Levofloxacin Actavis

Medicinal product

(Invented) name

Levofloxacin Actavis

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

Teva B.V., Nyderlandai

Date of authorisation

2016-04-06

Date of renewal

2021-03-05

Documents

3901 Pakuotės lapelis 2023 04 11.docx

3901 Levofloxacin Actavis RPP 2023 04 11.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

SE/H/1715/001

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
60810	75100	1075100	flakonas	5 ml N1		Receptinis	LT/1/16/3901/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2021-03-05	Perregistruotas
2016-04-06	Registruotas