Simbrinza

Medicinal product

(Invented) name

Simbrinza

Active substance (s)

Brinzolamidas/Brimonidino tartratas

Strength

10 mg/2 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)

S01EC54, Brinzolamide, combinations

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2014-06-18

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Eye drops, suspension	1 ml
Brinzolamidas	10 mg
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
59687	73921	1073921	buteliukas	5 ml N1		Receptinis	EU/1/14/933/001	Tiekiama	-	-	No	-	-
59688	73922	1073922	buteliukas	5 ml N3		Receptinis	EU/1/14/933/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-06-18	Registruotas