Topotecan Hydrochloride shortage — IT supply status & alternatives

Topotecan Hydrochloride

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In supply · Australia

Topocan

In supply · 🇦🇺 Australia · short in🇮🇹 IT🇺🇸 US🇬🇷 GR

In supply in Australia

Reading today’s signals…

✓ 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

Active ingredient (INN)	Topotecan Hydrochloride
Brand names	Topocan

Controlled substance	No

Marketing-authorisation holders	Accord Healthcare, Inc., PFIZER CANADA ULC, MYLAN PHARMACEUTICALS ULC

Registrations on file	3

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

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Dispensed (DPMQ)

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Pack

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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

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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

Scinopharm Taiwan LTDEmcure Pharmaceuticals LTDNovartis Pharmaceuticals Corp

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

Verified timeline regulator events

🇮🇹 1 Oct 2026

Shortage resolved

🇬🇷 18 Feb 2026

medium reported

🇮🇹 1 Feb 2026

critical reported

🇮🇹 24 Feb 2023

Shortage resolved

🇺🇸 18 June 2021

high reported

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders3 registrations · 3 MA holders

Product	Strength	Form	Market	MA holder	Status
topotecan hydrochloride	4mg/4mL	injection	🇺🇸 US	Accord Healthcare, Inc.	Active
Topotecan Hydrochloride For	—	solution	🇨🇦 CA	PFIZER CANADA ULC	Active
Mylan-Topotecan Hydrochloride For	—	solution	🇨🇦 CA	MYLAN PHARMACEUTICALS ULC	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.