Latanoprost/Timolol Actavis

Medicinal product

(Invented) name

Latanoprost/Timolol Actavis

Active substance (s)

Latanoprostas/Timololis

Strength

50 µg/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

Actavis Group PTC ehf., Islandija

Date of authorisation

2011-05-11

Date of renewal

2014-11-10

Documents

2456_1_3 Latanoprost_Timolo Actavis PZ PL 180516.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DK/H/2768/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Latanoprostas	50 µg
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
37501	51141	1051141	buteliukas	2,5 ml N1		Receptinis	LT/1/11/2456/001	Netiekiama	-	-	No	-	-	Download
46772	60581	1060581	buteliukas	2,5 ml N3		Receptinis	LT/1/11/2456/002	Netiekiama	-	-	No	-	-
46773	60582	1060582	buteliukas	2,5 ml N6		Receptinis	LT/1/11/2456/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-08-05	Išregistruotas
2014-11-10	Perregistruotas
2011-05-11	Registruotas