欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IS/H/0175/001
药品名称
Pinex
活性成分
Paracetamol 24.0 mg/ml
剂型
Oral solution
上市许可持有人
Actavis Group PTC ehf. Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland
参考成员国 - 产品名称
Iceland (IS)
Pinex
互认成员国 - 产品名称
Sweden (SE)
Pinex
Hungary (HU)
DOLORAMOL 24 mg/ml belsőleges oldat
许可日期
2011/03/29
最近更新日期
2025/01/28
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 PL
|
IS_H_0175_IA_026_PIL_Paracetamol_Teva_oral_solution_28_01_2025
Date of last change:2025/01/28
Final SPC
|
IS_H_0175_IA_026_SmPC_Paracetamol_Teva_oral_solution_28_01_2025
Date of last change:2025/01/28
Final Product Information
|
IS_H_0175_001_IB_020_lab_inner_clean_Pinex_oralsolution_Actavis_04_02_2021
Date of last change:2024/09/06
Final Labelling
|
IS_H_0175_001_IB_020_lab_outer_Clean_Pinex_oralsolution_Actavis_04_02_2021
Date of last change:2024/09/06
PubAR
|
IS_H_0175_0176_001_DC_PAR_Paracetamol_Actavis
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase