Notice Type
Notice Title

Provisional Consent to the Distribution of a New Medicine

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:


Product: Vita-B12 Injection
Active Ingredient: Hydroxocobalamin acetate 1.044mg/mL equivalent to hydroxocobalamin 1mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Delpharm Tours, Chambray Les Tours, France

This consent is given subject to the following condition:

The medicine may only be marketed or distributed when no other hydroxocobalamin solution for injection 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 17th day of April 2023.

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