Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product: Alfentanil (1mg/2mL) (Medicianz)
Active Ingredient: Alfentanil hydrochloride 0.544mg/mL equivalent to alfentanil 0.5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Medicianz Healthcare Limited
Manufacturer: HBM Pharma s.r.o., Martin, Slovakia
   
Product: Alfentanil (1mg/2mL) (Medsurge)
Active Ingredient: Alfentanil hydrochloride 0.544mg/mL equivalent to alfentanil 0.5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Medicianz Healthcare Limited
Manufacturer: HBM Pharma s.r.o., Martin, Slovakia
   
Product: Alfentanil (5mg/10mL) (Medicianz)
Active Ingredient: Alfentanil hydrochloride 0.544mg/mL equivalent to alfentanil 0.5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Medicianz Healthcare Limited
Manufacturer: HBM Pharma s.r.o., Martin, Slovakia
   
Product: Alfentanil (5mg/10mL) (Medsurge)
Active Ingredient: Alfentanil hydrochloride 0.544mg/mL equivalent to alfentanil 0.5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Medicianz Healthcare Limited
Manufacturer: HBM Pharma s.r.o., Martin, Slovakia
   
Product: Heparin Sodium Panpharma
Active Ingredient: Heparin sodium 5000IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Panpharma GmbH, Trittau, Germany
   
Product: Nyxoid (General sale)
Active Ingredient: Naloxone hydrochloride dihydrate 2.2mg equivalent to naloxone 1.8mg per 100mcL
Dosage Form: Nasal spray solution
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturer: Summit Biosciences LLC, Kentucky, United States of America


Dated this 14th day of August 2020.

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