Bondulc

Medicinal product

(Invented) name

Bondulc

Active substance (s)

Travoprostas

Strength

40 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)

S01EE04, Travoprost

Marketing authorisation holder

Teva B.V., Nyderlandai

Date of authorisation

2014-04-28

Date of renewal

2019-03-04

Documents

3547 Pakuotės lapelis 2023 04 13.docx

3547 Bondulc RPP 2023 04 13.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

SE/H/1792/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml 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
54695	68693	1068693	buteliukas	2,5 ml N1		Receptinis	LT/1/14/3547/001	Netiekiama	2025-04-01	-	No	-	-	Download
58966	73186	1073186	buteliukas	2,5 ml N3		Receptinis	LT/1/14/3547/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-03-04	Perregistruotas
2014-04-28	Registruotas