Please be aware that stock which was originally intended for supply in New Zealand will be distributed in Australia to avoid a disruption in supply of OxyNorm® injection. This will be the case until appropriately packaged product is available for importation in Australia. This applies to OXYNORM® 50MG/1ML solution for infusion ampoule (oxycodone hydrochloride) – batch number: BV656.
The product sourced from New Zealand is exactly equivalent with respect to quality to that approved for supply in Australia in terms of:
- Manufacturing site
- Product specifications
Due to different labelling requirements in Australia and New Zealand, the packaging in New Zealand is different to that in Australia. The key differences between the labelling of the two products are as follows:
- The medicine classification is the same in both countries as controlled drug. However, Class B3 is only applicable to New Zealand labelling.
- The Australian Registration number (AUST R: 152411) is not included on the New Zealand label.
- Mundipharma contact details are specific for each country. Information related to the company address, website and medical information phone number are different.
- The data sheet provided as a pack insert with the medicine is similar in content to the Australian Product information, with differences in the general layout, Dosage and Administration section with sub-heading Posology.
Please discard the enclosed New Zealand Datasheet and refer the Australian PI available here: https://www.mundipharma.com.au/products/prescription-medicines/
The indication is the same.
Please note that, prior to the supply of the New Zealand stock of Oxynorm® injection to the Australian market, approval for this activity was sought and gained from the TGA.
Please do not hesitate to contact Medical Information should you have any queries concerning the stock that you have been supplied.
Our Medical information team is available via email firstname.lastname@example.org or telephone 1800 188 009.