Latanoprost/Timolol Polpharma

Medicinal product

(Invented) name

Latanoprost/Timolol Polpharma

Active substance (s)

Latanoprostas/Timolis

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

Pharmaceutical Works POLPHARMA S.A., Lenkija

Date of authorisation

2026-01-16

Date of renewal

Documents

5940 pakuotes lapelis_2026-01-16.docx

5940 Latanoprost-Timolol Polpharma.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

CZ/H/1250/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Latanoprostas	50 µg
Timolis	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
119632	105738	1105738	buteliukas	2,5 ml N1		Receptinis	LT/1/26/5940/001	Netiekiama	-	-	No	-	-
119633	105739	1105739	buteliukas	7,5 ml N1		Receptinis	LT/1/26/5940/002	Netiekiama	-	-	No	-	-
119634	105740	1105740	buteliukas	7,5 ml N2		Receptinis	LT/1/26/5940/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-01-16	Registruotas