欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/0396/001
药品名称
EZETROL 10 mg Tabletten
活性成分
Ezetimibe 10.0 mg
剂型
Tablet
上市许可持有人
Organon Healthcare GmbH Pestalozzistr. 31 80469 München Bayern Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Denmark (DK)
Ezetrol
Belgium (BE)
Netherlands (NL)
Luxembourg (LU)
Iceland (IS)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Austria (AT)
Ezetrol 10 mg Tabletten
France (FR)
Spain (ES)
Italy (IT)
Greece (GR)
Sweden (SE)
Norway (NO)
Finland (FI)
Hungary (HU)
Ezetrol 10mg tabletta
Cyprus (CY)
EZETROL 10MG 24M0153
Slovakia (SK)
EZETROL
Slovenia (SI)
Bulgaria (BG)
Romania (RO)
Portugal (PT)
Czechia (CZ)
12829/07
Malta (MT)
许可日期
2003/03/04
最近更新日期
2024/12/27
药物ATC编码
C10AX09 ezetimibe
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 SPC
|
DE_H_396_399_01_II_35_34_Ezetrol_final PI_clean
Date of last change:2024/09/06
Final Product Information
|
EZETROL_DE_H_0396_0399_001_WS_687_PI_EU_en_CRT
Date of last change:2024/09/06
Final Product Information
|
EZETROL_DE_H_0396_0399_001_WS_687_PI_EU_en_WRM
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase