Pituitary apoplexy Medication errors Apart from medication errors, there was no new information received during the reporting period for identified or potential risks. Important potential risk Cardiovascular diseases Missing information Use in patients with renal impairment Use in patients with hepatic impairment Use in children Summary of post-marketing data The PBRER concluded that the adverse event profile of leuprorelin acetate has been well established in both clinical studies and in post marketing experience. The product has not been withdrawn or suspended for a safety reason in any country. The safety data remains in accordance with the previous cumulative experience and with the current RSI (CCDS). The content of the report does not change the current positive benefit risk assessment of ELIGARD in its various presentation forms. The report represents information on 238,874 patient years of exposure, and consists of 31 serious ADEs collected from clinical trials and 2,415 ADEs from post marketing sources. This report therefore adds significant support to the assessment of the safety and risk benefit profile of this medicine. The CCDS was in effect at the start of this reporting period included both the palliative treatment indication currently registered in Australia, as well as the extension of indication proposed in this application. The PBRER therefore provides additional information relevant to both the safety and risk benefit of Eligard when used in the extension of indication proposed in this application. Apart from lack of efficacy due to the wrong administration technique, there was no new information relevant to these important identified or potential risks detected during the current reporting period. The conclusion provided in Benefit-Risk Analysis Evaluation section of the PBRER adequately reflects the impact of the information provided in this report on the risk benefit profile of Eligard. The overall appraisal of the benefit risk profile for ELIGARD remains favourable for the approved indication and population (including the proposed extension of indication for Australia). Review of safety data from worldwide sources during the period covered by the revealed no new clinically significant safety signals that warrant an immediate change to the reference safety information (RSI). All known AEs with leuprorelin acetate are listed in the current CCDS and there are no new risks identified other than those currently listed in the CCDS of ELIGARD dated 20 May 2014. The proposed Australian PI reflects the information contained in the CCDS.
Pituitary apoplexy Medication errors Apart from medication errors, there was no new information received during the reporting period for identified or potential risks. Important potential risk Cardiovascular diseases Missing information Use in patients with renal impairment Use in patients with hepatic impairment Use in children Summary of post-marketing data The PBRER concluded that the adverse event profile of leuprorelin acetate has been well established in both clinical studies and in post marketing experience. The product has not been withdrawn or suspended for a safety reason in any country. The safety data remains in accordance with the previous cumulative experience and with the current RSI (CCDS). The content of the report does not change the current positive benefit risk assessment of ELIGARD in its various presentation forms. The report represents information on 238,874 patient years of exposure, and consists of 31 serious ADEs collected from clinical trials and 2,415 ADEs from post marketing sources. This report therefore adds significant support to the assessment of the safety and risk benefit profile of this medicine. The CCDS was in effect at the start of this reporting period included both the palliative treatment indication currently registered in Australia, as well as the extension of indication proposed in this application. The PBRER therefore provides additional information relevant to both the safety and risk benefit of Eligard when used in the extension of indication proposed in this application. Apart from lack of efficacy due to the wrong administration technique, there was no new information relevant to these important identified or potential risks detected during the current reporting period. The conclusion provided in Benefit-Risk Analysis Evaluation section of the PBRER adequately reflects the impact of the information provided in this report on the risk benefit profile of Eligard. The overall appraisal of the benefit risk profile for ELIGARD remains favourable for the approved indication and population (including the proposed extension of indication for Australia). Review of safety data from worldwide sources during the period covered by the revealed no new clinically significant safety signals that warrant an immediate change to the reference safety information (RSI). All known AEs with leuprorelin acetate are listed in the current CCDS and there are no new risks identified other than those currently listed in the CCDS of ELIGARD dated 20 May 2014. The proposed Australian PI reflects the information contained in the CCDS.
auspar-leuprorelin-180905-cer.docx