欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2531/001
药品名称
Acetilcisteína Generis
活性成分
acetylcysteine 200.0 mg
剂型
Effervescent tablet
上市许可持有人
Generis Farmacêutica, S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Belgium (BE)
Netherlands (NL)
Acetylcysteine Sanias 200 mg, bruistabletten
Spain (ES)
许可日期
2022/05/25
最近更新日期
2024/01/04
药物ATC编码
R05CB01 acetylcysteine
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
PubAR
|
663924_663925_20220729_PAR_CRN
Date of last change:2024/09/06
Final Labelling
|
common_outer
Date of last change:2024/09/06
Final PL
|
common_pl
Date of last change:2024/09/06
Final Product Information
|
DCP_Acetylcysteine Effervescent tab_LAB_clean
Date of last change:2024/09/06
Final Product Information
|
DCP_Acetylcysteine Effervescent tab_PIL_clean
Date of last change:2024/09/06
Final Product Information
|
DCP_Acetylcysteine Effervescent tab_SPC_clean
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase