Brinzolamide/Timolol Accord

Medicinal product

(Invented) name

Brinzolamide/Timolol Accord

Active substance (s)

Brinzolamidas/Timololio maleatas

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2020-02-27

Date of renewal

2024-07-29

Documents

4522_Brinzol_Tim_Accord_perr2024-07-29corr.docx

4522_pakuotes lapelis_2024-07-29.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

SE/H/1989/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml suspensijos yra	1 ml
Brinzolamidas	10 mg
Timololio maleatas	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
103370	89472	1089472	buteliukas	5 ml N1		Receptinis	LT/1/20/4522/001	Netiekiama	-	-	No	-	-
103371	89473	1089473	buteliukas	5 ml N3		Receptinis	LT/1/20/4522/002	Netiekiama	-	-	No	-	-
103372	89474	1089474	buteliukas	5 ml N6		Receptinis	LT/1/20/4522/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-29	Perregistruotas
2020-02-27	Registruotas