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).