欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FR/H/0105/001
药品名称
Omacor 1000 mg, capsules, soft
活性成分
OMEGA-3-ACID ETHYL ESTERS 1000.0 mg
剂型
Capsule, soft
上市许可持有人
BASF AS PO BOX 420 1327 LYSAKER NORVEGE
参考成员国 - 产品名称
France (FR)
互认成员国 - 产品名称
Germany (DE)
Belgium (BE)
Netherlands (NL)
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Austria (AT)
OMACOR - Kapseln
Spain (ES)
Portugal (PT)
Greece (EL)
Poland (PL)
Latvia (LV)
Lithuania (LT)
Estonia (EE)
Hungary (HU)
Cyprus (CY)
Slovenia (SI)
Malta (MT)
许可日期
2008/04/05
最近更新日期
2025/01/02
药物ATC编码
C10AX06 omega-3-triglycerides incl. other esters and acids
申请类型
TypeLevel1:
TypeLevel2:
TypeLevel3:
TypeLevel4:
TypeLevel5:
附件文件下载
Final Labelling
|
common_labelinner_clean
Date of last change:2024/09/06
Final Labelling
|
common_labelouter_clean
Date of last change:2024/09/06
Final PL
|
FR_H_0105_001_common_pil_clean
Date of last change:2024/09/06
Final SPC
|
FR_H_0105_001_common_spc_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase