C1 esterase inhibitor Injectable Solution
- Brand(s)
- Berinert, Cinryze, Ruconest
- Category(s)
- other, prescription
- SPL Type(s)
- Human Prescription, Plasma Derivative
- Master SPL
- Csl Behring Gmbh (2015-09-14)
- Oldest Current Product
- 2008-12-01
- License(s)
- BLA
- RxNORM
- INJECTABLE SOLUTION\C1 ESTERASE INHIBITOR
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CONESTAT ALFA
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HUMAN C1-ESTERASE INHIBITOR - SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CONESTAT ALFA
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HUMAN C1-ESTERASE INHIBITOR
product(s) by strength(s)
c1 esterase inhibitor (human) 100 unt/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 422270081 | Cinryze | BLA | Viropharma Biologics | 2008-12-01 | HUMAN C1-ESTERASE INHIBITOR | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 125267 | d53a911f-070d-498a-8a61-baab72b9d0fe |
c1 esterase inhibitor (human) 50 unt/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | application | spl |
|---|---|---|---|---|---|---|---|
| 1 | 638330825 | Berinert | BLA | Csl Behring Gmbh | 2011-12-22 | 125287 | 8ea0c7fe-da9d-4218-a080-0509e09bedc6 |
c1 esterase inhibitor (recombinant) 150 unt/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 680120350 | Ruconest | BLA | Santarus, Inc. | 2014-09-22 | CONESTAT ALFA | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | 125495 | 6f8b81df-48fe-4798-8d54-fc8f65888489 |
application(s)
| # | id | title | approved | tradenames | fda division |
|---|---|---|---|---|---|
| 1 | 125267 | C1 Esterase Inhibitor (Human) Application | 2008-10-10 | Cinryze | CBER |
| 2 | 125287 | C1 Esterase Inhibitor (Human) Application | 2009-10-09 | Berinert | CBER |
| 3 | 125495 | C1 Esterase Inhibitor (Recombinant) Application | 2014-07-16 | RUCONEST | CBER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 6f8b81df-48fe-4798-8d54-fc8f65888489 (view SPL) | These highlights do not include all the information needed to use RUCONEST safely and effectively. See full prescribing information for RUCONEST. RUCONEST (C1 esterase inhibitor [recombinant])For Intravenous Use, Lyophilized Powder For Reconstitution Initial U.S. Approval: 2014 | prescription | Human Prescription | Santarus, Inc. | API MANUFACTURE | 2014-12-10 | 12 | 680120350 |
| 2 | 8ea0c7fe-da9d-4218-a080-0509e09bedc6 (view SPL) | These highlights do not include all the information needed to use Berinert safely and effectively. See full prescribing information for Berinert. Berinert [C1 Esterase Inhibitor (Human)] For intravenous use. Freeze-Dried Powder for Reconstitution. Initial U.S. Approval: 2009 | other | Plasma Derivative | Csl Behring Gmbh | MANUFACTURE | 2015-09-14 | 20 | 638330825 |
| 3 | d53a911f-070d-498a-8a61-baab72b9d0fe (view SPL) | These highlights do not include all the information needed to use CINRYZE safely and effectively. See full prescribing information for CINRYZE. CINRYZE (C1 Esterase Inhibitor [Human]) For Intravenous Use, Freeze-Dried Powder for ReconstitutionInitial U.S. Approval: 2008 | other | Plasma Derivative | Viropharma Biologics | ANALYSIS, LABEL, MANUFACTURE, PACK | 2014-11-13 | 23 | 422270081 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII