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 renewed consent is valid for two years from 20 February 2022.

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 renewed consent is valid for two years from 20 February 2022.