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Notice Type
Departmental
Notice Title

Renewal of Provisional Consent to the Distribution of Medicines

Publication Date
20 Feb 2024

Tags

Medicines Act Renewal of provisional consent to the distribution of medicines Health

Notice Number

2024-go653
Title
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File Type and Size
PDF (34 KB)

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 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: Clinect NZ Pty Limited
Manufacturer: Sanofi SRL, Scoppito, Italy

Note: This consent is given subject to 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 2024.
   
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, Italy

Note: This consent is given subject to 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 2024.


Dated this 19th day of February 2024.

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