Product Details for: Pegasys Copegus Combination Pack
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
180MCG/0.5ML & 800MG
351(a)
Pegasys Copegus Combination Pack
Disc
002
180MCG/0.5ML &1000MG
351(a)
Pegasys Copegus Combination Pack
Disc
003
180MCG/0.5ML & 1200MG
351(a)
Pegasys Copegus Combination Pack
Disc
Proper Name
peginterferon alfa-2a and ribavirin
peginterferon alfa-2a and ribavirin
BLA Number
125083
125083
Applicant
Hoffmann-La Roche Inc.
Hoffmann-La Roche Inc.
Original Approval Date
June 4, 2004
June 4, 2004
Date of First Licensure