欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/3265/001
药品名称
Glyronul
活性成分
glycopyrronium bromide 0.2 mg/ml
剂型
Solution for injection
上市许可持有人
EQL Pharma AB Stortorget 1, 22223 Lund Sweden
参考成员国 - 产品名称
Denmark (DK)
Glycolac
互认成员国 - 产品名称
Sweden (SE)
Norway (NO)
Finland (FI)
许可日期
2022/05/04
最近更新日期
2022/09/13
药物ATC编码
A03AB02 glycopyrronium bromide
申请类型
TypeLevel1:
Known Active Substance
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 Labelling
|
1_3_1_ Label_common_clean
Date of last change:2024/09/06
Final SPC
|
Common SmPC_1_3_1 common_smpc_cl
Date of last change:2024/09/06
Final PL
|
common_pil
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase