Human Drugs View

Product Information BR-1429_PI_01.pdf
Registration Number BR-1429
Generic Name Nonacog alfa
Brand Name BeneFIX
Dosage Strength 1000IU
Dosage Form Lyophilized Powder for Solution for Injection (IV)
Classification Prescription Drug (RX)
Pharmacologic Category -
Packaging Single use. One box contains: 10 mL Type I borosilicate glass vial with gray chlorobutyl rubber stopper and aluminum flip-off seal, 5 mL Type I borosilicate pre filled glass syringe with grey bromobutyl rubber plunger stopper and syringe closure (0.234% Sodium Chloride as diluent), vial adapter reconstitution device, infusion set, plaster, gauze pad, and two (2) alcohol swabs.
Manufacturer Wyeth Farma, S.A.
Country of Origin Spain
Trader N/A
Importer Pfizer, Inc.
Distributor Pfizer, Inc.
Application Type Monitored Release (MR)
Issuance Date 08 November 2022
Expiry Date 08 November 2027