欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0297/001
药品名称
Lorastad
活性成分
loratadine 1.0 mg/ml
剂型
Tablet
上市许可持有人
STADA Arzneimittel AG Stadastrasse 2-18 D-61118 Bad Vilbel Germany
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Luxembourg (LU)
Italy (IT)
Belgium (BE)
许可日期
2002/05/17
最近更新日期
2023/04/06
药物ATC编码
R06AX13 loratadine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Non Prescription (including OTC)
附件文件下载
Final Labelling
|
1_3_1_LAB_outer_common_en_NL_H_0297_001_cl
Date of last change:2024/09/06
Final PL
|
1_3_1_PIL_common_en_NL_H_0297_001_cl
Date of last change:2024/09/06
Final SPC
|
1_3_1_SPC_common_en_NL_H_0297_001_cl
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase