欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0278/002
药品名称
Cipralex
活性成分
Escitalopram 10.0 mg
剂型
Film-coated tablet
上市许可持有人
H. Lundbeck 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)
Denmark (DK)
Belgium (BE)
Slovenia (SI)
Luxembourg (LU)
Iceland (IS)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Austria (AT)
Cipralex 10 mg - Filmtabletten
France (FR)
Spain (ES)
Italy (IT)
Greece (GR)
Norway (NO)
Finland (FI)
Poland (PL)
Lexapro
Latvia (LV)
Cipralex 10 mg apvalkotās tabletes
Lithuania (LT)
Cipralex 10 mg plėvele dengtos tabletės
Estonia (EE)
CIPRALEX
Hungary (HU)
CIPRALEX 10 mg filmtabletta
Bulgaria (BG)
Cipralex
Cyprus (CY)
CIPRALEX 10MG F.C TABS
Czechia (CZ)
Romania (RO)
Cipralex 10 mg comprimate filmate
Slovakia (SK)
Malta (MT)
Portugal (PT)
许可日期
2002/05/07
最近更新日期
2024/11/27
药物ATC编码
N06AB10 escitalopram
申请类型
TypeLevel1:
New Active Substance
TypeLevel2:
Additional Strength/Form
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_0278_002_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_0278_002_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_0278_002_PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase