Shortage of CYSTAGON mercaptamine (cysteamine) 150 mg capsules – Alternative UK supply available under Section 19A

Dear Healthcare Professional,

Shortage of CYSTAGON mercaptamine (cysteamine) (as bitartrate) 150 mg capsule bottle (AUST R: 60452)

Pro Pharmaceuticals Group recognises the importance of maintaining access to essential medicines in Australia and would like to advise healthcare professionals of an alternative supply arrangement for CYSTAGON 150 mg capsules.

The Australian-registered medicine, CYSTAGON mercaptamine (cysteamine) (as bitartrate) 150 mg capsule bottle (AUST R: 60452), sponsored by Alphapharm Pty Ltd, is currently in shortage.

Pro Pharmaceuticals Group has arranged supply of an alternative product:

CYSTAGON cysteamine (as mercaptamine bitartrate) 150 mg hard capsules (UK).

This product is not registered in Australia. Its importation and supply have been authorised by the Therapeutic Goods Administration under section 19A of the Therapeutic Goods Act 1989.

The Section 19A approval is effective from 28 July 2026 until 30 November 2026. The approved indication is:

Management of nephropathic cystinosis in children and adults. 

The UK product is registered and marketed in the United Kingdom by Recordati Rare Diseases.

Important pack-size difference

The Australian-registered product is supplied in a bottle containing 500 capsules.

The UK Section 19A product is supplied in a bottle containing 100 capsules.

Healthcare professionals should take this pack-size difference into account when prescribing, ordering, dispensing and managing continuity of treatment.

For detailed product information, prescribing guidance and the comparison with the Australian-registered medicine, please refer to the TGA-approved Dear Healthcare Professional letter and accompanying product information.

For orders or further information

Email: orders@propg.com.auPhone: 1300 077 674Website: www.propg.com.au

For regulatory, pharmacovigilance or product-quality enquiries:

Email: regulatory@propg.com.au

Please circulate this information to the relevant pharmacy, nephrology, metabolic medicine, paediatric, procurement and clinical teams within your organisation.