欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
RO/H/0215/001
药品名称
Orocalmin 1,5 mg/ml spray bucofaringian, soluţie
活性成分
benzydamine hydrochloride 1.5 mg/ml
剂型
Oromucosal spray, solution
上市许可持有人
Zentiva, k.s. U kabelovny 130, 102 37 Praga 10, Dolní Měcholupy, Republica Cehă
参考成员国 - 产品名称
Romania (RO)
Orocalmin 1,5 mg/ml spray bucofaringian, soluţie
互认成员国 - 产品名称
许可日期
2022/06/08
最近更新日期
2023/06/26
药物ATC编码
R02AX03 benzydamine
申请类型
TypeLevel1：
[not specified]
TypeLevel2：
[not specified]
TypeLevel3：
[not specified]
TypeLevel4：
[not specified]
TypeLevel5：
[not specified]
附件文件下载
PAR
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LT_H_0166_001_002_DC_Benzydamine HCl Zentiva_PAR Summary
Date of last change:2022/10/05
PAR
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LT_H_0166_001_002_DC_Benzydamine HCl Zentiva_PAR Scientific discussion
Date of last change:2022/10/05
Final Product Information
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LT_H_0166_001_002_DC_Benzydamine hydrochloride_15_30_D210_SmPC_clean_2022 06 08
Date of last change:2022/06/08
Final Product Information
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LT_H_0166_001_002_DC_Benzydamine hydrochloride_15_D210_PIL_clean_2022 06 08
Date of last change:2022/06/08
Final Product Information
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LT_H_0166_001_002_DC_Benzydamine hydrochloride_30_D210_PL_clean_2022 06 08
Date of last change:2022/06/08
Final Product Information
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specifications
Date of last change:2022/06/08
Final Product Information
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LT_H_0166_001_002_DC_Benzydamine HCL Zentiva_D210_Q_2022 06 08
Date of last change:2022/06/08
Final Product Information
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LT_H_0166_001_002_DC_Benzydamine hydrochloride_D210_Outer_clean_2022 06 08
Date of last change:2022/06/08
Final Product Information
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LT_H_0166_001_002_DC_Benzydamine HCl Zentiva_D210_FAR_2022_06_08
Date of last change:2022/06/08
Final Product Information
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LT_H_0166_001_002 DC_Benzydamine HCl Zentiva_D210_EoP_2022 06 08
Date of last change:2022/06/08
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase