Notice Type
Secondary Legislation
Notice Title

Provisional Consent to the Distribution of a New Medicine

Publication Date
16 Mar 2026

Tags

Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number

2026-sl1447
Title
View PDF
File Type and Size
PDF (21 KB)

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product:

Aspen Dexamfetamine

Active Ingredient:

Dexamfetamine sulfate 5mg

Dosage Form:

Tablet

New Zealand Sponsor:

Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics

Manufacturer:

Aspen Pharma Pty Limited, Melbourne, Australia

Note: This consent is given subject to the following condition:

  • The medicine may only be marketed or distributed when no other dexamfetamine medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet Pharmac supply obligations.

Note: This consent is valid for two years from the date of publication of this notice.


Dated this 13th day of March 2026.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).