healthcare professional, patient, minimisation for or consumer. this risk: “The product packaging, [information has been redacted] labelling, and supporting CZP educational program are designed to minimize the potential for medication errors in the administration of the product.” Therefore, the Sponsor should also apply additional risk minimisation activities in Australia. The sponsor should [information redacted] [information clarify the status of redacted] the auto-injector Therefore, the and update the RMP Sponsor should accordingly. The apply additional risk sponsor should also minimisation comment on the activities in number and types of Australia. medication errors that have occurred during post-market experience. It is recommended UCB directs the evaluator to page The potential for that the sponsor 95 of the Cimzia RMP Version 9.3, harm from overdose summarise all additionally: has not been reports of overdose adequately [information redacted]. This from post-market addressed in the concern is considered addressed experience with RA. RMP Version 9.3 as part of the overall The sponsor does Part II Section 1. enhancement in product as not discuss the risk This section should previously discussed. of overdose in the be updated to PsA EU-RMP or the include the EU-RMP and cumulative simply refers to the data comments within regarding overdose the RA-RMP that the Sponsor has provided in the adjacent comment. The sponsor should Off-label use of Cimzia is listed as The potential for clarify from missing information for Cimzia in label use has not the UCB Risk Management Plan been adequately experience the (RMP). Off-label use is the use of addressed in the number of pharmaceutical drugs for an RMP Version 9.3
healthcare professional, patient, or consumer. [information has been redacted] minimisation for this risk: “The product packaging, labelling, and supporting CZP educational program are designed to minimize the potential for medication errors in the administration of the product.” Therefore, the Sponsor should also apply additional risk minimisation activities in Australia. The sponsor should clarify the status of the auto-injector and update the RMP accordingly. The sponsor should also comment on the number and types of medication errors that have occurred during post-market experience. [information redacted] [information redacted] Therefore, the Sponsor should apply additional risk minimisation activities in Australia. It is recommended that the sponsor summarise all reports of overdose from post-market experience with RA. The sponsor does not discuss the risk of overdose in the PsA EU-RMP or the EU-RMP and simply refers to the comments within the RA-RMP UCB directs the evaluator to page 95 of the Cimzia RMP Version 9.3, additionally: [information redacted]. This concern is considered addressed as part of the overall enhancement in product as previously discussed. The potential for harm from overdose has not been adequately addressed in the Version 9.3 Part II Section 1. This section should be updated to include the cumulative data regarding overdose that the Sponsor has provided in the adjacent comment. The sponsor should clarify from experience the number of Off-label use of Cimzia is listed as missing information for Cimzia in the UCB Risk Management Plan (RMP). Off-label use is the use of pharmaceutical drugs for an The potential for use has not been adequately addressed in the Version 9.3 label RMP RMP
auspar-certolizumab-140815.docx