Naltrexone hydrochloride (Naltrexone AOP) tab 50 mg: Supply issue

Supply issue Active

Teva, the supplier of naltrexone hydrochloride tab 50 mg has advised that it is temporarily out of stock of Naltraccord (Pharmacode 2380374).

Affected product

Schedule listing for naltrexone(external link)

Alternative product

Teva has secured 1,000 packs of an alternative product, Naltrexone AOP (Pharmacode 2664941). The alternative is not Medsafe approved and must be prescribed and dispensed in line with section 29 of the Medicines Act. 

The alternative will be listed on the Pharmaceutical Schedule from 1 October 2023. It is available for ordering. The pack size is 28 tabs per pack and the price is equivalent to the Naltraccord brand (pro rata).

Prescribing and supplying an unapproved medicine

Section 29 of the Medicines Act 1981 allows for medicines that are not Medsafe approved to be prescribed and supplied to people. The medicine must be prescribed by someone registered with the Medical Council of New Zealand – such as, a doctor. 

We know supplying a medicine under section 29 is not ideal. In this case, however, this will allow patients to be able to access an appropriate treatment. 

We apologise for any inconvenience this causes. 

Advice for prescribing under section 29 – BPAC website(external link) 

Prescriber and pharmacist requirements for section 29 medicines – Medsafe website (external link)

Medsafe’s section 29 Declaration / Notification Form [DOC](external link)

What patients need to know about unapproved medicines – Healthify website(external link)

Resupply December 2023

Teva expects Naltraccord to be available again from early December 2023.

Who to contact

If you have questions about this issue, email enquiry@pharmac.govt.nz

Please include as much information as you can about the product (presentation, brand, pharmacode) and who your wholesaler is.  

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