NODOM

Medicinal product

(Invented) name

NODOM

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

Zakłady Farmaceutyczne POLPHARMA S.A., Lenkija

Date of authorisation

2012-01-06

Date of renewal

2017-12-27

Documents

2763 NODOM PCS 2022 03 28.docx

2763 Pakuotės lapelis 2021 07 26.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PL/H/0165/001/DC

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
39300	52983	1052983	buteliukas	5 ml N1		Receptinis	LT/1/11/2763/001	Netiekiama	-	-	No	-	-	Download
67275	81822	1081822	buteliukas	5 ml N3		Receptinis	LT/1/11/2763/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-05-30	Išregistruotas
2017-12-27	Perregistruotas
2012-01-06	Registruotas