LUXFEN

Medicinal product

(Invented) name

LUXFEN

Active substance (s)

Brimonidino tartratas

Strength

2 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)

S01EA05, Brimonidine

Marketing authorisation holder

BAUSCH + LOMB IRELAND LIMITED, Airija

Date of authorisation

2008-10-29

Date of renewal

2013-10-09

Documents

1312 LUXFEN II PL 2024 02 16.docx

1312 Pakuotės lapelis 2024 02 16.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

CZ/H/0646/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Brimonidino tartratas	2 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
23639	5466	1005466	buteliukas	5 ml N1		Receptinis	LT/1/08/1312/001	Netiekiama	-	-	No	-	-	Download
23911	26592	1026592	buteliukas	5 ml N3		Receptinis	LT/1/08/1312/002	Netiekiama	-	-	No	-	-
32346	34736	1034736	buteliukas	5 ml N6		Receptinis	LT/1/08/1312/003	Netiekiama	-	-	No	-	-
32347	34737	1034737	buteliukas	10 ml N1		Receptinis	LT/1/08/1312/004	Netiekiama	-	-	No	-	-
32348	34738	1034738	buteliukas	10 ml N3		Receptinis	LT/1/08/1312/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-10-09	Perregistruotas
2008-10-29	Registruotas