Discontinuation of Protaphane InnoLet (insulin isophane human)
The Therapeutic Goods Administration (TGA) has made a Serious Scarcity Substitution Instrument (SSSI) to help manage the discontinuation of Protaphane InnoLet (insulin isophane human).
Novo Nordisk has advised the TGA that it will discontinue Protaphane InnoLet on 1 February 2025.
The TGA has implemented an SSSI which allows a pharmacist to dispense Protaphane Penfills in the place of Protaphane InnoLet without prior approval from the prescriber.
The SSSI will be in effect until 28 February 2026. This should give you time to change your patients’ prescriptions to available presentations of insulin medicines.
For detailed information on the SSSI, as well as information on the other insulin presentations that Novo Nordisk are discontinuing, go to: About the discontinuation of Protaphane InnoLet insulin cartridges.
Protaphane Penfill supplied in accordance with the SSSI continue to be subsidised by the PBS.
For more information about SSSIs see Serious Scarcity Substitution Instruments (SSSIs).
Factsheet available here.
Contact the Medicine Shortages Section if you require further information.
Medicine Shortages Section
Pharmacovigilance Branch
Phone: 02 6289 4646
Email: medicine.shortages@health.gov.au
Therapeutic Goods Administration
Department of Health and Aged Care
PO Box 100
Woden ACT 2606
www.tga.gov.au