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Notice Title

Renewal of Provisional Consent to the Distribution of Medicines

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines are set out in the Schedule hereto:

Schedule

Product: H5N1 Influenza Vaccine
Active Ingredient: Influenza Virus Type A haemagglutinin 30mcg
Dosage Form: Suspension for injection
New Zealand Sponsor: Seqirus (NZ) Limited
Manufacturer: Seqirus Pty Limited, Melbourne, Australia

Note: Provisional consent under section 23 of the Medicines Act 1981 is recommended with the following condition:

  • The vaccine may only be marketed or distributed in accordance with the directives contained in the current version of the New Zealand Influenza Pandemic Action Plan.
Note: This renewed consent is valid for two years from 9 February 2026.
   
Product: Nozinan
Active Ingredient: Levomepromazine maleate 33.8mg equivalent to levomepromazine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Clinect NZ Pty Limited
Manufacturer: Sanofi SRL, Scoppito (L’Aquila), Italy

Note: Provisional consent under section 23 of the Medicines Act 1981 is recommended with the following condition:

  • 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 PHARMAC supply obligations.
Note: This renewed consent is valid for two years from 20 February 2026.
   
Product: Nozinan
Active Ingredient: Levomepromazine maleate 135mg equivalent to levomepromazine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Clinect NZ Pty Limited
Manufacturer: Sanofi SRL, Scoppito (L’Aquila), Italy

Note: Provisional consent under section 23 of the Medicines Act 1981 is recommended with the following condition:

  • 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 PHARMAC supply obligations.
Note: This renewed consent is valid for two years from 20 February 2026.
   
Product: Panvax vaccine
Active Ingredient: Influenza Virus Type A haemagglutinin 30mcg
Dosage Form: Suspension for injection
New Zealand Sponsor: Seqirus (NZ) Limited
Manufacturer: Seqirus Pty Limited, Melbourne, Australia

Note: Provisional consent under section 23 of the Medicines Act 1981 is recommended with the following condition:

  • The vaccine may only be marketed or distributed in accordance with the directives contained in the current version of the New Zealand Influenza Pandemic Action Plan.
Note: This renewed consent is valid for two years from 6 March 2026.


Dated this 26th day of January 2026.

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