Latanoprost Cipla

Medicinal product

(Invented) name

Latanoprost Cipla

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

Cipla Europe NV, Belgija

Date of authorisation

2015-10-12

Date of renewal

Documents

3807_1-3 Latanoprost_Cipla_DP.docx

3807_1_3 Latanoprost Cipla II PL 151218.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

UK/H/5632/001/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
58282	72425	1072425	buteliukas	2,5 ml su lašintuvu N1		Receptinis	LT/1/15/3807/001	Netiekiama	-	-	No	-	-
63808	78252	1078252	buteliukas	2,5 ml su lašintuvu N3		Receptinis	LT/1/15/3807/002	Netiekiama	-	-	No	-	-
63809	78253	1078253	buteliukas	2,5 ml su lašintuvu N6		Receptinis	LT/1/15/3807/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-07-04	Išregistruotas
2015-10-12	Registruotas