Details

Product Name in the RMS: Betaklav 875 mg/ 125 mg

MR Number: CZ/H/0503/002
Date of outcome: 15.06.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Additional Strength/Form Generic Chemical Substance Prescription Only
Active Substances	amoxicillin 1000 mg clavulanic acid 125 mg
Form	Film coated tablet
MA Holder in the RMS	KRKA d.d. Novo Mesto Šmarješka cesta 6, 8501 Novo Mesto, Slovenia
RMS	Czech Republic
Date of last change	13.04.2021
ATC-Code	J01CR02 Amoxicillin and enzyme inhibitor

CMS Country	Domestic Product Name
Austria	Amoxicillin/Clavulansäure Krka 875 mg/125 mg Filmtabletten
Bulgaria	Betaklav
Croatia	Betaklav 875 mg/125 mg filmom obložene tablete
Estonia	BETAKLAV
Finland
Hungary	BETAKLAV 875 mg/125 mg filmtabletta
Italy
Latvia	Betaklav 875 mg/125 mg apvalkotās tabletes
Lithuania	Betaklav 875 mg / 125 mg plėvele dengtos tabletės
Poland	Hiconicl comb
Portugal
Romania	Amoxicilină/Acid clavulanic Krka 875 mg/125 mg comprimate filmate
Slovak Republic	Betaklav 875 mg/125 mg filmom obalené tablety
Slovenia
Spain
Sweden

Documents
Finalised Product Information:	CZ_H_0503_002_FinalPI.pdf (29.03.2021)