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Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of a New Medicine

Publication Date
20 Nov 2025

Tags

Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number

2025-go6656
Title
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File Type and Size
PDF (21 KB)

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 medicine set out in the Schedule hereto:

Schedule

Product: Nitrofurantoin
Active Ingredient: Nitrofurantoin 50mg
Dosage Form: Tablet
New Zealand Sponsor: Clinect NZ Pty Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada

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

The medicine may only be marketed or distributed when no other nitrofurantoin immediate release oral 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 consent is valid for two years from the date of publication of this notice.


Dated this 18th day of November 2025.

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