Dorzolamide/Timolol Teva

Medicinal product

(Invented) name

Dorzolamide/Timolol Teva

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

Teva Pharma B.V., Nyderlandai

Date of authorisation

2010-06-08

Date of renewal

2017-09-05

Documents

2033_1-4 Dorzolamide_Timolol_Teva_perr0905.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

UK/H/1505/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename mililitre 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
29571	32058	1032058	buteliukas	5 ml N1		Receptinis	LT/1/10/2033/001	Netiekiama	-	-	No	-	-	Download
41352	55109	1055109	buteliukas	5 ml N2		Receptinis	LT/1/10/2033/002	Netiekiama	-	-	No	-	-
41353	55110	1055110	buteliukas	5 ml N3		Receptinis	LT/1/10/2033/003	Netiekiama	-	-	No	-	-
41354	55111	1055111	buteliukas	5 ml N6		Receptinis	LT/1/10/2033/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-11-07	Išregistruotas
2017-09-05	Perregistruotas
2010-06-08	Registruotas