Dorzolamide ELVIM

Medicinal product

(Invented) name

Dorzolamide ELVIM

Active substance (s)

Dorzolamidas

Strength

20 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)

S01EC03, Dorzolamide

Marketing authorisation holder

SIA ELVIM, Latvija

Date of authorisation

2011-02-19

Date of renewal

2018-09-27

Documents

2336 Pakuotės lapelis 2023 02 16.docx

2336 Dorzolamide ELVIM RPP 2023 02 16.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

LV/H/0192/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Dorzolamidas	20 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
35870	38202	1038202	buteliukas	5 ml N1		Receptinis	LT/1/10/2336/001	Tiekiama	-	-	No	-	-	Download
45000	58798	1058798	buteliukas	5 ml N3		Receptinis	LT/1/10/2336/002	Netiekiama	-	-	No	-	-
45001	58799	1058799	buteliukas	5 ml N6		Receptinis	LT/1/10/2336/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-09-27	Perregistruotas
2011-02-19	Registruotas