Section 19A medicines subsidised by the Pharmaceutical Benefits Scheme
In the event of a medicine shortage, a provision under section 19A of the Therapeutic Goods Act 1989 allows for temporary approvals to be granted for the import or supply of a brand of medicine that is not registered on the Australian Register of Therapeutic Goods, which could act as a substitute for the medicine that is unavailable or in short supply. A list of section 19A medicines approved for supply are available on the TGA website.
Where possible, the Australian Government works with medicine sponsors to organise PBS subsidised access to section 19A medicines.
Provided below is a list of section 19A medicines currently subsidised by the Pharmaceutical Benefits Scheme (PBS).
Applying for PBS listing of section 19A product
If the brand, drug, form, manner of administration and responsible person of the section 19A medicine are all the same as the PBS listed product in short supply, then the section 19A medicine is a ‘pharmaceutical benefit’ as defined in the National Health Act 1953 and may be subsidised under the existing PBS listing. The responsible person of a section 19A medicine must be the sponsor for whom the TGA approval is granted. Please note that the list below does not include section 19A medicines that are subsidised in this way and have not been considered by the Pharmaceutical Benefits Advisory Committee.
Where the brand, drug, form, manner of administration and responsible person of the section 19A medicine are not all the same as the PBS listing in short supply, sponsors must submit an application to list the item on the PBS.
From 1 July 2026, sponsors must submit s19A applications through the Health Products Portal (HPP).
When logged into HPP, sponsors can select and lodge a section 19A application. The system will guide users through the application process, including mandatory fields and pre-filled information where available.
- Access HPP: Sign in · Health Products Portal
- For first-time users registering an organisation in the Health Products Portal (HPP), refer to the guide here: Registering an organisation in the HPP · Health Products Portal.
For any extension or renewal of a current or lapsed section 19A product, sponsors must submit a new application for the Department’s consideration. Applications for extensions and renewals must be submitted through HPP.
If you have any questions regarding s19A applications, please contact the s19A team at s19A.PBS@health.gov.au.
For technical support with the HPP system, or if you do not have access to the HPP system, please contact the HPP Support Team at HPP.support@health.gov.au.
There are no cost recovery fees associated with the temporary listing of a section 19A item.
In addition to listing section 19A medicines to manage medicine shortages, the Department also works to implement PBS subsidy arrangements for TGA issued Serious Scarcity Substitution Instruments. Further information is available at PBS subsidy arrangements for medicines subject to a Serious Scarcity Substitution Instrument.
|
Section 19A medicine |
Section 19A Responsible person |
TGA Section 19A approval |
Date PBS listed |
Notes |
|---|---|---|---|---|
|
Cyclophosphamide (Northstar, USA) Powder for injection 2 g (NorthStar, USA) (s19A) |
Reach Pharmaceuticals Pty Ltd |
Cyclophosphamide for injection, USP 2 grams powder for injection vial (NorthStar Rx, USA) |
1 July 2026 |
|
|
Benzylpenicillin benzathine (Brancaster Pharma, UK) Powder for injection 1,200,000 units (s19A) |
