Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of New Medicines

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 medicines set out in the Schedule hereto:

Schedule

Product: Hydroxocobalamin
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 conditions:

  • Provisional consent is to be granted for one year to address an urgent shortage in the market.
  • 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 sole tender obligations.
Note: This consent is valid for one year from the date of publication of this notice.
   
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 conditions:

  • Provisional consent is to be granted for one year to address an urgent shortage in the market.
  • 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 sole tender obligations.
Note: This consent is valid for one year from the date of publication of this notice.


Dated this 29th day of October 2020.

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