Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS, Online, from 13 February 2024, 10:00 (CET) to 13 February 2024, 11:30 (CET)
Variations not requiring assessment (veterinary medicines)
Focus group on veterinary pharmacovigilance reporting in poultry, European Medicines Agency, Amsterdam, the Netherlands, 11 October 2023
Orphan designation: fidanacogene elaparvovec Treatment of haemophilia B, 19/11/2018 Withdrawn
Orphan designation: Veliparib Treatment of ovarian cancer, 17/12/2010 Withdrawn
Orphan designation: Eflornithine Treatment of neuroblastoma, 27/09/2011 Withdrawn
Orphan designation: Genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor for the treatment of ovarian cancer Treatment of ovarian cancer, 29/04/2014 Withdrawn
Orphan designation: (6aR, 10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydro-cannabinol-9-carboxylic acid Treatment of systemic sclerosis, 12/01/2017 Withdrawn
Orphan designation: Adeno-associated viral vector serotype 9 encoding a codon-optimised human aspartylglucosaminidase transgene Treatment of aspartylglucosaminuria, 19/10/2020 Withdrawn
Orphan designation: (6aR,10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydrocannabinol-9-carboxylic acid- Treatment of cystic fibrosis, 14/10/2016 Withdrawn