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Product Information BR-1383_PI_01.PDF
Registration Number BR-1383
Generic Name Moroctocog Alfa
Brand Name Xyntha
Dosage Strength 500 IU
Dosage Form Lyophilized Powder for Injection (IV)
Classification Prescription Drug (RX)
Packaging Single dose. One box contains Type I glass vial with chlorobutyl rubber stopper and sealed with a flip-off crimp seal + Type I pre-filled glass syringe with bromobutyl rubber plunger and a V-OVS 10.6 closure x 4 mL (0.9% Sodium Chloride as diluent) + plunger rod for assembly, one vial adapter, one sterile infusion set, two alcohol swabs, one bandage, and one gauze.
Pharmacologic Category -
Manufacturer Wyeth Farma, S.A.
Country of Origin Spain
Trader
Importer Pfizer, Inc.
Distributor Pfizer, Inc.
Application Type -
Issuance Date 10 December 2021
Expiry Date 10 December 2026