Gazette.govt.nzPursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
| Product: | Difflam Anti-inflammatory + Antibacterial (Sugar Free Honey and Lemon Flavour) |
| Active Ingredients: | Benzydamine hydrochloride 3mg Cetylpyridinium chloride monohydrate 1.33mg |
| Dosage Form: | Lozenge |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturer: | Unique Pharmaceuticals Laboratories, Nani Daman, India |
| Product: | Difflam Anti-inflammatory + Antibacterial (Sugar Free Orange Flavour) |
| Active Ingredients: | Benzydamine hydrochloride 3mg Cetylpyridinium chloride monohydrate 1.33mg |
| Dosage Form: | Lozenge |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturer: | Unique Pharmaceuticals Laboratories, Nani Daman, India |
| Product: | Enablex |
| Active Ingredient: | Darifenacin hydrobromide 8.929mg equivalent to darifenacin 7.5mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Aspen Bad Oldesloe GmbH, Bad Oldesloe, Germany |
| Product: | Enablex |
| Active Ingredient: | Darifenacin hydrobromide 17.85mg equivalent to darifenacin 15mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Aspen Bad Oldesloe GmbH, Bad Oldesloe, Germany |
| Product: | Flumazenil |
| Active Ingredient: | Flumazenil 0.1mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Max Health Limited |
| Manufacturer: | Siegfried Hameln GmbH, Hameln, Germany |
| Product: | Foscavir |
| Active Ingredient: | Foscarnet sodium hexahydrate 24mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Link Pharmaceuticals Limited |
| Manufacturer: | Fresenius Kabi Austria GmbH, Graz, Austria |
| Product: | Rozlytrek |
| Active Ingredient: | Entrectinib 100mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | Mayne Pharma Inc, North Carolina, United States of America |
| Product: | Rozlytrek |
| Active Ingredient: | Entrectinib 200mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | Mayne Pharma Inc, North Carolina, United States of America |
| Product: | Synflorix |
| Active Ingredients: | Pneumococcal polysaccharide type 1 1mcg Pneumococcal polysaccharide type 14 1mcg Pneumococcal polysaccharide type 18C 3mcg Pneumococcal polysaccharide type 19F 3mcg Pneumococcal polysaccharide type 23F 1mcg Pneumococcal polysaccharide type 4 3mcg Pneumococcal polysaccharide type 5 1mcg Pneumococcal polysaccharide type 6B 1mcg Pneumococcal polysaccharide type 7F 1mcg Pneumococcal polysaccharide type 9V 1mcg |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | GlaxoSmithKline (NZ) Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA, Rixensart, Belgium GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France |
Dated this 19th day of February 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).