欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
EE/H/0350/001
药品名称
Paramax
活性成分
Paracetamol 500.0 mg
剂型
Powder for oral solution in sachet
上市许可持有人
Vitabalans OY Varastokatu 7-9 Hämeenlinna 13500 Finland
参考成员国 - 产品名称
Estonia (EE)
互认成员国 - 产品名称
Czechia (CZ)
Paramax Hot
Slovakia (SK)
Slovenia (SI)
Germany (DE)
Denmark (DK)
Sweden (SE)
Finland (FI)
Poland (PL)
Paramax Quick
Latvia (LV)
Lithuania (LT)
Hungary (HU)
许可日期
2022/04/14
最近更新日期
2025/01/16
药物ATC编码
N02BE01 paracetamol
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:
Non Prescription (including OTC)
附件文件下载
Final Labelling
|
2022_04_14_lab_inner_paramaxhot_common
Date of last change:2024/09/06
Final Labelling
|
2022_04_14_lab_outer_paramaxhot_common
Date of last change:2024/09/06
Final PL
|
2022_04_14_pl_paramaxhot_common
Date of last change:2024/09/06
Final SPC
|
2022_04_14_spc_paramaxhot_common
Date of last change:2024/09/06
PubAR
|
EE_H_350_PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase