Dabrafenib — supply status, manufacturers & alternatives

Dabrafenib

ATC L01EC02

🇦🇺 AUST R 397093 · Novartis Pharmaceuticals Australia Pty Ltd

In supply · Australia

Tafinlar

In supply · 🇦🇺 Australia

In supply in Australia

No active shortage reported.

Reading today’s signals…

🇦🇺 AUAEMPA$3264.44DPMQ A$6814.82details →

✓ Can I substitute?

In supply

no shortage substitution needed

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)

Brand names	Tafinlar

ATC level 5	L01EC02

ATC level 4	L01EC

Therapeutic category	Auto-created by National Organisation for Medicines — Drug Shortages scraper

Controlled substance	No

Marketing-authorisation holders	Novartis Pharmaceuticals Australia 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$3264.44

AEMP

Dispensed (DPMQ)

A$6814.82

incl. fees

Pack

dabrafenib 10 mg dispersible tablet, 2 x 210

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

Valary Lab Private LTDMsn Laboratories Private LTDGuangdong Raffles Pharmatech CO LTD

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders3 registrations · 1 MA holder

Product	Strength	Form	Market	MA holder	Status
TAFINLAR dabrafenib	10 mg	—	🇦🇺 AU	Novartis Pharmaceuticals Australia Pty Ltd	Active
TAFINLAR dabrafenib	75 mg	—	🇦🇺 AU	Novartis Pharmaceuticals Australia Pty Ltd	Active
TAFINLAR dabrafenib	50 mg	—	🇦🇺 AU	Novartis Pharmaceuticals 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.