Important Immune mediated adverse events X - potential For haematological malignancies: risks increased risk of severe complications of allogenic stem cell transplantation in patients who have previously received pembrolizumab Immunogenicity – Safety in patients with moderate Missing – – information or severe hepatic impairment Safety in patients with severe – – renal impairment Safety in patients with active – – systemic autoimmune disease Safety in patients with HIV or – – Hepatitis B or Hepatitis C Safety in paediatric patients - - Reproductive and lactation data * - Safety in various ethnic groups - - ‘n/a’ Potential pharmacodynamic - - interaction with systemic immunosuppressants Missing information: term safety’ has been deleted by the sponsor without adequate justification. ‘Long Key: * Enhanced routine pharmacovigilance with the use of structured targeted follow-up questionnaires X Risk minimisation content in PI/CMI considered to be inadequate Listed by the sponsor in the ASA as ‘n/a’ ‘n/a’ Listed by the sponsor in the ASA as however, listed in the adverse events section of PI. ‘n/a’ ‘n/a’; Pharmacovigilance activities Routine pharmacovigilance is proposed for all concerns, with the use of targeted follow up questionnaires for all the important identified risks and for the important potential risk: syndrome’. ‘Myasthenic Monitoring and analysis of safety data from the ongoing trials is listed as additional pharmacovigilance for all safety concerns; this includes monitoring of immunogenicity which will be assessed in anti-drug antibody assessments. No paediatric investigation plan is described in the Core-RMP with ASA. Risk minimisation activities Routine and additional risk minimisation activities are implemented to mitigate all the important identified risks, including:
Important potential risks Immune mediated adverse events For haematological malignancies: increased risk of severe complications of allogenic stem cell transplantation in patients who have previously received pembrolizumab X - Immunogenicity – Missing information Safety in patients with moderate or severe hepatic impairment – – Safety in patients with severe renal impairment – – Safety in patients with active systemic autoimmune disease – – Safety in patients with HIV or Hepatitis B or Hepatitis C – – Safety in paediatric patients - - Reproductive and lactation data * - Safety in various ethnic groups - ‘n/a’ - Potential pharmacodynamic interaction with systemic immunosuppressants - - Missing information: ‘Long term safety’ has been deleted by the sponsor without adequate justification. Key: * Enhanced routine pharmacovigilance with the use of structured targeted follow-up questionnaires X Risk minimisation content in PI/CMI considered to be inadequate ‘n/a’ Listed by the sponsor in the ASA as ‘n/a’ ‘n/a’ Listed by the sponsor in the ASA as ‘n/a’; however, listed in the adverse events section of PI. Pharmacovigilance activities Routine pharmacovigilance is proposed for all concerns, with the use of targeted follow up questionnaires for all the important identified risks and for the important potential risk: ‘Myasthenic syndrome’. Monitoring and analysis of safety data from the ongoing trials is listed as additional pharmacovigilance for all safety concerns; this includes monitoring of immunogenicity which will be assessed in anti-drug antibody assessments. No paediatric investigation plan is described in the Core-RMP with ASA. Risk minimisation activities Routine and additional risk minimisation activities are implemented to mitigate all the important identified risks, including:
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