Pro Pharmaceuticals Group Pty Ltd |
1 July 2026 |
||
|
Phenobarbital Tablets, USP 30 mg (Rising Pharmaceuticals, USA) Tablet 30 mg (s19A) |
Medsurge Healthcare Pty Ltd |
Phenobarbital Tablets, USP 30mg (Rising Pharmaceuticals, USA) |
1 July 2026 |
|
|
Salbutamol (as sulfate) (Accord, UK) Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 20 (s19A) |
The Trustee for ORSPEC PHARMA UNIT TRUST |
Salbutamol (as sulfate) 5mg/2.5ml Nebuliser Solution ampoule (Accord, UK) |
1 May 2026 |
|
|
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablet 600mg/200 mg/300 mg (Camber, USA) Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg (s19A) |
Pro Pharmaceuticals Group Pty. Ltd. |
1 March 2026 |
|
|
|
Tablet 600 mg (Korea) (s19A) |
Link Medical Products Pty Ltd |
1 March 2026 |
|
|
|
Tablet containing methylphenidate hydrochloride 27 mg (modified release) (Spain) (S19A) |
Arrotex Pharmaceuticals Pty Ltd |
ATENZA methylphenidate hydrochloride 27mg prolonged-release tablets (Spain) |
1 January 2026 |
Supply only till 30 November 2026 |
|
Tablet containing methylphenidate hydrochloride 54 mg (modified release) (Spain) (S19A) |
Arrotex Pharmaceuticals Pty Ltd |
ATENZA methylphenidate hydrochloride 54mg prolonged-release tablets (Spain) |
1 January 2026 |
Supply only till 30 November 2026 |
|
Fludarabine Phosphate Injection, USP 50 mg/2mL (Areva, USA) Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL (s19A) |
Pro Pharmaceuticals Group Pty Ltd |
Fludarabine Phosphate Injection, USP 50 mg/2mL (25 mg/mL) Single-Dose Vial (Areva, USA) |
1 January 2026 |
|
|
Praziquantel tablets, USP 600 mg (Endo, USA) Tablet 600 mg (s19A) |
Pro Pharmaceuticals Group Pty Ltd |
1 January 2026 |
|
|
|
Powder for injection 5,000 units with solvent (s19A) |
Medsurge Healthcare Pty Ltd |
1 January 2026 |
|
|
|
Ritalin LA 10 mg (Switzerland) Capsule containing methylphenidate hydrochloride 10 mg (modified release) (Switzerland)(S19A) |
Phero Pharma Pty Ltd |
RITALIN LA methylphenidate hydrochloride 10mg capsules (Switzerland) |
1 November 2025 |
|
|
Ritalin LA 20 mg (Switzerland) Capsule containing methylphenidate hydrochloride 20 mg (modified release) (Switzerland) (s19A) |
Phero Pharma Pty Ltd |
RITALIN LA methylphenidate hydrochloride 20mg capsules (Switzerland) |
1 November 2025 |
|
|
Ritalin LA 30 mg (Switzerland) Capsule containing methylphenidate hydrochloride 30 mg (modified release) (Switzerland) (s19A) |
Phero Pharma Pty Ltd |
RITALIN LA methylphenidate hydrochloride 30mg capsules (Switzerland) |
1 November 2025 |
|
|
Ritalin LA 40 mg (Switzerland) Capsule containing methylphenidate hydrochloride 40 mg (modified release) (Switzerland) (s19A) |
Phero Pharma Pty Ltd |
RITALIN LA methylphenidate hydrochloride 40mg capsules (Switzerland) |
1 November 2025 |
|
|
Capsule 100 mg (S19A) |
ORSPEC Pharma Pty Ltd |
1 November 2025 |
||
|
Clopidogrel Tablets, USP 75 mg (Novadoz, USA) Tablet 75 mg (as bisulfate) (Novadoz, USA) (S19A) |
Phero Pharma Pty Ltd |
1 November 2025 |
||
|
Clopidogrel Tablets, USP 75 mg (Aurobindo, USA) Tablet 75 mg (as bisulfate) (Aurobindo, USA) (S19A) |
Link Medical Products Pty Ltd |
1 November 2025 |
||
|
Powder for injection 1,200,000 units with diluent 4 mL (S19A) |
Neon Healthcare Pty Limited |
1 September 2025 |
||
|
Injection 135 micrograms in 0.5 mL single use pre-filled syringe (s19A) |
Echo Therapeutics Pty Ltd |
PEGASYS peginterferon alfa-2a 135 micrograms/0.5mL injection pre-filled syringe (Ireland) |
1 September 2025 |
