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: | Brintellix |
| Active Ingredient: | Vortioxetine hydrobromide 6.355mg equivalent to vortioxetine 5mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | H Lundbeck A/S, Valby, Denmark |
| Product: | Brintellix |
| Active Ingredient: | Vortioxetine hydrobromide 12.71mg equivalent to vortioxetine 10mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | H Lundbeck A/S, Valby, Denmark |
| Product: | Brintellix |
| Active Ingredient: | Vortioxetine hydrobromide 19.065mg equivalent to vortioxetine 15mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | H Lundbeck A/S, Valby, Denmark |
| Product: | Brintellix |
| Active Ingredient: | Vortioxetine hydrobromide 25.42mg equivalent to vortioxetine 20mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | H Lundbeck A/S, Valby, Denmark |
| Product: | Caelyx |
| Active Ingredient: | Doxorubicin hydrochloride 2mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturers: |
TTY Biopharm Co Limited, Taiwan, China GlaxoSmithKline Manufacturing SpA, Parma, Italy |
| Product: | Forxiga |
| Active Ingredient: | Dapagliflozin propanediol monohydrate 12.3mg equivalent to dapaglifozin 10mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturers: |
Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico AstraZeneca Pharmaceuticals LP, Indiana, United States of America |
| Product: | Ipol |
| Active Ingredients: | Polio virus type 1 40DAgU Polio virus type 2 8DAgU Polio virus type 3 32DAgU |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturers: |
Sanofi Pasteur SA, Marcy L’Etoile, France Sanofi Pasteur SA, Val-De-Reuil, France Sanofi Winthrop Industrie, Le Trait, France |
| Product: | Sirturo |
| Active Ingredient: | Bedaquiline fumarate 120.89mg equivalent to bedaquiline 100mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Recipharm Pharmaservices Private Limited, Nelamangala, India |
Dated this 26th 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).