Important None identified potential risks Missing Use in children 5 years of – – age Use in elderly 65 years of – – age Use in pregnant and lactating – – women Inflammatory condition in the – – oral cavity# Forced expiratory volume in 1 second (FEV1) < 70% of – – predicted value (adults)# Severe asthma (children)# – – Malignancy or systemic diseases affecting the immune system (for example – – autoimmune diseases, immune complex diseases or immune deficiency diseases)# Children with symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at – – randomisation have been excluded from clinical trials as inter-current infections are a concern at initiation of treatment before the patient has developed tolerance.# Simultaneous immunotherapy with other allergens# – – # indicates safety concerns that were recommended for inclusion by the RMP evaluator, and which the sponsor has committed to including at the next revision of the EU-RMP and ASA. Adequate risk minimisation statements are included in the current version of the PI. New and outstanding recommendations - Round 2 The sponsor has adequately addressed the recommendations made in the trial round RMP evaluation. The sponsor has committed to update the Summary of Safety Concerns in accordance with the recommendations of the RMP evaluator. Specifically, it is noted that the sponsor has committed to add the following safety concerns as missing information:
Important potential risks None identified Missing Use in children 5 years of age – – Use in elderly 65 years of age – – Use in pregnant and lactating women – – Inflammatory condition in the oral cavity# – – Forced expiratory volume in 1 second (FEV1) < 70% of predicted value (adults)# – – Severe asthma (children)# – – Malignancy or systemic diseases affecting the immune system (for example autoimmune diseases, immune complex diseases or immune deficiency diseases)# – – Children with symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomisation have been excluded from clinical trials as inter-current infections are a concern at initiation of treatment before the patient has developed tolerance.# – – Simultaneous immunotherapy with other allergens# – – # indicates safety concerns that were recommended for inclusion by the RMP evaluator, and which the sponsor has committed to including at the next revision of the EU-RMP and ASA. Adequate risk minimisation statements are included in the current version of the PI. New and outstanding recommendations - Round 2 The sponsor has adequately addressed the recommendations made in the round RMP evaluation. The sponsor has committed to update the Summary of Safety Concerns in accordance with the recommendations of the RMP evaluator. Specifically, it is noted that the sponsor has committed to add the following safety concerns as missing information: trial
auspar-phleum-pratense-180403.docx