|
|
Injection 180 micrograms in 0.5 mL single use pre-filled syringe (s19A) |
Echo Therapeutics Pty Ltd |
PEGASYS peginterferon alfa-2a 180 micrograms/0.5mL injection pre-filled syringe (Ireland) |
1 September 2025 |
|
|
Azithromycin Tablets, USP 500 mg (Precision Dose, USA) Tablet 500 mg (as dihydrate) (s19A) |
Reach Pharmaceuticals Pty Ltd |
1 July 2025 |
||
|
Prazosin Hydrochloride Capsules, USP 1 mg (Novitium Pharma, USA) |
Medsurge Healthcare Pty Ltd |
Prazosin hydrochloride capsules, USP 1mg (Novitium Pharma, USA) |
1 May 2025 |
|
|
Estramon (Germany, Sandoz) |
Sandoz Pty Ltd |
ESTRAMON estradiol 100 micrograms/24 hours transdermal patch (Hexal, Germany) |
1 March 2025 |
This product is NOT a-flagged to Estradot 100, Estradiol Transdermal System (Sandoz, USA) and Estraderm MX 100 |
|
Estramon (Germany, Sandoz) |
Sandoz Pty Ltd |
ESTRAMON estradiol 25 microgram/24 hours transdermal patch (Hexal, Germany) |
1 February 2025 |
|
|
Estramon (Germany, Sandoz) |
Sandoz Pty Ltd |
ESTRAMON estradiol 50 microgram/24 hours transdermal patch (Hexal, Germany) |
1 February 2025 |
|
|
Estramon (Germany, Sandoz) |
Sandoz Pty Ltd |
ESTRAMON estradiol 75 microgram/24 hours transdermal patch (Hexal, Germany) |
1 February 2025 |
|
|
Single dose pack containing powder for irrigation 30 mg, 4 vials(s19A) |
Link Medical Products Pty Ltd |
VesiCulture BCG 30mg/vial powder for bladder irrigation (AJ Vaccines) |
1 January 2025 |
|
|
OVIDREL (USA) |
Merck Healthcare Pty Ltd |
OVIDREL choriogonadotropin alfa 250 mcg / 0.5mL solution for injection pre-filled syringe (USA) |
1 November 2024 |
|
|
Cefuroxime Powder for oral suspension 125 mg (as axetil) per 5 mL, 70 mL (S19A) |
Reach Pharmaceuticals Pty Ltd |
ZINNAT Cefuroxime axetil 125 mg/5 mL granules for oral suspension (UK) |
01 October 2023 |
This product is not a-flagged to Zinnat |
|
Tablet containing imipramine hydrochloride 25 mg (s19A), |
Pro Pharmaceuticals Group Pty. Ltd. |
Imipramine Hydrochloride Tablets, USP, 25mg 100 tablets (Leading Pharma, LLC) |
1 July 2022 |
|
|
Injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3 (s19A) |
Medsurge Healthcare Pty Ltd |
1 March 2022 |
|
|
|
Oral solution containing hydromorphone hydrochloride 1 mg per mL, 473 mL |
Link Medical Products Pty Ltd |
HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION 1mg/mL USP 473mL (Hikma)
|
1 December 2021 |
A-flagged to s19A medicine HYDROmorphone Hydrochloride 1mg/mL oral solution, USP 473mL (Rhodes) and NOT a-flagged to Dilaudid. |
|
Hydromorphone, oral solution containing hydromorphone hydrochloride 1 mg per mL, 473 mL |
Medsurge Healthcare Pty Ltd |
HYDROmorphone Hydrochloride 1mg/mL oral solution, USP 473mL (Rhodes) |
1 July 2021 |
This product is not a-flagged to Dilaudid. |
|
Oral liquid 50 mg per mL, 100 mL |
Douglas Pharmaceuticals Australia Pty Ltd |
VERSACLOZ clozapine 50 mg/mL oral suspension (TruPharma, USA) |
1 August 2018 |
|
|
Injection containing naloxone hydrochloride 2 mg in 2 mL pre-filled syringe |
Phebra Pty Ltd |
PRENOXAD 1mg/mL Solution for Injection in a pre-filled syringe (naloxone hydrochloride) |
1 April 2017 |
|
|
Capsule 3 mg |
Boucher & Muir Pty Ltd |
1 October 2017 |
|
|
|
Phenoxybenzamine, capsules containing phenoxybenzamine hydrochloride 10 mg, 30 |
Amdipharm Mercury (Australia) Pty Limited |
1 March 2016 |
||
|
Injection set containing 550 micrograms with diluent |
Stallergenes Australia Pty Ltd |
HYMENOPTERA VENOM PRODUCT - Wasp Venom Protein (550 MCG) powder for solution |
1 February 2016 |
|