UNIFLOX

Medicinal product

(Invented) name

UNIFLOX

Active substance (s)

Ofloksacinas

Strength

3 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)

S03AA, Antiinfectives

Marketing authorisation holder

UNIMED PHARMA spol. s r.o., Slovakija

Date of authorisation

2009-07-21

Date of renewal

2014-12-05

Documents

1614 UNIFLOX RPP 2022 08 16.docx

1614 Pakuotės lapelis 2022 08 16.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Ofloksacinas	3 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
22067	24895	1024895	talpyklė su lašintuvu	5 ml N1		Receptinis	LT/1/09/1614/001	Netiekiama	-	-	No	-	-
22068	24896	1024896	talpyklė su lašintuvu	10 ml N1		Receptinis	LT/1/09/1614/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-12-05	Perregistruotas
2009-07-21	Registruotas