Human Drugs View

Product Information BR-862_PI_01.pdf
Registration Number BR-862
Generic Name Belimumab
Brand Name Benlysta
Dosage Strength 120 mg vial Each vial contains a sufficient amount of belimumab to deliver 120 mg in 1.5 mL when reconstituted as recommended with sterile Water for Injections. After reconstitution, each mL of solution contains 80 mg belimumab. 400 mg vial Each vial contains a sufficient amount of belimumab to deliver 400 mg in 5.0 mL when reconstituted as recommended with sterile Water for Injections. After reconstitution, each mL of solution contains 80 mg belimumab.
Dosage Form Powder for Solution for Injection (IV Infusion)
Classification Prescription Drug (Rx)
Pharmacologic Category -
Packaging Single dose. 5 mL (120 mg/vial) USP Type I glass vial with chlorobutyl rubber stopper, sealed with aluminum crimp and flip-off cap (Box of l’s) Single dose. 20 mL (400 mg/vial) USP Type I glass vial with chlorobutyl rubber stopper, sealed with aluminum crimp and flip-off cap (Box of 1’s)
Manufacturer GlaxoSmithKline Manufacturing S.P.A.
Country of Origin Italy
Trader
Importer GlaxoSmithKline Philippines Inc.
Distributor GlaxoSmithKline Philippines Inc.
Application Type Initial
Issuance Date 12 October 2021
Expiry Date 17 April 2025