Pomalidomide shortage — IT supply status & alternatives

Pomalidomide

—

🇦🇺 AUST R 335279 · Juno Pharmaceuticals Pty Ltd

In supply · Australia

Pomalidomide Viatris 1, 2

In supply · 🇦🇺 Australia · short in🇮🇹 IT🇫🇷 FR🇧🇪 BE

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$264.06details →

✓ 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

Brand names	Pomalidomide Viatris 1, 2

Therapeutic category	Auto-created by Agence nationale de sécurité du médicament — Disponibilité scraper

Controlled substance	No

Marketing-authorisation holders	Juno Pharmaceuticals Pty Ltd, Sandoz Pty Ltd, Medicianz Healthcare Pty Ltd, Celgene Pty Ltd

Registrations on file	30

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$264.06

AEMP

Dispensed (DPMQ)

—

incl. fees

Pack

pomalidomide 1 mg capsule, 14

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

14 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

Msn Laboratories Private LTDMatrix Pharmacorp Private LTDOlon SPAHetero Labs LTDSynthon BVNatco Pharma LTD+8 more

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

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Dec 2025

Latest approval

Shortage status by regulator official notices

🇮🇹

Italy

AIFA · 4h ago

Critical

🇫🇷

France

ANSM · 5h ago

High

🇧🇪

FAMHP · 9d ago

Medium

Recalls official enforcement reports

🇮🇹

Pomalidomide Viatris

Viatris Italia Srl · Jan 2025

Class ?details ↗

Verified timeline regulator events

🇮🇹 1 June 2027

Shortage resolved

🇮🇹 1 Dec 2026

Shortage resolved

🇮🇹 1 June 2026

critical reported

🇫🇷 14 Jan 2025

high reported

🇮🇹 19 Dec 2024

critical reported

🇧🇪 13 Dec 2024

medium reported

Sources official regulators

🇮🇹

AIFA

verified 4h ago

verify ↗

🇫🇷

ANSM

verified 5h ago

verify ↗

🇧🇪

FAMHP

verified 9d ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders30 registrations · 4 MA holders

Product	Strength	Form	Market	MA holder	Status
POMOLIDE pomalidomide	2 mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
Jn	1 mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
Juno	4 mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
Jn	4 mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
POMOLIDE pomalidomide	4 mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
Jn	2 mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
Jn	3 mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
Juno	3 mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
POMOLIDE pomalidomide	1 mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
Juno	2 mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
Juno	1 mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
POMOLIDE pomalidomide	3 mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
Sandoz	2 mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active
Sandoz	3 mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active
Sandoz	4 mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active

+15 more registrations on file

Mederti Drug Report

Generated 1 July 2026 · Australia market · 3 regulatory sources

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.