Traelb

Medicinal product

(Invented) name

Traelb

Active substance (s)

Travoprostas

Strength

40 µg/ml

Pharmaceutical form

akių lašai (tirpalas)

Route (s) of administration

vartoti į akis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01EE04, Travoprost

Marketing authorisation holder

Alfred E. Tiefenbacher (GmbH & Co. KG), Vokietija

Date of authorisation

2015-11-26

Date of renewal

2021-02-10

Documents

3844_pakuotes lapelis_2021-02-10.docx

3844_Traelb_akiu_tirp_perr2021-02-10.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/3291/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 mililitre tirpalo yra	1 ml
Travoprostas	40 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
59727	73961	1073961	buteliukas	2,5 ml N1		Receptinis	LT/1/15/3844/001	Netiekiama	-	-	No	-	-
64347	78829	1078829	buteliukas	2,5 ml N3		Receptinis	LT/1/15/3844/002	Netiekiama	-	-	No	-	-
64348	78830	1078830	buteliukas	2,5 ml N6		Receptinis	LT/1/15/3844/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-29	Išregistruotas
2021-02-10	Perregistruotas
2015-11-26	Registruotas