where it appears the EU SmPC is more restrictive. A table summarising the The sponsor states: This is “Tables pharmacovigilance and summarising planned generally risk minimisation activities pharmacovigilance actions acceptable, for all of the specified (see section 1.13.1 although ongoing safety concerns Australian Specific Annex, Table 3.2: and missing information 3.2) and risk minimisation ‘Safety proposed for Australia activities (see section 1.13.1 concerns and should be included in the Australian Specific Annex, overview of revised ASA. Annex 1) for all safety planned concerns proposed for Australia have been actions’ included in the revised ASA”. is included in Section 3: ‘Risk Minimisation Plan’ of the ASA. This table should logically be relocated to Section 2: Practice’ of the ASA or included as a separate annex to the ASA. This amendment to the ASA can be dealt with when this document is next updated. In regard to the proposed [information redacted] The This is routine risk minimisation distribution and supply of generally activities, it is blood products are managed acceptable, recommended to the by the NBA. In the case of although the Delegate that the draft PI Albunate being supplied, an sponsor document be revised to appropriate communication should include a precautionary plan would be prepared and explicitly statement to the effect that provided to all stakeholders include such the Albunate product (including the NBA, the an assurance range is not ARCBS and clinicians). in a revised interchangeable with Therefore CSL Behring does ASA, including Albumex product range, not propose to include the provision which may be statements about to the TGA of to the dosage the details of
where it appears the EU SmPC is more restrictive. A table summarising the pharmacovigilance and risk minimisation activities for all of the specified ongoing safety concerns and missing information proposed for Australia should be included in the revised ASA. The sponsor states: “Tables summarising planned pharmacovigilance actions (see section 1.13.1 Australian Specific Annex, 3.2) and risk minimisation activities (see section 1.13.1 Australian Specific Annex, Annex 1) for all safety concerns proposed for Australia have been included in the revised ASA”. This is generally acceptable, although Table 3.2: ‘Safety concerns and overview of planned actions’ is included in Section 3: ‘Risk Minimisation Plan’ of the ASA. This table should logically be relocated to Section 2: Practice’ of the ASA or included as a separate annex to the ASA. This amendment to the ASA can be dealt with when this document is next updated. In regard to the proposed routine risk minimisation activities, it is recommended to the Delegate that the draft PI document be revised to include a precautionary statement to the effect that the Albunate product range is not interchangeable with Albumex product range, which may be to the dosage [information redacted] The distribution and supply of blood products are managed by the NBA. In the case of Albunate being supplied, an appropriate communication plan would be prepared and provided to all stakeholders (including the NBA, the ARCBS and clinicians). Therefore CSL Behring does not propose to include statements about This is generally acceptable, although the sponsor should explicitly include such an assurance in a revised ASA, including the provision to the TGA of the details of