Latanoprost NTC

Medicinal product

(Invented) name

Latanoprost NTC

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

NTC S.r.l., Italija

Date of authorisation

2011-11-09

Date of renewal

2017-03-27

Documents

2686_1-3 Latanoprost_NTC_perr0327.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/1876/001/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
38430	52107	1052107	talpyklė su lašintuvu	2,5 ml N1		Receptinis	LT/1/11/2686/001	Netiekiama	-	-	No	-	-
49688	63558	1063558	talpyklė su lašintuvu	2,5 ml N3		Receptinis	LT/1/11/2686/002	Netiekiama	-	-	No	-	-
49689	63559	1063559	talpyklė su lašintuvu	2,5 ml N6		Receptinis	LT/1/11/2686/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-04-05	Išregistruotas
2017-03-27	Perregistruotas
2011-11-09	Registruotas