Brinzolamide/Timolol Zentiva

Medicinal product

(Invented) name

Brinzolamide/Timolol Zentiva

Active substance (s)

Brinzolamidas/Timololis

Strength

10 mg/5 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)

S01ED51, Timolol, combinations

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2023-11-27

Date of renewal

Documents

5276_pakuotes lapelis_2023-11-27.docx

5276_Brinzolamide_Timolol Zentiva.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/7263/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml suspensijos yra:	1 ml
Brinzolamidas	10 mg
Timololis	5 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
112139	98254	1098254	buteliukas	5 ml N1		Receptinis	LT/1/23/5276/001	Tiekiama	-	-	No	-	-
112140	98255	1098255	buteliukas	5 ml N3		Receptinis	LT/1/23/5276/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-11-27	Registruotas