Drug specific serious opportunistic infections”. Injection site antibody UCB S.A. will assess all four bullet reactions formation points mentioned in TGA HIV or hepatitis C proposals for the next version of Injection site (important the EU-RMP, once the next reactions missing dataset for the PSUR is available information) Hypersensitivity (Mar 2014). reactions The Sponsor should The evaluator’s comments are add the above risks Change in noted in regards to: to the list of ongoing morphology / HIV or hepatitis C safety concerns. It is severity of important to note psoriasis UCB S.A. advises that this will be that the ACSOM evaluated at the next major The following committee update of the EU RMP for should be added to supported the inclusion. It is clinically prudent the list of important inclusion of all the that HIV and hepatitis C status missing information: recommended are investigated prior to initiation additional safety Long term safety of TNF antagonists. concerns made by The evaluator’s comments are the evaluator. noted in regards to: Septic shock UCB S.A. considers septic shock a likely outcome of some serious infections (known and well characterized product risk). UCB S.A. respectfully advises that this will not be incorporated as an additional safety concern. It is recommended UCB has now updated Cimzia This is acceptable. that the sponsor RMP to version 9.3; studies are justify the exclusion now included in the PV Plan (see of the ongoing page 194). studies from the pharmacovigilance plan relating to PsA and AxSpA The sponsor should UCB has now updated Cimzia This is acceptable. clarify the exact RMP to version 9.3. The number of studies pharmacovigilance plan as included within the summarised on p 193 contains: 4 pharmacovigilance registries (o Pregnancy data plan, for example collections (ongoing studies, are studies marketing reports and ARTIS and included? RABBIT) Furthermore the o milestones for the o Targeted follow-up with studies in the reporters with TB questionnaire pharmacovigilance plan should be clarified.
Drug specific antibody formation Injection site reactions Hypersensitivity reactions Change in morphology / severity of psoriasis The following should be added to the list of important missing information: Long term safety serious opportunistic infections”. UCB S.A. will assess all four bullet points mentioned in TGA proposals for the next version of the EU-RMP, once the next dataset for the PSUR is available (Mar 2014). The evaluator’s comments are noted in regards to: HIV or hepatitis C UCB S.A. advises that this will be evaluated at the next major update of the EU RMP for inclusion. It is clinically prudent that HIV and hepatitis C status are investigated prior to initiation of TNF antagonists. The evaluator’s comments are noted in regards to: Septic shock UCB S.A. considers septic shock a likely outcome of some serious infections (known and well characterized product risk). UCB S.A. respectfully advises that this will not be incorporated as an additional safety concern. Injection site reactions HIV or hepatitis C (important missing information) The Sponsor should add the above risks to the list of ongoing safety concerns. It is important to note that the ACSOM committee supported the inclusion of all the recommended additional safety concerns made by the evaluator. It is recommended that the sponsor justify the exclusion of the ongoing studies from the pharmacovigilance plan relating to PsA and AxSpA UCB has now updated Cimzia to version 9.3; studies are now included in the PV Plan (see page 194). This is acceptable. The sponsor should clarify the exact number of studies included within the pharmacovigilance plan, for example are studies included? Furthermore the milestones for the studies in the pharmacovigilance plan should be clarified. UCB has now updated Cimzia to version 9.3. The pharmacovigilance plan as summarised on p 193 contains: 4 registries (o Pregnancy data collections (ongoing studies, reports and ARTIS and RABBIT) o o Targeted follow-up with reporters with TB questionnaire This is acceptable. RMP RMP marketing
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