Clevidipine shortage — AU supply status & alternatives

Clevidipine

ATC C08CA16

🇦🇺 AUST R 203313

In shortage · Australia

CleviprexSingle UseCLEVIPREX clevidipine

In declared shortage · 🇦🇺 Australia & also short in🇨🇦 CA

Critical shortage

Reading today’s signals…

✓ Can I substitute?

Yes — under S19A

TGA-approved overseas product

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

July 2026

Sponsor est. via TGA

Product attributes reference data we hold

Active ingredient (INN)	Clevidipine
Brand names	Cleviprex, Single Use, CLEVIPREX clevidipine

ATC level 4	C08CA

Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper

Controlled substance	No

Registrations on file	2

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

✓

Section 19A approval in force

An overseas-registered product has been approved for supply under Section 19A. See the website and search for the active ingredient: www.tga.gov.au/resources/section-19a-approvals

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

6 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.

Moderate concentration risk

Msn Laboratories Private LTDVeranova LPAlp Pharm Beijing CO LTDChemwerth INCInke SANanjing Libravo Pharmaceutical CO LTD

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders2 registrations

Product	Strength	Form	Market	MA holder	Status
CLEVIPREX clevidipine	25 mg	—	🇦🇺 AU	—	Active
CLEVIPREX clevidipine	50 mg	—	🇦🇺 AU	—	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.