欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/0299/001
药品名称
Xusal
活性成分
Levocetirizine dihydrochloride 5.0 mg
剂型
Film-coated tablet
上市许可持有人
UCB Pharma GmbH Alfred-Nobel-Str. 10 40789 Monheim Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Denmark (DK)
Belgium (BE)
Netherlands (NL)
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Austria (AT)
Xyzall 5 mg Filmtabletten
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Greece (GR)
Norway (NO)
Finland (FI)
Poland (PL)
Xyzal
Latvia (LV)
Lithuania (LT)
Xyzal 5mg plėvele dengtos tabletės
Estonia (EE)
XYZAL
Hungary (HU)
Xyzal 5mg
Cyprus (CY)
Czechia (CZ)
Slovakia (SK)
Xyzal
Slovenia (SI)
Malta (MT)
许可日期
2001/08/16
最近更新日期
2025/01/27
药物ATC编码
R06AE09 levocetirizine
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 Product Information
|
common_final_combined_0299_001__V100
Date of last change:2024/09/06
Final Product Information
|
common_final_combined_0299_002__V100
Date of last change:2024/09/06
Final Product Information
|
common_final_combined_0299_003__V100
Date of last change:2024/09/06
Final SPC
|
PI_DE299_442_01_R03_R02_common_combined_fcten
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase