欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IT/H/0331/001
药品名称
VICKS FLU ACTION
活性成分
ibuprofen 200.0 mg
pseudoephedrine hydrochloride 30.0 mg
剂型
Film-coated tablet
上市许可持有人
Procter & Gamble S.r.l. Viale Giorgio Ribotta, 11 00144 Roma Italy
参考成员国 - 产品名称
Italy (IT)
互认成员国 - 产品名称
Germany (DE)
WICK DuoGrippal 200 mg/30 mg Filmtabletten
Austria (AT)
WICK DayMed Duo 200 mg/30 mg Filmtabletten
Spain (ES)
Poland (PL)
Infex Zatoki
Hungary (HU)
IBUPROFEN/PSZEUDOEFEDRIN WICK 200 mg/30 mg filmtabletta
Romania (RO)
TEDOLFEN 200 mg / 30 mg comprimate filmate
许可日期
2014/02/06
最近更新日期
2023/09/18
药物ATC编码
R01BA52 pseudoephedrine, combinations
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
|
common_pil
Date of last change:2023/04/17
Final SPC
|
common_Smpc
Date of last change:2023/04/17
Final Product Information
|
en-common-pil-rev
Date of last change:2021/03/06
Final Product Information
|
en-common-spc-rev
Date of last change:2021/03/06
PAR
|
PAR_IT_H_0331_001__DC_v04
Date of last change:2014/10/09
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase