on a MAOI’. It is determination by the recommended that the Delegate. Delegate considers the adequacy of PI in the context of the information provided for products in the same class. Depression, suicidal ideation and behaviour: the approved PIs for other SNRIs in Australia appear to contain the following additional advice: for ‘Prescriptions (product name) should be written for the smallest quantity of tablets consistent with good patient management, in order to It reduce the risk of overdose.’ is recommended that the Delegate considers the adequacy of PI in the context of the information provided for products in the same class. Angle closure glaucoma: ‘The pupillary dilation that occurs following use of many antidepressant drugs including FETZIMA® may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.’ The wording is confusing as patent iridectomy is a procedure, not a state or a condition. Summary of recommendations It is considered that the sponsor’s response to the TGA has adequately addressed most of the issues identified in the RMP evaluation report. Outstanding issues are detailed below. Outstanding issues Issues in relation to the RMP Details on the following outstanding issues are provided in 14 above. Recommendation 1: The nonclinical evaluation report has made several recommendations to the safety specification of the RMP. The sponsor should update the RMP documents as recommended.
on a MAOI’. It is recommended that the Delegate considers the adequacy of PI in the context of the information provided for products in the same class. Depression, suicidal ideation and behaviour: the approved PIs for other SNRIs in Australia appear to contain the following additional advice: ‘Prescriptions for (product name) should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.’ It is recommended that the Delegate considers the adequacy of PI in the context of the information provided for products in the same class. Angle closure glaucoma: ‘The pupillary dilation that occurs following use of many antidepressant drugs including FETZIMA® may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.’ The wording is confusing as patent iridectomy is a procedure, not a state or a condition. determination by the Delegate. Summary of recommendations It is considered that the sponsor’s response to the TGA has adequately addressed most of the issues identified in the RMP evaluation report. Outstanding issues are detailed below. Outstanding issues Issues in relation to the RMP Details on the following outstanding issues are provided in 14 above. Recommendation 1: The nonclinical evaluation report has made several recommendations to the safety specification of the RMP. The sponsor should update the RMP documents as recommended.
auspar-levomilnacipran-161213.docx