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: | Alprolix |
| Active Ingredient: | Eftrenonacog alfa 250IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Alprolix |
| Active Ingredient: | Eftrenonacog alfa 500IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Alprolix |
| Active Ingredient: | Eftrenonacog alfa 1000IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Alprolix |
| Active Ingredient: | Eftrenonacog alfa 2000IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Alprolix |
| Active Ingredient: | Eftrenonacog alfa 3000IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Flixotide |
| Active Ingredient: | Fluticasone propionate 125mcg |
| Dosage Form: | Aerosol inhaler, metered dose |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | Glaxo Wellcome Production, Evreux, France Glaxo Wellcome SA, Burgos, Spain |
| Product: | Flixotide |
| Active Ingredient: | Fluticasone propionate 250mcg |
| Dosage Form: | Aerosol inhaler, metered dose |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | Glaxo Wellcome Production, Evreux, France Glaxo Wellcome SA, Burgos, Spain |
| Product: | Flixotide Junior |
| Active Ingredient: | Fluticasone propionate 50mcg |
| Dosage Form: | Aerosol inhaler, metered dose |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | Glaxo Wellcome Production, Evreux, France Glaxo Wellcome SA, Burgos, Spain |
| Product: | FluQuadri |
| Active Ingredients: | Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15mcg Influenza virus A/Switzerland/8060/2017 (H3N2) like strain 15mcg Influenza virus B/Colorado/06/2017 - like strain 15mcg Influenza virus B/Phuket/3073/2013 - like strain 15mcg |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturer: | Sanofi Pasteur Inc, Pennsylvania, United States of America |
| Product: | Janumet |
| Active Ingredients: | Metformin hydrochloride 500mg Sitagliptin phosphate monohydrate 64.25mg equivalent to sitagliptin 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturers: | Patheon Puerto Rico Inc., Manati, Puerto Rico Aesica Queenborough Limited, Queenborough, United Kingdom |
| Product: | Janumet |
| Active Ingredients: | Metformin hydrochloride 850mg Sitagliptin phosphate monohydrate 64.25mg equivalent to sitagliptin 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturers: | Patheon Puerto Rico Inc., Manati, Puerto Rico Aesica Queenborough Limited, Queenborough, United Kingdom |
| Product: | Janumet |
| Active Ingredients: | Metformin hydrochloride 1000mg Sitagliptin phosphate monohydrate 64.25mg equivalent to sitagliptin 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturers: | Patheon Puerto Rico Inc., Manati, Puerto Rico Aesica Queenborough Limited, Queenborough, United Kingdom |
Dated this 23rd day of July 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).