Xalopticom

Medicinal product

(Invented) name

Xalopticom

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

Zakłady Farmaceutyczne POLPHARMA S.A., Lenkija

Date of authorisation

2011-04-21

Date of renewal

2015-03-13

Documents

2431 Xalopticom PCS PL 2022 10 23.docx

2431 Pakuotės lapelis 2022 10 23.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

CZ/H/0580/001

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
37502	51142	1051142	buteliukas	2,5 ml N1		Receptinis	LT/1/11/2431/001	Netiekiama	-	-	No	-	-	Download
46476	60283	1060283	buteliukas	2,5 ml N3		Receptinis	LT/1/11/2431/002	Netiekiama	-	-	No	-	-
46477	60284	1060284	buteliukas	2,5 ml N6		Receptinis	LT/1/11/2431/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-01	Išregistruotas
2015-03-13	Perregistruotas
2011-04-21	Registruotas