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: Nozinan
Active Ingredient: Levomepromazine maleate 33.8mg equivalent to levomepromazine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Sanofi-Aventis New Zealand Limited
Manufacturer: Sanofi SpA, Scoppito, Italy

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

- Provisional consent is to be granted for 2 years to address an urgent shortage in the market.
- The medicine may only be marketed or distributed when no other levomepromazine tablet medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
- Provisional consent can only be renewed while assessment of an application to allow for resumed supply of the New Zealand product is in progress.

Note: This consent is valid for two years from the date of publication of this notice.
   
Product: Nozinan
Active Ingredient: Levomepromazine maleate 135mg equivalent to levomepromazine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Sanofi-Aventis New Zealand Limited
Manufacturer: Sanofi SpA, Scoppito, Italy

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

- Provisional consent is to be granted for 2 years to address an urgent shortage in the market.
- The medicine may only be marketed or distributed when no other levomepromazine tablet medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
- Provisional consent can only be renewed while assessment of an application to allow for resumed supply of the New Zealand product is in progress.

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


Dated this 14th day of February 2020.

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