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:
| Product: | Cosentyx |
| Active Ingredient: | Secukinumab 150mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Cosentyx (75mg/0.5mL) |
| Active Ingredient: | Secukinumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Cosentyx (150mg/1mL) |
| Active Ingredient: | Secukinumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Pharmaceutical Manufacturing GmbH, Langkampfen, Austria |
| Product: | Cosentyx (300mg/2mL) (Pre-filled syringe) |
| Active Ingredient: | Secukinumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Cosentyx (300mg/2mL) (Pre-filled pen) |
| Active Ingredient: | Secukinumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Prezista |
| Active Ingredient: | Darunavir ethanolate 81.31mg equivalent to darunavir 75mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturers: | Janssen-Cilag SpA, Latina, Italy Janssen Ortho LLC, Gurabo, Puerto Rico |
| Product: | Prezista |
| Active Ingredient: | Darunavir ethanolate 162.52mg equivalent to darunavir 150mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturers: | Janssen-Cilag SpA, Latina, Italy Janssen Ortho LLC, Gurabo, Puerto Rico |
| Product: | Prezista |
| Active Ingredient: | Darunavir ethanolate 325.23mg equivalent to darunavir 300mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Janssen Ortho LLC, Gurabo, Puerto Rico |
| Product: | Prezista |
| Active Ingredient: | Darunavir ethanolate 433.64mg equivalent to darunavir 400mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturers: | Janssen-Cilag SpA, Latina, Italy Janssen Ortho LLC, Gurabo, Puerto Rico |
| Product: | Prezista |
| Active Ingredient: | Darunavir ethanolate 650.46mg equivalent to darunavir 600mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Janssen Ortho LLC, Gurabo, Puerto Rico |
| Product: | Prezista |
| Active Ingredient: | Darunavir ethanolate 867.28mg equivalent to darunavir 800mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturers: | Janssen-Cilag SpA, Latina, Italy Janssen Ortho LLC, Gurabo, Puerto Rico |
Dated this 18th day of October 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).