OFTIDOR

Medicinal product

(Invented) name

OFTIDOR

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

BAUSCH + LOMB IRELAND LIMITED, Airija

Date of authorisation

2011-05-11

Date of renewal

2016-08-08

Documents

2457 OFTIDOR 20mg_ml PCS PL 2023 05 26.docx

2457 Pakuotės lapelis 2023 05 26.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

CZ/H/0582/001

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
25814	28406	1028406	buteliukas	5 ml N1		Receptinis	LT/1/11/2457/001	Netiekiama	-	-	No	-	-	Download
46774	60583	1060583	buteliukas	5 ml N3		Receptinis	LT/1/11/2457/002	Netiekiama	-	-	No	-	-
46775	60584	1060584	buteliukas	5 ml N6		Receptinis	LT/1/11/2457/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-12-31	Išregistruotas
2016-08-08	Perregistruotas
2011-05-11	Registruotas