evolocumab Auto-Injector
- Brand(s)
- Repatha
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Amgen Inc (2015-09-23)
- Oldest Current Product
- 2015-08-31
- License(s)
- BLA
- RxNORM
- AUTO-INJECTOR\EVOLOCUMAB
- SPL Active
- SUBCUTANEOUS\INJECTION, SOLUTION\EVOLOCUMAB
- SPL Moiety
- SUBCUTANEOUS\INJECTION, SOLUTION\EVOLOCUMAB
product(s) by strength(s)
1 ml evolocumab 140 mg/ml auto-injector
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 555130760 | Repatha | BLA | Amgen Inc | 2015-08-31 | EVOLOCUMAB | SUBCUTANEOUS | INJECTION, SOLUTION | 125522 | 709338ae-ab8f-44a9-b7d5-abaabec3493a |
application(s)
| # | id | title | approved | tradenames | fda division |
|---|---|---|---|---|---|
| 1 | 125522 | evolocumab Application | 2015-08-27 | Repatha | CDER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 709338ae-ab8f-44a9-b7d5-abaabec3493a (view SPL) | These highlights do not include all the information needed to use REPATHA safely and effectively. See full prescribing information for REPATHA . REPATHA (evolocumab) injection, for subcutaneous use Initial U.S. Approval: 2015 | prescription | Human Prescription | Amgen Inc | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-09-23 | 6 | 555130760, 555130750 | evolocumab Prefilled Syringe |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII