Details

Product Name in the RMS: Levalox 5 mg/ml otopina za infuziju

MR Number: HR/H/0100/003
Date of outcome: 27.01.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Additional Strength/Form Generic Chemical Substance Prescription Only
Active Substances	levofloxacin hemihydrate 256,23 mg
Form	Solution for infusion
MA Holder in the RMS	Krka d.d. Novo Mesto Šmarješka cesta 6, 8501 Novo Mesto Slovenia
RMS	Croatia
Date of last change	31.08.2018
ATC-Code	J01MA12 Levofloxacin

CMS Country	Domestic Product Name
Bulgaria	Levalox
Czech Republic	Levalox 5 mg/ ml infuzní roztok
Estonia	LEVNIBIOT
Hungary	Levnibiot 5 mg/ml oldatos infúzió
Latvia	Levalox 5 mg/ml šķīdums infūzijām
Lithuania	Levalox 5 mg/ml infuzinis tirpalas
Poland
Romania	LEVALOX
Slovak Republic
Slovenia

Documents
PAR:	HR_H_0100_003_PAR.pdf (20.03.2015)
Finalised Product Information:	HR_H_0100_003_FinalPI.pdf (27.01.2015)