Carmustine (BiCNU) Inj 100 mg vial: Hospital medicine issue resolved

Carmustine (BiCNU) was listed with a section 29 endorsement and a new pharmacode 2571234. This was a temporary measure until the product received Medsafe approval following changes to the manufacturing plant.

Update 20 September 2024

Luminarie's registered product is back in stock and back orders have been filled.

There is no stock left of the alternative that we listed, Novadoz.

What's happening

Because of a change to the finished product manufacturing site, Luminarie sent a changed medicine notification (CMN) to Medsafe. 

Initially an unapproved version of BiCNU was supplied to cover this supply issue. This stock ran out, so Pharmac listed the alternative Novadoz.

Affected product

  • Chemical: Carmustine
  • Presentation: Inj 100 mg vial 
  • Brand: BiCNU 
  • Pharmacode: 2571234
  • Subsidy: $710.00
  • Measure / Qty: per 1

Alternative product

This product will be listed from 1 September 2024 and will be available soon after this. This medicine is not Medsafe approved and will need to be prescribed and dispensed in line with section 29 of the Medicines Act. 

  • Pharmacode: 2689375
  • Brand name: Novadoz
  • Pack size: 1 x 100 mg vial
  • Price: $710

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. 

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. 

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)

Resolved mid-September 2024

Luminarie expects back orders for BiCNU to be filled by 13 September 2024.

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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