Details of the certification process are included in the amended ASA, Module 1.8.2 Risk Management Plan for Australia. The sponsor should provide Certification will be restricted to This is acceptable details as to which groups of from an RMP urologists and sexual health medical practitioners will be physicians. perspective. able to access the Peyronie’s training. The Australian PI should The sponsor acknowledges the This is acceptable contain the following recommendations of the from an RMP clinically relevant statement perspective. evaluator and has amended the appears in the EU AU PI accordingly. Summary of Product The new text will appear in the Characteristics (SmPC): PI amendments are Clinical trials section of the AU subject to Patients with penile curvature PI. The AU PI has been amended approval by the >90° were not included in the so that the clinical section Delegate. clinical studies. Treatment in contains this additional this group can therefore not statement be recommended. Patients with penile curvature >90° were not included in the clinical studies. Treatment in this group can therefore not be recommended The amended AU PI was provided. It is noted that the EU SmPC Each pack of Xiaflex will contain The sponsor’s contains a detailed two inserts: one for the treating approach is description of the penile physician and one (CMI) for the acceptable from an modelling procedure patient. RMP perspective. however the proposed PI The physician's insert will does not. The Delegate contain the PI and an integrated should consider inclusion of "Physician's Guide". The this information in the PI if Physician's Guide will contain appropriate. detailed information regarding the preparation and reconstitution of Xiaflex, administration of the injection as well as information on the penile modelling procedure. The CMI insert will contain detailed information on the penile modelling procedure as well as other text normally required in the CMI. The Physician leaflet was provided. The EU SmPC contains the The sponsor acknowledges the This is acceptable following clinically relevant from an RMP recommendations of the perspective.
Details of the certification process are included in the amended ASA, Module 1.8.2 Risk Management Plan for Australia. The sponsor should provide details as to which groups of medical practitioners will be able to access the Peyronie’s training. Certification will be restricted to urologists and sexual health physicians. This is acceptable from an RMP perspective. The Australian PI should contain the following clinically relevant statement appears in the EU Summary of Product Characteristics (SmPC): Patients with penile curvature >90° were not included in the clinical studies. Treatment in this group can therefore not be recommended. The sponsor acknowledges the recommendations of the evaluator and has amended the AU PI accordingly. The new text will appear in the Clinical trials section of the AU PI. The AU PI has been amended so that the clinical section contains this additional statement Patients with penile curvature >90° were not included in the clinical studies. Treatment in this group can therefore not be recommended The amended AU PI was provided. This is acceptable from an RMP perspective. PI amendments are subject to approval by the Delegate. It is noted that the EU SmPC contains a detailed description of the penile modelling procedure however the proposed PI does not. The Delegate should consider inclusion of this information in the PI if appropriate. Each pack of Xiaflex will contain two inserts: one for the treating physician and one (CMI) for the patient. The physician's insert will contain the PI and an integrated "Physician's Guide". The Physician's Guide will contain detailed information regarding the preparation and reconstitution of Xiaflex, administration of the injection as well as information on the penile modelling procedure. The CMI insert will contain detailed information on the penile modelling procedure as well as other text normally required in the CMI. The Physician leaflet was provided. The sponsor’s approach is acceptable from an RMP perspective. The EU SmPC contains the following clinically relevant The sponsor acknowledges the recommendations of the This is acceptable from an RMP perspective.
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