mutations and therefore, it is observed in any of address this safety recommended that the sponsor these patients. concern is considered adds and tolerability in acceptable. ‘Safety in patients ‘Safety patients with high risk gene with HIV or 2.8.) The addition of mutations’ as missing infections’ has been this ongoing safety information in the of included as missing concern to the table of ongoing safety concerns. information in the ongoing safety appropriate concerns is considered Sections of the acceptable. However, RMP. it is recommended to the Delegate that the 2.7) ‘Medication wording used to including address this ongoing safety in home safety concern in the therapy setting’ has PI be revised.* already been included as a * The sponsor has potential risk in the proposed to use the Risk Management same generic wording Plan in response to to address all the evaluation of safety concerns in the the RMP by EMA. PI and CMI. This is considered not 2.8) in ‘Safety acceptable as it does patients with high not inform the health risk gene care professional and mutations’ has been the patient about the included as missing absence of clinical information in the data which could appropriate inform these ongoing Sections of the safety concerns. It is RMP. recommended that the sponsor amends the PI and CMI to provide more precise 3. It is recommended that the Section 2 This is considered pharmacovigilance section of acceptable. ‘Pharmacovigilance the ASA be amended to include Practice’ of the ASA reference to the TGA document has been amended requirements and to include reference ‘Australian recommendations for to the TGA pharmacovigilance document responsibilities of sponsors of ‘Australian medicines’, Version 1.1, requirements and December 2012. recommendations for pharmacovigilance responsibilities of sponsors of medicines’, Version 1.2, August 2013.
mutations and therefore, it is recommended that the sponsor adds ‘Safety and tolerability in patients with high risk gene mutations’ as missing information in the of ongoing safety concerns. observed in any of these patients. ‘Safety in patients with HIV or infections’ has been included as missing information in the appropriate Sections of the RMP. 2.7) ‘Medication including safety in home therapy setting’ has already been included as a potential risk in the Risk Management Plan in response to the evaluation of the RMP by EMA. 2.8) ‘Safety in patients with high risk gene mutations’ has been included as missing information in the appropriate Sections of the RMP. address this safety concern is considered acceptable. 2.8.) The addition of this ongoing safety concern to the table of ongoing safety concerns is considered acceptable. However, it is recommended to the Delegate that the wording used to address this ongoing safety concern in the PI be revised.* * The sponsor has proposed to use the same generic wording to address all safety concerns in the PI and CMI. This is considered not acceptable as it does not inform the health care professional and the patient about the absence of clinical data which could inform these ongoing safety concerns. It is recommended that the sponsor amends the PI and CMI to provide more precise 3. It is recommended that the pharmacovigilance section of the ASA be amended to include reference to the TGA document ‘Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines’, Version 1.1, December 2012. Section 2 ‘Pharmacovigilance Practice’ of the ASA has been amended to include reference to the TGA document ‘Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines’, Version 1.2, August 2013. This is considered acceptable.
auspar-simoctocog-alfa-rhu-160607.docx