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 |
Note: 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).