Encorafenib shortage — AU supply status & alternatives

Encorafenib

ATC L01EC03

🇦🇺 AUST R 295441 · Pierre Fabre Australia Pty Ltd

In shortage · Australia

Braftovi

In declared shortage · 🇦🇺 Australia

Critical shortage

Product discontinued / no longer available on the Australian market.

Reading today’s signals…

🇦🇺 AUAEMPA$763.61DPMQ A$7277.37details →

• Can I substitute?

No pathway on record

prescriber decision required

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Encorafenib

Brand names	Braftovi

ATC level 5	L01EC03

ATC level 4	L01EC

Therapeutic category	Canonical INN head (inn_resolution)

Controlled substance	No

Marketing-authorisation holders	Pierre Fabre Australia Pty Ltd

Registrations on file	2

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$763.61

AEMP

Dispensed (DPMQ)

A$7277.37

incl. fees

Pack

encorafenib 50 mg capsule, 28

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.

Global API supply base 🇺🇸 FDA Drug Master Files · active Type II

3 API manufacturers

Manufacturers with an active Type II Drug Master File — i.e. cleared to supply this active ingredient into the US market. A proxy for how concentrated the global manufacturing base is.

High concentration risk

Msn Laboratories Private LTDApitoria Pharma Private LTDValary Lab Private Limited

Manufacturing countries: India · Source: FDA List of Drug Master Files

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders2 registrations · 1 MA holder

Product	Strength	Form	Market	MA holder	Status
BRAFTOVI encorafenib	75 mg	—	🇦🇺 AU	Pierre Fabre Australia Pty Ltd	Active
BRAFTOVI encorafenib	50 mg	—	🇦🇺 AU	Pierre Fabre 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.