Travoprost/Timolol Polpharma

Medicinal product

(Invented) name

Travoprost/Timolol Polpharma

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

Pharmaceutical Works POLPHARMA S.A., Lenkija

Date of authorisation

2024-07-05

Date of renewal

Documents

5478_Travopr_Tim_Polpharma.docx

5478_pakuotes lapelis_2024-07-05.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

LV/H/0245/001/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
114119	100231	1100231	buteliukas	2,5 ml N1		Receptinis	LT/1/24/5478/001	Netiekiama	-	-	No	-	-
114120	100232	1100232	buteliukas	7,5 ml N1		Receptinis	LT/1/24/5478/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-05	Registruotas