Travoprost/Timolol ELVIM

Medicinal product

(Invented) name

Travoprost/Timolol ELVIM

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)

No

ATC code (s)

S01ED51, Timolol, combinations

Marketing authorisation holder

SIA ELVIM, Latvija

Date of authorisation

2022-08-10

Date of renewal

Documents

5017 Travoprost_Timolol ELVIM PZ 2022 12 06.docx

5017_pakuotes lapelis_2022-08-10.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

EE/H/0325/001/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
109177	95283	1095283	buteliukas	2,5 ml (su lašintuvu) N1		Receptinis	LT/1/22/5017/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-10	Registruotas