Proper Name: allogeneic processed thymus tissue–agdc
Manufacturer: Enzyvant Therapeutics GmbH
- For immune reconstitution in pediatric patients with congenital athymia.
- Package Insert - RETHYMIC
- Demographic Subgroup Information – allogeneic processed thymus tissue-agdc
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
- October 8, 2021 Approval Letter - RETHYMIC
- October 8, 2021 Summary Basis for Regulatory Action - RETHYMIC
- Approval History, Letters, Reviews, and Related Documents - RETHYMIC