Product Details for: Rebif
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PRODUCT LABEL
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
22MCG/0.5ML
Pre-Filled Syringe
351(a)
Rebif
Rx
002
Injection
Subcutaneous
44MCG/0.5ML
Pre-Filled Syringe
351(a)
Rebif
Rx
003
Injection
Subcutaneous
8.8MCG/0.2ML
Pre-Filled Syringe
351(a)
Rebif
Rx
004
Injection
Subcutaneous
8.8MCG/0.2ML
Autoinjector
351(a)
Rebif
Rx
005
Injection
Subcutaneous
22MCG/0.5ML
Autoinjector
351(a)
Rebif
Rx
006
Injection
Subcutaneous
44MCG/0.5ML
Autoinjector
351(a)
Rebif
Rx
Proper Name
interferon beta-1a
interferon beta-1a
BLA Number
103780
103780
Applicant
EMD Serono, Inc.
EMD Serono, Inc.
Original Approval Date
March 7, 2002
March 7, 2002
Date of First Licensure