pressure, Glaucoma, Ocular between two Hypertension’ and and seven days (infectious/ following the ‘Endophthalmitis non-infectious)’ in Australia, as injection. The some inconsistency is proposed observed in the EU RMP on Australian PI this matter (for example the provides no such tables included in Part V.1: detail. minimization measures Consequently ‘Risk by safety concern’, Table 9 16: this Table of Risk ‘Summary Minimization Measures’ and remains Table 9 19: Table of outstanding and ‘Summary Risk Minimization Measures’). should be adequately addressed preferably before this application is approved. The current UK SmPC states: The sponsor states: It is observed safety and efficacy of assessor’s that this “The “The Ozurdex administered to both observation is information is in eyes concurrently have not addressed in the fact now been studied. Therefore updated Australian PI, included in the administration to both eyes and the following Precautions concurrently is not sentence has been section, not in recommended”. This added to the draft PI the dosage and precautionary statement is under Dosage and administration cross referenced to the Administration: section, of the “The and method of safety and efficacy of proposed ‘Posology administration’ section of the Ozurdex administered Australian PI. UK SmPC and was related to to both eyes This is not the former ongoing safety concurrently have not entirely concern: been studied. satisfactory and ‘Systemic corticosteroid effects’. Therefore, it is reiterated However, a similar administration to that these precautionary statement does both eyes precautionary not appear to be included in concurrently is not statements the proposed Australian PI, but recommended.” should also be is included in the proposed cross referenced Australian CMI. The sponsor to the dosage should correct this oversight and and amend the proposed administration Australian PI accordingly. section of the proposed Australian PI. Furthermore Table 3–1: ‘Differences between the risk minimisation activities
pressure, Glaucoma, Ocular Hypertension’ and ‘Endophthalmitis (infectious/ non-infectious)’ in Australia, as some inconsistency is observed in the EU RMP on this matter (for example the tables included in Part V.1: ‘Risk minimization measures by safety concern’, Table 9 16: ‘Summary Table of Risk Minimization Measures’ and Table 9 19: ‘Summary Table of Risk Minimization Measures’). between two and seven days following the injection. The proposed Australian PI provides no such detail. Consequently this remains outstanding and should be adequately addressed preferably before this application is approved. The current UK SmPC states: “The safety and efficacy of Ozurdex administered to both eyes concurrently have not been studied. Therefore administration to both eyes concurrently is not recommended”. This precautionary statement is cross referenced to the ‘Posology and method of administration’ section of the UK SmPC and was related to the former ongoing safety concern: ‘Systemic corticosteroid effects’. However, a similar precautionary statement does not appear to be included in the proposed Australian PI, but is included in the proposed Australian CMI. The sponsor should correct this oversight and amend the proposed Australian PI accordingly. The sponsor states: “The assessor’s observation is addressed in the updated Australian PI, and the following sentence has been added to the draft PI under Dosage and Administration: “The safety and efficacy of Ozurdex administered to both eyes concurrently have not been studied. Therefore, administration to both eyes concurrently is not recommended.” It is observed that this information is in fact now included in the Precautions section, not in the dosage and administration section, of the proposed Australian PI. This is not entirely satisfactory and it is reiterated that these precautionary statements should also be cross referenced to the dosage and administration section of the proposed Australian PI. Furthermore Table 3–1: ‘Differences between the risk minimisation activities
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