Product Information
Registration NumberBR-1048
Generic NameAgalsidase Beta
Brand NameFabrazyme
Dosage Strength35 mg
Dosage FormPowder for Concentrate for Solution for Infusion (IV)
ClassificationPrescription Drug (RX)
Packaging20 mL Type I glass vial with gray chlorobutyl stopper and aluminum crimp seal (Box of 1's)
Pharmacologic Category-
ManufacturerGenzyme Ireland Limited
Country of OriginIreland
ImporterSanofi-Aventis Philippines, Inc.
Application TypeRenewal
Issuance Date21 November 2023
Expiry Date07 December 2028