UNILAT

Medicinal product

(Invented) name

UNILAT

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

UNIMED PHARMA spol. s r.o., Slovakija

Date of authorisation

2009-11-25

Date of renewal

2015-05-13

Documents

1794 UNILAT PZ PL 2022 12 05.docx

1794 Pakuotės lapelis 2022 12 05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SK/H/0107/001/DC

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
31738	34153	1034153	buteliukas	2,5 ml N1		Receptinis	LT/1/09/1794/001	Tiekiama	-	-	No	-	-
38333	51989	1051989	buteliukas	2,5 ml N3		Receptinis	LT/1/09/1794/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-05-13	Perregistruotas
2009-11-25	Registruotas