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 Mouth Gel Anti-inflammatory + Antibacterial |
| Active Ingredients: | Benzydamine hydrochloride 10mg/g Cetylpyridinium chloride monohydrate 1mg/g |
| Dosage Form: | Oral gel |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturer: | Ensign Laboratories Pty Limited, Melbourne, Australia |
| Product: | Entresto 24/26 |
| Active Ingredients: | Sacubitril 24.3mg Valsartan 25.7mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Farma SpA, Torre Annunziata, Italy Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Singapore City, Singapore |
| Product: | Entresto 49/51 |
| Active Ingredients: | Sacubitril 48.6mg Valsartan 51.4mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Farma SpA, Torre Annunziata, Italy Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Singapore City, Singapore |
| Product: | Entresto 97/103 |
| Active Ingredients: | Sacubitril 97.2mg Valsartan 102.8mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Farma SpA, Torre Annunziata, Italy Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Singapore City, Singapore |
| Product: | Exelon Patch 5 |
| Active Ingredient: | Rivastigmine 9mg |
| Dosage Form: | Transdermal patch |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | LTS Lohmann Therapie-Systeme AG, Andernach, Germany |
| Product: | Exelon Patch 10 |
| Active Ingredient: | Rivastigmine 18mg |
| Dosage Form: | Transdermal patch |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | LTS Lohmann Therapie-Systeme AG, Andernach, Germany |
| Product: | Exelon Patch 15 |
| Active Ingredient: | Rivastigmine 27mg |
| Dosage Form: | Transdermal patch |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | LTS Lohmann Therapie-Systeme AG, Andernach, Germany |
| Product: | Exelon Patch 20 |
| Active Ingredient: | Rivastigmine 36mg |
| Dosage Form: | Transdermal patch |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | LTS Lohmann Therapie-Systeme AG, Andernach, Germany |
| Product: | Omnitrope |
| Active Ingredient: | Somatropin 3.33mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Sandoz GmbH, Langkampfen, Austria |
| Product: | Omnitrope |
| Active Ingredient: | Somatropin 6.67mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Sandoz GmbH, Langkampfen, Austria |
| Product: | Omnitrope |
| Active Ingredient: | Somatropin 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Sandoz GmbH, Langkampfen, Austria |
| Product: | Trelegy Ellipta 100/62.5/25 |
| Active Ingredients: | Fluticasone furoate 100mcg Umeclidinium bromide 74.2mcg equivalent to umeclidinium 62.5mcg Vilanterol trifenatate 40mcg equivalent to vilanterol 25mcg |
| Dosage Form: | Powder for inhalation |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | Glaxo Operations UK Limited t/a Glaxo Wellcome Operations, Ware, United Kingdom GlaxoSmithKline LLC, North Carolina, United States of America |
| Product: | Twinrix |
| Active Ingredients: | Hepatitis A vaccine 720EU/mL Hepatitis B surface antigen, recombinant 20mcg/mL |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA, Wavre, Belgium GlaxoSmithKline Biologicals (Dresden), Dresden, Germany |
| Product: | Twinrix Junior |
| Active Ingredients: | Hepatitis A vaccine 720EU/mL Hepatitis B surface antigen, recombinant 20mcg/mL |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA, Wavre, Belgium GlaxoSmithKline Biologicals (Dresden), Dresden, Germany |
Dated this 16th day of May 2022.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).