欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2560/001
药品名称
Mucolysin
活性成分
acetylcysteine 600.0 mg
剂型
Effervescent tablet
上市许可持有人
Sandoz A/S Edvard Thomsens Vej 14 2300 Copenhagen S Denmark
参考成员国 - 产品名称
Denmark (DK)
Mucolysin
互认成员国 - 产品名称
Iceland (IS)
Mucolysin 600 mg Freyðitafla
许可日期
2015/07/13
最近更新日期
2024/04/11
药物ATC编码
R05CB01 acetylcysteine
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:
Non Prescription (including OTC)
附件文件下载
Final SPC
|
Common Mucolysin SmPC_clean
Date of last change:2024/04/11
Final PL
|
Common Mucolysin PIL_clean
Date of last change:2024/04/11
Final Labelling
|
Common Mucolysin LBL_clean
Date of last change:2024/04/11
Final Product Information
|
1 3 1 spc-label-pl-common-pl 15-04-2016 clean NHL
Date of last change:2016/04/19
Final Product Information
|
1 3 1 spc-label-pl - common -spc 18042016 clean NHL
Date of last change:2016/04/19
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase