欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1611/001
药品名称
Bysimin
活性成分
Hyoscine butylbromide 20.0 mg/ml
剂型
Solution for injection
上市许可持有人
Medochemie Ltd, Cyprus
参考成员国 - 产品名称
Sweden (SE)
54520
互认成员国 - 产品名称
Estonia (EE)
BYSIMIN
Bulgaria (BG)
Cyprus (CY)
BYSIMIN 20MG/ML SOL. FOR INJ.
Romania (RO)
Malta (MT)
Croatia (HR)
Bysimin 20 mg/ml otopina za injekciju
Portugal (PT)
许可日期
2017/03/08
最近更新日期
2025/01/21
药物ATC编码
A03BB01 butylscopolamine
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 PL
|
SE_H_1611_001_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1611_001_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_1611_001_PAR
Date of last change:2024/09/06
PubAR Summary
|
SE_H_1611_001_PAR Summary
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase