Orphan designation: Cedazuridine / decitabine Treatment of myelodysplastic syndromes, 16/08/2023 Positive
Orphan designation: Mitazalimab Treatment of pancreatic cancer, 16/08/2023 Positive
Orphan designation: Allogeneic faecal microbiota, pooled Treatment in haematopoietic stem cell transplantation, 16/08/2023 Positive
Orphan designation: alprostadil Treatment of in solid organ transplantation, 16/08/2023 Positive
Union Product Database - FAQs - questions and answers for industry users
Orphan designation: Adeno-associated viral vector serotype rh10 encoding miRNA against SOD1 mRNA Treatment of amyotrophic lateral sclerosis, 08/11/2023 Positive
Orphan designation: Oregovomab Treatment of ovarian cancer, 08/11/2023 Positive
Orphan designation: rucosopasem manganese Treatment of pancreatic cancer, 08/11/2023 Positive
EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information
Orphan designation: 5-bromo-N-(prop-2-yn-1-yl)-2-(1H-1,2,4-triazol-1-yl)pyrimidine-4,6-diamine Treatment of Prader-Willi syndrome, 08/11/2023 Positive