Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2024
Summary of opinion: Abecma, 25/01/2024 Positive
EMA confirms measures to minimise the risk of serious side effects with medicines containing pseudoephedrine
Clinical evaluation of medicinal products intended for treatment of hepatitis B - Scientific guideline
Enpr-EMA Coordinating Group and networks meeting, European Medicines Agency, Amsterdam, the Netherlands, 9 October 2023
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