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Product Information
Registration Number BR-411
Generic Name Factor IX Complex
Brand Name Profilnine SD
Dosage Strength 500 IU/5mL%
Dosage Form Iv
Classification Prescription Drug (RX)
Packaging Type I glass vial + Type I pre-filled glass syringe x 5mL (Sterile Water for Injection as diluent) with 1 syringe-vial adapter, 1 infusion set and 2 alcohol swabs (Box of 1's). Single dose.
Pharmacologic Category Plasma Fraction for Specific Use
Manufacturer Grifols Biologicals Inc.
Country of Origin U.S.A
Importer GB Distributors, Inc.
Distributor GB Distributors, Inc.
Application Type Renewal
Issuance Date 09 August 2019
Expiry Date 16 October 2028