Belimumab — supply status, manufacturers & alternatives

Belimumab

ATC L04AG04

🇦🇺 AUST R 173078 · GlaxoSmithKline Australia Pty Ltd

In supply · Australia

Benlysta

In supply · 🇦🇺 Australia · short in🇨🇦 CA

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

ATC level 5
Active ingredient (INN)	Belimumab
Brand names	Benlysta

ATC level 4	L04AG

Therapeutic category	Auto-created by FDA Drug Enforcement — Full Recall Database scraper

Controlled substance	No

Marketing-authorisation holders	GlaxoSmithKline Australia Pty Ltd

Registrations on file	3

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

—

Dispensed (DPMQ)

—

Pack

—

Not yet captured for Australia

Official pricing isn’t on file for this market yet. PBS (Australia), NHS Drug Tariff (United Kingdom) and CMS NADAC (United States) feeds are prioritised; this panel populates automatically once the data lands.

Substitution pathways 🇦🇺 Australia · TGA

—

No substitution instrument in force

Dispense per normal rules, or refer to the prescriber. No active SSSI/S19A instrument detected for this medicine.

Recalls official enforcement reports

🇦🇺

Belimumab 800mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous InfusionBatch:

Slade Health Pty Ltd · Nov 2025

Class IIdetails ↗

🇺🇸

BENLYSTA

Mckesson Medical-Surgical Inc. Corporate Office · Apr 2025

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders3 registrations · 1 MA holder

Product	Strength	Form	Market	MA holder	Status
BENLYSTA belimumab	400 mg	—	🇦🇺 AU	GlaxoSmithKline Australia Pty Ltd	Active
BENLYSTA belimumab	120 mg	—	🇦🇺 AU	GlaxoSmithKline Australia Pty Ltd	Active
BENLYSTA belimumab	200 mg	—	🇦🇺 AU	GlaxoSmithKline Australia Pty Ltd	Active

For health-professional reference only. Mederti aggregates shortage and substitution information from official regulatory sources. It is not clinical advice and data may be incomplete or delayed. Confirm any substitution or supply decision against the primary regulator source, the prescriber, and current clinical references (e.g. AMH) before acting. Terms.