Dorzolamide/Timolol ELVIM

Medicinal product

(Invented) name

Dorzolamide/Timolol ELVIM

Active substance (s)

Dorzolamidas/Timololis

Strength

20 mg/5 mg/ml

Pharmaceutical form

akių lašai (tirpalas)

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

SIA ELVIM, Latvija

Date of authorisation

2011-04-21

Date of renewal

2017-04-27

Documents

2420 Pakuotės lapelis 2022 07 11.docx

2420 Dorzolamide_Timolol ELVIM PCS PL 2022 07 11.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

LV/H/0190/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Dorzolamidas	20 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
35871	38203	1038203	buteliukas	5 ml N1		Receptinis	LT/1/11/2420/001	Tiekiama	-	-	No	-	-	Download
46378	60185	1060185	buteliukas	5 ml N3		Receptinis	LT/1/11/2420/002	Netiekiama	-	-	No	-	-
46379	60186	1060186	buteliukas	5 ml N6		Receptinis	LT/1/11/2420/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-04-27	Perregistruotas
2011-04-21	Registruotas