Xaloptic

Medicinal product

(Invented) name

Xaloptic

Active substance (s)

Latanoprostas

Strength

50 µg/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)

S01EE01, Latanoprost

Marketing authorisation holder

Zakłady Farmaceutyczne POLPHARMA S.A., Lenkija

Date of authorisation

2009-10-20

Date of renewal

2014-06-13

Documents

1758 pakuotės lapelis 2022 06 02.docx

1758 Xaloptic PCS PL 2022 06 02.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0631/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Latanoprostas	50 µg

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
22963	5360	1005360	buteliukas	2,5 ml N1		Receptinis	LT/1/09/1758/001	Netiekiama	-	-	No	-	-	Download
54517	68514	1068514	buteliukas	2,5 ml N3		Receptinis	LT/1/09/1758/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-01	Išregistruotas
2014-06-13	Perregistruotas
2009-10-20	Registruotas