Details

Product Name in the RMS: Amoxicillin/Clavulanic acid Actavis 500/125mg film-coated tablets

MR Number: AT/H/0948/001
Date of outcome: 03.09.2013

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	amoxicillin 500 mg clavulanic acid 125 mg
Form	Film coated tablet
MA Holder in the RMS	Actavis Group PTC ehf. Reykjavikurvegur 76-78 IS-220 Hafnarfjordur Iceland
RMS	Austria
Date of last change	22.11.2021
ATC-Code	J01CR02 Amoxicillin and enzyme inhibitor

CMS Country	Domestic Product Name
Denmark
Hungary
Latvia	Amoxicillin/Clavulanic acid Actavis 500 mg/125 mg apvalkotās tabletes
Lithuania	Amoxicillin/Clavulanic acid Actavis 500 mg/125 mg plėvele dengtos tabletės

Documents
PAR:	AT_H_0948_001_PAR.pdf (04.12.2018)
PARSummary:	AT_H_0948_001_PARSummary.pdf (04.12.2018)
FinalSPC:	AT_H_0948_001_FinalSPC_1of2.pdf (15.12.2020)
FinalSPC:	AT_H_0948_001_FinalSPC_2of2.pdf (15.12.2020)
FinalPL:	AT_H_0948_001_FinalPL.pdf (04.12.2018)
FinalLabelling:	AT_H_0948_001_FinalLabelling_1of2.pdf (15.12.2020)
FinalLabelling:	AT_H_0948_001_FinalLabelling_2of2.pdf (15.12.2020)
Finalised Product Information:	AT_H_0948_001_FinalPI_1of2.pdf (15.12.2020)
Finalised Product Information:	AT_H_0948_001_FinalPI_2of2.pdf (15.12.2020)