Dorzolamide/Timolol Bausch

Medicinal product

(Invented) name

Dorzolamide/Timolol Bausch

Active substance (s)

Dorzolamidas/Timololis

Strength

20 mg/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

2018-04-26

Date of renewal

2022-05-16

Documents

4215 Dorzolamide_Timolol Bausch PCS PL 2023 05 25.docx

4215 Pakuotės lapelis 2023 05 25.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DK/H/2477/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Dorzolamidas	20 mg
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
99386	85492	1085492	buteliukas	5 ml N1		Receptinis	LT/1/18/4215/001	Netiekiama	-	-	No	-	-
99387	85493	1085493	buteliukas	5 ml N3		Receptinis	LT/1/18/4215/002	Netiekiama	-	-	No	-	-
108497	94601	1094601	buteliukas	5 ml N4		Receptinis	LT/1/18/4215/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-30	Išregistruotas
2022-05-16	Perregistruotas
2018-04-26	Registruotas