LIFODROX

Medicinal product

(Invented) name

LIFODROX

Active substance (s)

Moksifloksacinas

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)

S01AE07, Moxifloxacin

Marketing authorisation holder

BAUSCH + LOMB IRELAND LIMITED, Airija

Date of authorisation

2014-03-05

Date of renewal

2018-10-08

Documents

3520 LIFODROX RPP 2021 12 07.docx

3520 Pakuotės lapelis 2021 12 07.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DK/H/2221/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Moksifloksacinas	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
52859	66796	1066796	buteliukas	5 ml N1		Receptinis	LT/1/14/3520/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2018-10-08	Perregistruotas
2014-03-05	Registruotas