DEXAL

Medicinal product

(Invented) name

DEXAL

Active substance (s)

Deksametazono natrio fosfatas

Strength

0,985 mg/g

Pharmaceutical form

akių gelis

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

BAUSCH + LOMB IRELAND LIMITED, Airija

Date of authorisation

2016-09-26

Date of renewal

2021-12-02

Documents

3968 DEXAL RPP 2023 06 01.docx

3968 Pakuotės lapelis 2023 06 01.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/4097/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g gelio yra	1 g
Deksametazono natrio fosfatas	0,985 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
59133	73355	1073355	tūbelė	5 g N1		Receptinis	LT/1/16/3968/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2021-12-02	Perregistruotas
2016-09-26	Registruotas