Levofloxacin UNIMED PHARMA

Medicinal product

(Invented) name

Levofloxacin UNIMED PHARMA

Active substance (s)

Levofloksacinas

Strength

5 mg/ml

Pharmaceutical form

akių lašai (tirpalas)

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01AE05, Levofloxacin

Marketing authorisation holder

UNIMED PHARMA spol. s r.o., Slovakija

Date of authorisation

2017-02-13

Date of renewal

2022-03-02

Documents

4044_Levofloxacin Unimed_Ph_perr2022-03-02.docx

4044_pakuotes lapelis_2022-03-02.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

HU/H/0449/001/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
64360	78842	1078842	buteliukas	5 ml N1		Receptinis	LT/1/17/4044/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-03-02	Perregistruotas
2017-02-13	Registruotas