid
Slovenia (SI)
Germany (DE)
Denmark (DK)
Belgium (BE)
Netherlands (NL)
Luxembourg (LU)
Iceland (IS)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Austria (AT)
SMOFlipid 200 mg/ml Emulsion zur Infusion
Spain (ES)
Portugal (PT)
Greece (GR)
Norway (NO)
Finland (FI)
Poland (PL)
SMOFlipid
Latvia (LV)
SMOFlipid 20 % emulsion for infusion
Lithuania (LT)
SMOFlipid 20% infuzinė emulsija
Estonia (EE)
许可日期
2004/07/06
最近更新日期
2024/07/05
药物ATC编码
B05BA02 fat emulsions
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Article 4.8 Di 65/65
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
SE_H_0421_001_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_0421_001_Final SPC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase