Ethnicity other than white Caucasian European patient experience Lactating women Pregnancy Patients with and/or hepatic impairment Concurrent significant disease including depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, thrombangiitis obliterans, scleroderma, or Sjögren’s syndrome. OPR reviewer comment Notwithstanding the evaluation of the non clinical and clinical aspects of the safety specifications, the listed ongoing safety concerns are considered acceptable. Pharmacovigilance plan The sponsor proposes routine and additional pharmacovigilance activities (a patient reported outcome study; and a 4 week vehicle controlled study) for important identified and potential risks and missing information. Risk minimisation activities The sponsor’s conclusion in regard to the need for additional risk minimisation activities is: risk management activities than labelling through the Summary of Product ‘No Characteristics (SmPC) and Patient Information Leaflet are proposed for identified risks or for missing information.’ OPR reviewer comment: The sponsor’s conclusion is acceptable. Risk minimisation plan No additional risk minimisation activities are proposed for brimonidine tartrate. Reconciliation of issues outlined in the RMP report Table 7 summarises the OPR’s first round evaluation of the RMP, the sponsor’s responses to issues raised by the OPR and the OPR’s evaluation of the sponsor’s responses. Table 7. Reconciliation of issues outlined in the RMP report. Recommendation in Sponsor’s response (or OPR evaluator’s RMP evaluation report summary of the comment response) Safety considerations may safety considerations This is considered ‘No be raised by the nonclinical were raised by nonclinical acceptable. and clinical evaluators and clinical evaluators via the through the TGA TGA consolidated request for consolidated request for further information or the further information and/or nonclinical or CER reports the nonclinical and clinical that impact the RMP. Should evaluation report (CER) such considerations arise, the
Ethnicity other than white Caucasian European patient experience Lactating women Pregnancy Patients with and/or hepatic impairment Concurrent significant disease including depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, thrombangiitis obliterans, scleroderma, or Sjögren’s syndrome. OPR reviewer comment Notwithstanding the evaluation of the non clinical and clinical aspects of the safety specifications, the listed ongoing safety concerns are considered acceptable. Pharmacovigilance plan The sponsor proposes routine and additional pharmacovigilance activities (a patient reported outcome study; and a 4 week vehicle controlled study) for important identified and potential risks and missing information. Risk minimisation activities The sponsor’s conclusion in regard to the need for additional risk minimisation activities is: ‘No risk management activities than labelling through the Summary of Product Characteristics (SmPC) and Patient Information Leaflet are proposed for identified risks or for missing information.’ OPR reviewer comment: The sponsor’s conclusion is acceptable. Risk minimisation plan No additional risk minimisation activities are proposed for brimonidine tartrate. Reconciliation of issues outlined in the RMP report Table 7 summarises the OPR’s first round evaluation of the RMP, the sponsor’s responses to issues raised by the OPR and the OPR’s evaluation of the sponsor’s responses. Table 7. Reconciliation of issues outlined in the RMP report. Recommendation in RMP evaluation report Sponsor’s response (or summary of the response) OPR evaluator’s comment Safety considerations may be raised by the nonclinical and clinical evaluators through the TGA consolidated request for further information and/or the nonclinical and clinical evaluation report (CER) ‘No safety considerations were raised by nonclinical and clinical evaluators via the TGA consolidated request for further information or the nonclinical or CER reports that impact the RMP. Should such considerations arise, the This is considered acceptable.
auspar-brimonidine-as-tartrate-150123.docx