Timlatan

Medicinal product

(Invented) name

Timlatan

Active substance (s)

Latanoprostas/Timololis

Strength

50 µg/5 mg/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)

S01ED51, Timolol, combinations

Marketing authorisation holder

BAUSCH + LOMB IRELAND LIMITED, Airija

Date of authorisation

2011-09-28

Date of renewal

2016-04-29

Documents

2639 Pakuotės lapelis 2023 04 06.docx

2639 Timlatan PCS PL 2023 04 06.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

IE/H/0228/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Latanoprostas	50 µg
Timololis	5 mg

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
40985	54722	1054722	buteliukas	2,5 ml N1		Receptinis	LT/1/11/2639/001	Netiekiama	-	-	No	-	-	Download
49070	62936	1062936	buteliukas	2,5 ml N3		Receptinis	LT/1/11/2639/002	Netiekiama	-	-	No	-	-
49071	62937	1062937	buteliukas	2,5 ml N6		Receptinis	LT/1/11/2639/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-12-31	Išregistruotas
2016-04-29	Perregistruotas
2011-09-28	Registruotas