| 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
|