OFTAN DEXA-CHLORA

Medicinal product

(Invented) name

OFTAN DEXA-CHLORA

Active substance (s)

Deksametazonas/Chloramfenikolis

Strength

1 mg/2 mg/g

Pharmaceutical form

akių tepalas

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01CA01, Dexamethasone and antiinfectives

Marketing authorisation holder

Santen Oy, Suomija

Date of authorisation

2000-11-09

Date of renewal

2010-03-19

Documents

1734 Pakuotės lapelis tepalas 2022 02 04.docx

1734 OFTAN DEXA_CHLORA akiu tepalas PCS PL 2022 02 04.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 g tepalo yra	1 g
Deksametazonas	1 mg
Chloramfenikolis	2 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
968	6823	1006823	tūbelė	3,5 g N1		Receptinis	LT/1/2000/1734/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-03-19	Perregistruotas
2000-11-09	Registruotas