Travoprost/Timolol Viatris [Travoprost/Timolol Mylan]

Medicinal product

(Invented) name

Active substance (s)

Travoprostas/Timololis

Strength

40 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)

ATC code (s)

S01ED51, Timolol, combinations

Marketing authorisation holder

Viatris Limited, Airija

Date of authorisation

2017-09-05

Date of renewal

2022-10-17

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

10(3)

Procedure number

DK/H/2638/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Travoprostas	40 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
97690	83785	1083785	buteliukas	2,5 ml N1		Receptinis	LT/1/17/4127/001	Tiekiama	-	-	No	-	-	Download
97691	83786	1083786	buteliukas	2,5 ml N3		Receptinis	LT/1/17/4127/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-10-17	Perregistruotas
2017-09-05	Registruotas