Daratumumab — supply status, manufacturers & alternatives

Daratumumab

ATC L01FC01

🇦🇺 AUST R 322685 · Janssen-Cilag Pty Ltd

In supply · Australia

In supply · 🇦🇺 Australia

In supply in Australia

No active shortage reported.

Reading today’s signals…

🇦🇺 AUAEMPA$554.98details →

✓ 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

Therapeutic category
Active ingredient (INN)	Daratumumab
ATC level 5	L01FC01
ATC level 4	L01FC

Controlled substance	No

Marketing-authorisation holders	Janssen-Cilag Pty Ltd

Registrations on file	3

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 PBS · July 2026

🇦🇺 AU

● Official price on file

Ex-manufacturer

A$554.98

AEMP

Dispensed (DPMQ)

—

incl. fees

Pack

daratumumab 100 mg/5 mL injection, 5 mL vial

Source: PBSEffective July 2026 · AUD

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.

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders3 registrations · 1 MA holder

Product	Strength	Form	Market	MA holder	Status
DARZALEX SC daratumumab	1800 mg	—	🇦🇺 AU	Janssen-Cilag Pty Ltd	Active
DARZALEX daratumumab	400 mg	—	🇦🇺 AU	Janssen-Cilag Pty Ltd	Active
DARZALEX daratumumab	100 mg	—	🇦🇺 AU	Janssen-Cilag 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.