OZURDEX

This brand name is authorized in Austria, Australia, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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 about Dexamethasone

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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

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