Brizadopt

Medicinal product

(Invented) name

Brizadopt

Active substance (s)

Brinzolamidas

Strength

10 mg/ml

Pharmaceutical form

akių lašai (suspensija)

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01EC04, Brinzolamide

Marketing authorisation holder

BAUSCH + LOMB IRELAND LIMITED, Airija

Date of authorisation

2015-04-22

Date of renewal

2020-09-30

Documents

3707 Brizadopt PCS PL 2022 07 01.docx

3707 Pakuotės lapelis 2022 07 01.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/2834/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Viename ml akių lašų (suspensijos) yra:	1 ml
Brinzolamidas	10 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
53955	67941	1067941	buteliukas	5 ml N1		Receptinis	LT/1/15/3707/001	Netiekiama	-	-	No	-	-
61841	76211	1076211	buteliukas	5 ml N3		Receptinis	LT/1/15/3707/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-07	Išregistruotas
2020-09-30	Perregistruotas
2015-04-22	Registruotas