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: Ruxience (100mg/10mL)
Active Ingredient: Rituximab 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Manufacturing Belgium NV, Puurs, Belgium
   
Product: Ruxience (500mg/50mL)
Active Ingredient: Rituximab 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Manufacturing Belgium NV, Puurs, Belgium
   
Product: Septanest 1:200,000 (1.7mL)
Active Ingredients: Adrenaline acid tartrate 0.0091mg/mL equivalent to adrenaline base 0.0050mg/mL
Articaine hydrochloride 40mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ivoclar Vivadent Limited
Manufacturer: Septodont SAS, Saint Maur des Fosses, France
   
Product: Septanest 1:200,000 (2.2mL)
Active Ingredients: Adrenaline acid tartrate 0.0091mg/mL equivalent to adrenaline base 0.0050mg/mL
Articaine hydrochloride 40mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Ivoclar Vivadent Limited
Manufacturer: Septodont SAS, Saint Maur des Fosses, France
   
Product: SonaTab
Active Ingredient: Naproxen 250mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: YSP Industries (M) Sdn. Bhd., Kajang, Malaysia


Dated this 17th day of August 2021.

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