Appendix 1: Acceptable intakes established for N-nitrosamines

Orphan designation: 2-{4-[4-(4-{5-[(1S)-1-amino-1-(4-fluorophenyl) ethyl]pyrimidin-2-yl}piperazin-1-yl)pyrrolo[2,1-f] [1,2,4]triazin-6-yl]-1H-pyrazol-1-yl}ethan-1-ol Treatment of mastocytosis, 21/04/2023 Positive

Orphan designation: Escherichia coli, strain Nissle 1917, expressing high affinity phenylalanine transporter, phenylalanine ammonia lyase and L-amino acid deaminase Treatment of hyperphenylalaninaemia, 21/04/2023 Positive

Orphan designation: Autologous blood-derived tumour and hypoxia educated macrophages Treatment of spinal cord injury, 22/05/2023 Positive

Orphan designation: doruxapapogene ralaplasmid Treatment of recurrent respiratory papillomatosis, 22/05/2023 Positive

Aprotinin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/S/0030

Aprotinin : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0030

Multi-annual artificial intelligence workplan 2023-2028: HMA-EMA joint Big Data Steering Group

Submission deadlines for paediatric applications 2024-2026

Orphan designation: H-L-tryphophanyl-L-seryl-glycyl-L-tryptophanyl-L-seryl-L-seryl-L-cysteinyl-L-seryl-L-arginyl-L-seryl-L-cysteinyl-glycyl-OH (disulfide bond), acetate salt Treatment of spinal cord injury, 15/02/2023 Positive