LATALUX

Medicinal product

(Invented) name

LATALUX

Active substance (s)

Latanoprostas

Strength

50 µg/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)

S01EE01, Latanoprost

Marketing authorisation holder

BAUSCH + LOMB IRELAND LIMITED, Airija

Date of authorisation

2010-09-16

Date of renewal

2015-09-21

Documents

2163 Pakuotės lapelis 2022 09 09.docx

2163 LATALUX RPP 2022 09 09.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/1654/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Latanoprostas	50 µg

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
33003	5623	1005623	buteliukas	2,5 ml N1		Receptinis	LT/1/10/2163/001	Netiekiama	-	-	No	-	-	Download
42619	56387	1056387	buteliukas	2,5 ml N3		Receptinis	LT/1/10/2163/002	Netiekiama	-	-	No	-	-
42620	56388	1056388	buteliukas	2,5 ml N6		Receptinis	LT/1/10/2163/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-12-31	Išregistruotas
2015-09-21	Perregistruotas
2010-09-16	Registruotas