欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/0920/001
药品名称
Levocetirizin TEVA 5 mg Filmtabletten
活性成分
levocetirizine dihydrochloride 5.0 mg
剂型
Film-coated tablet
上市许可持有人
TEVA GmbH Graf-Arco-Str. 3 89079 Ulm Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
Netherlands (NL)
France (FR)
Spain (ES)
Italy (IT)
Hungary (HU)
NOVOCETRIN 5 mg filmtabletta
Slovakia (SK)
Levocetirizin Teva 5 mg filmom obalené tablety
许可日期
2008/10/02
最近更新日期
2024/03/28
药物ATC编码
R06AE09 levocetirizine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Product Information
|
common_final_pl_0920_V026
Date of last change:2024/09/06
Final Product Information
|
common_final_spc_0920_V026
Date of last change:2024/09/06
Final Labelling
|
final_common_Intermediate Packaging_0920_028
Date of last change:2024/09/06
Final PL
|
final_common_PIL_0920_028
Date of last change:2024/09/06
Final SPC
|
final_common_SPC_0920_028
Date of last change:2024/09/06
PubAR
|
PAREN_DE_0920_Levocetirizine
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase