Dorzolamide/Timolol Actavis

Medicinal product

(Invented) name

Dorzolamide/Timolol Actavis

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 B.V., Nyderlandai

Date of authorisation

2011-05-11

Date of renewal

2017-09-28

Documents

2454 Pakuotės lapelis 2023 05 25.docx

2454 Dorzolamide_Timolol Actavis RPP 2023 05 25.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

SE/H/1771/001

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
35873	38205	1038205	buteliukas	5 ml N1		Receptinis	LT/1/11/2454/001	Tiekiama	-	-	No	-	-	Download
46770	60579	1060579	buteliukas	5 ml N3		Receptinis	LT/1/11/2454/002	Netiekiama	-	-	No	-	-
46771	60580	1060580	buteliukas	5 ml N6		Receptinis	LT/1/11/2454/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-09-28	Perregistruotas
2011-05-11	Registruotas