Interferon beta-1a Auto-Injector

Brand(s)
Rebif
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Emd Serono, Inc. (2015-10-07)
Oldest Current Product
2012-12-21
License(s)
BLA
RxNORM
AUTO-INJECTOR\INTERFERON BETA-1A
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\INTERFERON BETA-1A
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\INTERFERON BETA-1A

product(s) by strength(s)

interferon beta-1a 0.044 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1440870188RebifBLAEmd Serono, Inc.2012-12-21INTERFERON BETA-1ASUBCUTANEOUSINJECTION, SOLUTION103780c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f

0.5 ml interferon beta-1a 0.044 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1440873322RebifBLAEmd Serono, Inc.2012-12-21INTERFERON BETA-1ASUBCUTANEOUSINJECTION, SOLUTION103780c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f

0.5 ml interferon beta-1a 0.088 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1440873344RebifBLAEmd Serono, Inc.2012-12-21INTERFERON BETA-1ASUBCUTANEOUSINJECTION, SOLUTION103780c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f

application(s)

#idtitleapprovedtradenamesfda division
1103780interferon beta-1a Application2002-03-07RebifCDER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
1c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f (view SPL)These highlights do not include all the information needed to use REBIF safely and effectively. See full prescribing information for REBIF.REBIF (interferon beta-1a), for subcutaneous injectionInitial U.S. Approval: 1996prescriptionHuman PrescriptionEmd Serono, Inc.2015-10-0711440870188, 440873322, 440873344, 440870022, 440870044, 440878822Interferon beta-1a Prefilled Syringe

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII