TRUSOPT

Medicinal product

(Invented) name

TRUSOPT

Active substance (s)

Dorzolamidas

Strength

20 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)

S01EC03, Dorzolamide

Marketing authorisation holder

Santen Oy, Suomija

Date of authorisation

1996-03-29

Date of renewal

2008-02-08

Documents

1021 Pakuotės lapelis 2023 02 28.docx

1021 TRUSOPT RPP 2023 02 28.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Dorzolamidas	20 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
2269	2224	1002224	buteliukas	5 ml N1		Receptinis	LT/1/96/1021/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2008-02-08	Perregistruotas
1996-03-29	Registruotas