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 | 15.12.2020 |
ATC-Code |
J01CR02 Amoxicillin and enzyme inhibitor |
CMS Country | Domestic Product Name |
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Denmark | |
Estonia | |
Hungary | |
Iceland | Amoxicillin/Clavulanic acid Actavis 500 mg /125 mg Filmuhúðuð tafla |
Latvia | Amoxicillin/Clavulanic acid Actavis 500 mg/125 mg apvalkotās tabletes |
Lithuania | Amoxicillin/Clavulanic acid Actavis 500 mg/125 mg plėvele dengtos tabletės |
Documents | |
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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) |