Ozurdex

Medicinal product

(Invented) name

Ozurdex

Active substance (s)

Deksametazonas

Strength

700 µg

Pharmaceutical form

stiklakūnio implantas aplikatoriuje

Route (s) of administration

vartoti į stiklakūnį

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01BA01, Dexamethasone

Marketing authorisation holder

AbbVie Deutschland GmbH & Co. KG , Vokietija

Date of authorisation

2010-07-27

Date of renewal

Documents

Ozurdex mokomoji medziaga pacientams.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Intravitreal implant in applicator	1 vnt.
Deksametazonas	700 µg

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
42217	55982	1055982	maišiukas	N1		Receptinis	EU/1/10/638/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-07-27	Registruotas