OFTAQUIX

Medicinal product

(Invented) name

OFTAQUIX

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

Santen Oy, Suomija

Date of authorisation

2005-11-04

Date of renewal

2007-10-30

Documents

0325 OFTAQUIX PL 2023 11 30.docx

0325 Pakuotės lapelis 2023 11 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

FI/H/0989/001

Marketing authorisation procedure

Savitarpio pripažinimo 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
13804	18081	1018081	buteliukas	5 ml N1		Receptinis	LT/1/05/0325/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2007-10-30	Perregistruotas
2005-11-04	Registruotas