Provisional Consent to the Distribution of a New Medicine
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:
| Product: | Oxytocin PANPHARMA |
| Active Ingredient: | Oxytocin 10IU/mL equivalent to 16.6mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a BNM Group |
| Manufacturer: | Panpharma GmbH, Trittau, Germany |
Note: This consent is given subject to the following condition:
The medicine may only be marketed or distributed when no other oxytocin solution for injection 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 12th day of July 2023.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).