欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
EE/H/0348/001
药品名称
Tonufen
活性成分
ibuprofen 200.0 mg
pseudoephedrine hydrochloride 30.0 mg
剂型
Coated tablet
上市许可持有人
US Pharmacia Sp. z o.o. Ziębicka 40 street, 50-507, Wroclaw, Poland
参考成员国 - 产品名称
Estonia (EE)
互认成员国 - 产品名称
Latvia (LV)
Lithuania (LT)
-
Romania (RO)
Ibuprom ProSinus 200 mg/30 mg drajeuri
许可日期
2022/07/07
最近更新日期
2024/01/11
药物ATC编码
M01AE01 ibuprofen
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
|
Tonufen_lab_box_EN_clean
Date of last change:2023/05/19
Final SPC
|
Tonufen_SmPC_EN_track
Date of last change:2023/05/19
Final PL
|
Tonufen_PIL_EN_clean
Date of last change:2023/05/19
市场状态
Positive
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