the case, the card will be adapted to the local proposed for should be updated requirements in Australia. Australia. for the Australian Due to the potential population, for for serious adverse example changing events with referenced to the certolizumab SMPC. 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. It is recommended UCB Australia currently have a This response that the sponsor how to prescribe brochure, which appears inconsistent amend the includes dosing instructions, a with those provided following: copy of which is attached. This below and with the can be expanded upon to address content of the ASA. This document the comments above. UCB confirm should be updated The Sponsor that, if UCB decide to roll-out for the Australia remains unclear additional educational material population, for regarding their risk in Australia, the material will be example changing minimisation plan adapted to the local references to the proposed for requirements. SmPC. Australia. The ASA states that no The steps additional risk describing the minimisation injection activities will be preparation and applied in Australia, administrated however the should be Sponsor implies in numbered. this response that an Each additional risk administration minimisation picture should be activity (in the form placed with the of a brochure) will corresponding be applied. administration The to “how step. prescribe brochure” The three pages was not attached to regarding the S31 responses. “clinical efficacy of Cimzia” Furthermore, there should be is no mention of this removed and a document within the reference made to ASA. the prescriber Due to the potential guide, or placed at for serious adverse the back of the
the case, the card should be updated for the Australian population, for example changing referenced to the SMPC. will be adapted to the local requirements in Australia. proposed for Australia. 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. It is recommended that the sponsor amend the following: This document should be updated for the Australia population, for example changing references to the SmPC. The steps describing the injection preparation and administrated should be numbered. Each administration picture should be placed with the corresponding administration step. The three pages regarding “clinical efficacy of Cimzia” should be removed and a reference made to the prescriber guide, or placed at the back of the UCB Australia currently have a how to prescribe brochure, which includes dosing instructions, a copy of which is attached. This can be expanded upon to address the comments above. UCB confirm that, if UCB decide to roll-out additional educational material in Australia, the material will be adapted to the local requirements. This response appears inconsistent with those provided below and with the content of the ASA. The Sponsor remains unclear regarding their risk minimisation plan proposed for Australia. The ASA states that no additional risk minimisation activities will be applied in Australia, however the Sponsor implies in this response that an additional risk minimisation activity (in the form of a brochure) will be applied. The “how to prescribe brochure” 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
auspar-certolizumab-140815.docx