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: | Edurant |
| Active Ingredient: | Rilpivirine hydrochloride 27.5mg equivalent to rilpivirine 25mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Janssen-Cilag SpA, Latina, Italy |
| Product: | Ipca-Fluconazole |
| Active Ingredient: | Fluconazole 50mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Ipca Pharma (NZ) Pty Limited |
| Manufacturer: | Ipca Laboratories Limited, Silvassa, India |
| Product: | Ipca-Fluconazole |
| Active Ingredient: | Fluconazole 150mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Ipca Pharma (NZ) Pty Limited |
| Manufacturer: | Ipca Laboratories Limited, Silvassa, India |
| Product: | Ipca-Fluconazole |
| Active Ingredient: | Fluconazole 200mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Ipca Pharma (NZ) Pty Limited |
| Manufacturer: | Ipca Laboratories Limited, Silvassa, India |
| Product: | Lenvima |
| Active Ingredient: | Lenvatinib mesilate 4.9mg equivalent to lenvatinib 4mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Patheon Inc, Mississauga, Canada |
| Product: | Lenvima |
| Active Ingredient: | Lenvatinib mesilate 12.25mg equivalent to lenvatinib 10mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Patheon Inc, Mississauga, Canada |
| 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 |
| Product: | Tivicay |
| Active Ingredient: | Dolutegravir sodium 52.6mg equivalent to dolutegravir 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | Glaxo Operations UK Limited t/a Glaxo Wellcome Operations, Ware, United Kingdom Delpharm Poznan S.A., Poznan, Poland |
Dated this 29th day of August 2023
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).