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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 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).