the ongoing table of safety table of ongoing safety hepatic and renal concerns, and concerns as missing impairment and pharmacovigilance and risk information in the table of C.) previously minimisation activities should ongoing safety concerns untreated patients. be assigned as appropriate. based on the clinical Risk-Minimisation and evidence summarised below: C.) It is recommended that pharmacovigilance untreated patients” D). patients with mild to “previously activities should be be included in the table of moderate haemophilia assigned as ongoing safety as missing E). thrombotic events appropriate. information. Pharmacovigilance and risk minimisation activities should be assigned as appropriate. D.) It is recommended that with mild to moderate “patients haemophilia” be included in the table of ongoing safety as missing information. Pharmacovigilance and risk minimisation activities should be assigned as appropriate. E.) It is recommended to the Delegate to draw the attention of the clinical evaluator to assess whether it is appropriate not to include thrombotic events in the table of ongoing safety concerns. It is recommended that the RMP Should the Delegate request The RMP is not the be revised to include adherence the RMP be revised as Delegate’s of the pharmacovigilance recommended by the responsibility but that activities in accordance to the evaluator, Biogen Idec will of the RMP evaluator Australian requirements as revise the RMP to include and the director of the described in the document adherence of RMP section. requirements and pharmacovigilance activities “Australian This recommendation recommendations for in accordance to the remains. pharmacovigilance Australian requirements. responsibilities of sponsors of medicines”, version 1.1, dated Dec-2012. It is recommended that the Should the Delegate request The RMP is not the sponsor revises the RMP to revisions to the RMP to Delegate’s include submission dates for include submission for responsibility but that interim and final study data to data from ongoing studies to of the RMP evaluator the TGA. the TGA as recommended by and the director of the the evaluator, Biogen Idec RMP section. agrees to modify the tables of This recommendation the RMP to indicate [the remains. requested information]
the ongoing table of safety concerns, and pharmacovigilance and risk minimisation activities should be assigned as appropriate. C.) It is recommended that “previously untreated patients” be included in the table of ongoing safety as missing information. Pharmacovigilance and risk minimisation activities should be assigned as appropriate. D.) It is recommended that “patients with mild to moderate haemophilia” be included in the table of ongoing safety as missing information. Pharmacovigilance and risk minimisation activities should be assigned as appropriate. E.) It is recommended to the Delegate to draw the attention of the clinical evaluator to assess whether it is appropriate not to include thrombotic events in the table of ongoing safety concerns. table of ongoing safety concerns as missing information in the table of ongoing safety concerns based on the clinical evidence summarised below: D). patients with mild to moderate haemophilia E). thrombotic events hepatic and renal impairment and C.) previously untreated patients. Risk-Minimisation and pharmacovigilance activities should be assigned as appropriate. It is recommended that the RMP be revised to include adherence of the pharmacovigilance activities in accordance to the Australian requirements as described in the document “Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines”, version 1.1, dated Dec-2012. Should the Delegate request the RMP be revised as recommended by the evaluator, Biogen Idec will revise the RMP to include adherence of pharmacovigilance activities in accordance to the Australian requirements. The RMP is not the Delegate’s responsibility but that of the RMP evaluator and the director of the RMP section. This recommendation remains. It is recommended that the sponsor revises the RMP to include submission dates for interim and final study data to the TGA. Should the Delegate request revisions to the RMP to include submission for data from ongoing studies to the TGA as recommended by the evaluator, Biogen Idec agrees to modify the tables of the RMP to indicate [the requested information] The RMP is not the Delegate’s responsibility but that of the RMP evaluator and the director of the RMP section. This recommendation remains.