This document A copy of the patient guide is minimisation plan should be updated attached. proposed for for the Australian Australia. population, for The for “guide example changing patients” was not references to the attached to the S31 SmPC. responses. A statement should Furthermore, there be added regarding is no mention of this hepatitis B infection document within the under the heading ASA. you “information Due to the potential should know about for serious adverse Cimzia”. events with A statement should certolizumab be added regarding treatment, in the potential of addition to the certolizumab to ongoing safety influence the ability concerns associated to drive and use with the product, machines. This additional risk statement should be minimisation to the effect of activities, as applied may have a in the EU, are “Cimzia minor influence on required in the ability to drive Australia. and use machines. Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of Cimzia)”. A section should be added regarding when to seek medical advice, such as signs of infection or an injection site reaction. A statement should be added regarding the use of the patient alert card, its purpose and the importance of carrying it with the patient at all times.
This document should be updated for the Australian population, for example changing references to the SmPC. A statement should be added regarding hepatitis B infection under the heading “information you should know about Cimzia”. A statement should be added 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)”. A section should be added regarding when to seek medical advice, such as signs of infection or an injection site reaction. A statement should be added regarding the use of the patient alert card, its purpose and the importance of carrying it with the patient at all times. A copy of the patient guide is attached. minimisation plan proposed for Australia. The “guide for patients” was not attached to the S31 responses. Furthermore, there is no mention of this document within the ASA. Due to the potential for serious adverse 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.
auspar-certolizumab-140815.docx