The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Ozurdex

700 microgram(s) Infus/Pdr/Oral Soln

Allergan Pharmaceuticals IrelandEU/1/10/638/001

Main Information

Trade NameOzurdex
Active SubstancesDexamethasone
Strength700 microgram(s)
Dosage FormInfus/Pdr/Oral Soln
Licence HolderAllergan Pharmaceuticals Ireland
Licence NumberEU/1/10/638/001

Group Information

ATC CodeS01BA Corticosteroids, plain
S01BA01 dexamethasone

Status

Authorised/WithdrawnAuthorised
Licence Issued
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Marketing Status

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Educational Materials - Patient

« Back