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 set out in the Schedule hereto:

Schedule

Product: Mirtazapine
Active Ingredient: Mirtazapine 30mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Noumed Pharmaceuticals Limited
Manufacturer: Fourrts India Laboratories Pvt Limited, Chennai, India

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

The medicine may only be sold or supplied when no other mirtazapine 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 renewed consent is valid for two years from the date of publication of this notice.
   
Product: Mirtazapine
Active Ingredient: Mirtazapine 45mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Noumed Pharmaceuticals Limited
Manufacturer: Fourrts India Laboratories Pvt Limited, Chennai, India

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

The medicine may only be sold or supplied when no other mirtazapine 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 renewed consent is valid for two years from the date of publication of this notice.


Dated this 9th day of August 2023.

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