Oftan Dexa

Medicinal product

(Invented) name

Oftan Dexa

Active substance (s)

Deksametazonas

Strength

1 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)

S01BA01, Dexamethasone

Marketing authorisation holder

Santen Oy, Suomija

Date of authorisation

1995-04-05

Date of renewal

2011-05-23

Documents

2483 Pakuotės lapelis 2022 02 03.docx

2483 Oftan Dexa akiu lasai PCS PL 2022 02 03.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Deksametazonas	1 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
46877	60688	1060688	buteliukas	5 ml N1 (su lašintuvu)		Receptinis	LT/1/95/2483/001	Netiekiama	-	-	No	-	-
944	6808	1006808	buteliukas	5 ml N1		Receptinis	LT/1/95/2483/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2011-05-23	Perregistruotas
1995-04-05	Registruotas