Human Drugs View

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)
Pharmacologic Category -
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.
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