document to events with ensure that the certolizumab most relevant treatment, in information is at addition to the the front of the ongoing safety document. concerns associated with the product, A statement additional risk regarding minimisation appropriate activities, as applied dosing and/or a in the EU, are dosing table required in should be added Australia. to enhance safe use of medicine. A should be added showing the very common, common and rare side effects of certolizumab, similar to that shown in the SmPC. A statement should • be trial regarding the potential of certolizumab to influence the ability to drive and use machines. This statement should be to the effect of may have a “Cimzia minor influence on the ability to drive and use machines. Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of Cimzia” PsA and axSpA UCB Australia currently produces This response Patient Medication a for patients, which will be appears inconsistent Guide extended to patients with PsA and with those provided axSpA. This guide includes an below and the It is recommended overview of adverse events and content of the ASA. that the sponsor incorporates risks, such as amend the The Sponsor hepatitis infection and infections, following: remains unclear but can be updated to include regarding their risk ability to drive and use machines.
document to ensure that the most relevant information is at the front of the document. A statement regarding appropriate dosing and/or a dosing table should be added to enhance safe use of medicine. A should be added showing the very common, common and rare side effects of certolizumab, similar to that shown in the SmPC. • A statement should be regarding the potential of certolizumab to influence the ability to drive and use machines. This statement should be to the effect of “Cimzia may have a minor influence on the ability to drive and use machines. Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of Cimzia” events with certolizumab treatment, in addition to the ongoing safety concerns associated with the product, additional risk minimisation activities, as applied in the EU, are required in Australia. PsA and axSpA Patient Medication Guide It is recommended that the sponsor amend the following: UCB Australia currently produces a for patients, which will be extended to patients with PsA and axSpA. This guide includes an overview of adverse events and incorporates risks, such as hepatitis infection and infections, but can be updated to include ability to drive and use machines. This response appears inconsistent with those provided below and the content of the ASA. The Sponsor remains unclear regarding their risk trial
auspar-certolizumab-140815.docx