Latanoprost Actavis

Medicinal product

(Invented) name

Latanoprost Actavis

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

Teva B.V., Nyderlandai

Date of authorisation

2009-08-05

Date of renewal

2014-08-01

Documents

1660 Latanoprost Actavis II PL 2024 02 21.docx

1660 Pakuotės lapelis 2024 02 21.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0784/001

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
29653	32132	1032132	buteliukas	2,5 ml N1		Receptinis	LT/1/09/1660/001	Tiekiama	-	-	No	-	-	Download
36392	38724	1038724	buteliukas	2,5 ml N3		Receptinis	LT/1/09/1660/002	Netiekiama	-	-	No	-	-	Download
36393	38725	1038725	buteliukas	2,5 ml N6		Receptinis	LT/1/09/1660/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-08-01	Perregistruotas
2009-08-05	Registruotas