Kivizidiale

Medicinal product

(Invented) name

Kivizidiale

Active substance (s)

Travoprostas/Timololis

Strength

40 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

2018-01-24

Date of renewal

2023-11-22

Documents

4188_Kivizidiale_perr2023-11-22.docx

4188_pakutes lapelis_2023-11-22.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DK/H/2713/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Travoprostas	40 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
98793	84897	1084897	buteliukas	2,5 ml N1		Receptinis	LT/1/18/4188/001	Netiekiama	-	-	No	-	-
98794	84898	1084898	buteliukas	2,5 ml N3		Receptinis	LT/1/18/4188/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-30	Išregistruotas
2023-11-22	Perregistruotas
2018-01-24	Registruotas