cipaglucosidase alfa-atga 105 MG Injection
- RxCUI
- 2667440
- RxNorm name
- cipaglucosidase alfa-atga 105 MG Injection
- Display name
- cipaglucosidase alfa-atga 105 MG Injection
- Full name
- cipaglucosidase alfa-atga 105 MG Injection
- Term type
- PSN
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:23
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761204 | Pombiliti | cipaglucosidase alfa-atga | 351(a) | Rx | 2026-08-01 |
UNII Substances#
No records found.
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| POMBILITI ATGA | CIPAGLUCOSIDASE ALFA-ATGA | AMICUS THERAPEUTICS US, LLC | d77aa596-910d-516b-e053-2995a90a0839 | 2026-08-12 | Boxed warning, Warnings, Adverse reactions | 2667440 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| d77aa596-910d-516b-e053-2995a90a0839 | cipaglucosidase alfa-atga 105 MG Injection [PSN] · cipaglucosidase alfa-atga 105 MG Injection [SCD] | 2 | 5 | These highlights do not include all the information needed to use POMBILITI ® safely and effectively. See full prescribing information for POMBILITI. POMBILITI (cipaglucosidase alfa-atga) for injection, for intravenous use Initial U.S. Approval: 2023 | 20241127 |