Akistan

Medicinal product

(Invented) name

Akistan

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

Pharmaselect International Beteiligungs GmbH, Austrija

Date of authorisation

2012-05-28

Date of renewal

Documents

2952_1_3 Akistan RPP 151026.docx

2952_1_3 Akistan akiu lasai RPP keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml akių lašų 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
43780	57557	1057557	buteliukas	2,5 ml su lašintuvu N1		Receptinis	LT/1/12/2952/001	Netiekiama	-	-	No	-	-
59492	73721	1073721	buteliukas	2,5 ml su lašintuvu, N3		Receptinis	LT/1/12/2952/002	Netiekiama	-	-	No	-	-
59493	73722	1073722	buteliukas	2,5 ml su lašintuvu, N6		Receptinis	LT/1/12/2952/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-03-23	Išregistruotas
2012-05-28	Registruotas