Levomepromazine (Nozinan) Injections: Supply issue

Supply issue Active

The supplier has advised there is an issue with supply of levomepromazine hydrochloride (Nozinan), Pharmacode: 549142.

22 September 2022: Details about the formulation differences added. Resupply date removed. 

Affected product

Due to delays with the manufacturer of levomepromazine hydrochloride, there is an out of stock of levomepromazine hydrochloride (Nozinan) Inj 25 mg per ml, 1 ml ampoule (Pharmacode 549142).

Schedule listing for Nozinan(external link)

Resupply

Resupply of the registered brand of levomepromazine has been delayed. We are working with the supplier to ascertain a new resupply date.

Alternative product

A new section 29 brand of Nozinan is listed from 1 September 2022.

  • Brand: Nozinan S29 
  • Presentation: Inj 25 mg per ml, 1 ml ampoule
  • Pharmacode: 2642840
  • Subsidy: $16.75
  • Measure / Qty: per 5

Schedule listing for Nozinan s29(external link)

Supplies of the previous alternative product (Neuraxpharm | 2640457) were limited. The listing will remain for some time to allow for all product to move through the supply chain. 

Schedule listing for Neuraxpharm(external link)

Formulation difference

It has been brought to our attention that the recently listed unapproved levomepromazine hydrochloride’s  (brand name Nozinan S29 and Neuraxpharm) have the European formulations which is slightly different to the New Zealand formulation for the registered brand (Nozinan).

The New Zealand and unapproved versions of Nozinan Injection contain the same active ingredient; however, the products differ in strength

 

NZ FORMULATION

GERMAN FORMULATION (unapproved) 2640457

FRENCH FORMULATION (unapproved) 2642840

 

Nozinan 25 mg/mL injection

Nozinan 25 mg/mL Solution for Injection in Ampoule (IM)

Nozinan 25 mg/mL Solution for Injection in Ampoule (IM)

Active ingredient

levomepromazine base 22.5 mg/mL

(as levomepromazine hydrochloride 25mg/mL)

levomepromazine base 25.00 mg/mL

(as levomepromazine hydrochloride 27.8 mg/mL)

levomepromazine base 25.00 mg/mL

(as levomepromazine hydrochloride 27.78 mg/mL)

Excipients

Ascorbic acid

Sodium sulphite

Sodium chloride

Water for injections

Ascorbic acid

sodium hydroxide

Sodium chloride

Water for injections

Ascorbic acid

Sodium sulphite

Sodium chloride

Water for injections

Pack size

10 x 1 mL ampoules

5 x 1 mL ampoules

5 x 1 mL ampoules

  • The French and German formulations contain approximately 11% more levomepromazine base than the New Zealand formulation
  • Doses may need to be adjusted when changing to the French or German product
  • Patients will need to be closely monitored to check if further dosage adjustment is necessary

Prescribing and supplying a medicine under section 29

Section 29 of the Medicines Act 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 – e.g., doctors. 

We know supplying a medicine under section 29 is not ideal. In this case, however, the alternative would be for patients to have no levomepromazine. 

We apologise for any inconvenience this causes. 

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

What patients need to know about section 29 medicines – Health Navigator website(external link)

Who to contact

If you have questions about funding other alternative products, email enquiry@pharmac.govt.nz

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