OZURDEX

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

The drug OZURDEX contains one active pharmaceutical ingredient (API):

1	Dexamethasone UNII 7S5I7G3JQL - DEXAMETHASONE
	Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low mineralocorticoid activity. It has an approximately 7 times greater anti-inflammatory potency than prednisolone, another commonly prescribed corticosteroid. At high doses it reduces the immune response.
	Read more about Dexamethasone

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
OZURDEX Intravitreal implant in applicator	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
S01BA01	Dexamethasone	S Sensory organs → S01 Ophthalmologicals → S01B Antiinflammatory agents → S01BA Corticosteroids, plain
Discover more medicines within S01BA01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	10943Y, 11317P, 11469P
BR	Câmara de Regulação do Mercado de Medicamentos	501006801171418
CA	Health Products and Food Branch	02363445
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	29970-08-11
EE	Ravimiamet	1488449
ES	Centro de información online de medicamentos de la AEMPS	10638001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	192867
FR	Base de données publique des médicaments	67392081
GB	Medicines & Healthcare Products Regulatory Agency	176585
HK	Department of Health Drug Office	60336
IL	מִשְׂרַד הַבְּרִיאוּת	6947
IT	Agenzia del Farmaco	040138012
LT	Valstybinė vaistų kontrolės tarnyba	1055982
NL	Z-Index G-Standaard, PRK	97470
NZ	Medicines and Medical Devices Safety Authority	13932
PL	Rejestru Produktów Leczniczych	100230850
SG	Health Sciences Authority	14058P
TN	Direction de la Pharmacie et du Médicament	3983061H
TR	İlaç ve Tıbbi Cihaz Kurumu	8699490588017
US	FDA, National Drug Code	0023-3348
ZA	Health Products Regulatory Authority	44/15.2/0045