Shortage of FLUDARABINE JUNO fludarabine phosphate 50 mg powder for injection vial (AUST R: 147831) - Extended
Updated: Aug 28
Historical supply notice: This article relates to a previous medicine shortage or regulatory approval. Availability and regulatory status may have changed. Healthcare professionals should contact Pro Pharmaceuticals Group to confirm the current supply position.
For current Australian shortage and supply information, see medicine shortages in Australia.
Dear Healthcare Professional,
Shortage of FLUDARABINE JUNO fludarabine phosphate 50 mg powder for injection vial (AUST R: 147831)
Pro Pharmaceuticals Group recognises the importance of supplying essential medicines in Australia and would like to advise you of the change in supply status of FLUDARABINE JUNO fludarabine phosphate 50 mg powder for injection vial (AUST R: 147831) in Australia.
The Australian registered medicine, FLUDARABINE JUNO fludarabine phosphate 50 mg powder for injection vial (AUST R: 147831) sponsored by Juno Pharmaceuticals Pty Ltd is currently in shortage due to manufacturing issues.
Pro Pharmaceuticals Group has arranged for the supply of an alternative product, Fludarabine Phosphate Injection, USP 50mg/2mL (25mg/mL) Single-Dose Vial (Fresenius Kabi, USA). This product is NOT registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under section 19A of theTherapeutic Goods Act 1989 until 31st January 2027.
For detailed information, including administration instructions and a comparison with the ARTG-listed product, please refer to the attached Dear Healthcare Professional (DHCP) letter approved by the TGA. Please note the UK-sourced alternative now in effect supersedes the USA-sourced product referenced above.
For orders or further information:
1300 077 674
For any regulatory or pharmacovigilance enquiries, please contact: regulatory@propg.com.au
Please circulate this information to the relevant teams within your organisation.
