Oftidorix

Medicinal product

(Invented) name

Oftidorix

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

BAUSCH + LOMB IRELAND LIMITED, Airija

Date of authorisation

2011-05-11

Date of renewal

2017-02-27

Documents

2458 Oftidorix PCS PL 2023 06 13.docx

2458 Pakuotės lapelis 2023 06 13.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

PL/H/0388/001

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
35558	37891	1037891	buteliukas	5 ml N1		Receptinis	LT/1/11/2458/001	Netiekiama	-	-	No	-	-	Download
46776	60585	1060585	buteliukas	5 ml N3		Receptinis	LT/1/11/2458/002	Netiekiama	-	-	No	-	-
46777	60586	1060586	buteliukas	5 ml N6		Receptinis	LT/1/11/2458/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-06-28	Išregistruotas
2017-02-27	Perregistruotas
2011-05-11	Registruotas