Rivaroxaban shortage — AU supply status & alternatives

Rivaroxaban

ATC B01AF01

🇦🇺 AUST R 298198 · Bayer Australia Ltd

In shortage · Australia

Arx-Rivaroxaban

In declared shortage · 🇦🇺 Australia & also short in🇩🇪 DE🇨🇦 CA🇪🇸 ES🇫🇷 FR🇮🇹 IT🇧🇪 BE🇬🇷 GR🇮🇪 IE

Critical shortage

Reading today’s signals…

🇦🇺 AUAEMPA$11.39DPMQ A$38.12details →

• Can I substitute?

No pathway on record

prescriber decision required

⇄ Best alternative

Product attributes reference data we hold

Active ingredient (INN)	Rivaroxaban
Brand names	Arx-Rivaroxaban
ATC level 5	B01AF01
ATC level 4	B01AF
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
Controlled substance	No
Marketing-authorisation holders	Bayer Australia Ltd, Sandoz Pty Ltd, Teva Pharma Australia Pty Ltd, Accord Healthcare Pty Ltd
Registrations on file	18
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$11.39

AEMP

Dispensed (DPMQ)

A$38.12

incl. fees

Pack

rivaroxaban 10 mg tablet, 30

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£1.03

concession

🇺🇸 US

US$19.56

Acquisition

🇮🇹 IT

€43.54

Retail price

🇪🇸 ES

€16.66

Retail price

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

63 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.

Low concentration risk

Micro Labs LTDSms Pharmaceuticals LTDVasudha Pharma Chem LTDZhejiang Tianyu Pharmaceutical CO LTDZaklady Farmaceutyczne Polpharma SAInnovare Labs Private LTD+57 more

Manufacturing countries: India, China, Poland, Germany, United States, Israel, Malta, Canada, Mexico, Taiwan, Malaysia, Spain · Source: FDA List of Drug Master Files

Shortage status by regulator official notices

🇦🇺

Australia

TGA · 1h ago

Critical

🇩🇪

Germany

BfArM · 3d ago

High

🇨🇦

Canada

HC · 1h ago

Medium

🇮🇹

Italy

AIFA · 1d ago

Medium

🇫🇷

France

ANSM · 1d ago

Medium

🇬🇷

EOF · 1d ago

Medium

🇧🇪

FAMHP · 1d ago

Medium

🇮🇪

Ireland

HPRA · 1d ago

Medium

Recalls official enforcement reports

🇺🇸

Rivaroxaban Active Pharmaceutical Ingredient Packaged In Var

Attix Pharmaceuticals · Nov 2014

Class IIdetails ↗

🇺🇸

Rivaroxaban Tablet

Aidapak Services, LLC · July 2013

Class IIdetails ↗

Verified timeline regulator events

🇮🇹 15 July 2026

medium reported

🇮🇪 28 June 2026

medium reported

🇧🇪 19 June 2026

medium reported

🇩🇪 15 June 2026

high reported

🇪🇸 10 June 2026

medium reported

🇧🇪 5 June 2026

medium reported

Sources official regulators

🇨🇦

verified 1h ago

verify ↗

🇦🇺

TGA

verified 1h ago

verify ↗

🇮🇹

AIFA

verified 1d ago

verify ↗

🇫🇷

ANSM

verified 1d ago

verify ↗

🇬🇷

EOF

verified 1d ago

verify ↗

🇧🇪

FAMHP

verified 1d ago

verify ↗

🇮🇪

HPRA

verified 1d ago

verify ↗

🇪🇸

AEMPS

verified 2d ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders18 registrations · 4 MA holders

Product	Strength	Form	Market	MA holder	Status
XARELTO rivaroxaban	2.5 mg	—	🇦🇺 AU	Bayer Australia Ltd	Active
Sandoz	20 mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active
Sandoz	10 mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active
Sandoz	15 mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active
Tv	15 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
Te	20 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
Teva	20 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
Tv	2.5 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
Tv	10 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
Te	2.5 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
Tv	20 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
Teva	15 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
Te	10 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
Teva	10 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
Te	15 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active

+3 more registrations on file

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.