Notice Title

Provisional Consent to the Distribution of a New Medicine

Publication Date
16 Apr 2026

Tags

Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number

2026-sl2057
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: Ciprofloxacin Kabi
Active Ingredient: Ciprofloxacin hydrogen sulfate 2.59mg/mL equivalent to ciprofloxacin 2mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturers: Fresenius Kabi Polska Sp. z o.o., Kutno, Poland
HP Halden Pharma AS, Halden, Norway

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

The medicine may only be marketed or distributed when no other ciprofloxacin solution for infusion 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 14th day of April 2026.

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