Sponsor response AstraZeneca agrees to notify the TGA of the results of all pharmacovigilance activities via appropriate mechanisms, including reporting in PSURs and/or applications to amend the product registration details, as available. Evaluator’s comment The sponsor’s response is acceptable in the context of this evaluation. Recommendation #8 in RMP evaluation report Given naloxegol is now registered in several countries it is expected that the medication error and off-label use sections of the EU-RMP will be updated with post marketing data as it becomes available. Sponsor response AstraZeneca agrees to update all relevant sections of the EU RMP will be updated with post marketing data as it becomes available. Evaluator’s comment The sponsor’s response is acceptable in the context of this evaluation. Recommendation #9 in RMP evaluation report The following EU SmPC contraindication which does not appear in the proposed PI is considered clinically relevant and should be included unless the sponsor can provide a compelling justification for its omission: Conditions in patients with cancer pain Patients with underlying cancer who are at heightened risk of GI perforation, such as those with: underlying malignancies of gastrointestinal or peritoneum recurrent or advanced ovarian cancer vascular endothelial growth factor (VEGF) inhibitor treatment. Sponsor response AstraZeneca acknowledges the evaluator’s comment and proposes adoption of this language in the proposed PI. CONTRAINDICATIONS (new text underlined, deleted text in strikethrough): Conditions in patients with cancer pain Patients with underlying cancer who are at heightened risk of GI perforation, such as trial with: underlying malignancies of gastrointestinal or peritoneum recurrent or advanced ovarian cancer vascular endothelial growth factor (VEGF) inhibitor treatment. Evaluator’s comment The sponsor’s response is acceptable from an RMP perspective. PI amendments are subject to approval by the Delegate. Recommendation #10 in RMP evaluation report The CYP3A4 contraindication should also contraindicate the concomitant consumption of grapefruit juice as it does in the EU SmPC.
Sponsor response AstraZeneca agrees to notify the TGA of the results of all pharmacovigilance activities via appropriate mechanisms, including reporting in PSURs and/or applications to amend the product registration details, as available. Evaluator’s comment The sponsor’s response is acceptable in the context of this evaluation. Recommendation #8 in RMP evaluation report Given naloxegol is now registered in several countries it is expected that the medication error and off-label use sections of the EU-RMP will be updated with post marketing data as it becomes available. Sponsor response AstraZeneca agrees to update all relevant sections of the EU RMP will be updated with post marketing data as it becomes available. Evaluator’s comment The sponsor’s response is acceptable in the context of this evaluation. Recommendation #9 in RMP evaluation report The following EU SmPC contraindication which does not appear in the proposed PI is considered clinically relevant and should be included unless the sponsor can provide a compelling justification for its omission: Conditions in patients with cancer pain Patients with underlying cancer who are at heightened risk of GI perforation, such as those with: underlying malignancies of gastrointestinal or peritoneum recurrent or advanced ovarian cancer vascular endothelial growth factor (VEGF) inhibitor treatment. Sponsor response AstraZeneca acknowledges the evaluator’s comment and proposes adoption of this language in the proposed PI. CONTRAINDICATIONS (new text underlined, deleted text in strikethrough): Conditions in patients with cancer pain Patients with underlying cancer who are at heightened risk of GI perforation, such as with: underlying malignancies of gastrointestinal or peritoneum recurrent or advanced ovarian cancer vascular endothelial growth factor (VEGF) inhibitor treatment. Evaluator’s comment The sponsor’s response is acceptable from an RMP perspective. PI amendments are subject to approval by the Delegate. Recommendation #10 in RMP evaluation report The CYP3A4 contraindication should also contraindicate the concomitant consumption of grapefruit juice as it does in the EU SmPC. trial
auspar-naloxegol-oxalate-160601_0.docx