欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
CZ/H/0148/001
药品名称
Cezera 5 mg
活性成分
levocetirizine 5.0 mg
剂型
Film-coated tablet
上市许可持有人
KRKA d.d. Šmarješka cesta 6, 8501 Novo mesto Slovenia
参考成员国 - 产品名称
Czechia (CZ)
85256/12
互认成员国 - 产品名称
Poland (PL)
Cezera
Hungary (HU)
CEZERA 5 mg filmtabletta
Romania (RO)
Cezera 5 mg
Slovakia (SK)
Cezera 5 mg
Slovenia (SI)
Germany (DE)
L-Ceti TAD 5 mg Filmtabletten
Denmark (DK)
Netherlands (NL)
Levocetirizine Krka 5 mg filmomhulde tabletten
Ireland (IE)
Austria (AT)
Levocetirizin Krka 5 mg Filmtabletten
France (FR)
Spain (ES)
Italy (IT)
Greece (GR)
Lithuania (LT)
Cezera 5 mg plėvele dengtos tabletės
Estonia (EE)
Bulgaria (BG)
Cezera
许可日期
2008/02/22
最近更新日期
2024/03/14
药物ATC编码
R06AE09 levocetirizine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
Commitments statement
Date of last change:2024/09/06
Final SPC
|
Commitments statement_FR
Date of last change:2024/09/06
Final Product Information
|
common_combined_cl_doc
Date of last change:2024/09/06
Final Labelling
|
CZ_H_0148_155_001_DC_Labeling_Day195
Date of last change:2024/09/06
Final PL
|
CZ_H_0148_155_001_DC_PIL_Day195
Date of last change:2024/09/06
Final SPC
|
CZ_H_0148_155_001_DC_SmPC_Day195
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase