Carmustine (BiCNU): Hospital medicine update

Medicine update Hospital only Active

Carmustine (BiCNU) has been listed with a section 29 endorsement and a new pharmacode 2571234. This is a temporary measure until the product receives Medsafe approval after a change to the manufacturing plant.

What's happening

Lumanarie will be supplying a section 29 BiCNU (Pharmacode: 2680556) by mid-June 2024. This is listed in the Pharmaceutical Schedule and HML from 1 June 2024. 

Because of a change to the finished product manufacturing site, Lumanarie sent a changed medicine notification (CMN) to Medsafe. Medsafe is currently evaluating the change to ensure that it does not affect the established quality, safety and efficacy of a registered medicine. 

Affected product

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

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)

Expected resolution

We do not currently have a timeframe for when the product will be officially registered.

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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