Drug information for OZURDEX

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
IMPLANT; INTRAVITREAL 0.7MG Prescription  (Reference Drug) DEXAMETHASONE Dexamethasone ALLERGAN 22315
2012-02-29 Letter

2012-02-28 Label

2010-09-29 Letter

2010-09-29 Label

2010-09-07 Letter

2009-10-29 Review

2009-10-29 Summary Review

2009-06-23 Letter

2009-06-22 Label

Drug Adverse Effects information for OZURDEX

Role code Indications Reaction # Reports
PS CYSTOID MACULAR OEDEMA CORNEAL DISORDER 1
PS CYSTOID MACULAR OEDEMA CORNEAL OEDEMA 1
PS CYSTOID MACULAR OEDEMA DEVICE DISLOCATION 2
PS CYSTOID MACULAR OEDEMA IRIS DISORDER 1
PS EYE INFLAMMATION CORNEAL OEDEMA 1
PS EYE INFLAMMATION DEVICE DISLOCATION 1
PS EYE INFLAMMATION INTRAOCULAR PRESSURE INCREASED 1
PS INTERMEDIATE UVEITIS CORNEAL DECOMPENSATION 2
PS INTERMEDIATE UVEITIS DEVICE DISLOCATION 2
PS MACULAR OEDEMA BLINDNESS UNILATERAL 2
PS MACULAR OEDEMA CORNEAL DISORDER 1
PS MACULAR OEDEMA CORNEAL OEDEMA 4
PS MACULAR OEDEMA DEVICE DISLOCATION 4
PS MACULAR OEDEMA DRUG INEFFECTIVE 1
PS MACULAR OEDEMA ENDOPHTHALMITIS 4
PS MACULAR OEDEMA EYE PAIN 2
PS MACULAR OEDEMA GLAUCOMA 1
PS MACULAR OEDEMA INTRAOCULAR PRESSURE INCREASED 1
PS MACULAR OEDEMA OCULAR HYPERAEMIA 2
PS MACULAR OEDEMA VISUAL IMPAIRMENT 2
PS MACULAR OEDEMA VITREOUS HAEMORRHAGE 1
PS PRODUCT USED FOR UNKNOWN INDICATION COMPLICATION OF DEVICE INSERTION 2
PS PRODUCT USED FOR UNKNOWN INDICATION CORNEAL DISORDER 2
PS PRODUCT USED FOR UNKNOWN INDICATION CORNEAL OEDEMA 2
PS PRODUCT USED FOR UNKNOWN INDICATION DEVICE DISLOCATION 6
PS PRODUCT USED FOR UNKNOWN INDICATION ENDOPHTHALMITIS 3
PS PRODUCT USED FOR UNKNOWN INDICATION INTRAOCULAR PRESSURE INCREASED 1
PS PRODUCT USED FOR UNKNOWN INDICATION LENTICULAR OPACITIES 2
PS PRODUCT USED FOR UNKNOWN INDICATION MACULAR OEDEMA 1
PS PRODUCT USED FOR UNKNOWN INDICATION OCULAR VASCULAR DISORDER 1
PS PRODUCT USED FOR UNKNOWN INDICATION RETINAL VASCULAR DISORDER 2
PS PRODUCT USED FOR UNKNOWN INDICATION ULCERATIVE KERATITIS 1
PS PRODUCT USED FOR UNKNOWN INDICATION VISUAL ACUITY REDUCED 1
PS RETINAL VEIN OCCLUSION CATARACT 1
PS RETINAL VEIN OCCLUSION ENDOPHTHALMITIS 4
PS RETINAL VEIN OCCLUSION INCORRECT DRUG ADMINISTRATION DURATION 1
PS RETINAL VEIN OCCLUSION INJECTION SITE REACTION 1
PS RETINAL VEIN OCCLUSION INTRAOCULAR PRESSURE DECREASED 1
PS RETINAL VEIN OCCLUSION RETINAL DETACHMENT 4
PS RETINAL VEIN OCCLUSION VISUAL IMPAIRMENT 1
PS UVEITIS DEVICE DISLOCATION 2
PS UVEITIS IRIS DISORDER 2
SS CYSTOID MACULAR OEDEMA DEVICE DISLOCATION 1
SS CYSTOID MACULAR OEDEMA IRIS DISORDER 1
SS MACULAR OEDEMA INTRAOCULAR PRESSURE INCREASED 1
SS MACULAR OEDEMA VITREOUS HAEMORRHAGE 1
SS UVEITIS DEVICE DISLOCATION 2
SS UVEITIS IRIS DISORDER 2
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