adapting of the dose to the patient’s needs D.) Inclusion of the Therapeutic Monitoring information within the Precautions section of the Australian PI. All these activities are considered routine risk minimisation activities and therefore, should be removed from the pharmacovigilance section and included in the risk minimisation plan section of the ASA. Furthermore, the sponsor should provide further clarification as to how the awareness of physicians will be raised, as mentioned in point A.), above. 9. The statement Table 16 The sponsor refers to A surveillance protocol in the EU-RMP should be Section 5.1 Risk constitutes an additional amended to describe that minimization measures by pharmacovigilance of pregnancy and safety concern has been activity, not an additional ‘Effects foetal outcomes’ is the only updated, where Table 5.1.1 risk minimisation ongoing safety concerns, for Risk minimization activity. Consequently, which additional measures: pregnancy and Table 5.1.1, and any pharmacovigilance activities breast-feeding has included other table as required, are carried out, in form of a the US surveillance protocol should be amended to surveillance protocol. which included exposure describe that no during pregnancy and additional risk assessment of foetal minimisation activity is outcomes as a means to carried out for the risk of assess the effectiveness risk and ‘pregnancy minimization measure. but that an additional pharmacovigilance activity is carried out. This recommendation remains. 10. It is recommended that the In response to the This is considered sponsor amends the EU-RMP recommendation above, the acceptable. to include information sponsor refers to Section regarding the potential for 2.6.4 potential for medical medication errors. errors within the updated EU-RMP which addresses
adapting of the dose to the patient’s needs D.) Inclusion of the Therapeutic Monitoring information within the Precautions section of the Australian PI. All these activities are considered routine risk minimisation activities and therefore, should be removed from the pharmacovigilance section and included in the risk minimisation plan section of the ASA. Furthermore, the sponsor should provide further clarification as to how the awareness of physicians will be raised, as mentioned in point A.), above. 9. The statement Table 16 in the EU-RMP should be amended to describe that ‘Effects of pregnancy and foetal outcomes’ is the only ongoing safety concerns, for which additional pharmacovigilance activities are carried out, in form of a surveillance protocol. The sponsor refers to Section 5.1 Risk minimization measures by safety concern has been updated, where Table 5.1.1 Risk minimization measures: pregnancy and breast-feeding has included the US surveillance protocol which included exposure during pregnancy and assessment of foetal outcomes as a means to assess the effectiveness risk minimization measure. A surveillance protocol constitutes an additional pharmacovigilance activity, not an additional risk minimisation activity. Consequently, Table 5.1.1, and any other table as required, should be amended to describe that no additional risk minimisation activity is carried out for the risk of ‘pregnancy and but that an additional pharmacovigilance activity is carried out. This recommendation remains. 10. It is recommended that the sponsor amends the EU-RMP to include information regarding the potential for medication errors. In response to the recommendation above, the sponsor refers to Section 2.6.4 potential for medical errors within the updated EU-RMP which addresses This is considered acceptable.
auspar-carglumic-acid-150902.docx