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

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

22 November 2023 Update

The registered product has arrived in New Zealand and released by the supplier. It may still take time for the product to make its way through the supply chain to pharmacies around the motu. 

Affected product

Schedule listing for naltrexone(external link)

Alternative product

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

The alternative was listed on the Pharmaceutical Schedule from 1 October 2023. The pack size was 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)

Resupplied November 2023

Teva received a shipment of Naltraccord in November. It has been released to the market. 

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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