Cosopt

Medicinal product

(Invented) name

Cosopt

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

Santen Oy, Suomija

Date of authorisation

1998-12-23

Date of renewal

2011-12-21

Documents

0082 Pakuotės lapelis 2023 03 21, KR_2473.docx

0082 Cosopt RPP 2023 03 21, KR_2473.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

Marketing authorisation procedure

Nacionalinė 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
11135	3292	1003292	buteliukas	5 ml N1		Receptinis	LT/1/98/0082/001	Tiekiama	-	-	No	-	-	Download
42119	55883	1055883	buteliukas	5 ml N3		Receptinis	LT/1/98/0082/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-12-21	Perregistruotas
1998-12-23	Registruotas