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 | |
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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 |
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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 | |
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Finalised Product Information: | CZ_H_0503_003_FinalPI.pdf (02.12.2020) |