COSOPT sine

Medicinal product

(Invented) name

COSOPT sine

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

2018-10-08

Date of renewal

2023-06-21

Documents

4276_pakuotes lapelis_2023-06-21.docx

4276_Cosopt sine_perr2023-06-21.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DK/H/0134/003/DC

Marketing authorisation procedure

Decentralizuota 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
100261	86370	1086370	buteliukas	10 ml N1		Receptinis	LT/1/18/4276/001	Tiekiama	-	-	No	-	-
100262	86371	1086371	buteliukas	10 ml N2		Receptinis	LT/1/18/4276/002	Netiekiama	-	-	No	-	-
100263	86372	1086372	buteliukas	10 ml N3		Receptinis	LT/1/18/4276/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-06-21	Perregistruotas
2018-10-08	Registruotas