Details

Product Name in the RMS: Betaklav 457 mg/ 5 ml

MR Number: CZ/H/0503/003
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 400 mg clavulanic acid 62,7 mg
Form	Powder for oral suspension
MA Holder in the RMS	KRKA d.d. Novo Mesto Šmarješka cesta 6, 8501 Novo Mesto, Slovenia
RMS	Czech Republic
Date of last change	11.01.2021
ATC-Code	J01CR02 Amoxicillin and enzyme inhibitor

CMS Country	Domestic Product Name
Bulgaria	Betaklav
Croatia	Betaklav 400 mg/57 mg u 5 ml prašak za oralnu suspenziju
Estonia
Hungary	BETAKLAV 400 mg/57 mg/5 ml por belsőleges szuszpenzióhoz
Latvia	Betaklav 400 mg/57 mg/5 ml pulveris iekšķīgi lietojamas suspensijas pagatavošanai
Lithuania	Betaklav 400 mg / 57 mg/ 5 ml milteliai geriamajai suspensijai
Poland	Hiconcil comb
Portugal
Romania	Amoxicilină/Acid clavulanic Krka 400 mg/57 mg/5 ml pulbere pentru suspensie orală
Slovak Republic	Betaklav 400 mg/57 mg/5 ml prášok na perorálnu suspenziu
Slovenia

Documents
Finalised Product Information:	CZ_H_0503_003_FinalPI.pdf (02.12.2020)