Brinzolamide Sandoz

Medicinal product

(Invented) name

Brinzolamide Sandoz

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

Sandoz d.d., Slovėnija

Date of authorisation

2016-12-08

Date of renewal

2019-12-23

Documents

4011 Pakuotės lapelis 2022 08 11.docx

4011 Brinzolamide Sandoz PCS PL 2022 08 11.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/2900/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Kiekviename ml 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
67231	81777	1081777	buteliukas	5 ml N1		Receptinis	LT/1/16/4011/001	Netiekiama	-	-	No	-	-
67232	81778	1081778	buteliukas	5 ml N3		Receptinis	LT/1/16/4011/002	Netiekiama	-	-	No	-	-
67233	81779	1081779	buteliukas	10 ml N1		Receptinis	LT/1/16/4011/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-28	Išregistruotas
2019-12-23	Perregistruotas
2016-12-08	Registruotas