In the with other medicines’ section, the PI [recommendation repeated accidentally] [recommendation ‘Interaction should include examples of drugs that inhibit repeated accidentally] (such as tacrolimus, cyclosporine, diltiazem, amiodarone, carvedilol, nifedipine, verapamil, ketoconazole, itraconazole, quinidine, ritonavir, saquinavir, nelfinavir, ranolazine valspodar, and isradipine) to assist clinicians referring to this section. In the with other medicines’ section, the PI Appropriate PI changes were made by the sponsor. This was considered ‘Interaction should include examples of substances transported by acceptable. or other transporters to assist clinicians referring to this section. In the with other medicines’ section, the PI Appropriate PI changes were made by the sponsor. This was considered ‘Interaction should include examples of cytoreductive therapies to acceptable. assist clinicians referring to this section. In the events’ section, the sponsor should include Appropriate PI changes were made by the sponsor. This was considered ‘Adverse increased systolic blood pressure. acceptable. In the and administration’ section, the sponsor Appropriate PI changes were made by the sponsor. This was considered ‘Dosage should include more detailed dosing recommendations for acceptable. patients with thrombocytopaenia to assist prescribers with dose adjustments. In the and administration’ section, the sponsor Appropriate PI changes were made by the sponsor. This was considered ‘Dosage should add information on dose modification on acceptable. response.
In the ‘Interaction with other medicines’ section, the PI should include examples of drugs that inhibit (such as tacrolimus, cyclosporine, diltiazem, amiodarone, carvedilol, nifedipine, verapamil, ketoconazole, itraconazole, quinidine, ritonavir, saquinavir, nelfinavir, ranolazine valspodar, and isradipine) to assist clinicians referring to this section. [recommendation repeated accidentally] [recommendation repeated accidentally] In the ‘Interaction with other medicines’ section, the PI should include examples of substances transported by or other transporters to assist clinicians referring to this section. Appropriate PI changes were made by the sponsor. This was considered acceptable. In the ‘Interaction with other medicines’ section, the PI should include examples of cytoreductive therapies to assist clinicians referring to this section. Appropriate PI changes were made by the sponsor. This was considered acceptable. In the ‘Adverse events’ section, the sponsor should include increased systolic blood pressure. Appropriate PI changes were made by the sponsor. This was considered acceptable. In the ‘Dosage and administration’ section, the sponsor should include more detailed dosing recommendations for patients with thrombocytopaenia to assist prescribers with dose adjustments. Appropriate PI changes were made by the sponsor. This was considered acceptable. In the ‘Dosage and administration’ section, the sponsor should add information on dose modification on response. Appropriate PI changes were made by the sponsor. This was considered acceptable.
auspar-ruxolitinib-140121.docx