Levalox

Medicinal product

(Invented) name

Levalox

Active substance (s)

Levofloksacinas

Strength

5 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01MA12, Levofloxacin

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2015-03-13

Date of renewal

2022-04-04

Documents

3691 Pakuotės lapelis inf 2025 01 25.docx

3691 Levalox inf PCS PL 2025 01 25.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HR/H/0100/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Levofloksacinas	5 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
58746	72942	1072942	flakonas	100 ml N1		Receptinis	LT/1/15/3691/001	Netiekiama	2025-05-14	-	No	-	-
61525	75865	1075865	flakonas	100 ml N5		Receptinis	LT/1/15/3691/002	Netiekiama	-	-	No	-	-
61526	75866	1075866	flakonas	100 ml N10		Receptinis	LT/1/15/3691/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-04-04	Perregistruotas
2015-03-13	Registruotas